The FDA (Food and Drug Administration) “stands accused of being little more than a rubber-stamping agency for Big Pharma.”
“The FDA has progressively morphed into a mere pawn and instrument of the drug industry, which has little to do with drug safety, and everything to do with maximizing profits.” writes Dr. Mercola in an article, on the Food Consumer web site.
Ronald Kavanagh, a “whistleblower” from the FDA has stepped forward to reveal the agency’s questionable practices.
In an interview by Martha Rosenberg from the online news magazine ‘Truth-Out’, Mr. Kavanagh says:
“In the Center for Drugs [Center for Drug Evaluation and Research or CDER], as in the Center for Devices, the honest employee fears the dishonest employee.
There is also irrefutable evidence that managers at CDER have placed the nation at risk by corrupting the evaluation of drugs and by interfering with our ability to ensure the safety and efficacy of drugs. While I was at FDA, drug reviewers were clearly told not to question drug companies and that our job was to approve drugs. We were prevented, except in rare instances, from presenting findings at advisory committees.
In 2007, formal policies were instituted so that speaking in any way that could reflect poorly on the agency could result in termination. If we asked questions that could delay or prevent a drug’s approval – which of course was our job as drug reviewers – management would reprimand us, reassign us, hold secret meetings about us, and worse. Obviously in such an environment, people will self-censor.”
The FDA’s internal rules and regulations seem to be designed to circumvent serious safety reviews from the get-go.
Drug companies are not required to include adverse events on the drug’s label if the adverse reaction is:
- Below a certain percentage
- Below double the rate of the adverse event found in a placebo
According to Kavanagh:
“By this rule, certain serious and potentially lethal adverse events that eventually resulted in a drug being withdrawn from the market would not have had any mention of the adverse events made in the labeling at all.”
The FDA’s mission statement reads as follows:
“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.”
The Subcommittee on Science and Technology, detailed how the FDA cannot fulfill its stated mission because:
- Its scientific base has eroded and its scientific organizational structure is weak
- Its scientific workforce does not have sufficient capacity and capability, and
- Its information technology (IT) infrastructure is inadequate
