Consumers Ask for More Transparency at the FDA

July 21, 2009
Category: Uncategorized

Americans are demanding to know how the US Food and Drug Administration makes its decisions about the medicine they take and the food they consume.
Your immediate action is needed. A recent public meeting was held at which consumers, doctors, and scientists told the FDA administration they deserve to have more detail about the FDA’s decision-making process. And representatives from the pharmaceutical and medical device industry stated that their confidential commercial information should not be made public. While certainly a balance should be struck between the public’s right to know how the FDA makes decisions about their medicine and food on the one hand, and industry’s right to trade secret privacy on the other, very often it is the consumers’ rights that are trampled in favor of moneyed interests.
A recent recall of defective implantable heart devices revealed, for example, that both the FDA and the device manufacturer knew of the defects, but kept doctors and patients alike in the dark. The FDA had made the decision not to release the information to physicians using the devices because vital trade secrets might be revealed about the devices. It was a full two years before physicians were notified that the devices they were using were defective. How can the FDA possibly claim that patient safety is their highest priority?
A senior health policy analyst at Consumers Union, Steve Findlay, has recommended that notification of meetings between FDA government officials and representatives of the industries they regulate be posted at the FDA website, so that watchdog groups and the general public can stay fully informed.
FDA reform has become a rallying cry for many consumers. They believe the FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability. They say the FDA does not have the capacity to ensure the safety of food for the nation. They feel the development of medical products based on new scientific discoveries cannot adequately be regulated by the FDA and, more importantly, that the FDA cannot fulfill its mission because its scientific base is weak.
Good drugs are either not approved or are approved after interminable delays. Even after new drugs are shown to be safe, doctors cannot use them with terminally ill patients whose cases are otherwise hopeless. Even worse, bad drugs are approved—often on the recommendation of panels whose members include drug company consultants.
The FDA has as bad a record with food safety as it does with drug safety. When fresh food turns out to be contaminated, the only solution the Agency can come up with is to “nuke” it with radiation. What does this do to food? The FDA certainly does not know. If irradiated salad is not unappetizing enough, how about cloned meat, also recently approved?
Producers of food extracts and dietary supplements would like to tell the American public about the scientific research that has been done on their products. Millions of lives could be saved as a result. But the FDA will not permit it. The Agency ignores First Amendment protections and censors the communication of valid scientific information.
The FDA’s decisions directly affect your life each day. Would you please take a moment to address your concerns to the FDA? Our online advocacy tool will let you send your letter effortlessly. (The FDA makes it almost impossible to email them directly, so for your convenience we will collect and hand-deliver your messages for you.)
Voice your ideas and get involved!

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