The U.S. Food and Drug Administration (FDA) is charged with the following mission: to promote and protect the public health. Recent evidence suggests they are failing miserably.
Consumers and health care professionals depend on certain government agencies to protect the public welfare. We’ve seen recently how esteemed institutions like the Centers for Disease Control (CDC) are under fire for failing in this regard. Now the FDA is following suit.
According to a recent Reader’s Digest piece (Strong Medicine: What’s Ailing the FDA?):
Recent headlines have uncovered one shocking lapse after another at the Food and Drug Administration: A popular diabetes drug can sharply increase the risk of heart attack, a finding the agency knew but took two years to reveal. An FDA-approved antibiotic can destroy your liver in just five days. And despite mounting concerns about the safety of Chinese-made drugs, the agency had only enough field inspectors last year to check a mere 13 of the 714 Chinese factories that produce medicines for U.S. consumers.
Many of the nation’s leading doctors, scientists and lawmakers now agree that the FDA is in crisis. Lurching from one disaster to another, the 102-year-old agency learns of dangers too late and then moves too slowly to remedy them. Insiders say it’s woefully underfunded, dangerously understaffed and fractured by bitter internal tensions. Instead of depending on the FDA, Americans are doubting it — and for good reason.
In typical bureaucratic fashion, the FDA is about to be handed even more responsibilities with fewer resources to handle them. The New York Times reports that the Supreme Court is about to weigh in on the infamous “pre-emption” rule, which essentially states that if the FDA approves a drug, that drug’s manufacturer cannot be held liable for adverse health claims, even if said manufacturer had prior knowledge of such effects. Many people believe the Court will rule in favor of big pharma.
The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.
So let’s get this straight. We are to trust the FDA, an overwhelmed, underfunded agency, with protecting us to such a degree that we should absolve pharmaceutical companies, IN ADVANCE, from all blame. Is it just me, or is this nuts? Even the FDA commissioner, Andrew C. von Eschenbach, has acknowledged “that the agency faces a crisis and may not be ‘adequate to regulate the food and drugs of the 21st century’.” Only a few weeks ago, the agency admitted that it used plastics industry conflicted studies (and ignored relevant, independent scientific studies) to determine that BPA exposure poses no risks to human health – only to find out that they were wrong. The FDA has already demonstrated they are unable to effectively police pharma. The process is badly broken, and children are once again the victims. The AP reported only yesterday that surging numbers of hospitalized children are suffering from adverse reactions to medications. How are we to ensure their safety? The FDA is not protecting our children.
When are we going to stand up, as a society, and start valuing the lives of children? We must speak for them, and we must do so now.