FDA Reauthorization Steers Clear Of Agency’s OTC Authority, DSHEA, AER Law
This article was originally published in The Tan Sheet
The FDA reauthorization bill Congress has passed does not rock the boat on FDA's current authority over either over-the-counter switches or dietary supplements
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The agency solicits public comment on a draft guidance regarding the reportable food registry, which is slated for implementation Sept. 8. Under RFR, responsible parties - including manufacturers, processors and packagers - will need to alert the agency through its main Web portal that an adulterated food product has the potential to "cause serious adverse health consequences or death to humans," FDA said June 11. The comment period ends June 26. The guidance includes information on when RFR reports must be filed and the information they must include. As specified in the FDA Amendments Act of 2007, RFR reporting requirements exclude infant formula and dietary supplements (1"The Tan Sheet" Sept. 24, 2007)
FDA executives say behind-the-counter status for nonprescription drugs resonates in discussions at the agency, but a former deputy commissioner says the agency's BTC interests are stifled by not having explicit authority
Janet Woodcock's move to become director of the Center for Drug Evaluation and Research illustrates the operational challenges FDA faces: The agency remains committed to its historic bargain with the drug industry to take user fees in order to improve application review, but it is finding it increasingly hard to meet deadlines or to perform any other outside projects