Under Obama, a reinvigorated FDA
Within a recent two-week span, the Food and Drug Administration weighed in on the controversial issue of genetically engineered salmon, announced tighter controls on a popular anti- diabetes drug, and rebuked the makers of popular mouthwash products over misleading advertisements.
Simultaneously, it warned consumers that devices supposedly offering protection against sudden infant death syndrome could themselves be lethal, and it pressed ahead with investigations into the biggest recalls in history of contaminated eggs and children’s pediatric medicines.
On Friday, the agency announced that the anti- obesity drug Meridia was being pulled from the market.
The flurry of activity reflects a regulatory activism that seems destined to ramp up as the Obama administration seeks to further its agenda through executive orders rather than through an increasingly contentious Congress.
The FDA has long been seen by consumer groups as too slow, too entangled in its own bureaucracy, and too cozy with the industries it was supposed to regulate. Now, “I think the general approach has clearly been more warning letters, more regulatory activity, a much more rigorous approach to regulating products on the market,” said Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development, a nonprofit research institute partly funded by pharmaceutical firms.
Warning letters for misleading labeling and other violations issued by the FDA’s Center for Drug Evaluation and Research jumped from 24 in 2005 and 21 in 2006 to 103 in 2009, according to the FDA. Additional warning letters also come from FDA regional offices and from other agency offices responsible for the safety and effectiveness of food, biologics, medical devices, cosmetics and other products.
The agency hasn’t gone full throttle yet. It has refused, at least for now, to ban the controversial plastics additive bisphenol A, or BPA, calling instead for further study; and it has also declined calls for sharp restrictions on antibiotics in food animals in favor of recommendations to limit the use of the drugs to promote growth.
“They’re not instinctively anti-industry. They understand the need for regulatory flexibility,” said Lewis Grossman, who teaches food and drug law at American University. “I would describe them as cautiously energetic.”
David Acheson, the FDA’s top food safety official during the George W. Bush administration, contends that the agency is overzealous in pursuing allegedly bogus health claims made by food producers. But “on balance, it’s been mainly science,” he said.
The new activism at the agency has put industry on alert. For example, last fall the FDA ordered treatment of Gulf Coast oysters to prevent a form of bacterial contamination. Oystermen descended on Capitol Hill, saying that treating the mollusks would increase their cost and ruin their taste, and that the 15 or so deaths annually attributed to eating untreated raw oysters were not excessive considering the volume consumed. Sympathetic representatives forced the agency to back down.
The agency has also been thwarted in its effort to gain broader authority to regulate and recall food. A food safety bill passed last year in the House has stalled in the Senate over budgetary issues.
Rep. Darrell Issa (R-Vista), the ranking member of a House investigative panel that has looked into the agency, said inefficiency, not lack of authority, is the FDA’s basic problem. “FDA seems to have too many people spread over too many areas with too many authorities.… Inefficiency doesn’t get better by getting bigger.”
FDA Principal Deputy Commissioner Joshua Sharfstein sees a different problem: poor communication. “If FDA doesn’t explain itself well, not only will people object, they will misunderstand the decision,” he said in an interview.
The agency proposes to do more to increase transparency, including releasing information about unapproved drugs and medical devices and other currently confidential data, which is likely to trigger industry opposition.
It could also pursue reforms on food safety and other issues on its own, using rulemaking instead of new legislation, a tack it took years ago in beefing up oversight of juices and seafood.
But having explicit authorization in new law would “make everything faster and less likely to be challenged,” Sharfstein said.
Generally, big bumps in agency authority have tended to coincide with a public health crisis, said American University’s Grossman.
For that reason, Grossman said, he had expected the recent salmonella outbreak to lead to passage of the pending food safety bill. He was sure the crisis that sickened more than 1,600 people and led to the recall of more than half a billion eggs would “finally get that bill passed.”
“But it didn’t,” he said ruefully.”I just don’t know what will.”
azajac@tribune.com
