Food and Drug Administration News

Drug-Plant Inspections Ebbed as Tainted Pills Flowed to U.S.

Inspections of foreign drug manufacturers by the U.S. Food and Drug Administration have fallen in recent years despite increasing worry about the safety and quality of generic medications, congressional investigators said. FDA inspections of overseas pharmaceutical manufacturers declined 10% from …

J&J CEO Spurns U.S. Congressional Hearing on Carcinogens in Talc Products

Johnson & Johnson Chief Executive Officer Alex Gorsky has declined to appear at a U.S. congressional hearing set for Tuesday on the safety of the company’s Baby Powder and other talc-based cosmetics. In an announcement, the House of Representatives Subcommittee …

FDA is Green-Lighting Drugs at Breakneck Speed and Raising Alarm

The U.S. is approving new drugs so fast that companies are now preparing for a green light months in advance of the scheduled decision date, a pace that’s helping patients with rare or untreatable diseases but raising alarm among consumer …

Powder Keg: FDA Bowed to Industry for Decades as Alarms Were Sounded Over Talc

At an invitation-only gathering late last year, U.S. regulators and their guests huddled at a hotel near Washington, D.C., to discuss the best way to detect cancer-causing asbestos in talc powders and cosmetics. The “Asbestos in Talc Symposium,” sponsored by …

Dollar Tree Gets FDA Warning for Potentially Dangerous Drugs

Dollar Tree received a warning letter from U.S. regulators for buying over-the-counter drugs from foreign manufacturers that were made in such substandard conditions that they had been barred from entry to the U.S. The letter sent to Greenbrier International Inc., …

Bausch Yanked Talc From Its Body Powder Months Before J&J Recall

As retailers pull Johnson & Johnson’s recalled talc-based baby powder from their shelves over reports of asbestos contamination, one competitor has yanked the mineral from its product altogether. Bausch Health Cos. Inc., maker of Shower to Shower powder, said it …

Georgia Plant Agrees to Close in Fight Over Gas Emissions

ATLANTA — Georgia officials reached an agreement Monday to temporarily shut down a medical sterilization facility that uses a gas that studies have linked to an increased risk of cancer. A Newton County judge signed off on a deal between …

J&J Says New Tests Find no Asbestos in Same Baby Powder Bottle that Sparked Recall

Johnson & Johnson said on Tuesday that 15 new tests found no asbestos in a bottle of baby powder that the U.S. Food and Drug Administration says tested positive for trace amounts of asbestos, a finding the agency stands by. …

Walmart, CVS Pulling J&J Baby Powder Off Shelves Amid Recall

Walmart Stores Inc. and CVS Health Corp. are pulling some bottles of Johnson & Johnson’s Baby Powder off store shelves after government regulators found tiny amounts of asbestos in one lot of the talc-based product. Rhode Island-based CVS, the largest …

Carcinogen Worry Causes Generic Zantac Recall at U.S. Pharmacies

Some generic Zantac is being pulled from major chain pharmacies in the U.S. shortly after French officials recalled all versions of the popular stomach drug amid a global investigation into a carcinogen found in the pills. Canadian drugmaker Apotex Inc. …