HJU120000 PAGE 1

1 ALDERSON COURT REPORTING

2 CHRISTINE ALLEN

3 HJU120000

4 MARKUP OF H.R. 965, THE CREATES ACT;

5 H.R. 2375, THE PRESERVE ACCESS TO AFFORDABLE GENERICS AND

6 BIOSIMILARS ACT;

7 H.R. 2374, THE STOP SIGNIFICANT AND TIME-WASTING ABUSE

8 LIMITING LEGITIMATE INNOVATION OF NEW GENERICS ACT; AND

9 H.R. 2376, THE PRESCRIPTION PRICING FOR PEOPLE ACT OF 2019.

10 Tuesday, April 30, 2019

11 House of Representatives

12 Committee on the Judiciary

13 Washington, D.C.

14 The committee met, pursuant to call, at 2:22 p.m., in

15 Room 2141, Rayburn Office Building, Hon. Jerrold Nadler

16 [chairman of the committee] presiding.

17 Present: Representatives Nadler, Lofgren, Jackson Lee,

18 Cohen, Jeffries, Cicilline, Lieu, Raskin, Demings, Correa,

19 Scanlon, Garcia, Neguse, Stanton, Dean, Murcarsel-Powell,

20 Collins, Sensenbrenner, Chabot, Gohmert, Jordan, Buck, Roby, HJU120000 PAGE 2

21 Johnson of Louisiana, Biggs, McClintock, Reschenthaler,

22 Cline, Armstrong, and Steube.

23 Staff present: David Greengrass, Senior Counsel; Senior

24 Advisor; Lisette Morton, Director of Policy, Planning, and

25 Member Services; Madeline Strasser, Chief Clerk; Moh Sharma,

26 Member Services and Outreach Advisor; Susan Jensen,

27 Parliamentarian/Senior Counsel; Amanda Lewis, ACAL Counsel;

28 Joseph Van Wye, Professional Staff Member, ACAL; Lina Khan,

29 Counsel, ACAL Subcommittee; Slade Bond, Chief Counsel, ACAL;

30 Brendan Belair, Minority Chief of Staff; Robert Parmiter,

31 Minority Deputy Chief of Staff; Jon Ferro, Minority

32 Parliamentarian; Tom Stoll, Minority Chief Counsel,

33 Intellectual Property Subcommittee; Daniel Flores, Minority

34 Chief Counsel, Antitrust Subcommittee; Erica Barker, Minority

35 Chief Clerk; and Andrea Woodard, Minority Professional Staff

36 Member.

37 HJU120000 PAGE 3

38 Chairman Nadler. The Judiciary Committee will please

39 come to order, a quorum being present. Without objection,

40 the chair is authorized to declare a recess at any time.

41 Pursuant to Committee Rule II and House Rule XI, Clause

42 2, the chair may postpone further proceedings today on the

43 question of approving any measure or matter or adopting any

44 amendment for which a recorded vote for the yeas and nays are

45 ordered.

46 Pursuant to notice, I now call up H.R. 2375, the

47 Preserve Access to Affordable Generics and Biosimilars Act,

48 for purposes of markup and move that the committee report the

49 bill favorably to the House.

50 The clerk will report the bill.

51 Ms. Strasser. H.R. 2375, to prohibit prescription drug

52 companies from compensating other prescription drug companies

53 to delay the entry of a generic drug, biosimilar, biological

54 product, or interchangeable biological product into the

55 market.

56 Chairman Nadler. Without objection, the bill is

57 considered as read and open for amendment at any point.

58 [The bill follows:]

59 HJU120000 PAGE 4

60 Chairman Nadler. I will begin by recognizing myself for

61 an opening statement.

62 H.R. 2375, the Preserve Access to Affordable Generics

63 and Biosimilars Act, is one of a series of bipartisan

64 measures that we are considering today to address the

65 critical need to lower the soaring costs of prescription

66 drugs, which is jeopardizing the health and wellbeing of

67 millions of Americans. Too many Americans simply cannot

68 afford lifesaving medicines. Others find their budgets

69 strained to the limit because of the high cost of

70 prescription drugs. Some patients delay essential care, cut

71 their pills in half, or skip drug treatment all together, all

72 because of unaffordable drug prices, and their health suffers

73 as a result.

74 Several of the bills we are considering today address in

75 different ways one of the leading drivers of high

76 prescription drug costs, efforts by branded drug companies to

77 preserve their monopolies by preventing or delaying

78 competition from lower-priced generic and biosimilar drugs.

79 The Preserve Access to Affordable Generics and Biosimilars

80 Act prohibits one of these outrageous delay tactics, so-

81 called pay-for-delay settlement agreements. These agreements

82 occur when a generic drug maker seeks to enter the market and

83 compete with a brand-name drug product. If the drug patent

84 has not yet expired, patent litigation ensues, and the HJU120000 PAGE 5

85 branded drug firm may seek a settlement agreement as a

86 vehicle to pay the potential generic competitor to delay

87 entering the market with a lower-cost generic product. These

88 agreements result in a financial windfall for both drug

89 companies. The brand-name drug company gets to keep its

90 monopoly, and the generic gets paid off with a portion of the

91 monopoly profits, but consumers inevitably lose.

92 According to a Federal Trade Commission study, pay-for-

93 delay agreements are estimated to cost American consumers $3-

94 and-a-half billion per year, $35 billion over the decade from

95 2010 to 2020. And despite a clear holding by the Supreme

96 Court in the Actavis case nearly 6 years ago that such

97 agreements may be significantly anticompetitive and illegal

98 under the antitrust laws -- I almost feel like saying "you

99 think" -- they still persist today.

100 In 2015 alone, there were 14 settlements between branded

101 and generic drug companies that contained potential pay-for-

102 delay provisions, covering 11 branded drugs totaling $4.6

103 billion in sales. And the FTC continues to investigate and

104 challenge potential pay-for-delay agreements that keep

105 affordable generic drugs off the market. That is why these

106 anticompetitive practices must be prohibited all together.

107 The significance of generic competition on drug prices

108 cannot be overstated. According to the FTC, the first

109 generic competitor's product is typically offered at a 20 to HJU120000 PAGE 6

110 30 percent discount from the branded product's price.

111 Subsequent generic entry creates massive price discounts with

112 additional competition reducing the cost of prescription

113 drugs by as much as 85 percent or more off the branded price.

114 To help ensure that these generic alternatives can enter

115 the market, this bill would establish that certain pay-for-

116 delay agreements are presumptively anticompetitive, and would

117 authorize the FTC to initiate an enforcement proceeding

118 against parties to such an agreement involving the sale of a

119 drug or biological product. Importantly, the Preserve Access

120 to Generics and Biosimilars Act also includes safe harbors

121 that preserve the incentives of generic and biosimilar

122 competitors to challenge weak patents and enter the market as

123 early as possible.

