Citing sources, Reuters reported Friday afternoon that President Trump is close to naming Scott Gottlieb as the next FDA commissioner. The news could come any moment, according to the wire service, resolving an issue that has huge implications for biopharma.
If the story holds up, Gottlieb’s nomination would be widely applauded by the biopharma industry, which would likely see the move as a commitment for continued reform without the kind of wholesale deregulation that would scuttle the agency’s gold standard for drug reviews.
As I reported two weeks ago, Gottlieb has mapped out an aggressive reform agenda in anticipation of this appointment.
According to his statements as well as comments to people familiar with his thinking on the FDA, Gottlieb intends to shoot for the rapid approval of complex generics, ushering in a wave of less expensive rivals to some of the biggest blockbusters on the market. He’s also likely to spur the FDA to follow the course laid out by agency cancer czar Richard Pazdur in speeding new approvals, possibly setting up a special unit aimed at orphan drugs to hasten OKs with smaller, better designed clinical trials.
Other potential reforms include the possible quick adoption of new devices that could be used to improve the kind of medtech Apple, Verily and others have been working on.
Gottlieb has also backed the publication of the FDA’s complete response letters, detailing the reasons why the agency rejects a drug. Over the years regulators have routinely complained that many companies have been less than honest in recounting the FDA’s position on a drug. The FDA is currently restricted by law in its public discussion about a new drug approval.
The move could also spell relief for Amicus Therapeutics and CEO John Crowley, who personally lobbied the president on the FDA’s decision to delay any final decision on their drug for Fabry disease so they could see the results of a safety study in 2019.
Left out in the move: Jim O’Neill. The close associate of Peter Thiel, O’Neill famously suggested that drugs should be approved based on safety alone, letting consumers sort out what works. That left many fearing that Trump intended to toss out the regulatory framework for new drug approvals, raising fears that his idea of competition would allow de facto placebos to compete for market share.
Trump has repeatedly criticized biopharma for outrageously high drug prices, vowing to simplify the drug development process as he also sought to dramatically lower the price of drugs.
Reprinted from Endpoints News. Copyright 2017. Endpoints News reports and analyzes the top global biotech and pharmaceutical R&D news of the day. Sign up for its free reports at https://endpts.com