REGULATORY UPDATE REGULATORY UPDATE CONSUMER DRUGS Pediatric Rare Disease Voucher Japan Wants EMA To Stay In Digital Marketing: Health Care Brands’ Program Faces Expiration, p. 12 UK Post-Brexit, p. 15 Window Into Consumers’ Lives, p. 20 Pharma intelligence Pinkpink.pharmamedtechbi.comSheetVol. 78 / No. 38 September 19, 2016 informa Mylan NV was subpoenaed for material Pharma Pricing, Non-Profit Ties Get about the pricing of its generic doxycycline and communications with competitors. And Valeant Pharmaceuticals International Inc. is Increasing Scrutiny From Prosecutors facing several probes about its pricing and BRENDA SANDBURG [email protected] patient assistance programs (see chart, p. 5). Mylan’s doxycycline price increases were called out by Sen. Bernie Sanders, I-Vt., and Rep. Elijah Cummings, D-Md., in October 2014 when they sent letters to 14 generic drug makers about the pricing of their prod- ucts. They noted that from October 2013 to April 2014, the average price charged for a 500-count bottle of 100 mg tablets had risen from $20 to $1,829, an 8,281% increase. Mylan is now under fire for repeatedly rais- ing the price of its severe allergy treatment EpiPen (epinephrine), which has increased from about $100 for a two-pack in 2008 to more than $600. Members of Congress sent a flurry of letters to the company requesting an explanation for the price hikes. And on Sept. 6, New York Attorney Gen- Shutterstock: blvdone Shutterstock: eral Eric Schneiderman announced that his office has begun an investigation into rug makers have been unable to programs, contractual agreements with Mylan with regard to EpiPen, saying a pre- shake free of government inves- pharmacy benefit managers, support of liminary review revealed that Mylan may Dtigations of their marketing and non-profit organizations, and calculation have inserted potentially anticompetitive sales practices. But the focus of the probes of average manufacturer and best prices. terms into its EpiPen sales contracts with has shifted in the last few years and one A look at recent Securities and Exchange numerous local school systems. word now routinely pops up – pricing. Commission filings of more than a dozen That has been the hot button issue roil- pharma companies shows the practices GOING BEYOND ing industry the past year as several com- that have drawn government attention. MISBRANDING CASES panies have been excoriated by Congress At least four companies – Biogen Inc., The government has subpoenaed several and the media for their steep price hikes. Celgene Corp., Gilead Sciences Inc. and other generic companies about their pric- The Department of Justice has also honed Jazz Pharmaceuticals PLC – have received ing. Most recently, Sun Pharmaceutical In- in on the issue. It is investigating firms subpoenas for information about their re- dustries Ltd. reported that it had received for details about their patient assistance lationships with charitable organizations. CONTINUED ON PAGE 4 BROUGHT TO YOU BY THE EDITORS OF SCRIP REGULATORY AFFAIRS, THE RPM REPORT, TAN SHEET, GOLD SHEET, PINK SHEET DAILY AND PINK SHEET Maximize Your Reimbursement Potential The balance of power behind the prescribing decision is changing: payers are ever more in charge. That means that insight into how payers make decisions – how they evaluate drugs, one against another – will be crucial to any successful drug launch. RxScorecard objectively, authoritatively, and systematically assesses marketed and pipeline drugs in a therapeutic indication from the payer’s point of view. 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See the payer perspective. cover 12 15 exclusive online content inside: COVER Pharma Pricing, Non-Profit Ties Get Increasing Scrutiny Global Pharma Guidance Tracker – August 2016 From Prosecutors http://bit.ly/2d0h09o BIOSIMILARS Stay up to date on regulatory guidelines from around the world, with the Pink Sheet’s new monthly Guidance Tracker. 8 Biosimilar Launch Notification May Head Back To Court 9 Biosimilar Interchangeability May Be Losing Luster As Approval Goal Spectrum’s Apaziquone Pooled Analysis Can’t Make Up For Negative Studies LITIGATION http://bit.ly/2cCv7zB 10 EU Pay-For-Delay Ruling Against Lundbeck Sends Signal Faced with two unsuccessful pivotal trials, FDA advisory To Others, Including UK committee concludes substantial evidence of a treatment effect in non-muscle invasive bladder cancer has not been FDA demonstrated. 