124 This legislation builds on the committee's strong

125 tradition of bipartisan work to lower the cost of

126 prescription drugs through the full benefits of competition.

127 This committee has been and will continue to be active in

128 stopping drug companies from reaping monopoly profits at the

129 expense of the health of American consumers.

130 I am proud of this work to provide meaningful relief to

131 Americans who struggle every day with the high cost of

132 prescription medicine along with other outrageous healthcare

133 costs. I thank Ranking Member Collins for his leadership on

134 this issue, and I urge my colleagues to support this HJU120000 PAGE 7

135 legislation. And speaking of Ranking Member Collins, I now

136 recognize the ranking member of the Judiciary Committee, the

137 gentleman from Georgia, Mr. Collins, for his opening

138 statement.

139 Mr. Collins. Thank you, Mr. Chairman, and I will be

140 brief on this. But thank you for your leadership and

141 introducing the Preserve Access to Affordable Generics and

142 Biosimilars Act, and I am proud to be the lead co-sponsor on

143 the Republican side for this important bill.

144 Years ago when the Congress passed the Hatch-Waxman Act,

145 the hope was that it would dramatically help speed the

146 introduction of low-cost generic alternatives to high-cost

147 brand-name prescription drugs. At the same time, it was also

148 hoped that the legislation had struck the right balance to

149 preserve healthy incentives for the innovation of new drugs

150 branded by manufacturers. To a degree these hopes have been

151 realized, but unfortunately too often those hopes have been

152 stymied by the use of pay-for-delay settlements.

153 In these often anticompetitive settlements, the generic

154 manufacturer has filed for FDA approval to produce a generic

155 alternative. The branded manufacturer raises patent

156 litigation in response, and the pay-for-delay settlement buys

157 the peace. The generic manufacturer agrees to delay for a

158 certain time, and the branded manufacturer agrees to pay the

159 generic manufacturer for that delay. HJU120000 PAGE 8

160 There is just one catch. While the situation looks rosy

161 for the two manufacturers, consumers who would benefit from

162 the lower cost of a new generic drug get stuck still paying

163 the high cost of the branded drug. That is true even if the

164 threatened patent litigation is not justified. However long

165 the delay endures, higher costs prevail. That is not right,

166 and it is part of the reason that American consumers still

167 pay too much for prescription drugs.

168 The Preserve Access to Affordable Generics and

169 Biosimilars Act would solve this problem and accelerate the

170 lowering of prescription drug prices in America. It doesn't

171 prevent litigants from entering into bona fide pro-

172 competitive settlements that would help consumers, but it

173 does prevent the anticompetitive settlements that just line

174 drug company's pockets while consumers pay the bill, and I

175 would urge my colleagues to support this bill. Mr. Chairman,

176 I yield back.

177 Chairman Nadler. Thank you, Mr. Collins. I now

178 recognize the chair of the Subcommittee on Antitrust,

179 Commercial, and Administrative Law, the gentleman from Rhode

180 Island, Mr. Cicilline, for his opening statement.

181 Mr. Cicilline. Thank you, Mr. Chairman, and thank you

182 for holding today's important markup of bold legislation to

183 address the skyrocketing costs of prescription drugs.

184 The average American spends roughly $1,200 on HJU120000 PAGE 9

185 prescription drugs every year, more than people in any other

186 country. And over the past decade, prescription drug costs

187 have grown by 200 percent, resulting in higher insurance

188 premiums, larger hospital bills, and billions of taxpayer

189 dollars ending up in the pockets of giant prescription drug

190 companies, drug companies that are able to extract monopoly

191 profits for off-patent drugs at the expense of American

192 patients. That is hard-earned taxpayer dollars that could go

193 to fixing our Nation's crumbling infrastructure, making

194 higher education more affordable, and improving access to

195 healthcare.

196 H.R. 2375, the Preserve Access to Affordable Generics

197 and Biosimilars Act, would prohibit anticompetitive

198 settlements, also called pay-for-delay agreements, that block

199 access to affordable prescription drugs. These settlements

200 literally involve a high-cost branded drug company paying off

201 a generic competitor to stay out of the market. In response

202 to this problem, the Preserve Access to Affordable Generics

203 and Biosimilars Act would establish that these agreements are

204 presumptively illegal under the antitrust laws, and authorize

205 the Federal Trade Commission to impose significant penalties

206 on companies that engage in these pay-for-delay schemes.

207 Mr. Michael Kades of the Washington Center for Equitable

208 Growth, an antitrust attorney with over 2 decades of

209 experience in pay-for-delay litigation at the FTC, testified HJU120000 PAGE 10

210 before the Antitrust Subcommittee in March that this practice

211 is still a problem today. As he noted, and I quote, "Despite

212 the U.S. Supreme Court's clear signal in the Actavis case

213 that pay-for-delay can be anticompetitive, the FTC continues

214 to spend substantial resources and time challenging clear

215 violations. Tougher laws, such as the Preserve Access to

216 Affordable Generics Act, would deter such conduct and free up

217 limited resources to attack other anticompetitive conduct."

218 According to the Congressional Budget Office, ending

219 pay-for-delay agreements will save the government hundreds of

220 millions of dollars in Medicare savings. Moreover, by

221 lowering the FTC's burden to prove the obvious point of

222 paying a competitor not to compete as anticompetitive, this

223 legislation would free up FTC resources, resources that can

224 be put to work for American patients in other healthcare

225 markets.

226 I thank the chairman for his introduction of this great

227 piece of legislation. I strongly support it and urge my

228 colleagues to do the same. And with that, I yield back.

229 Chairman Nadler. Thank you. I now recognize the

230 ranking member of the Antitrust Subcommittee, the gentleman

231 from Wisconsin, Mr. Sensenbrenner, for his opening statement.

232 Mr. Sensenbrenner. Well, I thank the gentleman, and I

233 want to commend both the chairman and the ranking member, Mr.

234 Collins, for introducing this legislation. They have fully HJU120000 PAGE 11

235 described why it is necessary. I support it, and yield back

236 the balance of my time.

237 Chairman Nadler. Wow.

238 [Laughter.]

239 Chairman Nadler. Thank you, Mr. Sensenbrenner. Without

240 objection, all other opening statements will be included in

241 the record. Are there any amendments to H.R. 2375? The

242 gentleman from Pennsylvania, Mr. Reschenthaler.

243 Mr. Reschenthaler. Mr. Chairman, I move to strike the

244 last word.

