A year ago, Dr. Andrew von Eschenbach, an U.S. Food and Drug Administration (FDA) Commissioner, requested that the Science Board, which is the Advisory Board to the Commission, form a subcommittee to assess whether science and technology at the agency can support current and future regulatory needs. It has become quite apparent that the FDA has failed to do the job required of the agency in an adequate manner. This special committee recently released its report, and we have summarized some of its major findings:
- The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.
- The FDA’s inability to keep up with scientific advances means that American lives are at risk.
- The world looks to the FDA as a leader in medicine and science. Not only can the agency not lead, it can’t even keep up with the advances in science.
- Due to constrained resources and lack of adequate staff, the FDA cannot adequately monitor development of food and medical products because it is unable to keep up with scientific advances.
- The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.
- The lack of a trained workforce means that the FDA is ineffective in fulfilling its mission.
- The FDA cannot fulfill its mission because its information technology infrastructure is inadequate.
- Reports of product dangers are not rapidly compared and analyzed, as inspectors’ reports are still handwritten and slow to work their way through the system.
- There are inadequate emergency backup systems in place, which has resulted in the loss of FDA data in the past.
At a time when the Bush Administration and big Pharma are pushing jointly for total immunity from lawsuits for drugs or products that are FDA approved, these findings by the FDA should be enough to eliminate any thought of pre-emption. Previous FDA internal committees have found problems similar to those now identified within the FDA. But, this report clearly proves that the crises warned about in previous FDA reports have now become realities. As a result, American lives are at risk.
Those Americans who were at risk and became victims are typical of the folks that our firm represents in lawsuits. Each of the victims has a constitutional right to go to court when he or she is harmed or injured by a product or drug. It’s a fundamental truth that none of them should have the courthouse door shut in their face by George Bush or by big Pharma. The argument that approval of a product or drug by the FDA, which admittedly cannot perform its job adequately, should immunize those products from scrutiny by a jury, has clearly been refuted by the very organization big Pharma attempts to hide behind. Once the American people became aware of what the Bush White House and big Pharma are trying to do to them, I believe you will see a public outcry against preemption and against a shutting down of the American jury system.