Possible FDA Split Could Mean Safer Drugs, Fewer Medical Injuries
Critics of the U.S. Food and Drug Administration (FDA) have long believed that the agency should be split into two parts to ensure adequate safety processes for drug approvals and, in turn, fewer medical injuries. If President Obama’s recent actions are any indication of whats to come, these critics will soon have their wish.
Last month, President Obama appointed two health experts to top positions at the FDA. Former New York City health commissioner, Margaret Hamper, is the President's choice for the agency's commissioner; while pediatrician and child safety expert, Joshua Sharfstein, is the President's choice for deputy commissioner. Experts believe that the President's choice of two experts is an indication that he is in favor of splitting the FDA into two separate units.
FDA critics have long argued that the agency is overworked and simply unable to monitor the safety of the vast amounts of pharmaceutical drugs, medical products, and medical devices that come through its doors. The agency suffers from under staffing and a shortage of resources necessary to ensure drug safety. FDA officials, themselves, admit that the agency is unable to meet the changing demands of a globalized world, where pharmaceutical drugs are frequently sourced from foreign plants. In 2005, the FDA approved close to 3,200 applications for marketing of new medical devices. Yet, the agency has only a fraction of the scientist and researchers necessary to process so many applications. Because of this the FDA often has no other option, but to rely on the device makers themselves to disclose the risks of their products.
FDA Division Supporters
The drug industry has been quietly supporting a possible division of the agency, because it could result in faster approvals of pharmaceutical drugs. The FDA experiences frequent delays in its approval and review processes for pharmaceutical drugs due to its shortage of staff. However, medical injury lawyers would welcome an FDA split due to the possibility of more stringent monitoring of review processes and, therefore, enhanced safety of drugs and devices approved for promotion.
In recent years the FDA has battled several food safety crises. Every time there is a contaminated batch of peanut butter or pistachios, the agency is forced to turn its attention to food safety. It has become increasingly clear that we cannot continue to expect the agency, responsible for making sure tomatoes and peppers are free of pathogens, to also be responsible for monitoring the safety of bone graft products, implantable cardioverter defibrillators and drug eluting stents.
If you've been injured through use of a defective drug, medical device, contact a medical injury lawyer at Arnold & Itkin LLP for a free evaluation.