245 Chairman Nadler. The gentleman is recognized.

246 Mr. Reschenthaler. Thank you, Mr. Chairman. I applaud

247 the bipartisan work the committee is undertaking today to the

248 lower the cost of prescription drugs. Like the chairman and

249 the ranking member, I believe that pay-for-delay agreements

250 should be strictly prohibited, and I thank them for

251 addressing this important issue. I do, however, have some

252 concerns with this bill, and while I am not offering an

253 amendment as I had originally planned to do today, I hope

254 that we can work together on the issue moving forward.

255 My concern is with the provision in the underlying bill

256 that treats certain patent settlements as presumptively

257 anticompetitive. The burden is on the generic or the

258 biosimilar developer to prove their agreement is above board

259 and complies with the law. We know that in many instances, HJU120000 PAGE 12

260 patent settlements actually speed up market entry of generics

261 and biosimilars. They protect generic manufacturers from

262 unpredictable and costly litigation. In fact, studies have

263 shown that the ability to settle patent litigation is a key

264 factor in determining investment decisions about bringing

265 medicines to market.

266 Additionally, since the Supreme Court's 2013 decision in

267 FTC v. Actavis, the total number of patent settlements has

268 increased while the number of potential anticompetitive

269 settlement agreements has, in fact, decreased. For example,

270 in Fiscal Year 2016, the FTC flagged just one settlement as

271 anticompetitive. This shows the success of the Actavis

272 decision in the FTC's effort to combat anticompetitive deals.

273 Again, I support the chairman and the ranking member's

274 efforts on this bill, and I wholeheartedly agree that we must

275 prevent pay-for-delay settlements. I do, however, feel that

276 if the government alleges anticompetitive conduct, they have

277 to be the ones to prove it. The government should carry that

278 burden. And I remain concerned that while well intentioned,

279 the bill as it is currently drafted may make it harder to

280 bring generics and biosimilars to market.

281 So, again, I thank the chairman and the ranking member

282 for introducing this legislation, which I do plan to support.

283 I just ask that we continue this important conversation as we

284 prepare this bill for floor consideration. I now would yield HJU120000 PAGE 13

285 the remainder of my time to Ranking Member Collins.

286 Mr. Collins. Thank you, and I thank my friend from

287 Pennsylvania for his comments. And they are well founded,

288 and I think they raise a legitimate point. The bill is

289 strongly-needed medicine to prevent anticompetitive pay-for-

290 delay settlements, and I support it. But at the same time, I

291 acknowledge that the standard of proof drug manufacturers

292 must meet under the bill to show that their settlements are

293 pro-competitive, not anticompetitive, is high.

294 I share the gentleman's concern that this aspect of the

295 bill may need some more work so that we strike the right

296 balance. I would be happy to work with the gentleman on this

297 issue as the legislative process continues, and it is my hope

298 that we will be able to reach a complete consensus on where

299 to draw the line on the burden of that proof. With that, I

300 yield back.

301 Chairman Nadler. Thank you. I recognize myself. I

302 thank the gentleman from Pennsylvania, and I understand your

303 concerns. And I agree that patent settlements can be helpful

304 to ensuring timely market entry of affordable generic and

305 biosimilar medicines. That is why we worked extensively with

306 stakeholders and the Federal Trade Commission to address

307 these concerns through the inclusion of safe harbors in H.R.

308 2375 that are tailored for certain pro-competitive settlement

309 provisions, such as an acceleration clause to allow for early HJU120000 PAGE 14

310 entry by generic drug companies.

311 These safe harbors are tailored to encourage, rather

312 than discourage, settlement provisions that facilitate early

313 generic entry and the associated cost savings for taxpayers

314 from generic competition. Additionally, H.R. 2375 is

315 narrowly drafted only to target anticompetitive settlements

316 where branded drug companies literally paying or transferring

317 value to a low-cost generic drug company to stay off the

318 market. And even in those instances, the companies can

319 overcome the bill's presumption that this behavior is illegal

320 by showing that the pre-competitive effects of the settlement

321 clearly and convincingly outweigh its anticompetitive

322 effects.

323 Nonetheless, I look forward to continuing our bipartisan

324 work to improve the bill, and I will commit to working with

325 the gentleman and with the ranking member to try and address

326 the concerns expressed by the gentleman before the bill gets

327 to the House floor. Are there any other -- the gentleman

328 , Mr. Correa.

329 Mr. Correa. Thank you, Mr. Chairman. I move to strike

330 the last word.

331 Chairman Nadler. The gentleman is recognized.

332 Mr. Correa. Chairman Nadler and Ranking Member Collins,

333 thank you very much for holding this most important markup.

334 I fully support this legislation. Medical device and HJU120000 PAGE 15

335 pharmaceutical companies are very important to my district in

336 Orange County. Many of my constituents have found good-

337 paying, rewarding jobs that have opened the pathway for the

338 middle class for them and their families.

339 These companies have created miracle drugs that have

340 revolutionized cancer treatment and have invented lifesaving

341 medical devices, such as heart valves. The work done in

342 California is the envy of the world. This research has

343 extended lives and created better lives for many people. Yet

344 all of this research is worth nothing if it is only the

345 wealthy that have access and only the wealthy that can afford

346 it. We must ensure that everyone has access and can afford

347 these miracle cures. We as policymakers must achieve that

348 balance, namely meaningful access to miracle cures, while

349 assuring investment in tomorrow's cures. I yield the

350 remainder of my time.

351 Chairman Nadler. I thank the gentleman. Does anyone

352 else seek recognition?

353 [No response.]

354 Chairman Nadler. If not, a reporting quorum being

355 present, the question is on the motion to report the bill,

356 H.R. 2375, favorably to the House.

357 Those in favor, say aye.

358 Opposed?

359 The ayes have it, and the bill is ordered reported HJU120000 PAGE 16

360 favorably to the House.

361 Members will have 2 days to submit views.

362 Pursuant to notice, I now call up H.R. 965, the CREATES

363 Act, for purposes of markup and move that the committee

364 report the bill favorably to the House.

365 The clerk will report the bill.

366 Ms. Strasser. H.R. 965, to promote competition in the

367 market for drugs and biological products by facilitating the

368 timely entry of lower-cost generic and biosimilar versions of

369 those drugs and biological products.

370 Chairman Nadler. Without objection, the bill is

371 considered as read and open for amendment at any point.

372 [The bill follows:]

373 HJU120000 PAGE 17

374 Chairman Nadler. I will begin by recognizing myself for

375 an opening statement.

376 H.R. 965, the Creating and Restoring Equal Access to

377 Equivalent Samples Act of 2019, or the CREATES Act, is

378 bipartisan legislation that would substantially lower drug

379 prices by making it easier for generic pharmaceutical

380 companies to obtain drug samples from branded companies,

381 samples which they require in order to perform testing

382 necessary to enter the market.

