The kind of cuts in its workforce and major policy changes that the FDA has seen in the last month, it did not see in its entire 100-plus-year history. This, in turn, has exposed what the FDA was always accused of; being a strongly politically-influenced organization that is not as independent as it claims. But does it mean that the FDA will change its stated core principle of product approval decisions supported by facts? Would products be approved that do not muster the data to support them fully?
The FDA is an organization within the US federal government and hence its senior management has always been responsive to the administration in power. Although the FDA has insisted that its decisions are above politics, the policies enacted by the politically-appointed commissioner of the FDA, and the staff he or she gathers around them, are obviously influenced by their personal inclinations. That said, so far, most of the FDA’s 20,000 (now about 18,000) employees are career regulators and are placed far from the politics of its management. All those regulators follow standard operating procedures (SOPs) listed in their MAPPs (Manuals of Policies and Procedures) for everything they do. There are elaborate regulatory and legal procedures around all FDA tasks, and everything is meticulously documented for future review. All the FDA tasks are done by its employees and it does not use consultants or advisers for critical jobs. This system ensures that the Agency functions are independent of external forces.
So, what happens when the FDA goes through politically motivated upheavals of the kind it is experiencing these days? All government employees, including those at the FDA, have been ordered to be “loyal” to the current administration or get fired. There are reports of conflict of interest in the firing of some reviewers tied to the review of products owned by the very people firing them. Can the FDA reviewers be coerced to make favorable decisions on applications by the politicians or leaders who control their jobs and blatantly threaten to fire the reviewers if they decide otherwise? It may not be that easy.
First, it is impossible to lie about the risks and benefits of a medical product. The clinical and non-clinical scientific data does not depend on the politics of the people doing the experiments. Fraud and/or sloppiness are relatively easy to detect in scientific experiments. And, it would be hard to imagine a reviewer willing to sign off on an application they know to be bad, even if at the risk of losing their job. Second, even if somehow products are approved by the FDA due to political pressure, if they don’t work in the patients or if they cause serious adverse effects, the manufacturers will be the ones paying the price by withdrawing the products, dealing with tort lawsuits. So, the incentive to get approval for a bad product does not exist.
And this should give us a pause before we start getting worried about FDA approving harmful products due to political influence. The system as designed is intended to deal with such situations and will most likely do that.
