Hot & Bothered – Congress Sends Out Yet Another Missive Concerning FDA

January 31, 2008

Over the past few weeks, Congress has taken an acute interest in a broad range of FDA issues and FDA-regulated products, penning several letters and holding or expressing intent to hold hearings and investigations on various matters.  Below is a list of recent congressional activity:

  • On January 7, 2008, the U.S. House Energy and Commerce Committee sent a letter to Pfizer concerning an investigation of LIPITOR (atorvastatin calcium) direct-to-consumer advertisements involving Dr. Robert Jarvik (the inventor of the artificial heart);
  • On January 16, 2008, the U.S. House Energy and Commerce Committee sent a letter to the Government Accountability Office (“GAO”) concerning the study of behind-the-counter drugs (see FDA Law Blog Post here);

  • On January 22, 2008, several influential Democrats sent a letter to FDA criticizing the Agency’s decision to issue a proposed rule clarifying its Changes Being Effected Supplement regulations (see FDA Law Blog Post here);

  • On January 25, 2008, the U.S. House Energy and Commerce Committee issued a memorandum concerning a business meeting to vote on the issuance of subpoenas for witnesses and documents in connection with the Subcommittee on Oversight and Investigation’s ongoing investigation of KETEK (telithromycin).  On January 29, 2008, it was announced that the subpoenas would be issued;

  • On January 25, 2008, members of the U.S. House Energy and Commerce Committee commented on FDA’s plans to station inspectors in the developing world to improve the Agency’s import program;

  • On January 29, 2008, the U.S. House Energy and Commerce Committee held a hearing, titled “Science and Mission at Risk: FDA’s Self-Assessment.”  At the hearing, GAO released two reports, one on challenges for FDA on conducting manufacturer inspections, and the other on FDA’s food protection plan; and

  • On January 30, 2008, Sen. Charles Grassley (R-IA), Ranking Member of the U.S. Senate Finance Committee, sent a letter to GlaxoSmithKline concerning a leaked New England Journal of Medicine manuscript about a clinical study concerning AVANDIA (rosiglitazone maleate).

One of the most recent missives is a letter sent by Representative Henry Waxman (D-CA) and Senator Edward Kennedy (D-MA) to the GAO requesting an examination of FDA’s oversight of food, user fees, and Information Technology (“IT”).  According to the letter:

Despite its growing list of responsibilities and accompanying needs, FDA’s budget has declined in real terms. In recent years, its annual budget requests have not covered its own needs, its annual appropriations have not kept pace with inflation, and the agency has become increasingly dependent on user fees. Federal funding for other public health agencies . . . has increased, but FDA’s federal funding is dwindling. The effects of this situation are now being felt acutely by the agency and those it serves. . . .

We are concerned about the dilemma that FDA faces in its oversight of foods and critical medical products.  Although our government always faces financial constraints, we cannot afford to put FDA, which performs tasks vital to the public health, in a situation in which it cannot succeed.  We know that we are not alone in our concern. Public confidence in FDA, and the foods and medical products it regulates, is waning. Therefore, we are requesting that you examine the staffing and other resources necessary for FDA to successfully carry out its oversight of foods, drugs, biologics, and medical devices.

The Congressional Letter goes on to cite a November 2007 FDA Science Board report, which found that “FDA’s resource shortfalls have resulted in a plethora of inadequacies that threaten our society.” 

With respect to foods, the Congressional Letter requests that GAO examine FDA’s resources necessary for the Agency to carry out its food safety responsibilities, including the effects of drug, biologic, and device user fees on the availability of funding for food oversight, and FDA’s food budget over the past 10 years.

On user fees, the Congressional Letter notes that “several key components of FDA’s oversight of drugs and devices are not, or are clearly insufficiently, supported by user fees, including generic drug review, the scientific base of the agency; inspections and general enforcement; and oversight of clinical trials and enforcement of human subject protections.” The letter requests that GAO examine, among other things, the extent to which FDA has been able to meet responsibilities not funded by user fees.

Finally, the Congressional Letter expresses concern that FDA has been unable to “effectively modernize and use its IT systems to fulfill its mission needs.”  The letter goes on to note several findings in the November 2007 FDA Science Board report concerning the Agency’s obsolete IT infrastructure, and requests that GAO review FDA’s IT system.  FDA’s PDUFA IV performance goals include several IT objectives that the Agency plans to accomplish by the end of Fiscal Year 2012.  One of the IT goals is to publish a final IT plan in 2008.  In October 2007, FDA held a meeting on the Agency’s IT strategic plan.  On December 28, 2007, FDA announced the availability of a draft plan.

We anticipate that Congress will continue to ramp up its scrutiny of FDA, particularly once President Bush publishes his Fiscal Year 2009 budget request for FDA next week. 

By Kurt R. Karst