383 One of the anticompetitive tactics that many branded

384 drug companies employ to keep lower-cost generics off the

385 shelf is to refuse to provide samples of their drugs to

386 generic and biosimilar competitors. The branded companies

387 argue that FDA-imposed safety measures prevent them from

388 giving samples to generic companies, claiming that the

389 generics cannot follow the required safety protocols. But in

390 many cases this appears to be nothing more than gamesmanship

391 designed to prolong the branded companies' monopoly power.

392 The plainly-anticompetitive behavior perpetuates the

393 branded company's monopoly over the drug, enabling it to

394 charge excessive prices. These higher prices cost patients

395 and taxpayers billions of dollars in unnecessary spending,

396 and, perhaps most importantly, they lead some patients who

397 cannot afford such high prices to forego the use of

398 prescription drugs all together, placing their health in HJU120000 PAGE 18

399 greater jeopardy.

400 The CREATES Act ends this abusive delay tactic by

401 providing generic and biosimilar competitors with tailored

402 relief to obtain samples necessary to enter the market.

403 Furthermore, in cases where the brand-name drug company has

404 no legitimate business justification for withholding samples

405 from a generic competitor, the bill also includes a civil

406 penalty.

407 The Subcommittee on Antitrust, Commercial, and

408 Administrative Law held a hearing in March on competition in

409 the healthcare marketplace. During this hearing, several

410 bipartisan witnesses testified in strong support for the

411 CREATES Act, noting that it would significantly reduce drug

412 prices and create competition where there is none today. For

413 example, minority witness, Dr. Craig Garthwaite of

414 Northwestern University, testified that the CREATES Act is

415 "an attractive piece of legislation that should be passed at

416 the earliest opportunity." Michael Kades, a leading

417 antitrust practitioner with the Washington Center for

418 Equitable Growth, similarly testified that the CREATES Act

419 "would stop both sample blockades and safety protocol

420 filibusters, which delay competition with no countervailing

421 benefit."

422 This legislation would preserve important safety

423 measures while ensuring that lower-price generic competition HJU120000 PAGE 19

424 that benefits consumers is not unreasonably delayed from

425 entering the market. Accordingly, I thank the gentleman from

426 , Subcommittee Chairman Cicilline, and the

427 gentleman from Wisconsin, Subcommittee Ranking Member

428 Sensenbrenner, for their leadership on this critical issue,

429 and I urge my colleagues to support this important bipartisan

430 legislation.

431 I now recognize the ranking member of the Judiciary

432 Committee, the gentleman from Georgia, Mr. Collins, for his

433 opening Statement.

434 Mr. Collins. Thank you, Mr. Chairman. I would like to

435 thank Subcommittee Chairman Cicilline and the ranking member

436 of the subcommittee, Mr. Sensenbrenner, for introducing this

437 important bill.

438 Competition from generic and biosimilar prescription

439 drugs is one of the key ways to obtain lower prescription

440 drug prices, but if before generic or biosimilar can enter

441 the market its manufacturer has to gain FDA approval to do

442 that, the manufacturer has to obtain samples from the branded

443 drug with which it intends to compete so it can perform tests

444 to show FDA that its product also should be allowed to gain

445 entry into the market. And therein lies the rub. If the

446 branded manufacturer denies the provision of samples, it can

447 delay the competitors' approval and prop up its own high drug

448 cost. HJU120000 PAGE 20

449 This should not be happening. Our laws are written to

450 allow generic and biosimilars to compete and lower drug

451 prices for the benefit of consumers. True, they also are

452 written to protect the legitimate rights of innovative

453 branded manufacturers, but that does not include rights to

454 game the system to keep the competition wrongfully out or

455 consumer drug prices artificially high.

456 The CREATES Act will prevent this kind of gaming and

457 make sure that the generic and the biosimilar manufacturers

458 can gain samples to complete testing and win FDA approval.

459 It does so in a very simple and straightforward way. It

460 allows generic and biosimilars manufacturers to bring

461 antitrust suits against branded manufacturers who wrongfully

462 hold up their samples.

463 In these suits, courts can order branded manufacturers

464 to provide the samples. If justified, the Court can also

465 award the generic and biosimilar manufacturers damages based

466 on the revenues that branded manufacturers reap while

467 wrongfully withholding samples. These are the consequences

468 that should make clear to the branded manufacturers from the

469 get-go that there is no benefit to be had from trying to game

470 the system or denying samples. As a result, this legislation

471 should bring this anticompetitive behavior to a grinding

472 halt.

473 The CBO has estimated that the CREATES Act will save the HJU120000 PAGE 21

474 Federal government $3.9 billion in prescription spending. It

475 should lower prescription drug costs even more when non-

476 government spending is taken into account. This is strong

477 relief for Americans suffering from the burden of

478 excessively-high prescription drug costs. I'm a co-sponsor

479 of this legislation and would urge all of my colleagues to

480 support the bill, and I will yield back the remainder of my

481 time.

482 Chairman Nadler. I thank the gentleman. I now

483 recognize the chair of the Subcommittee on Antitrust,

484 Commercial, and Administrative Law and the chief sponsor of

485 this bill, the gentleman from Rhode Island, Mr. Cicilline,

486 for his opening statement.

487 Mr. Cicilline. Thank you, Mr. Chairman. Across the

488 country, the outrageous cost of prescription drugs are

489 destroying lives. According to Kaiser Health, a quarter of

490 Americans cannot afford their medicine while many cancer

491 patients are delaying care, cutting their pills in half, or

492 skipping drug treatment entirely as an example.

493 It is a dark reality that for far too many Americans,

494 the life of a loved depends on whether they can raise enough

495 money on a crowd-funding platform to pay for treatment before

496 time runs out. Faced with no other option, Americans are

497 left to beg strangers for help to keep their loved ones

498 alive. Prices are skyrocketing, and people are dying or HJU120000 PAGE 22

499 going bankrupt because they can't afford their prescription

500 medicines. And despite decades of rising costs, the United

501 States ranks dead last in health outcomes among similarly-

502 developed countries.

503 Ending this crisis is a top priority of mine as chairman

504 of the Antitrust Subcommittee and a top priority for House

505 Democrats to keep our promise to work for the people by

506 taking on drug profiteering and other barriers to affordable

507 healthcare. H.R. 965, the CREATES Act, would lower the costs

508 of prescription drugs by billions of dollars by putting a

509 stop to abusive delay tactics that prevent generic

510 competitors from offering lower-cost alternatives to costly

511 brand-name drugs.

