The FDA hoped to release more than 100 draft guidance documents this year, but has only released 6 documents since Trump’s inauguration, according to a Regulatory Affairs Professional Society’s Regulatory Focus report.
Since January 20, nearly 3 months ago, the agency has only released 2 guidance documents and 4 final guidances, according to the report.
All of the documents released so far have been updates on previous guidance, updates to expiration dates on other guidances or consultation guidance from the International Council for Harmonisation, according to RAPS.
Over the 3 months before Trump took office, the FDA released 37 draft and final guidance documents.
There’s no clear reason why the agency has been slow to issue new guidances, according to the RF report, which said that when asked, the FDA referred the publication to the White House for comment, and the White House referred them to the Department of Health and Human Services and the Office of Management and Budget, who did not respond.
Releases could increase once former FDA deputy commissioner Scott Gottlieb is confirmed in his role at the head of the agency. Gottlieb was named the Trump administration’s top choice to head the agency in March, according to a Bloomberg report.
Gottlieb has held several senior positions at the FDA during the George W. Bush administration, and has regularly spoken on plans to lower prescription drug cost through modernizing the federal watchdog’s approval process, according to the report.
Gottlieb serves as a fellow at the conservative American Enterprise Institute and as an assistant professor at the New York University School of Medicine. During his time at the FDA, he served as senior adviser for medical technology, director of medical policy development and deputy commissioner for medical & scientific affairs. Before that he was a senior policy adviser at the Centers for Medicare & Medicaid Services.
