How Dare the FDA Do Its Job!

The origins of the Food and Drug Administration lie in a sort of wild West of unregulated medical practice, a world where anything could be slapped in a bottle and called a tonic, even if it killed people, where no regulations existed to protect food products, where people could merrily push contaminated cheese and whatever else they wanted on the general public. Anything could be labeled and sold in any way, and the results were nothing short of horrifying as people died, developed severe medical complications, failed to receive adequate treatment for health conditions because they thought they were treating themselves appropriately. It took several tries at it, but eventually the US government created a fairly firm regulatory framework for controlling foods and drugs to protect the general public.

This seems to be forgotten in arguments about the function of the FDA and suggestions that it is being too stodgy. It is too aggressive, not functional, too hidebound in bureaucracy. Or people claim that it fails to protect the public, even as the FDA’s funding is slashed and programmes that protect people from harmful pathogens are targeted for elimination or severe cutbacks. It is difficult for a regulatory agency to perform its core functions without the financial and social support to do so; when pathogens do burst onto the open market, organisations like the FDA and the CDC will be blamed, even though they may have been powerless to stop it because of defunding initiatives.

Pharmaceutical companies are complaining about the FDA, arguing that the organization is too erratic and out of control. It takes too long to get regulatory approval for drugs, drug companies don’t know how to craft a successful application because approvals seem arbitrary, and the organisation yanks drugs from the shelves when it thinks they might be unsafe, or encourages drug companies to voluntarily withdraw products so the FDA doesn’t have to initiate proceedings to get them out of reach of the public.

These companies have wisely chosen an excellent hill to fight from, using cancer medications as the thrust of their arguments, as cancer is perhaps one of the most popular social causes in the world of health care. The FDA, they inform the public, is actively harming cancer patients by holding up the regulatory process. People are dying because the FDA cannot move things along and seems to demand more and more evidence of efficacy and safety. The FDA costs patients money by yanking regulatory approval for certain uses, meaning that insurance companies drop coverage for those applications and patients must pay out of pocket if they want to access these lifesaving drugs.

The underling message here is clear: The FDA hates cancer patients. Indeed, the organisation is clearly on an eliminationist quest to leave cancer patients high and dry with no access to treatment. Goon squads of paper pushers cackle in the halls of this regulatory agency, rubbing their hands together with glee at the thought of all the cancer patients they can harm with a simple red stamp, a request for additional review, a hearing to discuss the merits of a drug.

Recent months have seen a slew of FDA hearings to discuss the safety and efficacy of a range of medications. Some of these hearings have resulted in a withdrawal of regulatory approval for these medications because they are apparently unsafe and ineffective, according to review by the FDA. The FDA practices evidence-based medicine. It looks at what is likely to benefit the largest number of people and it works on accomplishing that. Which means that, yes, some patients who respond well to a drug and do not experience harmful side effects may suffer from a decision to revoke approval; those patients are the outliers, and decisions like this are hard on them. The FDA acknowledges this, even as it focuses on the utilitarian practice of regulation.

This is not something the FDA takes pleasure in. You would be hard pressed to find a regulator who thinks it’s fantastic when regulatory decisions harm patients. On the other hand, failing to make those decisions might result in harm to many more patients, while the creation of exceptions like compassionate use grants allows at least some patients to benefit from medications that help them in spite of overwhelming evidence that they shouldn’t. The FDA is doing its primary job, which is protection of the public as a whole, not saving the lives of individual patients.

The framing of the FDA as a dangerous organisation out to kill patients with its overzealous regulations is a dangerous one because it sets the stage for more funding cuts. Lobbying on the part of pharmaceutical companies can and will change the perception of the FDA from a public safety organisation to a dangerous one that wants your aunt, cousin, partner, you yourself, to die. This in turn creates political pressure to defund the FDA, to limit the kinds of programmes it can use to track and prevent health problems, to eliminate entire sectors deemed ‘harmful.’ To dilute the agency’s power. Which, in turn, is going to result perhaps not in a return to the old days, but certainly in increased dangers, and the FDA will be blamed for missing them, and this will be used to argue for further funding cuts, because who wants to fund an agency that does not do its job?

Like all government agencies, the FDA is probably in need of some restructuring and reevaluation to organise its priorities and get it more functional. The agency itself would probably admit this. But that doesn’t mean that the organisation should be thrown out, not even at the behest of pharmaceutical companies eager to get their products into the hands of consumers; not to save their lives, but to increase profits for their manufacturers.