512 The Federal Trade Commission reports that generic drugs

513 can reduce the price of branded drugs by more than 85

514 percent. Even the presence of just one generic competitor

515 can decrease prescription drug prices by 20 to 30 percent.

516 But over the past decade, some branded drug companies have

517 abused safety protocols of the Food and Drug Administration

518 in order to keep prices high and affordable drugs out of

519 reach for hardworking Americans.

520 Congress never intended these safety programs, called

521 risk evaluation mitigation strategies, to allow a branded

522 drug company to block or delay generic competitors from

523 getting FDA approval to enter the market. And yet some drug HJU120000 PAGE 23

524 companies have exploited the FDA safety protocols to delay

525 generic competition, if only by days and months, to prolong

526 their ability to charge monopoly prices. For some Americans,

527 days or months could mean life or death. To these companies,

528 months of delay could be worth hundreds of millions of

529 dollars in additional monopoly revenues as the generic sits

530 on the sidelines as patent law expert, Professor Robin

531 Feldman, has noted.

532 Although this abusive behavior often violates antitrust

533 law, as the FTC testified last Congress, fighting this

534 conduct in court often takes too long to provide effective

535 relief for the American people. The CREATES Act is a

536 powerful solution to this abusive conduct by pharmaceutical

537 companies. The bill will stop these delays by creating a

538 tailored path for generic drug manufacturers to obtain the

539 samples they need to bring low-cost drugs to market. By

540 lowering the cost of prescription drugs, the CREATES Act

541 would save American taxpayers $3.8 billion over 10 years

542 through savings through Medicare and Medicaid, according to

543 the nonpartisan Congressional Budget Office. Furthermore,

544 private estimates found that the bill would save American

545 consumers an additional $5.4 billion.

546 This bipartisan, bicameral legislation is supported by a

547 broad group of U.S. senators, including Senators Patrick

548 Leahy, Chuck Grassley, Amy Klobuchar, and Mike Lee. It is HJU120000 PAGE 24

549 also backed by a diverse coalition of healthcare providers,

550 patient groups, and public interest organizations across the

551 political spectrum, including AARP, Freedom Works, and Public

552 Citizen, among more than 90 others.

553 I want to particularly thank Ranking Member

554 Sensenbrenner for his support and co-sponsorship and

555 leadership on this legislation, and thank the members of the

556 committee and ask that you support this legislation as well.

557 And with that, I yield back.

558 Chairman Nadler. Thank you, Mr. Cicilline. I now

559 recognize the ranking member of the Antitrust Subcommittee,

560 the gentleman from Wisconsin, Mr. Sensenbrenner, for his

561 opening statement.

562 Mr. Sensenbrenner. Thank you, Mr. Chairman. Let me

563 begin by saying that the desire to lower prescription drug

564 prices is not the exclusive prerogative of one of our great

565 political parties. It is a Republican priority, and that is,

566 I think, one of the reasons by being bipartisan we are going

567 to have a much better chance of seeing this go all the way

568 into law. And I certainly am thankful to both the chairman

569 and the ranking member of the full committee and Chairman

570 Cicilline for their efforts in this matter. I think we are

571 all on board with this, and I think that this is an example

572 where we can go back and tell our constituents we are

573 actually doing something good for them. Sometimes they do HJU120000 PAGE 25

574 have their doubts about that.

575 According to the Centers for Medicare and Medicaid

576 Services, Americans' spending on healthcare now accounts for

577 17.8 percent of the U.S. GDP. That is over $3.6 trillion, or

578 over $10,000 a person. These astronomical costs are the

579 result of many factors. Front and center among them are

580 obstacles to patients' access to low-cost generic drugs.

581 Subcommittee Chair Cicilline and I addressed this problem

582 head on during the first weeks of this Congress by

583 reintroducing the CREATES Act.

584 This strong bipartisan legislation will deter branded

585 pharmaceutical companies from manipulating test sample

586 availability to block cheaper generic alternatives from

587 obtaining FDA approval and entering the marketplace. The

588 CREATES Act will lead to lower costs for patients by ensuring

589 that they have faster access to safe and effective FDA-

590 approved generic drugs.

591 The Congressional Budget Office has estimated that our

592 bill would produce a multibillionaire decrease in the Federal

593 deficit. Savings to consumers and private insurers will

594 likely be much greater. I urge all my colleagues to support

595 the bill and yield back the balance of my time.

596 Chairman Nadler. Thank you, Mr. Sensenbrenner. Without

597 objection, all other opening statements will be included in

598 the record. HJU120000 PAGE 26

599 Are there any other amendments to H.R. 965?

600 [No response.]

601 Chairman Nadler. In that case, a reporting quorum being

602 present, the question is on the motion to report the bill,

603 H.R. 965, favorably to the House.

604 Those in favor, say aye?

605 Opposed, no?

606 The ayes have it, and the bill is ordered reported

607 favorably to the House. Members will have 2 days to submit

608 views.

609 Pursuant to notice, I now call up H.R. 2374, the Stop

610 Stalling Act, for purposes of markup and move that the

611 committee report the bill favorably to the House.

612 The clerk will report the bill.

613 Ms. Strasser. H.R. 2374, to enable the Federal Trade

614 Commission to deter filing of sham citizen petitions to cover

615 an attempt to interfere with approval of a competing generic

616 drug or biosimilar, to foster competition, and facilitate the

617 efficient review of petitions filed in good faith to raise

618 legitimate public health concerns, and for other purposes.

619 Chairman Nadler. Without objection, the bill is

620 considered as read and open for amendment at any point.

621 [The bill follows:]

622 HJU120000 PAGE 27

623 Chairman Nadler. I will begin by recognizing myself for

624 an opening statement.

625 H.R. 2374, the Stop Stalling Act, takes an important

626 step toward lowering drug prices and increasing competition

627 in healthcare markets. It does this by addressing sham

628 citizen petitions, a delay tactic that some brand-name

629 companies use to keep low-cost generic competitors off the

630 market. Sham petitions result in higher drug prices,

631 potentially causing higher mortality among those who can

632 least afford such higher costs.

633 The citizen petition process provides an avenue for the

634 public to raise legitimate scientific and health concerns

635 about drugs under review by the Food and Drug Administration.

636 But instead of serving this important function, this process

637 has often been misused by brand-name drug manufacturers to

638 stifle competition from generics and biosimilars. These

639 companies flood the FDA with sham petitions, lacking any

640 scientific or health-related basis, in order to bog the

641 agency down in paperwork and grind the approval process to a

642 halt.

