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 California, 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 Rhode Island, 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 United States 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.]