US drug industry leaders are reported to be privately supporting proposals to split the Food and Drug Administration (FDA) into two separate agencies, one with responsibility for food issues and the other dealing with drugs and medical products.
They believe that these proposals, which are included in the Food Safety Modernization Act of 2009 introduced in the House by Representative Rosa DeLauro and in the Senate by Richard Durbin, would enable the drug approval process to be speeded up.
High-profile food disasters such as the recent peanut-related salmonella outbreak and serious problems with contaminated produce and imported milk have drawn the agency’s attention away from timely drug and device approvals, say critics. Late last year, agency officials acknowledged that, in the first 10 months of 2008, the FDA had missed 20% of deadlines for new drugs and biological products related to fees received from industry under the Prescription Drug User Fee Act (PDUFA).
Moreover, it is further suggested that President Barack Obama’s recent appointment of former New York City Health Commissioner Margaret Hamburg to be his FDA Commissioner and of Baltimore Health Commissioner (and long-time industry critic) Joshua Sharfstein as principal deputy commissioner indicates that the President would be supportive of dividing the agency, and that he would then name Dr Hamburg to lead the food operation and Dr Sharfstein to run the drug body.
The Pharmaceutical Research and Manufacturers of America (PhRMA) has made no comment on the proposals. Nor is any industry figure willing to make a public announcement supporting such a split, reports the Associated Press, which quotes Steve Brozak, president of drug/biotech investment brokerage WBB Securities as stating: “every CEO that I know in healthcare is in favor of this, but none that value their share prices will go on the record for fear of retribution from the FDA.”
Mr Brozak is a leading advocate for dividing the agency’s current responsibilities. “As presently constituted, the FDA has too many objectives. It is an agency that needs focus,” he wrote earlier this year in the Food and Drug Law Journal. To achieve that focus, he suggested in the article that the agency’s responsibilities should be split among three federal departments, with food and veterinary oversight going to the Department of Agriculture, cosmetics regulation to the Department of Commerce and oversight for drugs and medical devices remaining with the Department of Health and Human Services’ newly-constituted Drug and Device Agency.
Pointing out that the agency’s budget of $1.738 billion for this year translates to $5.80 per US citizen, Mr. Brozak writes: “if FDA does its job well, the price the US consumer pays for this service is truly a bargain. If FDA fails in its mission, it is wasted money.”
