FDA to call out branded drugmakers for blocking generics
- The Food and Drug Administration will launch a website Thursday to put brand drug manufacturers on notice if they block generic competition as part of President Donald Trump's plan to tackle high drug prices, Commissioner Scott Gottlieb said this week.
- The site, to be updated on a continuous basis, aims to curb the practice of branded manufacturers limiting access to samples generic drugmakers need to develop copies.
- The FDA received more than 150 letters from generic drugmakers about difficulties accessing product samples from brand manufacturers, according to HHS Secretary Alex Azar. Some brand manufacturers use Risk Evaluation and Mitigation Strategy (REMS) programs or specialty distribution programs to keep samples out of the hands of generic drugmakers.
On the heels of President Trump's remarks last week, Gottlieb is pushing forward with the first steps of a plan to increase competition with the aim of lowering drug prices, described in briefings with reporters on Monday and Tuesday at HHS and at the Alliance for Health Policy.
"I think that the problem is that we have such a Byzantine, complex system. That to think that there one policy reform that you are going to implement that is just going to create a much more competitive landscape, that's not the reality. This system was built up over many years through the hard work of a lot of lobbying dollars," Gottlieb said.
"And I think that in order to start to dismantle it, it is going to take a series of interlocking reforms and someone who understands how these different parts are working together in a pernicious way to disadvantage consumers and patients."
The FDA will also shortly release new guidance aimed at addressing abuse of the REMS rules to allow generic manufacturers to use a non-shared REMS program when necessary to spur competition.
Gottlieb predicted the actions will alter company behavior.
"The guidance will say that FDA shall grant a waiver to a generic company if it can demonstrate to FDA that these negotiations are being dragged out," Gottlieb said Tuesday. "I think just by telling the marketplace that I'm willing to give a waiver to the generic companies to go their own way and develop their own REMS more easily, that's going to discourage the branded drug companies from doing this in the first place."
Gottlieb pushed back against calling the website public shaming, but said it will highlight situations where there is an obstacle to timely generic entry.
"Could it potentially serve as a deterrent to engaging in practices that are antithetical to the spirit, if not the letter of Hatch-Waxman? Perhaps. And if it does, I think that's a useful public health outcome," Gottlieb said Monday.
The generic drug lobby, the Association for Accessible Medicines, told BioPharma Dive that the plan to post the letters online is an important step, but not adequate on its own.
"It is important that the FDA shares the names of these companies that are abusing safety programs to pad their monopolies at the expense of patients, but shame hasn’t proven effective in changing behavior when billions of dollars are on the line. For the sake of American patients, the Administration must work with Congress to pass the CREATES Act and finally put an end to these abuses," said Allen Goldberg, AAM VP of communications.
The bill, which seeks to stop brand drug companies from blocking generic competition, would allow generic drug companies to sue to gain access to samples and grant FDA more authority to approve non-shared REMS programs if needed.
Gottlieb said that the FDA has provided technical assistance on the CREATES Act to Congress, but noted that the administration has not taken a formal stance on the legislation.
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