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,