The Goldberg Law Firm Co., LPA

The Goldberg Law Firm Co., LPA

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FDA Can’t Do Its Job

There are several reasons why the FDA is unable to really do a good job of regu­lating the drug manufacturers. One of them is that Congress has failed to fund the agency properly. Most folks are shocked when they learn that the FDA receives nearly $400 million from the drug industry. That amounts to 20% of the agency’s total budget.

Another problem with the FDA is that it has to deal with the “fast track’ approach to new drug approvals. Since the FDA sped up the approval process to accommodate BIG PHARMA, one in five new drugs have had to be removed from the market or receive a black box warning after FDA approval. Source: Pubic Citizen

Dr. Andrew von Eschen bach, 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 summa rized 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; and
  • There are inadequate emergency backup systems in place, which has resulted in the loss of FDA data in the past.

Americans 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 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 become aware of what big Pharma are trying to do to them, you will see a public outcry against preemption and against a shutting down of the American jury system.