The Food and Drug Administration is notoriously allergic to the concept of tradeoffs: FDA bureaucrats see eliminating risk as their highest goal, no matter what benefits might be destroyed in the process. This tendency has manifested itself most tragically in the current drug shortage.
About 150 drugs considered “medically necessary,” including anesthetics and medications that treat lethal illnesses such as leukemia, are today in shortage. This problem has been growing since at least 2005, and there are several causes for it — but overly stringent FDA regulations are one reason it has reached such immense proportions.
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Since the “tainted drugs” crisis that incited a media panic a few years ago, the FDA has made its quality-enforcement policies far more burdensome, stepping up its “Good Manufacturing Practice” rules, as well as its efforts to regulate drugs that were introduced before 1938 (and thus grandfathered out of regulations). Thanks to the FDA’s zero-tolerance enforcement, any drug manufacturer that participates in the U.S. market has to pass inspections with flying colors; otherwise, entire production lines are shut down for retooling.
One might think the market could respond to this pressure, especially given that many of these drugs are out of patent: When the FDA shuts down a line, a competing company could up production. But many production lines run at full capacity, and the FDA has foreclosed this possibility, anyhow. In order to enforce its rules so strictly, the FDA has to keep manufacturers on rigid, pre-approved production schedules. If a shortage develops, other manufacturers have to wait for FDA approval to make more drugs — or even to move scheduled drug batches forward.
Industry groups — who wouldn’t dare suggest taming the FDA, for fear of repercussions — have suggested requiring drug manufacturers to warn the FDA when they sense an impending drug shortage, so that the government can approve production of the drug or a substitute elsewhere. Two Democratic senators have introduced legislation to this effect — which, by placing additional burdens on drug manufacturers, including the prospect of being dragged before Congress for failure to predict a shortage, could prompt some to leave the market. And it does nothing to prevent shortages in the first place.
For that, we’ll need a more reasonable tradeoff between keeping drugs clean and keeping drugs available; whatever the benefits of stricter regulations, it is simply unacceptable that hospitals are forced to choose which patients get life-saving medications simply because a manufacturer fails to satisfy the FDA’s every demand. The FDA should eliminate manufacturing regulations that offer little benefit; allow manufacturers to change their production schedules at will, especially in response to shortages; and find a way to punish minor infractions without shutting down production.
That won’t solve the shortage problem — the other causes of which, we might add, include frivolous lawsuits, Medicaid price controls, and drug-war policies that make it difficult to manufacture pharmaceuticals whose ingredients include controlled substances. But it would move the FDA closer to its core function — which should be to strike a balance between risk and reward, not to reduce risk at any cost.
This is a pressing clinical issue, the consequences of which are quite serious. In my neurocritical care practice, my patients contend with critical daily shortages of simple IV calcium, magnesium, and phosphorus replacement drugs. The consequences of an FDA which wants to regulate the risk out of everything is that patients will die at a far greater rate than if they had some measure of a common sense approach.
By the way, thalidomide is a profoundly bad example. It was never cleared by the FDA in the US for general use, and the fewer that 10 (yes, ten) cases of birth defects reported in the US were tied to Thalidomide obtained outside the US.
@Charles -- You'll have to excuse MikeB as his responses tend to be reflexive rather than based on thoughtful research. He probably thinks DDT is a dangerous chemical and would rather have millions of poor dark-skinned Africans perish due to malaria than question the bogus "evidence" of Rachel Carson or the decree of EPA chief Ruckelshaus.
He probably also thinks LNT on radiation is an appropriate preventive approach. Don't take any flights or walk under an EXIT sign, MikeB.
Mike b...thalidomide has been a life saving drug to treat multiple myeloma. Thanks to FDA regs every patient and doctor must go through the REMs program to certify that grandma isn't pregnant at ninty and is using proper contracecption. The regulations mean that a drug which should cost pennies is several thousands dollars per month.
FDA, CMS, and FTC are the reasons that the cost of healthcare are spiraling skyward.
Mike b...actually thalidomide is a lifesaving drug for patients with multiple myeloma. Thanks to the FDA Patients and doctors must go through the REMs program to certify that grandma is not pregnant at ninty and using proper contraception.
Thanks to FDA, CMS and FTC a medicine that should be pennies costs thousands of dollars per month.
I don't think its possible to completely eliminate risk from our lives and anyone who tries is on a fool's errand. The FDA seems bent on eliminating risk in all areas under their control.
I don't this situation being solved by more regulation as Chuck Schumer has proposed. That seems to be a problem that most Democrats and some Republicans have. This problem won't be fixed until we have someone in Washington who is willing, and politically able, to clean house.
It gets worse; the FDA wants to approve the effacacy of "grandfathered" drugs. "Cochicine" (standard anti-gout treatment) has been tested and the price is climbing? Who knows which drug is next?
