FDA Revives Unapproved Drugs Initiative

The FDA is reversing the Trump administration’s decision to end the Unapproved Drugs Initiative.

This program, which launched in 2006, requires pharmaceutical manufacturers to seek approval for drugs that were never approved but were on the market because they predated stricter regulatory requirements. Critics have complained that, after winning approval for drugs that led to price hikes or shortages, some companies established monopolies.

When U.S. Department of Health and Human Services (HHS) officials announced the program was being halted in November 2020, they claimed “serious legal concerns” over whether the program was implemented correctly, citing a third-party analysis that showed that ending the initiative would save billions of dollars. The FDA argued that the HHS announcement “contained multiple legal and factual inaccuracies.”

In addition, an analysis published in JAMA Internal Medicine in May found that more than half of 21 drugs approved under the initiative had market exclusivity for longer than intended (3.4 years). Also, five years after the program began, most of those drugs had fewer competitors and higher prices.

“We’re pretty clear that the initiative, as it was conducted over the years by the FDA, caused prices to peak and that’s a bad outcome that should be avoided,” said Benjamin Rome, MD, coauthor of the study and an instructor of medicine at the Program on Regulation, Therapeutics, and Law at Harvard Medical School and Brigham and Women’s Hospital. “It was a laudable goal, but if FDA is going to revive it, the agency needs to reform the program so it doesn’t have adverse consequences.”

Sources: STAT, May 27, 2021; Gunter SJ, Kesselheim AS, Rome BN. Market Exclusivity and Changes in Competition and Prices Associated With the US Food and Drug Administration Unapproved Drug Initiative. JAMA Intn Med. Published online May 17, 2021. doi:10.1001/jamainternmed.2021.1989