Can the US Government Overrule the FDA’s Approval for a Drug?

• By: Staff Editor
• Date: December 15, 2011

Yes – as shown by the Department of Health and Human Services’ (HHS) overruling of the FDA’s approval of the sale of Plan B contraceptive pill to adolescents without a prescription.

This, however, is the first time in history that a senior US government official overruled the FDA’s approval for a drug. Until this, the FDA’s approval for a drug was considered final. The decision by Kathleen Sibelius, the Secretary of the HHS, has set a historical, and controversial, precedent. Many observers (from the industry, scientific and healthcare fields) feel that this has diminished the FDA’s scientific drug approval process. Critics of the decision say that political considerations have trumped scientific decision-making.