FDA Scientists Call Out Agency Officials for Misconduct

 

 

In a letter to Congress dated October 14th, eight scientists with the Food and Drug Administration say federal health officials ignored their and other scientists concerns by approving unsafe or ineffective medical devices for sale. They say this move is cause for “serious misconduct.”

The House Committee on Energy and Commerce, headed by Representative John D. Dingell, is investigating the accusations and promises they will uncover whether activity at the top of the FDA’s management “has compromised the health and safety of American consumers.”

Agency managers are more likely to want to approve drugs or devices, while scientists want to be more certain of the trials and tend to call for further testing before the drugs and devices are put on the market. And usually these internal conflicts are done in private. However, the scientists state in their letter that agency managers ordered experts to change their opinions and conclusions. This “corrupted the scientific review of medical devices.”

Some of the devices in question include cardiac stents, imaging equipment, breast implants, and nerve stimulators that relieve depression.

FDA assistant commissioner for integrity and accountability, William McConagha, believes the evidence is compelling and is pushing for the removal of some of the agency’s managers. Of course, agency managers who have done an investigation of their own have refused to take any action. The letter to Congress states that scientists who raised questions were instead targeted for reprisals by their managers.