The recent flurry of regulatory activity by the Food and Drug Administration reflects the agency’s revitalization under the Obama administration, a shift that has put industry on alert, according to assessments by both the Los Angeles Times and Newsweek.
Consumer groups have long criticized the FDA for being too slow, too entangled in bureaucracy and too cozy with the industries it was supposed to regulate. But, under the Obama administration, the agency has shifted gears to the point that a Bush administration FDA official called it overzealous.
Over a recent two-week span, the Times reported, the agency slapped strict controls on the anti-diabetes drug Avandia, rebuked mouthwash makers for misleading advertising, warned consumers against using infant sleep positioners and pressed ahead with investigations on the contamination and quality control problems that led to massive recalls of eggs, along with children’s Tylenol and other Johnson & Johnson over-the-counter pediatric medicines.
Another sign of change: Last year the agency issued 103 warning letters for misleading labeling and other violations, compared to 21 three years earlier.
Under the Bush administration, Newsweek said, FDA enforcement actions dropped by about 50 percent, even though the number of problems identified by field inspectors remained steady.
Officials say the budget has been too low for an agency that regulates products accounting for an estimated 25 percent of consumer spending in the United States. But President Obama is requesting a 19 percent budget increase over last year for the FDA, to $3.2 billion, and the agency is in the midst of a three-year plan to raise the number of inspectors from 1,200 to 1,700.
The agency’s bid to broaden its reach has met resistance. For example, a food safety bill passed in the House of Representatives last year has languished in the Senate, despite the salmonella outbreak that sickened more than 1,600 people and led to the recall of more than a half-billion eggs. Still, even without the legislation, the agency instituted new egg safety rules in July.
The FDA also is pushing increased transparency. The New York Times reports that when the agency took action against Avandia last month, it acknowledged that some top scientists vehemently disagreed with the decision, and posted dissenting memorandums on its website.
