On July 12-13, Q1 Productions hosted a conference in Alexandria, Virginia: "Regulatory Clearance & Commercialization of Generic Drugs & Biosimilars" to a full house. FLH Partner Brian J. Malkin spoke on "Biobetters and Extending into the Marketplace Beyond Patent Expiration", moderated and commented in a kickoff panel with Marcie McClinitic Coates, Chief of Staff Mylan and Hayden Rhudy, Senior Health Policy Advisor, The Office of Senator Orrin G. Hatch, on "Preparing for the Evolution of the Generic Drug and Biosimilar Industry", and chaired the Biosimilars Tracked Session in the afternoon. Other featured key conference speakers included FDA's Peter Beckerman, Senior Policy Advisor, Office of the Commissioner, and Russell Wesdyk, Center for Drug Evaluation and Research ("CDER"), Office of Pharmaceutical Science, and Bruce Pokras, Senior Corporate Counsel, Pfizer, and Elizabeth Jex, Attorney Advisor, Federal Trade Commission ("FTC").
Q1 Productions Regulatory Clearance & Commercialization of Generic Drugs & Biosimilars
In the kickoff panel, Coates questioned whether there was a "patent cliff", given the numerous opportunities to improve up on currently-marketed products and the inevitable development of a biosimilar pathway. Coates, moreover, had been involved in the Generic Drug User Fee Act ("GDUFA") negotiations and was hopeful that with the infusion of generic drug use fees starting in October 2012, the generic drug industry would see faster review times and a more responsive FDA when it came to new product development for generics.
In the same panel, Malkin asked Rhudy how the Biosimilars Price Competition and Innovation Act ("Biosimilars Act") came to be added to the Patient Protection and Affordable Care Act ("Affordable Care Act") in March 2010. Rhudy replied that once Congress had reached agreement on the exclusivity period for new biologicals (12 years), Congress essentially lifted the language from the most well-supported bill at the time without additional debate. Coates and Malkin then discussed why they thought that no applicant had filed a biosimilar application almost two and half years since the Biosimilars Act was passed. Much of their discussion regarding the lack of a developing biosimilars industry in the U.S. centered on the uncertain regulatory framework articulated by FDA and the complicated litigation pathway that would undoubtedly be costly for a biosimilar applicant to pursue. For instance, they noted that to date FDA had only partially discussed in its initial guidances the analytical process to compare a proposed biosimilar with its referenced product, while leaving out important details such as the clinical requirements for interchangeability, product naming, and what requirements FDA may waive. In response to these criticisms, Rhudy said that Congress would be focused more on the Affordable Care Act, now that the Supreme Court said that it was Constitutional, and the election, knowing that if they opened up the Biosimilars Act for debate, it might never be passed again. In essence, Rhudy said that Congress wanted to give more time to the Biosimilars Act to work, especially since Congress provided FDA with considerable discretion to help develop the industry and improve patients' access to affordable biological medicines.
Following the kickoff presentation, another key presentation featured Coates, Beckerman, and Wesdyk, speaking about GDUFA--why it was needed and what it hoped to accomplish. The speakers noted that since the industry took off with the Hatch-Waxman Act in 1984, the industry has continued to grow with increasing foreign product and active pharmaceutical ingredient development, which has strained FDA's limited resources. Wesdyk stressed that GDUFA differed from the previous iterations of the Prescription Drug User Fee Acts ("PDUFAs") in that it featured efficiency enhancements that promised to provide greater impact of the approximate $299 million in user fees per year at a relatively-low cost (less than one-half of one percent of generic drug sales), resulting in anticipated ten-month review cycles. Coates cautioned that since GDUFA mandated FDA to collect backlog fees for pending abbreviated new drug applications ("ANDAs") as of September 30, 2012, ANDA applicants should take a careful look at their ANDA portfolios to make sure that they withdraw any pending ANDAs that they were no longer pursuing. The FDA panelists noted that GDUFA had no waivers or grace period for backlog fees but thought most of the fees were "de minimis," noting that most GDUFA fees would be collected via a similar system as PDUFA. Failure to pay fees not tied to backlog fees, however, could lead to a product being deemed misbranded, the FDA panelists cautioned, but these fees had a limited grace period. The FDA panelists hoped that the fees would incentivize the generic drug industry to submit higher quality ANDAs resulting in fewer review cycles.