Lawmakers Pledge to Move on FDA Reform in the Next Congress

Washington, DC (Nov. 18)-Reps. John D. Dingell (D-MI), current chairman of the Committee on Energy and Commerce in the US House and Representatives, and Bart Stupak (D-MI), chairman of that committee’s Oversight and Investigations Subcommittee, said that moving the Food and Drug Administration Globalization Act and other measures for drug and food safety will be a key priority for the next Congress. The lawmakers introduced a discussion draft of the Food and Drug Administration Globalization Act in April 2008 and a revised draft in July 2008. The next Congress, the 111th, will convene in January 2009.

“Over the course of our investigation, the committee has found that FDA not only failed in its basic mission, but refused to admit its failures and take steps to protect Americans from unsafe food and drugs,” Dingell said in a Nov. 18 press release. “Now, the policy chieftains at FDA are scrambling to convince the new Administration that they are willing to do what they have failed to do for the past eight years. While this change of heart is welcome, I believe it is only because of the fine work of Chairman Stupak and the Oversight and Investigations Subcommittee. Regardless, in the 111th Congress, the committee will swiftly move FDA reform legislation that is needed to ensure FDA does its job.”

The legislators say FDA has recently taken enforcement actions that they and other members of the Committee on Energy and Commerce have urged over the last two years. These examples include:

• On October 28, FDA sent warning letters to Bayer HealthCare (Morristown, NJ) regarding the marketing of aspirin combination products, including Bayer Women’s Low Dose Aspirin with calcium and Bayer Aspirin with Health Advantage, a dietary supplement with cholesterol-lowering properties. This followed a committee letter requesting an explanation for the lack of agency action on the Bayer product that combined aspirin with the dietary supplement that allegedly lowers cholesterol. The committee said that subcommittee hearings revealed that FDA had either not taken action or delayed action against a number of misleading direct-to-consumer ads, including a Johnson and Johnson ad that promoted off-label use of a drug that has been shown to shorten the lives of cancer patients when prescribed improperly.

• On November 6, FDA seized 11 lots of contaminated heparin at Celsus Laboratories (Cincinnati, OH).  “At an April 29 hearing, FDA assured the Committee that the heparin contamination had been contained and that FDA had agreements from the US processors to test all lots,” said the committee in a press release.  “While the agency refused to send out an import alert, the agency maintained that all heparin API [active pharmaceutical ingredient] and raw heparin arriving at US ports was being tested. Apparently the FDA knew as early as April 8 that this processor was not taking the basic precautions to keep contaminated product out of the US drug supply.”

• On November 10, FDA issued an import alert that required testing of all milk products and processed food containing milk solids from China for the presence of the chemical melamine, which the committee says has resulted in four deaths and the sickening of 50,000 children. The committee said that melamine contamination in foodstuffs from China has been the subject of the committee’s concern since the imported wheat gluten processed into pet food killed thousands of household pets during 2007. “As recently as October 2nd the committee wrote FDA asking for a briefing on the steps that the agency intended to take to protect Americans from the latest widespread contamination of food in China that could make its way into our food supply,” said the committee.

• On November 14, FDA had the Department of Justice request an injunction against the production of generic drugs from the Little Falls, New Jersey, plant Actavis Totowa, a subsidiary of the generic drug firm Actavis (Morristown, NJ). The firm had recalled all its products from that plant due to manufacturing violations. The committee said that because of a similar situation with another generic drug manufacture, Ranbaxy (Gurgaon, Haryana, India), which was cited for manufacturing violations, the committee asked the FDA for information regarding its history of inspections of the plant prior to approving generic drug applications of the company.

In addition to urging for legislative reform through action on the Food and Drug Administration Globalization Act, the lawmakers also are seeking changes in personnel at FDA. “The investigations that Chairman Dingell and I have led over the past two years found that the Bush Administration’s political appointees and high-level FDA bureaucrats have lined their pockets with outrageous bonuses, while neglecting the agency’s core mission of protecting Americans from contaminated food and unsafe drugs,” said Stupak, in a committee press release. “Now, in the Administration’s final days, policymakers at FDA want to appear to be tough on industry. This latest posturing is no reason for FDA political appointees to retain their positions. I encourage the incoming Obama Administration to clean house among FDA’s political appointees and bring change to an agency that badly needs it.”