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FDA Reform Planned

Aug 22, 2008 | Parker Waichman LLP

Federal lawmakers are looking to reform the U.S. Food and Drug Administration (FDA), which regulates drugs and 80 percent of the food Americans eat.  The U.S. Department of Agriculture (USDA) regulates the other 20 percent of food—generally meat.  Despite that the FDA monitors the overwhelming majority of this nation’s food, it only received a fraction of the funding and the staffing of the USDA.

Meanwhile, we have long been reporting on the issue of food regulation in the U.S. in the face of ongoing, often massive nationwide outbreaks of deadly food borne illnesses such as Salmonella, Listeria, and E. coli, to name a few.  Given the recent problems with meat and produce that have sickened thousands and hospitalized dozens in the past couple of months, perhaps our food safety systems needs—if not an overhaul—some changes to better protect Americans.

Although the U.S. is not the only “developed country” to suffer problems associated with tainted food products, we are quickly gaining a reputation for being terribly lax in handling the problem.  In other countries, foreign agencies can recall dangerous food products and also require producers to recall products when there is reason to believe products might be unsafe.  This is not done in the US.  Worse, the FDA has not implemented the food protection plan it announced last year, which included focusing its resources on the highest risks.  The FDA has only gone so far as to have recently informed Congress on how much money is needed for the plan.

Even in the face of ongoing complaints over inadequate funding, some embarrassing and widely publicized blunders, and lawmaker objection, the FDA announced this spring that it increased employee bonuses by a whopping 29 percent and paid out $35 million in staff incentives for year ending April 12, a significant increase from the $27.1 million it paid the prior year, according to records posted on the House Energy and Commerce Committee’s Website.  Just last year, lawmakers complained that the FDA was issuing too many bonuses, especially to high-ranking officials. This recent increase, which was shown in records provided by the FDA, prompted renewed objections by Representative Bart Stupack—Democrat-Michigan—chairman of the panel's investigative subcommittee.  "It is outrageous that bonuses for top officials at FDA increased by nearly 30 percent over the past year despite the agency's poor management," Stupak said   "These bonuses are not going to the men and women in the field who FDA struggles to retain.  They're going to top agency officials in Washington who have presided over the agency while an unprecedented number of Americans have been sickened by contaminated food and drugs."

Stupak and other lawmakers faulted the FDA's handling of food and drug safety after consumers became ill from tainted spinach in 2006, peanut butter in 2007, and the blood thinner Heparin this year.  In the Heparin debacle, the FDA reported that since the end of 2007, it received over 700 reports of adverse reactions associated with Baxter's multiple-dose injectable Heparin; 40 percent of these reports were deemed serious.  That investigation revealed problems over inadequate FDA inspections of oversees drug and drug component manufacturers and ingredients obtained from shoddy, unregulated factories, highlighting some critical problems at the FDA, which led to government investigations and hearings over FDA practices.


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