Bioethics Discussion Blog: FDA's Interest: Science or Morality

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Tuesday, January 18, 2005

FDA's Interest: Science or Morality

As reported by the Associated Press on Yahoo yesterday
FDA Set to Decide on Morning-After Pill "The government is considering whether to make morning-after birth control available without a prescription, and like most issues that involve sex and pregnancy, it has generated heated debate. Fierce arguments have gone on inside and outside the Food and Drug Administration , which may decide as soon as this week whether drug stores can sell the emergency contraception known as Plan B without a prescription to women age 16 and older." The FDA rejected the first request by the manufacturer to make the pill available without a prescription. There is apparently no clear evidence that Plan B is not effective and not medically safe. The debate, as noted, may be within the FDA itself. "'Some staff have expressed the concern that this decision is based on non-medical implications of teen sexual behavior, or judgments about the propriety of this activity,' said the memo by the FDA's acting drug chief, Dr. Steven Galson.'These issues are beyond the scope of our drug approval process, and I have not considered them in this decision,' wrote Galson, who last spring rejected the first application for Plan B's sale over the counter."
The question arises as to what should be the FDA's interest in the authorization of OTC sales of prescription drugs. Should it be whether the drug, by scientific studies, is effective and safe for the consumer or should moral/political concerns be also included? What do you think? ..Maurice.

2 Comments:

At Wednesday, January 19, 2005 5:57:00 AM, Blogger Dave Schuler said...

Cobbler, stick to thy last. The FDA should limit their concerns in conformity to their statutory responsibilities in the safety and effectiveness of the pharmaceutical in question.

We have another body whose responsibility is the social, ethical, and moral suitability of the drug: the Congress. A poor thing but our own.

 
At Wednesday, January 19, 2005 10:51:00 AM, Blogger Maurice Bernstein, M.D. said...

I fully agree with Dave's view. In fact, if it is shown that FDA's decisions are, indeed, pressured by political bias, those who do the pressuring should be made known and accept criticism. ..Maurice.

 

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