Isn’t it amazing how liberating the truth is?
This morning the Dow Jones Newswires reported that a group of FDA (U.S. Food & Drug Administration) scientists delivered a letter to President-elect Barack Obama’s transition team pleading for fundamental changes in the administration of their agency. The scientist complained that the agency’s managers, likely all Bush appointees, used intimidation and reprisals to suppress honest employees from voicing disagreement with policies or scientific findings. The scientists voiced particular concern about the agency’s scientific review process for medical devices which was characterized as "corrupted and distorted by current FDA managers, thereby placing the American people at risk." Amazingly, it is this very scientific review process that the U.S. Supreme Court recently ruled "pre-empts the field," precluding people injured by such products from seeking recovery from the manufacturers in court if the product was approved by the FDA. The truth that these scientists are bringing forward is that science is being pushed into the closet when it comes to testing and evaluating these products, and the unlucky consumer damaged by the defective devices now has no recourse. This will be the legacy of the Bush Administration unless drastic changes are made at the management level of the agency, and the Supreme Court ruling is legislatively reversed.
We previously posted on the fact that a group of FDA scientists already reported to Congress that new regulatory changes or interpretations were being forced upon the agency by Bush appointed managers with the clear intent of eliminating civil liability for drug and medical devices manufacturers for their defective products. These scientists and career employees related that the agency had historically considered state court civil actions against the manufacturers as complimentary to their review, with both reviews serving to assure the safety and efficacy of the pharmaceuticals and devices being sold to Americans. This most recent letter reveals the extent to which the current FDA management was willing to sacrifice and suppress science in order to accomplish its goals of non-legislative tort reform. And now the FDA has opened an agency office in China to assist the Chinese government with enhancing product quality and safety? Are we teaching or learning?
Let’s trust the truth. The call to action by these scientists should be heard throughout the White House, the Congress, the courts and the media of this country. Do you really think that medical devices and pharmaceuticals will become safer when courtroom doors are closed to those that are injured by them? If not, then the FDA must be revamped and pre-emption in these fields reversed. These scientists are calling upon all of us to assert ourselves for our own protection, and the protection of our progeny. We must move to act now!