In case you missed it during the 2008 presidential primary news blizzard of the past few months, which has consumed the front page of newspapers nationwide, the Food and Drug Administration (FDA) has once again failed to protect the American public from harm caused by pharmaceutical drugs and devices. Choosing to protect the outrageous profits of the major drug manufacturers over the health and welfare of each of us, and after failing to gain the support of Congress in their quest to do so, the FDA went behind Congress’s back to President Bush to propose new rules concerning labeling requirements on drugs. In addition to the fact that important side effect information would be less likely to reach consumers under the proposed rule, the change would also permit companies to update their drug and device labels with new safety information without waiting for FDA approval.
Several members of Congress, Henry A. Waxman, John D. Dingell, Frank Pallone, Jr., Rosa L. DeLauro, and Edward Markey, from the U.S. House of Representatives, and Senators Edward M. Kennedy, Patrick J. Leahy, and Christopher J. Dodd, took it upon themselves to directly question the motives for such a proposal and sent a letter to the FDA on January 23, 2008 outlining their concerns and demanding accountability, and stated, “We are concerned that the intent of this proposal is to protect companies in the pharmaceutical and device industry from being held liable for marketing products they know are unsafe,” said the members in a letter to FDA Commissioner von Eschenbach. “Such a policy change comes at the expense of consumers and violates the mission of the FDA.”
The FDA’s Mission Statement completely supports the position taken by these members of Congress that the FDA’s SOLE responsibility is to the American people: “The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.” Nowhere in the mission statement is there made mention of protecting the profits of pharmaceutical companies.
The Association of American Justice, the leading attorney organization assisting injured Americans, has also called for the proposed rule to be withdrawn. Consumer protection groups are outraged and are calling on consumers, Congress and activitists to fight against these proposed changes. Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, summed up their collective feelings of frustration in stating, “This is a dangerous situation, made worse by the FDA’s poor record of approving harmful drugs based on limited, and even fraudulent, clinical trials performed by the drug companies.”
Shame on the FDA for “back-dooring” these proposed changes which can do nothing but further erode any remaining confidence the American public has in the Bush Administration and the FDA on this subject.