6:36 PM
Jun 23, 2017
 |  BioCentury  |  Politics, Policy & Law

Health & wealth

BioCentury’s interview with FDA Commissioner Scott Gottlieb

Scott Gottlieb has spent a great deal of time since he left FDA as deputy commissioner in 2007 thinking, writing and talking about ways the agency could do a better job of promoting biomedical innovation. In the first in-depth media interview since he returned to the agency as commissioner, Gottlieb told BioCentury how he plans to turn those ideas into action.

His first steps as commissioner have contradicted predictions from critics that Gottlieb would be too friendly to drug manufacturers. For instance, he quickly announced his intention to take aggressive efforts to stimulate generic competition, and to shut down strategies pharma use to stave off generic and biosimilar competition.

Gottlieb’s emphasis on combating abuse of opioids also positioned him squarely on the side of public health, including supporting FDA’s landmark decision to ask Endo International plc to remove Opana ER oxymorphone extended release from the U.S. market.

The priorities and proposals he discussed with BioCentury will cut at the core assumptions underlying the critics’ predictions -- that the interests of regulated industry and public health are inherently opposed.

In his conversation with BioCentury, Gottlieb expressed support for proposals biopharma innovators and patients will applaud, and for others that give many pharma companies heartburn. In the latter category: making complete response letters public after scrubbing them of proprietary data, and tweaking policies to make it easier for biosimilars to obtain interchangeability designations.

At the same time, Gottlieb is intensifying FDA’s commitment to precision medicine by creating policies to simplify the development of drugs for rare disorders that are driven by genetic variations.

Another priority, Gottlieb said, is ensuring that FDA’s policies do not prevent drug companies and payers from having the conversations needed to negotiate outcomes-based reimbursement agreements.

Gottlieb also reported he is spending a lot of time thinking about how FDA should be organized, and about how to help young, talented agency staff grow into leadership positions.

Deliberations about the agency’s structure are leaning toward greater vertical integration, for example by establishing centers of excellence to combine expertise in certain clinical areas from the agency’s centers for drugs, biologics and devices, Gottlieb said.

Both his critics and supporters have speculated that political instability, imagined as a 2 a.m. tweet from Mar-a-Lago, is Gottlieb’s biggest threat. So far, however, his reputation may be more at risk from basic misunderstandings of the role of the commissioner.

Gottlieb brushed off the notion that the public believes he personally makes or influences specific regulatory decisions. He told BioCentury that, consistent with decades of FDA practice, he will defer to professional staff to make regulatory decisions.

However, news and social media are already pointing to pending drug approval decisions as indicators of where Gottlieb is setting the approval bar.

The economic dimension

Traditionally, FDA has avoided involvement with or taking responsibility for the prices of medical products. At the same time, its generic drug and biosimilar programs are motivated principally by the idea that competition will bring lower prices, and that lower prices benefit public health by improving access to medicine.

Gottlieb plans to embrace and promote the idea that pursuing public health goals is good for the economy, and that improving the economics of medical product development can have health benefits, he told BioCentury.

In the long run, he said, developing effective drugs to treat common chronic diseases like diabetes and Alzheimer’s could generate far larger savings than anything that could be accomplished through reducing drug prices.

To help address immediate concerns about drug prices, Gottlieb has committed FDA to identify off-patent drugs that have little or no generic competition to highlight market opportunities, and to put ANDAs for generic versions of...

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