Towns proposes FDA drug recall bill
This article was originally published in The Tan Sheet
Executive Summary
The House Oversight and Government Reform Committee chairman introduces legislation to authorize FDA to mandate recalls of adulterated, misbranded or potentially unsafe drugs. Rep. Edolphus Towns offered 1H.R. 5740 July 15; the bill awaits action by the Energy and Commerce Committee. "Too often, the FDA has been in the position of having to persuade companies to recall suspect products," the New York Democrat said, adding H.R. 5740 would give the agency "the full authority to pull contaminated medication from the market when necessary." Towns' bill responds directly to Johnson & Johnson's extensive recalls of OTC children's products and his committee's investigation of the firm's manufacturing problems and FDA's response to them (2"The Tan Sheet" May 31, 2010). FDA currently has mandatory recall authority for medical devices, but not for drugs or dietary supplements
You may also be interested in...
Senate Bill Expands FDA's OTC Manufacturing Oversight
Legislation introduced in the Senate to give FDA mandatory recall authority for all drugs would bar the agency from considering a drug's prescription status when assessing risk to prioritize inspections
FDA To Toughen OTC Oversight, Seek New Authority In Wake Of J&J Recalls
FDA will monitor more closely OTC manufacturing operations and require comprehensive changes at firms with systemic quality deficiencies as a result of its investigation of Johnson & Johnson's McNeil Consumer Healthcare
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.