A modest proposal: introduce bioethical review into the drug approval process

There has been raucous furor over the decision of Kathleen Sibelius, the Secretary of Health and Human Services in the Obama administration, to overrule the FDA’s approval of the drug known as Plan B One-Step as an over-the-counter drug. It has never previously transpired that the FDA has been overruled on a matter that falls under its jurisdiction such as this, and FDA Commissioner Margaret Hamburg issued a carefully worded response which, given that Sibelius is her boss, was remarkable for its forthrightness:

I reviewed and thoughtfully considered the data, clinical information, and analysis provided by Center for Drug Evaluation and Research (CDER), and I agree with the Center that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.”

“However, this morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential. Because of her disagreement with FDA’s determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved.  Following Secretary Sebelius’s direction, FDA sent the complete response letter to Teva today.  Plan B One-Step will remain on the market and will remain available for all ages, but a prescription will continue to be required for females under the age of 17.

Art Caplan, Director of the Penn Center for Bioethics, came out fast and furious with his criticisms – bad policy trumping good science.  Writing in the New York Times, Daniel Carpenter, Professor of government at Harvard put out a call to make the FDA an independent body, free of government oversight (or, as some would have it, interference).

These are all interesting matters, but there is a larger issue that surfaces in a single paragraph in Carpenter’s op-ed piece that is worth pondering.

Critics of this idea will point out that the F.D.A. is equipped to review drugs from a health and safety point of view, not from a moral one. This is a reasonable point. But it doesn’t follow that the secretary or president should have a blanket veto over its decisions. Congress could easily establish a law providing for separate bioethical review.

Regulatory agencies such as the FDA have traditionally evaluated drugs on the basis of safety and efficacy alone – they have generally shied away from making determinations about drugs using anything but the raw data to guide their decisions. Such was clearly the case in the evaluation of Plan B One-Step, as FDA Commissioner Hamburg said:

It is our responsibility at FDA to approve drugs that are safe and effective for their intended use based on the scientific evidence.  The review process used by CDER to analyze the data applied a risk/benefit assessment consistent with its standard drug review process.  Our decision-making reflects a body of scientific findings, input from external scientific advisory committees, and data contained in the application that included studies designed specifically to address the regulatory standards for nonprescription drugs.

I accept that the criticism in this instance was aimed at heavy-handed meddling by Secretary Sibelius. But what about the larger issue? What about including bioethical review in the drug approval process?

There is probably little need to consider the impact that drugs have on society at large for most drugs that the regulatory agencies deal with, but for some, including the nuanced bioethical issues may be important. In the field that I know best, cognitive enhancement, it is clear that both experts and the public are divided over whether such drugs should be made available, and if so, to whom and how (exactly the kinds of issues that came up in the Plan B One-Step case). The deluge of lifestyle drugs that are anticipated to arrive in coming years represent a whole barrel full of headaches that regulatory authorities will be forced to contend with. Bioethicists have wrestled with these issues, and are in a position to provide thoughtful advice on the implications of one course or another. The problem is this: who decides? It is one thing to bring in a panel of scientific experts to evaluate the data on drug efficacy and safety, and it is quite another thing to bring in a group of bioethicists to opine on the pluses and minuses of introducing a particular drug in a particular way. As with people in general, bioethicists arrive with a variety of political positions, and the outcome might depend as much upon the choice of experts as anything else. Not so good.

And that is where my modest proposal comes in. Increasingly, bioethicists are carrying out empirical work – querying the public about their attitudes towards one issue or another. [Full disclosure: empirical work of this nature is the centrepiece of what we do here at the National Core for Neuroethics, so admittedly, my modest proposal is self-serving.] This empirical work produces data, and such data could be called upon as part and parcel of drug evaluation in cases where it is appropriate. The issue of who would listen to and adjudicate the data remains a thorny one, but moving from elite opinion to well-designed studies of public opinion would be an important step forward.

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