643 In one case, Shire ViroPharma, a major biopharmaceutical

644 company, abused the citizen petition process in order to

645 maintain a monopoly over Vancocin capsules, a drug used to

646 treat potentially life-threatening gastrointestinal

647 infections. For 6 years, ViroPharma inundated the FDA with HJU120000 PAGE 28

648 sham petitions to delay it from approving generic competitors

649 to Vancocin. According to the Federal Trade Commission's

650 antitrust complaint, ViroPharma's serial sham petitions

651 "lacked any supporting clinical data," yet they succeeded in

652 delaying generic entry at a cost of hundreds of millions of

653 dollars to patients and other purchasers.

654 Another appalling example of the use of sham petitions

655 -- I don't know what they are doing. Another appalling

656 example of the use of sham petitions to extend monopolies

657 resulted in dramatically increasing the cost of combatting

658 opioid abuse, a serious nationwide public health crisis. In

659 2016, together with the attorneys general of 34 other States,

660 the New York attorney general filed a lawsuit against

661 Indivior alleging that the drug manufacturer engaged in

662 citizen petition abuse and other anticompetitive business

663 practices to maintain its monopoly over Suboxone, a treatment

664 for patients who are addicted to prescription painkillers,

665 heroin and other drugs.

666 According to the complaint, Indivior filed a series of

667 sham petitions to prevent the generic competitor from

668 entering the market with the same Suboxone tablets that it

669 sold in the market for nearly 10 years at a profit of over $2

670 billion. By the time the FDA rejected the sham citizen

671 petitions, Indivior had pulled the Suboxone tablet version

672 from the market and converted the market to its newly- HJU120000 PAGE 29

673 patented Suboxone film. By abusing the citizen petition

674 process, Indivior reaped monopoly profits from the sale of

675 Suboxone film, and it deprived victims of opioid addiction

676 and medical practitioners the benefits of generic

677 competition.

678 The Stop Stalling Act will put an end to these abusive

679 and anticompetitive practices. The bill provides the

680 submission of a sham petition to prevent the delayed entry of

681 a generic or biosimilar competitor is presumptively illegal

682 under the antitrust laws. It also gives the FTC authority to

683 seek a civil penalty and other appropriate relief in response

684 to the filing of sham petitions by drug manufacturers.

685 Importantly, this measure applies only to petitions that are

686 used for anticompetitive purposes as a cover for an attempt

687 to interfere with the approval of a competing drug. In doing

688 so, the Stop Stalling Act carefully adheres to existing case

689 law and constitutional principles.

690 This legislation strikes a reasonable balance that will

691 help lower the cost of prescription drug prices by preventing

692 unnecessary delays and the approval of lower-cost generic

693 competitors while preserving the public's right to petition

694 the government. I thank my colleagues, Congressman Jeffries

695 and Subcommittee Ranking Member Sensenbrenner, for their

696 leadership on this important legislation, and I urge my

697 colleagues to support this potentially lifesaving measure. HJU120000 PAGE 30

698 I now recognize the ranking member of the Judiciary

699 Committee, the gentleman from Georgia, Mr. Collins, for his

700 opening statement.

701 Mr. Collins. Thank you, Mr. Chairman. I want to thank

702 also Mr. Jeffries and Mr. Sensenbrenner for their bipartisan

703 work on this legislation.

704 When used appropriately, citizen petitions filed with

705 the FDA allow all Americans to raise legitimate health and

706 safety concerns about prescription drugs proposed for FDA

707 approval. But for too long, drug manufacturers have been

708 allowed to game the system by submitting numerous or

709 baseless, bogus petitions simply so the FDA would delay

710 competing manufacturers' approvals. As long as the FDA is

711 tied up in reviewing petitions, the original manufacturer is

712 shielded from competition, and consumer drug prices stay

713 high.

714 Recently, the Third Circuit's decision in FTC v. Shire

715 ViroPharma made it harder for the FTC to use antitrust

716 enforcement to stop this anticompetitive behavior. The Stop

717 Stalling Act is sound bipartisan legislation to make sure

718 that the FTC has effective authority to act against sham

719 petitions, while preserving the rights of citizens to bring

720 legitimate health and safety concerns to the FDA. It should

721 stop in their tracks drug manufacturers who seek only to file

722 baseless petitions to keep competitors off the market and HJU120000 PAGE 31

723 prevent consumers from accessing lower-cost alternative

724 medications.

725 I am an original co-sponsor to this bill and would

726 encourage all my colleagues to support it as well. With

727 that, I yield back.

728 Chairman Nadler. I thank the gentleman. I now

729 recognize the chair of the Subcommittee on Antitrust,

730 Commercial, and Administrative Law, the gentleman from Rhode

731 Island, Mr. Cicilline, for his opening statement.

732 Mr. Cicilline. Thank you, Mr. Chairman. I want to urge

733 my colleagues to support H.R. 2374, the Stop Stalling Act,

734 and I want to thank the lead sponsor, Congressman Jeffries,

735 for this excellent bill. And I would like to yield the

736 balance of my time to him so he can explain it to the

737 committee.

738 Mr. Jeffries. I thank my good friend for yielding. I

739 also want to thank Chairman Nadler, Ranking Member Collins,

740 my good friend, Chairman Cicilline, as well as Ranking Member

741 Sensenbrenner, the lead Republican on this issue, for their

742 partnership in tackling the soaring cost of lifesaving

743 prescription drugs.

744 Today we are offering another bipartisan solution, the

745 Stop Stalling Act, to crack down on abusive behavior in the

746 pharmaceutical industry as we endeavor to make prescription

747 drugs more affordable for everyday Americans. Prescription HJU120000 PAGE 32

748 drug costs in the are skyrocketing. Four of

749 the top 10 prescription drugs in the U.S. have increased in

750 price by more than 100 percent since 2011.

751 Studies have shown that increased competition in the

752 pharmaceutical arena, rather than monopoly-like behavior,

753 lowers prescription drug costs. The entry of generic drugs

754 into the market to compete with brand-name drugs can

755 dramatically reduce prices for the American people. It is a

756 simple economic principle that is as American as apple pie.

757 Competition lowers prices.

758 In fact, the U.S. Food and Drug Administration said,

759 "Generic medicines have the same therapeutic effect as their

760 branded counterparts, but are typically sold for an estimated

761 80 to 85 percent less compared with the price of brand-name

762 medicine." In order to artificially inflate the cost of

763 prescription drugs, some companies are blocking generic

764 competition into the market. In this regard, stalling

765 tactics are sometimes used to delay the launch of generic

766 products that can compete with brand-name drugs.

