Bureaucracy Can Save Lives – The Legacy of Dr. Frances Kelsey

By Robert Field

What adjective would most people associate with the word “bureaucrat”? For many, it would be “inefficient,” “inept,” or “incompetent.” But another that is just as descriptive is “lifesaving.”

Dr. Frances Kelsey, who died this month at the age of 101, was celebrated as an American hero for her work as a medical officer at the Food and Drug Administration (FDA). She saved thousands of lives and prevented untold suffering by using techniques that earn bureaucrats a bad name, delay and obstruction, to keep the drug thalidomide from reaching the market in the United States in 1961.

Thalidomide is a sedative that had been approved for sale in Europe four years earlier and was prescribed for morning sickness during pregnancy. The American manufacturer, Richardson-Merrell, saw a large potential market in the United States. However, Dr. Kelsey, who was assigned to review its application for marketing approval, was troubled by questionable safety data. The law in effect in 1961 required that she issue a decision within 60 days, but she was able to buy more time by asking for additional information.

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Generics, Bioequivalence, and Justice

By Matthew L Baum

I have written previously on this blog about morally modifying technologies (here and here), which by definition work no better than existing technologies but enable the side-stepping of a moral tension associated with the first technology. Generic pharmaceuticals are a particularly well-known and widely endorsed form of morally modifying technology: they have no therapeutic advantage over name-brand drugs, but by costing less enable the sidestepping of some of the difficult moral issues involved in rationing healthcare.   With the current public focus on limiting the rising cost of healthcare, moreover, there is increasing emphasis on the development and use of generics as a cost-saving measure. Jonathan J. Darrow has already written on this blog questioning whether we should celebrate increasing public endorsement of the development of these drugs that bring with them no new therapeutic benefit. But I would like to highlight in this post a different challenge to the responsible pursuit of a golden age of generics: bioequivalence.

Helping the development costs of generics to stay low, the FDA has an abbreviated approvals process that hinges on the generic being shown ‘bioequivalent’ to the name-brand drug (on top of requiring the generic to contain the same active chemical and be taken by the same route and dosage form) [See here and here]. Bioequivalence may sound reasonable, but many would be surprised to learn that it does not mean therapeutic equivalence.

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Regulating Compounding Pharmacies: Why An Increased FDA Role Shouldn’t Be Our Default Option

By Patrick O’Leary

A friend and I were having a conversation about health policy the other day when he observed that drug regulators like FDA face an impossible task in terms of public expectations: as consumers, we expect the drugs we take to be 100% safe, 100% of the time. Of course, no regulator, no matter how powerful or well funded, could deliver on that expectation, and the reality is that FDA operates under a variety of limitations, both fiscal and legal.

The current deadly meningitis outbreak linked to contaminated injections made by a Massachusetts compounding pharmacy shocks us and upsets our expectation that the drugs we take to get better will not, at the very least, cause us harm. Responding reflexively to this crisis, many in the media and in Washington have already started to call for greater federal oversight. This is a natural impulse, but one that merits cool-headed consideration. FDA is an agency that already has a broad statutory mandate and limited resources. Enforcement resources are slim enough that the agency’s response to an HHS report this month finding rampant violation of dietary supplement-labeling laws was simply to say that the agency would “address the recommendations as its resources and priorities allow.” Before we add still further to FDA’s crowded plate at a time when it is already facing a potential budget crisis (and it is worth noting that according to at least one former FDA chief counsel and congressional testimony by agency officials, FDA already possesses the authority to regulate pharmacies like the one involved in the outbreak and historically has done so), it is worth asking whether FDA enforcement is the only or best solution to the problem.

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