Blueprint For the New FDA

David Kessler has one. So does Lyndon LaRouche. But the one that matters most belongs to Margaret Hamburg, MD.

As FDA commissioner, Hamburg has a vision for the agency's future. Like Kessler, the aggressive former FDA chief who lobbied to bring tobacco under FDA's jurisdiction, Hamburg believes the agency must be strong and active. Unlike LaRouche, the Libertarian who would like to dismantle FDA, Hamburg foresees more interaction with regulated industries, not less.

Interaction means more communication between the agency and its stakeholders. It also means faster, more-substantive enforcement. Consumer protection is FDA's primary mission, Hamburg told the Food and Drug Law Institute (FDLI) last month, which means regulated companies must comply with the rules, which means FDA must explain the rules more effectively, which means once everyone understands what's expected, rule breakers will quickly find themselves on the wrong end of a warning letter or worse.

Behind her logic is the conviction that strong enforcement deters violators, or as she told the FDLI, "others who would put the public at risk or prey upon vulnerable consumers."

She plans to be open about it, too. In her words, "Clearly explained enforcement actions inform members of the public about potential dangers." FDA's public relations department is going to need more people.

The enforcement policy is already in place. After streamlining the warning-letter process so that internal approvals took less time, the agency went after outlier swine-flu products. First, FDA posted a general warning to consumers in May. By early August, 65 warning letters were sent to owners of offending Web sites. The letters typically asked companies to reply within 48 hours or face heavy enforcement action.

QUOTE OF THE MONTH

"Clearly explained enforcement actions inform members of the public about potential dangers." - FDA commissioner Margaret Hamburg, MD

Clearly, Hamburg doesn't procrastinate. Nor does she seem intent on singling out supplement companies. Two soap and hand-sanitizer companies were among the group that received product-warning letters. Somehow, advising people to wash their hands seems less serious than some of the wacky claims intent on capitalizing on the flu scare. A personal favorite of the latter is the company that advised consumers to buy two bottles of its swine-flu cure-one for now, one in case the disease "goes pandemic."

While Hamburg deserves kudos for strengthening FDA's reaction time to obvious outliers, it remains to be seen exactly how the agency can cope with more inspections and the subsequent paperwork. The agency needs scientists and field inspectors as it is, or the budget to hire third-party contractors, none of which is likely in the current economic climate. In lieu of resources, will FDA sidestep certain procedures in hopes of catching the bad guys before they put products on the market? And not to sound alarmist, but to what lengths would FDA be willing to go to achieve its goals?

There was one telling comment during Hamburg's FDLI presentation. In discussing multiple warning letters, she mentioned that if the agency must address egregious violations, it would consider immediate action before issuing a warning letter. In the case of dangerous products, FDA should feel compelled to move quickly. Again, not to sound alarmist, but who is watching the watcher? We've seen strong and proactive before, not always for the good of us all.