Yesterday the Center for Reproductive Rights, on behalf of the several women’s rights groups, asked federal judges to grant a subpoena of White House documents and officials in its lawsuit against they filed last year against the FDA. The suit claims the prescription drug regulatory arm did not follow procedure when it sent a “not approvable” letter in response to the original application for sale of Plan B over-the-counter. The May 2004 letter ultimately led to a more than two year delay of non-prescription access to the emergency contraceptive.
Chris Mooney wrote for Mother Jones about the letter, which was sent in spite of a 23-4 vote in favor of approving the drug by the Reproductive Health Drugs Advisory Committee. One opposed adviser was David Hagar, a Kentucky obstetrician who was staunchly opposed to RU-486, had attacked the birth control pill for promoting promiscuity, and had written a book in which he advised Bible readings to relieve premenstrual syndrome, all before he was appointed by George W.
The FDA’s letter cited Hager’s concern for “inadequate sampling of younger age groups” saying there needed to be more data on Plan B’s use among girls younger than age 16. Never mind that scores of drugs are approved every year without data targeting specific age groups.
Barr Laboratories (now Barr Pharmaceuticals) subsequently submitted a revised application to make the drug available without a prescription only to girls and women ages 16 and older. The drug was finally approved for sale to those 18 and older, in August. (See Mother Jones‘ full timeline of Plan B hurdles here).
The FDA says it plans to file a motion for dismissal.
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