Gottlieb requested a new comparative standard for opioids and a reauthorization of the biosimilars approval pathway.
One week before stepping down as head of the U.S. Food and Drug Administration (FDA), Commissioner Scott Gottlieb appeared before the Senate Appropriations Committee to discuss the President’s Fiscal Year (FY) 2020 budget request for the agency. The request totals $6.1 billion, an increase of $643 million (or 12%) compared with that for FY 2019.
In a published statement, Gottlieb said that the requested funding would allow the agency to build on current efforts and “make significant progress on several important fronts, including fostering innovation and competition to bring better and more affordable products to market, promoting the development of innovative medical products, combatting the opioid epidemic, modernizing food safety and strengthening foodborne illness response and implementing the 21st Century Cures Act (Cures).” Four key areas of focus for the FDA in 2020 will be transforming medical device safety, cybersecurity, medical countermeasures and drug compounding.
As part of his testimony, Gottlieb requested that Congress create a new standard for the approval of new opioid drugs that includes a requirement for premarket demonstration of superiority over already approved opioid or opioid-containing drugs for the same general indication. He also suggested that Congress consider providing other incentives, such as exclusivity periods, to drive development of safer pain medications. The FDA, meanwhile, is implementing new requirements for longer effectiveness studies and abuse-prevention packaging.
Sen. Patrick Leahy (D-VT) raised the issue of biosimilar insulins, which will have a new approval framework beginning in 2020. Gottlieb indicated that the new biosimilars pathway should provide more competition for insulins and allow products to more easily get to market and compete interchangeably.
Gottlieb also stressed the importance of reauthorization of the biosimilar approval pathway if the Affordable Care Act is invalidated.