Could a New President Ban RU-486?
Emily YoffePosted Wednesday, Oct. 4, 2000, at 6:30 PM ETIn the presidential debate, George W. Bush said that if he were president, he wouldn't have the power to change the Food and Drug Administration's approval of abortion drug RU-486. Does the president have the power to change an FDA ruling?
Technically, no. Since a new president can choose his own secretary and commissioner, he could ask the FDA to review a drug's approval process. But that wouldn't require the commissioner to perform a review. And it is very unlikely a drug's approval would be overturned without compelling scientific evidence that the drug is neither safe nor effective.
The best bet would be Congress. It can outlaw a drug, and a president could urge and support such legislation. (Congress is working on various strategies now to limit the availability of RU-486.) Congressional intervention in FDA drug decisions is rare. But back in the 1970s, Congress passed a law preventing the FDA from taking a proposed action to ban saccharine.
Next question?
Explainer wishes to thank Richard A Merrill, professor of law at the University of Virginia Law School
Reader Comments from The Fray:
While I can already guess the "why," I am curious as to the motivations behind banning an FDA-approved pharmaceutical. Pharmaceuticals are to be prescribed and administered by trained medical personnel; namely, physicians. I cannot imagine that physicians would prescribe RU-486 without meeting the existing state regulations in their locale of practice. Truly, however, the reality of a ban extended beyond medicine and the wishes of an individual when there are votes to be garnered. Were RU-486 any other type of pharmaceutical, you'd never hear one word about it.
It seems to me that the introduction of a non-invasive, non-surgical means of abortion presents both sides with a problem--those who construe the process as murder will have to think up something pretty clever to make swallowing a couple of pills seems horrible and wrong, and those for it had better figure out how to show their kids this is not a means of birth control.
--Jay
(To reply, click
here.)
Presumably Bush would not have to formally ask his FDA chief to review the mifepristone decision. He would simply appoint someone who could be trusted to do this on his own, and could be further trusted to come up with the "right" decision on review. I would not rely on some notion that objective medical evidence would be immovably dispositive towards approval. Any judgement for the FDA to approve a medication in general, or to use it for a particular patient, rests on the idea that the benefits outweigh the risks. No matter how trivial we can prove the risks with medical evidence, if you believe that abortion is never a benefit, then the benefits will never outweigh the risks. The handling of mifepristone by Clinton's FDA is itself an illustration of how elastic and non-medical the judgement of benefit is, and almost has to be. The present restrictions are far in excess of those placed on medications and procedures much riskier to the patient. The current pro-choice FDA has obviously surveyed the political risks to mifepristone, and the future of a woman's right to choose, should there be even isolated and anecdotal reports of problems with the new medication. It has therefore imposed a burden of procedural restrictions that sacrifice the interests of individual patients to obtain the medication conveniently, in order to safeguard the health of a woman's right to choose in America.
--Glen Tomkins
(To reply, click
here.)
I'm not sure about this, and I hate to question Prof. Merrill (who taught my administrative law class), but I suspect that a President can issue an executive order to overturn an agency decision that he disagrees with. Of course, Congress can then go ahead and pass legislation to overturn the executive order, but my point is that I'm pretty sure that the President can do more than simply appoint a new agency head and hope for the best.
--Evan Schultz
(To reply, click
here.)
(10/4)
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Reader Comments from The Fray:
While I can already guess the "why," I am curious as to the motivations behind banning an FDA-approved pharmaceutical. Pharmaceuticals are to be prescribed and administered by trained medical personnel; namely, physicians. I cannot imagine that physicians would prescribe RU-486 without meeting the existing state regulations in their locale of practice. Truly, however, the reality of a ban extended beyond medicine and the wishes of an individual when there are votes to be garnered. Were RU-486 any other type of pharmaceutical, you'd never hear one word about it.
It seems to me that the introduction of a non-invasive, non-surgical means of abortion presents both sides with a problem--those who construe the process as murder will have to think up something pretty clever to make swallowing a couple of pills seems horrible and wrong, and those for it had better figure out how to show their kids this is not a means of birth control.
--Jay
(To reply, click here.)
Presumably Bush would not have to formally ask his FDA chief to review the mifepristone decision. He would simply appoint someone who could be trusted to do this on his own, and could be further trusted to come up with the "right" decision on review. I would not rely on some notion that objective medical evidence would be immovably dispositive towards approval. Any judgement for the FDA to approve a medication in general, or to use it for a particular patient, rests on the idea that the benefits outweigh the risks. No matter how trivial we can prove the risks with medical evidence, if you believe that abortion is never a benefit, then the benefits will never outweigh the risks. The handling of mifepristone by Clinton's FDA is itself an illustration of how elastic and non-medical the judgement of benefit is, and almost has to be. The present restrictions are far in excess of those placed on medications and procedures much riskier to the patient. The current pro-choice FDA has obviously surveyed the political risks to mifepristone, and the future of a woman's right to choose, should there be even isolated and anecdotal reports of problems with the new medication. It has therefore imposed a burden of procedural restrictions that sacrifice the interests of individual patients to obtain the medication conveniently, in order to safeguard the health of a woman's right to choose in America.
--Glen Tomkins
(To reply, click here.)
I'm not sure about this, and I hate to question Prof. Merrill (who taught my administrative law class), but I suspect that a President can issue an executive order to overturn an agency decision that he disagrees with. Of course, Congress can then go ahead and pass legislation to overturn the executive order, but my point is that I'm pretty sure that the President can do more than simply appoint a new agency head and hope for the best.
--Evan Schultz
(To reply, click here.)
(10/4)