Former FDA Reviewer Speaks Out About Intimidation, Retaliation and Marginalizing of Safety

From Truth-Out, the conclusion of an interview by Martha Rosenberg with Ronald Kavanaugh, formerly of the Food and Drug Administration (FDA):

MR: That is similar to the FDA’s claim with the device reviewers. Why do efforts to silence free speech always seem to be couched as “trade secrets”?

RK: Because much of the information we receive are trade secrets and companies explicitly label everything they provide the FDA as such and explicitly prohibit their dissemination. In spite of this, the Food Drug and Cosmetics Act explicitly allows communication of trade secrets by FDA employees to Congress, but since most people are unaware of this, FDA management can use the threat of jail for violation of the Trade Secrets Act, not only to discourage reviewers, but in my case they got Senator Grassley’s staff to destroy the evidence I provided them. The threats, however, can be much worse than prison. One manager threatened my children – who had just turned 4 and 7 years old – and in one large staff meeting, I was referred to as a “saboteur.” Based on other things that happened and were said, I was afraid that I could be killed for talking to Congress and criminal investigators.

MR: Still, the FDA transparency meeting transcripts indicate you not only went to members of Congress, you appealed to the Health and Human Services inspector general.

RK: Congress did put me in contact with the Justice Department, however, I don’t believe my complaints were taken seriously by the FBI or investigated. I believe that actual felonies may well have occurred. For example, I found evidence of insider trading of drug company stocks reflecting knowledge that likely only FDA management would have known. I believe I also have documentation of falsification of documents, fraud, perjury, and widespread racketeering, including witnesses tampering and witness retaliation.

MR: And in addition to this alleged wrongdoing, the public is at risk from unsafe drugs that were approved?

RK: Yes. In fact, thanks in part to the Prescription Drug User Fee Act, [in which drug companies pay for expedited reviews] thalidomide could not be stopped today.

Read the entire interview at Former FDA Reviewer Speaks Out About Intimidation, Retaliation and Marginalizing of Safety.

This information did not appear in the mainstream media.

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