24 FDA Neurology Clinical Team Leader Departure May Be Mountain Disguised As Molehill Removing Pfizer’s Chantix Boxed Warning A One-Off, REGULATORY UPDATE Committee Says 12 Pediatric Rare Disease Voucher Program Faces Expiration http://bit.ly/2cCvIl1 15 Japan Wants EMA To Stay In UK Post-Brexit Advisory committee says data supports dialing back safety label for the smoking cessation product, but shouldn’t be 18 Korean Health Tech Blueprint Highlights Precision, precedent setting. Regenerative Medicine INTELLECTUAL PROPERTY Paying For Cures Requires Bigger Budgets, 13 Pressure On Pharma: UN Report Backs Compulsory Not Lower Drug Prices – Execs Licensing http://bit.ly/2cC6rpg CLINICAL TRIALS Payers need to adopt a longer-term focus on coverage policies for prescription drugs and biologics that recognizes the benefits 16 India Moves To Replace Animal-Based Tests In Eye, of covering high-priced, but often curative, treatments like Skin Studies those for hepatitis C, panelists argue at AEI-sponsored event. 17 China Proposes Many New GLP Provisions For Pharma CONSUMER DRUGS 20 Digital Marketing: Health Care Brands’ Window Into ONLINE ONLY! Consumers’ Lives 22 Teva Seeds OTC Growth Synergies With Former FDA performance Allergan Business tracker GENERIC DRUGS 25 FDA’s ANDA Approvals Regularly updated information about new submissions, pending applications and FDA actions, online-only NEW PRODUCTS interactive content at your fingertips 24/7 at 25 FDA’s NDA And BLA Approvals pink.pharmamedtechbi.com/product-reviews- AdviSORY COMMITTEES and-approvals/fda-performance-tracker 26 Recent And Upcoming FDA Advisory Committees pink.pharmamedtechbi.com September 19, 2016 | Pink Sheet | 3 LITIGATION a subpoena for information pertaining to at DOJ, said that there is a big difference moted the sleep disorder drugs Nuvigil the pricing of its generic drugs. between issuing policy and standing (armodafinil) and Provigil (modafinil) off- In previous years, the DOJ has concen- in front of a judge and trying to prove label. The whistleblowers in these cases are trated on claims of off-label marketing and culpability. As a prosecutor, there is a «big pursuing the actions on their own. payment of kickbacks. These investigations distance between what you wish in the Several other investigations have resulted resulted in a slew of settlements, many top- case and what can be proven in the case,» in DOJ settlements. Among the most recent, ping $1bn. he said. “If you get enough bad outcomes Pfizer Inc. agreed to pay $784.6m to resolve Hogan Lovells partner Meredith Manning it will make you gun shy.” allegations that its Wyeth subsidiary paid said she thinks the government is trying to As for the focus of government investi- hospitals steep discounts if they purchased avoid cases alleging misbranding under the gations, both emphasized that the growth both oral and IV formulations of the acid- federal Food, Drug, and Cosmetic Act and is in federal regulation has meant and suppressant Protonix (pantoprazole). And looking for other theories of liability. will continue to mean growth in federal Roche and OSI Pharmaceuticals LLC reached “They run into First Amendment issues enforcement. Pauzé, a former assistant a $67m settlement to resolve claims they when they go down the misbranding route, US attorney, said that because there is so misrepresented the effectiveness of the and juries don’t want to convict individuals,” much talk about pricing it can lead to gov- non-small cell lung cancer drug Tarceva (er- Manning, a former attorney in FDA’s Office ernment scrutiny. Richter added that de- lotinib) (see story p. 6 for list of settlements). of Chief Counsel and a former assistant US spite the significant setbacks the govern- In addition to US healthcare fraud que- attorney, said. ment has faced in off-label cases recently ries, the government is also stepping up in- Indeed, in the last six months the gov- that area of inquiry is not dead. vestigations of foreign bribery. This year the ernment has struck out in two trials against DOJ increased the number of prosecutors individuals and got a limited conviction in a GOVERNMENT CLOSES looking into potential violations under the third. In March, a Texas jury found Vascular NOVARTIS, TEVA INQUIRIES Foreign Corrupt Practices Act and initiated a Solutions Inc. and its CEO Howard Root not Many government investigations evolve pilot program to give companies credit and guilty of off-label marketing of its Vari-Lase from False Claims Act complaints in which a reduction in fines for their cooperation. At vein ablation