767 One of these tactics is the filing of sham petitions

768 with the FDA. Citizen petitions were never designed as an

769 avenue for branded companies to artificially inflate drug

770 costs by stalling the entry of generic brands into the

771 market. Congress designed the citizen petition process to

772 let ordinary Americans raise legitimate public health HJU120000 PAGE 33

773 concerns with drugs under review by the FDA. Brand-name drug

774 companies have hijacked this process and started flooding the

775 FDA with fake, meritless safety concerns about generic drugs.

776 The FDA is required under law to respond to each

777 petition, thereby wasting time and taxpayer-funded resources

778 on often frivolous claims. While the sham petitions are in

779 review, the generic drugs being petitioned sit in limbo

780 without approval and out of reach from everyday Americans.

781 Take, for example, a brand-name company called

782 ViroPharma that inundated the FDA with 24 citizen petitions

783 and 22 other filings with respect to a competing generic drug

784 to treat gastrointestinal infections. In 2017, the current

785 Administration and the Federal Trade Commission said in the

786 court case, FTC v. Shire ViroPharma, that ViroPharma's

787 campaign had succeeded in delaying generic entry at a cost of

788 hundreds of millions of dollars.

789 The American people are indeed being played. We must

790 end these abusive tactics. That is why are advancing the

791 bipartisan Stop Stalling Act, and I urge all my colleagues to

792 support this legislation as we endeavor to lower prescription

793 drug prices on behalf of the American people. And I yield

794 back.

795 Chairman Nadler. I thank the gentleman. I now

796 recognize the ranking member of the Antitrust Subcommittee,

797 the gentleman from Wisconsin, Mr. Sensenbrenner, for his HJU120000 PAGE 34

798 opening statement.

799 Mr. Sensenbrenner. I thank my colleague, the gentleman

800 from New York, Mr. Jeffries, for partnering with me on the

801 Stop Stalling Act, and I also thank the chair and ranking

802 member for bringing the bill to markup. I sincerely hope we

803 can achieve enactment of this bill during this term of

804 Congress.

805 The Stop Stalling Act is yet another way in which drug

806 manufacturers game government processes to shut new generic

807 drug competition out of the market. No one will champion

808 more than I the right of American citizens to petition their

809 government for redress of grievances, but some incumbent drug

810 manufacturers too often abuse this right by filing sham

811 citizen petitions with the FDA. These sham petitions simply

812 gum up the FDA's generic approval process, delaying approvals

813 until the petitions can be looked at and disposed of by the

814 FDA.

815 While they can be quick and cheap for incumbent

816 manufacturers to gin up, they can keep drug prices high and

817 out of patients' reach. This is wrong, and it should stop.

818 With the Third Circuit's recent decision in FTC v. Shiro

819 ViroPharma, it stands to make it harder for the FTC to police

820 the behavior through antitrust enforcement. This strong

821 bipartisan bill responds by establishing a specific statutory

822 remedy against the filing of sham petitions. HJU120000 PAGE 35

823 The bill preserves every right of every citizen to bring

824 legitimate health and safety concerns to the FDA. At the

825 same time it makes sure that generic drug manufacturers can

826 sue under the antitrust laws those who file sham petitions

827 just to keep lower-cost generic drugs out of the market. I

828 urge my colleagues to support this bill and yield back the

829 balance of my time.

830 Chairman Nadler. Thank you, Mr. Sensenbrenner. Without

831 objection, all other opening statements will be included in

832 the record.

833 Are there any amendments to H.R. 2374?

834 [No response.]

835 Chairman Nadler. Well, a reporting quorum being

836 present, the question is on the motion to report the bill,

837 H.R. 2374, favorably to the House.

838 Those in favor, say aye?

839 Those opposed, no?

840 The ayes have it, and the bill is ordered reported

841 favorably to the House. Members will have 2 days to submit

842 views.

843 Pursuant to notice, I now call up H.R. 2376, the

844 Prescription Pricing for the People Act of 2019, for purposes

845 of markup and move that the committee report the bill

846 favorably to the House.

847 The clerk will report the bill. HJU120000 PAGE 36

848 Ms. Strasser. H.R. 2376, to require the Federal Trade

849 Commission to study the role of intermediaries in the

850 pharmaceutical supply chain and provide Congress with

851 appropriate policy recommendations, and for other purposes.

852 Chairman Nadler. Without objection, the bill is

853 considered as read and open for amendment at any point.

854 [The bill follows:]

855 HJU120000 PAGE 37

856 Chairman Nadler. I will begin by recognizing myself for

857 an opening statement.

858 H.R. 2376, the Prescription Pricing for the People Act

859 of 2019, would require the Federal Trade Commission to

860 conduct a comprehensive report on the state of competition in

861 the drug supply chain. In particular, this study would focus

862 on whether pharmacy benefit managers, or PBMs, have engaged

863 in certain behavior for anticompetitive purposes, such as

864 steering patients to pharmacies in which a PBM has an

865 ownership interest, giving such pharmacies more favorable

866 rates than it offers to competing pharmacies, or using its

867 market power to depress the use of lower-cost prescription

868 drugs.

869 PBMs are responsible for administering prescription drug

870 benefits through negotiations and contracts with drug

871 manufacturers, health insurers, healthcare providers, and

872 pharmacies. As leading economist, Fiona Scott Morton,

873 testified in the hearing on competition in the healthcare

874 marketplace held by the Subcommittee on Antitrust,

875 Commercial, and Administrative Law earlier this year, PBMs

876 play a dual role in the drug supply chain, facilitating price

877 competition among branded and generic companies while

878 negotiating for lower prices in competitive markets. This

879 role, she explained, is "critical because it is one of the

880 few agencies in our commercial pharmaceutical marketplace HJU120000 PAGE 38

881 that creates price competition."

882 However, the PBM marketplace is highly concentrated. In

883 fact, only three companies control the vast majority of the

884 market, and the biggest PBMs also own the Nation's largest

885 retail pharmacy chains, so they are negotiating against

886 themselves. As a result of this concentration of market

887 power and inherent to conflict of interest, these firms have

888 the incentive and the ability to leverage their dominance in

889 the PBM marketplace to steer business to their own pharmacies

890 and away from competitors or to raise their rivals' costs.

891 There is also growing concern that some PBMs engage in

892 anticompetitive contracting practices that lead to higher

893 drug prices. This concern is exacerbated by the lack of

894 transparency in the PBM marketplace. It is difficult for the

895 public to know whether the cost savings achieved by PBM

896 negotiations are ultimately passed on to consumers when the

897 drug pricing process is shrouded in secrecy.

898 The study required by this legislation will provide

899 helpful guidance to Congress as it considers ways to lower

900 drug prices, and I commend Ranking Member Collins for his

901 leadership and for his commitment to promoting greater

902 competition in the drug supply chain. I look forward to

903 working with him on this issue, and I urge my colleagues to

904 support this legislation.

