Spilt the FDA? Not so quick.

While it is not getting a great deal of attention in the traditional or new media, the issue of whether the FDA should be spilt into two agencies is getting a lot of discussion among those who have followed the agency over the past decade.

With a new FDA commissioner announced, but not yet confirmed—Dr. Margaret Hamburg—and with a deputy also picked out, there are some, including Dan Mitchell of the Daily Bread, a trade pub on the business of food, who believe that the choice of Hamburg actually signals the Administration’s interest in a split of the agency into two separate agencies; one for drugs and one for food safety. I could not disagree more. In his article “New FDA Head: Commissioner of Food?” Mitchell actually describes Hamburg’s experience as a nod toward a split of the organization. I think that Mitchell has not looked far enough into Dr. Hamburg’s background if he thinks that she is only qualified to be the Commissioner of Food.

Peggy was Dr. Fauci’s, Director of the NIAID of the NIH, special assistant for AIDS during the early years of the HIV epidemic. She had many occasions and many duties involved in the fight toward drug discovery, and review of HIV drugs, during these early years. She was instrumental in helping the Institute formulate its plans for HIV drug development grants and contracts and in the development of the overall DHHS response to the HIV epidemic. She was even the Assistant Secretary of the DHHS for planning and evaluation with responsibility over both the NIH and the FDA’s planning and evaluation of programs, not just of HIV, but all drug discovery efforts. Dr. Hamburg is more than ready to be commissioner of the entire FDA and I personally believe there is no reason to split the agency. What they lack is leadership, and they are about to get that. Furthermore, my contacts around town say that such a proposal has no hope of making it through Congress.

Hooray for the FDA!

Thank God the FDA will soon have the best possible commissioner that it could have found–Peggy Hamburg! I was expecting it, but my delight is something akin to the glee I felt when Obama was elected on Nov. 4. I know that is saying a lot, but perhaps many people don’t know how very broken FDA is and how in need of excellence that agency has grown.

Margaret Hamburg brings that excellence. She has the most diverse resume of any physician in Washington, and perhaps in this country with all of the jobs she has held and all her many accomplishments. On top of it all, she is a Mom and certainly the Chief Medical Officer of her household–someone who can relate to the fears and concerns of parents both in food and drug safety, as well as in many of FDA other responsbilities, such as the need to encourage clinical trials in pediatric populations, to broaden the availablility of pain medication to chronic pain sufferers, and much more.

I really look forward to her administration of this agency. Now, I only wish it were a cabinet post!