- Scott Gottlieb, the newly sworn-in commissioner of the Food and Drug Administration, indicated to agency staff Monday he plans to put rising drug prices front and center as he shapes his regulatory agenda, in line with steady rumblings from the Trump administration hinting at interest in legislative fixes.
- "Too many consumers are priced out of the medicines they need," Gottlieb said in his first address as FDA Commissioner. "Now, I know FDA doesn’t play a direct role in drug pricing. But we still need to be taking meaningful steps to get more low cost alternatives to the market, to increase competition, and to give consumers more options."
- Action on that front is likely to center of the FDA's treatment of biosimilars and complex generics, Gottlieb suggested. But the new FDA chief also wants to ensure generic drugmakers can't "game" the system and inappropriately delay competition — an issue that has been the subject of intense debate over the past year.
While the FDA has little regulatory scope to directly tackle increasing prescription drug costs, Gottlieb's comments Monday show he sees the ongoing controversy as directly impacting the regulator's mission.
"[Americans] need to have medicines and products that work. They need to have opportunities to improve their health," he said. "People can’t live a life of dignity if they don’t have access to these opportunities — if they don’t have access to the consumer protections that we provide and the tools of public health."
Gottlieb has been outspoken about his desire to see generic drugs approved more rapidly, and has written frequently on the topic prior to being appointed FDA Commissioner.
In an August 2016 op-ed published by The Wall Street Journal, Gottlieb argued the FDA's imposition of new regulations and standards on generic drugmakers slowed entry of cheaper medicines and reduced competition. And in comments to lawmakers during his confirmation hearings, Gottlieb said the FDA currently lacks the tools to effectively assess the interchangeability of complex generic products with their branded predecessors, making it more challenging to approve copycat versions of many blockbuster drugs.
Look for Gottlieb to work to change that, as well as continue to develop the regulatory framework supporting licensing of biosimilar drugs, which so far have delivered far less savings than typically seen in generic markets.
Only five biosimilars are currently approved in the U.S. though, meaning first-entrant biosimilar makers can price at a smaller discount to the branded reference product without fearing being undercut by other biosimilar rivals. As more biosimilars win approval, prices could begin to come down more substantially.
Gottlieb also hinted he may soon address generic drug pricing more firmly in the near future.
"We also need to take steps to make sure the generic drug process isn’t being inappropriately gamed to delay competition and disadvantage consumers," Gottlieb said. "I hope to have much more to say on this topic in the coming weeks."
Controversies such as Turing Pharmaceuticals' 5,000% price increase on an old toxoplasmosis drug have put this type of regulatory arbitrage in the spotlight, highlighting the dysfunctional markets that exist for some generic medicines.
Already under a sweeping federal price-fixing investigation, the generic industry could see yet more shake ups under Gottlieb's FDA.