905 I now recognize the ranking member of the Judiciary HJU120000 PAGE 39

906 Committee, the gentleman from Georgia, Mr. Collins, for his

907 opening statement.

908 Mr. Collins. Thank you, Mr. Chairman, and I appreciate

909 you partnering with me on this Prescription Pricing for the

910 People Act. This is something that has been a passion of

911 mine for the entire time I have been in Congress for the 6

912 years in dealing with this issue of PBMs. And I am glad to

913 see this along with the Administration and others making

914 moves to address this situation in our healthcare system.

915 Over the past decade, consolidation across the

916 healthcare and prescription drug markets have rapidly

917 increased. Nowhere is this more prevalent than the PBM, or

918 pharmacy benefit manger, marketplace. Since 2008, the market

919 has gone from more than 20 major players to three companies

920 controlling 85 percent of the market. As these companies

921 have consolidated horizontally, they have also merged

922 vertically with major pharmacies and health insurers.

923 The resulting consolidation has enabled PBMs to maneuver

924 in the shadows to block savings from reaching the patients

925 who depend on them to afford their medications. PBMs

926 consistently engage in anticompetitive behavior by targeting

927 competing pharmacies with unfair audits and under

928 reimbursements. PBMs are able to audit competing pharmacies,

929 viewing data including the pharmacy's acquisition cost and

930 patient data. PBMs then use the data to steer patients to HJU120000 PAGE 40

931 their own pharmacies and reimburse competing pharmacies at a

932 much lower rate, retaining the spread along the way. In

933 Ohio, CVS and OptumRx charge the State over $400 million more

934 than they paid out to their pharmacies.

935 PBMs exert immense control over the patient formularies,

936 allowing them to steer patients to high-cost medications

937 because these medications give them higher rebates. By

938 steering patients to high-cost medications, PBMs increase

939 patient copays and incentive manufacturers to increase drug

940 costs to pay the PBMs' higher rebate demands. PBMs' role as

941 intermediaries also allow them to extract rebates and price

942 concessions from competing pharmacies and manufacturers

943 without passing them on to the patients. Due to the lack of

944 transparency, these price concessions are often withheld from

945 the patients and payers, increasing PBM profits while failing

946 to decrease drug costs.

947 H.R. 2376, the Prescription Pricing for the People Act,

948 directs the FTC to review and report on these anticompetitive

949 behaviors of PBMs and other issues affecting the competition

950 for the pharmaceutical supply chain as a whole. The FTC is on

951 a short timeline to produce these reports so that we will be

952 able to legislate upon the results during this term of

953 Congress when the reports are in.

954 This is a bill that I appreciate the chairman partnering

955 with me on. This long overdue. It is time to shine sunshine HJU120000 PAGE 41

956 in a very dark place and see if we can get this fixed. And I

957 would all my colleagues to support this bill and yield back

958 the remainder of my time.

959 Chairman Nadler. Thank you, Mr. Collins. I now

960 recognize the chair of the Subcommittee on Antitrust,

961 Commercial, and Administrative Law, the gentleman from Rhode

962 Island, Mr. Cicilline, for his opening statement.

963 Mr. Cicilline. Thank you, Mr. Chairman. H.R. 2375, the

964 Prescription Pricing for the People Act of 2019 would require

965 the Federal Trade Commission to study the state of

966 competition in the drug supply chain to ensure that all

967 elements in the supply chain are aligned to reduce costs for

968 consumers and healthcare payers. I strongly support

969 promoting competition in every market, including within the

970 pharmaceutical supply chain.

971 It is critical that consumers ultimately receive the

972 benefit of lower drug prices, but as I have said before, I am

973 deeply skeptical of claims that pharmacy benefit managers,

974 PBMs, are a significant driver of high drug costs. PBMs are

975 responsible for negotiating with branded drug companies to

976 lower drug costs on behalf of health insurance payers and

977 employees. Moreover, PBMs reduce costs and improve patient

978 outcomes, as Professor Fiona Scott Morton recently testified

979 before the Antitrust Subcommittee. Those cost savings come

980 in addition to the billions of dollars saved by automatically HJU120000 PAGE 42

981 substituting generic drugs for branded drugs in retail

982 pharmacies when available, as Professor Feldman and other

983 leading experts have noted.

984 But make no mistake. Demonizing or scapegoating PBMs

985 and retail pharmacies in the drug supply chain is a

986 distraction from the leading causes of high drug prices.

987 These include the lack of competition in the manufacturing of

988 prescription drugs, regulatory abuse by branded drug

989 companies to delay generic competitors, and barriers to

990 generic competition, such as pay-for-delay settlements that

991 keep drug prices at artificially high monopoly levels.

992 Addressing these issues head on is a critical first step

993 for lowering the cost of prescription drugs, which is why

994 moving today's package of legislation is so important. That

995 said, it has been nearly 15 years since the Federal Trade

996 Commission last issued a study on this market. It is

997 important the public and this committee has the best data for

998 informed policy discussions.

999 I thank Ranking Member Collins and his staff for their

1000 work on this legislation. It is a balanced inquiry into the

1001 subject, and, most importantly, does not come at the expense

1002 of serious reforms to high drug prices. I urge my colleagues

1003 to support this bill, and I yield back the balance of my

1004 time.

1005 Chairman Nadler. I thank the gentleman and now HJU120000 PAGE 43

1006 recognize the ranking member of the Antitrust Subcommittee,

1007 the gentleman from Wisconsin, Mr. Sensenbrenner, for his

1008 opening statement.

1009 Mr. Sensenbrenner. Thank you very much, Mr. Chairman.

1010 I think that the previous speakers have said most of all, but

1011 I want to add one thing. I think one of the important things

1012 in this bill is that we will get the reports back from the

1013 FTC during this term in Congress. So this is something that

1014 will allow us to legislate either later on this year or next

1015 year to come up with something meaningful to address this

1016 part of the problem. I support this bill and urge my

1017 colleagues to vote for it. I yield back the balance of my

1018 time.

1019 Chairman Nadler. I thank the gentleman. Without

1020 objection, all other opening statements will be included in

1021 the record.

1022 Are there any amendments to H.R. 2376?

1023 [No response.]

1024 Chairman Nadler. A reporting quorum being present, the

1025 question is on the motion to report the bill, H.R. 2376,

1026 favorably to the House.

1027 Those in favor, say aye?

1028 Those opposed, no?

1029 The ayes have it, and the bill is ordered reported

1030 favorably to the House. Members will have 2 days to submit HJU120000 PAGE 44

1031 views.

1032 This concludes our business for today. I thank all of

1033 our members for attending. The markup is adjourned.

1034 [The information follows:]

1035 [Whereupon, at 3:11 p.m., the committee was adjourned.]