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Home 5 Articles 5 FDA Getting More Muscle to Take Unproven AA Drugs Off the Market

FDA Getting More Muscle to Take Unproven AA Drugs Off the Market

by | Mar 31, 2022 | Articles, News, Open Content

Created in 1982 in response to the HIV/AIDS epidemic, the U.S. Food and Drug Administration’s (FDA’s) Accelerated Approval (AA) Program provides for expedited approval of novel treatments of serious health conditions that the current market isn’t adequately serving. Then, if later studies don’t confirm the efficacy of the drug, AA is withdrawn. At least that’s the theory. In reality, sponsors of AA drugs put off those post-approval (Phase IV) studies for years and years; in some cases, the studies aren’t done at all. Adding to the problem is that the process FDA must use to withdraw AA approval is cumbersome and slow. All of this leaves ineffective and unproven drugs on the market for an extended period. Spurred by the recent Adulhem Alzheimer’s drug approval controversy, Congress is finally getting down to the business of fixing the AA program. Congressional representatives from each party have proposed bills. And while the Republican bill is far more industry-friendly than the Democratic version, both proposals would require sponsors to move faster on their Phase IV study efforts and make it easier for the FDA to exercise its AA withdrawal powers if they don’t. See the full story in the April 2022 issue of Laboratory […]

Glass bottles in production in the tray of an automatic liquid dispenser on the line in a pharmaceutical manufacturing plant.

Created in 1982 in response to the HIV/AIDS epidemic, the U.S. Food and Drug Administration’s (FDA’s) Accelerated Approval (AA) Program provides for expedited approval of novel treatments of serious health conditions that the current market isn’t adequately serving. Then, if later studies don’t confirm the efficacy of the drug, AA is withdrawn.

At least that’s the theory. In reality, sponsors of AA drugs put off those post-approval (Phase IV) studies for years and years; in some cases, the studies aren’t done at all. Adding to the problem is that the process FDA must use to withdraw AA approval is cumbersome and slow. All of this leaves ineffective and unproven drugs on the market for an extended period.

Spurred by the recent Adulhem Alzheimer’s drug approval controversy, Congress is finally getting down to the business of fixing the AA program. Congressional representatives from each party have proposed bills. And while the Republican bill is far more industry-friendly than the Democratic version, both proposals would require sponsors to move faster on their Phase IV study efforts and make it easier for the FDA to exercise its AA withdrawal powers if they don’t.

See the full story in the April 2022 issue of Laboratory Industry Report.