FDA: Fix Deficient Activity

First, Vioxx faced withdrawal despite FDA approval.

More recently, an impurity in an active ingredient that came from a Chinese factory caused Baxter International to recall its total production of various types of heparin. More than 60 people died from allergic reactions in the aftermath.

In the meantime, the U.S. Supreme Court took the first steps toward removing manufacturer liability when products meet FDA approval. In Riegel vs. Medtronic, it ruled that when the FDA approves the safety of a medical device, individuals have no legal recourse if something goes wrong. A similar case involving pharmaceuticals is due to be heard soon.

Is the FDA up to the task of protecting us? Several statistics depict a dire situation:

   - As of September 30, 12 out of 16 of the advisory committees in the Center for Drug Evaluation & Research were without chairmanship and had 83 vacancies. (Source: The RPM Report)

   - The number of FDA inspectors who certify that manufacturing plants meet current GMP standards has decreased by 25 percent since 2002. (Source: GAO)

   - More than half of the clinical trials used to support FDA approval remain unpublished in peer-reviewed literature for at least five years after approval has been granted. (Source: www.sciencebasedmedicine.org)

Apparently the FDA is deficient in maintaining leadership, staffing and transparency. Many agree it's time for fundamental restructuring.

Representative John Dingel (D-Michigan) is vocal about FDA shortcomings and believes that congressionally mandated change is needed. He is holding oversight committee meetings to take FDA leaders to task about making improvements. Dingel also is formulating an overhaul plan that he hopes to enact by year-end, or that may become a model for action under the new administration.

In a post on this blog on August 8 entitled "Our Healthcare Conundrum," I cited a candid assertion made by the FDA's Dr. Steven Gutman: "The health system will explode in three to four years and that will fix it." As I look at the FDA's current state, I understand his comment as coming from inside the volcano. But, as an optimist, I'm convinced that we can alleviate some pressure from the magma chamber before it blows.

Maybe we really can make progress in retooling the FDA into a organization that facilitates innovation while protecting us from harm. By more clearly defining the FDA's role and responsibilities, establishing strong leadership and accountability, and by providing the required resources, we can fix deficient activity.

— Tom DeSanto