With new bosses about to take over at the US Food and Drug Administration, a New York judge has ordered the federal drug regulator to make the morning after pill available to 17-year-olds and to review whether to make the emergency contraceptive available to all ages without a doctor’s order. Judge Edward R Korman’s 52-page decision is the outcome of a lawsuit by the Centre for Reproductive Rights against the FDA’s 2006 decision to deny girls younger than 18 access to the Plan B pill without a prescription.
The judge agrees with the lawsuit that the FDA’s handling of the issue was “arbitrary” and influenced by “political and ideological” considerations imposed by the Bush administration. By implication, the Centre for Reproductive Rights does not have any “ideological” bias and it is claiming to have “science” on its side in promoting use of the jumbo dose of hormones (in one brand of MAP, 50 times the level of a mini-pill) contained in Plan B as an aid to women’s “health”.
However, the FDA delayed for years in approving the drug at all owing to the lack of scientific studies on the effects of the high dose and repeated use of the morning after pill on both women and adolescents. Over-the-counter availability could lead, it is reasonably argued, to indiscriminate use by young women, without the benefit of parental or medical advice relating to their personal health profile.
Starting this week, a pharmacy chain in Britain is offering the morning after pill for sale online — up to three doses at a time, which has prompted concerns about women “stockpiling” the treatment and using it without medical advice. And starting in July, schoolgirls in the English county of Oxfordshire will be able to request the drug by text message to their school nurse. Parents will not automatically be informed of any request.
Opponents of free access also point out that it has not brought down the number of unwanted pregnancies or abortions in countries such as the UK, as advocates said it would. Nor has it reduced the number of sexually transmitted infections; rather, it is likely to increase them by removing only one consequence of “unprotected sex”.
President Obama recently issued an order that he said was designed to insulate scientific decisions throughout the government from political influence. Let’s see if the new brooms at the FDA are able to tell one from the other. ~ Washington Post, March 24