FDA Names Companies Potentially Blocking Generic Samples
FDA has released the names of 52 branded drug products whose manufacturers “have potentially been blocking access to the samples of their branded products” needed by generic drug companies to be able to develop and test their products. In a statement, FDA commissioner Scott Gottlieb said the agency hopes “that this increased transparency will help reduce unnecessary hurdles to generic drug development and approval.” The companies include major drug manufacturers including Novartis, AstraZeneca, Ranbaxy, Bayer, Mylan, Roche, Teva, Shire, Cephalon, Boehringer Ingelheim, Gilead, Celgene, GlaxoSmithKline, and Pfizer.”
Gottlieb’s comments were part of an overall FDA response to administration efforts to make drugs more affordable and improve access by increasing competition. “At FDA,” he said, “We’re taking steps across a broad range of areas to improve new and generic drug competition as a way to improve access and affordability. Among these efforts, we’re especially focused on addressing tactics we sometimes hear of branded companies pursuing as a way to forestall expected generic entry.”
According to Gottlieb, branded companies sometimes assert that they are precluded by limited distribution programs including Risk Evaluation and Management Strategies (REMS) with Elements to Assure Safe Use from selling samples to generic drug companies. In other cases, he says, it appears that branded companies have placed restrictions in their commercial contracts or agreements with prescription drug distributors, wholesalers, or specialty pharmacies that limit their ability to sell samples to generic firms for testing. “I want to be very clear: a path to securing samples of brand drugs for the purpose of generic drug development should always be available,” he declared. “Even in the case of limited distribution programs such as those required by certain REMS, there should be a path forward for generic drug development. Despite this, FDA has received more than 150 inquiries from generic drug developers seeking assistance in obtaining samples from brand companies.”
Gottlieb says the agency will update periodically the list of companies that may be blocking generic access to drug samples. “We’ll continue to look at more ways we can expand upon today’s action and call public attention to situations where the careful balance that Congress sought between product innovation and access may be being disrupted,” he says. “We’ll also continue working with the Federal Trade Commission where there may be anticompetitive business practices at play. And we’ll continue to strengthen our internal processes for handling inquiries related to problems generic drug developers report having in obtaining samples of brand products.”