Attention to Detail: Gottlieb Sets High Bar for Future FDA Commissioners

Regulatory NewsRegulatory News | 06 March 2019 |  By 

In a time when President Donald Trump calls the press “the enemy of the people,” it’s rare to see one of his appointees work with the media so closely and be devoted to honing and tailoring his agency’s message.

And for outgoing FDA Commissioner Scott Gottlieb, attention to detail was one of the signatures of his nearly two-year tenure. That attention to detail helped to inform his daily in-depth explanations of new policies, guidance and rulemakings, often stretching into thousands of words, which have not been seen with recent commissioners.

Initially criticized for his close ties to biopharma, the fast-talking Gottlieb handled the spotlight well, showcased his leadership skills during the partial government shutdown, and is now almost universally praised, particularly for his work related to the medical product sectors.

Gottlieb was the first FDA commissioner to call out and address drug prices head on, focusing his efforts on increasing generic drug and biosimilar competition (he famously called on brand drugmakers to “end the shenanigans” on delaying generics).

As part of his Drug Competition Action Plan, FDA published a list of off-patent, off-exclusivity branded drugs without approved generics, a list of brand name companies that refused to provide samples to generic applicants, and also implemented, for the first time, a new policy to expedite the review of generic drug applications where competition is limited. In addition, the agency got its competitive generic therapy (CGT) designation program off the ground during his tenure.

Also an advocate for biosimilars, Gottlieb told Focus in an interview last April that he thinks there will be interchangeable biosimilars on the market relatively soon and that the agency is looking to “educate providers and the public and help them understand FDA’s rigorous biosimilar review process.”

As part of FDA’s action plan on biosimilars, he said the agency is “actively exploring" whether "in some circumstances" FDA can "facilitate the increased use of non-US-licensed comparator products in certain studies to support" 351(k) applications.

As far as his focus on innovation, Gottlieb detailed how the agency is gearing up to deal with receiving upward of 200 INDs for cell and gene therapies each year, adding to the 800 active INDs for such products already filed with the agency.

And on the medical device side, Gottlieb spearheaded agency efforts around its pre-certification pilot program for digital health developers, and work to modernize the 510(k) regulatory review pathway, with more of a focus on predicate medical devices that are 10 years old or less.

So now that Gottlieb’s resignation is set, what’s coming for FDA in the coming month before his departure? He told an event at the Newseum on Wednesday that he hopes there will be an acting FDA commissioner in place before he leaves to enable a smooth transition.

And while he said his resignation is not linked to any particular policy, he also said Wednesday that he might even be willing to come back to the agency.

Updated on 3/7/2019 to note that reports say Principal Deputy Commissioner Amy Abernathy, who recently joined FDA, will not serve as acting commissioner.


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