Lester Crawford - confirmed as Director of the FDA upon his explicit promise to issue the ridiculously-delayed ruling on certification of “Plan B” emergency contraception by 1 September, 2005 - has announced that the issue will be delayed more than two months further for yet more “public commentary”.

The government on Friday put off its long-awaited final decision on whether to sell emergency contraception without a prescription, saying the pill was safe to sell over-the-counter to adults but grappling with how to keep it out of the hands of young teenagers.

In a surprise move, the Food and Drug Administration postponed for at least 60 days a final decision on how to allow nonprescription sales of the morning-after pill called Plan B just to women 17 or older.

The reason, ostensibly, is that there is no effective mechanism to keep teenagers under 16 from purchasing it if it is made available over the counter.

The agency’s independent scientific advisers overwhelmingly backed over-the-counter sales for everybody, not just adults, in December 2003.

FDA rejected that recommendation, citing concern about young teens’ use of the pills without a doctor’s guidance. Barr reapplied, asking that women 16 and older be allowed to buy Plan B without a prescription while younger teens continue to get a doctor’s note. Downey said the company thought it had satisfied all of FDA’s scientific and legal concerns about how to do that — noting that cigarettes are sold in drugstores with age restrictions.

Friday, FDA essentially boiled the issue down to regulatory precedent: Selling the same dose of a drug by prescription and without at the same time and for the same medical use has never been done. The FDA will allow 60 days of public comment on how to take such a step and enforce an age limit, but Crawford would not say how soon the agency could evaluate those comments and rule.

Why an age restriction at all? Crawford said the issue was at what age teens can understand how to use the pills properly.

It should be noted that Plan B is available in Europe over the counter to women of all ages, and has an excellent safety record there - facts which were taken into account in the FDA’s scientific review 2 years ago. The objection regarding teenagers was raised by lunatic Bush appointee David Hager in a personal letter to Crawford, issued after he was outvoted 23-4 by his colleagues on the safety panel. The objections Hager raised are the precise ones the FDA has since cited as its reason for not proceeding, even though its safety panel considered and rejected them at the time. Hager was appointed to the FDA precisely for his history of opposing contraception and medical abortion - and has made good on the deal not only by fabricating objections but by somehow wielding the clout to see that his personal objections drove agency policy even after his committee’s work was done and Hager himself had been pushed off the committee (following lurid revelations about his personal behavior). Now Crawford has broken his promise - after safely receiving the confirmation he had waited for - and the FDA has yet again acted unilaterally to block a proven medication and to impose an idiosyncratic view of how much - and how little - control women may have over their own reproduction.

Hat tip: Jill at Feministe.

UPDATE: Fred Vincy at Stone Court has the perfect response.