The Food and Drug Administration will launch one of its first programs following the release of the Trump administration's new drug price plan this week.
The agency will launch on Thursday a website that offers more details on the branded drugs generic drugmakers have trouble getting their hands on, said FDA Commissioner Scott Gottlieb, M.D. The website will retroactively include information on about 150 inquiries made about 50 brand-name medications and will be updated on ongoing basis in the future, he said.
Some drugs had several inquiries from generic drug manufacturers, while others may only have had one, he said.
The FDA head gave a look into the agency's plans as part of the Trump administration's overall strategy to lower drug prices at a briefing with reporters on Tuesday morning.
"Branded companies are on notice," Gottlieb said.
It will also indicate which drugs require a Risk Evaluation and Mitigation Strategy (REMS) and which could make it harder for generic drug companies to acquire samples for development. The FDA will note if it sent an official letter to the brand-name drug company in the case, Gottlieb said.
Generic drug companies have long complained of impeded generic drug development by brand-name drug manufacturers who hinder access to samples. Increasing competition in the markets by encouraging generic drug and biosimilar development is a key element of the White House's plan to lower drug prices, which was unveiled last Friday.
In addition to the website's launch this week, FDA is planning to release guidance at the end of the month that would allow generic drug companies to apply for waivers to create their own REMS if they can show that the negotiations to acquire samples are dragging on, Gottlieb said.
Just taking steps to suggest that these waivers could be offered would likely be a deterrent to the abuse the Trump administration decried in its pricing plan, he said.
Gottlieb also noted the role that pharmacy benefit managers can play in preventing generic drugmakers from accessing samples. Brand-name drug companies will bring contract provisions to them, he said, but the FDA hasn't seen any PBMs "say they'll stop" withholding the samples thus far.
In addition, the FDA will unveil an overhaul to its approval process in early June, Gottlieb said, which should help bring more drugs to market and increase competition.
#FDA will unveil in June a major updating of the structure and function of its new drug review process to make it more modern, rigorous, to better integrate cross disciplinary science as part of collaborative teams, develop more focused review divisions https://t.co/4rVo6OKjH5— Scott Gottlieb, M.D. (@SGottliebFDA) May 15, 2018
Another step the FDA is taking, Gottlieb said, is examining how it could push drug companies to boost transparency by including drug prices in advertising. He said he doesn't "want to get to too far ahead of the process," but that there are legal hurdles to be addressed before a program could truly be launched, as there's a risk that requiring price transparency would be unconstitutional "compelled speech."
The FDA has convened a working group to dive further into this issue, he said. One of the key issues that group will have to iron out if they can push pharma companies to include prices in ads is determining which price is most effective. Most patients don't pay the list price, for example, he said, so there may be "better proxies" to use.
Gottlieb also sounded off on elements of the plan that touch on coverage for drugs and proposed changes to Medicare that the administration is backing. The administration's plan calls for payers and PBMs to move from the current rebate-centric model to a straight discount model for drug pricing, so that patients more directly see the savings. That's a change that Medicare can drive, Gottlieb said.
Medicare's drug coverage needs to catch up to the current times, he said. The administration is taking another look at Part B because "we're in a much different situation today" than when the program was established.
Drugs in certain Part B categories—such as cancer medications—aren't as novel as they were at one time, so re-evaluating payment to keep up with the proliferation of these medications is key, he said.
"I don't think anyone anticipated how competitive these categories would become," Gottlieb said.