NYT Editorial: Morning-After Maneuvers

The New York Times Editorial
Morning-After Maneuvers
Published: August 30, 2005

Just when we thought that the Food and Drug Administration had run out of excuses to avoid ruling on whether the morning-after pill should be made available without a prescription, the agency found yet another lame reason to delay. Last week the F.D.A. finally acknowledged that science supports granting over-the-counter access to the pill, known as Plan B, to women 17 and older. But the agency said it needed more time to ponder novel regulatory issues as well as the practical question of how to keep the pill out of the hands of younger girls.

Such issues will require a 60-day comment period, when opponents of the pill will barrage the agency with reasons why the pill should not be made available without a prescription, followed by an indefinite period of thumb-sucking within the agency. All we have is a pledge from the agency's commissioner, Lester Crawford, that he will expedite the decision, but after the agency's past refusals to act, that pledge must be taken skeptically.

The agency's justification for the delay is that Plan B supposedly raises unprecedented policy issues, including whether age can be a criterion for determining whether a drug should be available only by prescription or sold over the counter, and whether the same package and dosage can be used for both versions. That explanation is hard to accept at face value. The agency has known for more than a year that the manufacturer, to surmount previous F.D.A. objections, is proposing that age be such a criterion. If profound issues have been raised, the agency has had plenty of time to grapple with them.

The morning-after pill has been safely used by millions of women in this country and abroad, and an F.D.A. advisory committee overwhelmingly recommended that it be made available without a prescription. If the F.D.A. ultimately uses age-criterion issues as an excuse for blocking easy access, the manufacturer should apply to sell the pill over the counter to any woman, regardless of age.

米FDA、緊急経口避妊薬の店頭販売の最終判断を60日間延期 - WSJ