Biotech Values

[DewDiligence]

Judge Says FDA F’d Up on Plan B

[Please see #msg-12448241 and #msg-12815369 for background on this bizarre episode.]

http://online.wsj.com/article/SB123783499518316521.html

›MARCH 23, 2009, 9:55 P.M. ET
By ALICIA MUNDY

A federal judge ordered the Food and Drug Administration to allow sales of the Plan B morning-after contraceptive to women 17 years and older without a prescription, rolling back an age limit imposed by the Bush administration. The judge also told the FDA to "reconsider" its decision restricting over-the-counter sales to anyone.

In a 52-page ruling Monday, Judge Edward Korman of the Eastern District of New York criticized current and former FDA officials for using "political considerations, delays and implausible justifications" to hold up nonprescription sales of the birth-control drug for several years.

The Plan B contraceptive has been shown to reduce the risk of pregnancy if taken within 72 hours after sexual intercourse. The FDA allowed over-the-counter sales of the drug to women 18 years and older in 2006, after a battle with Democrats and abortion-rights supporters. Bush administration officials at the time argued that teenagers wouldn't be able to make rational decisions about their reproductive health.

Under the ruling, the FDA must act within 30 days to allow 17-year-olds to buy the pills, made by Barr Pharmaceuticals Inc., a unit of Teva Pharmaceuticals Industries Ltd. Teva hailed the ruling.

If the Obama White House doesn't appeal the ruling, it would mark the fourth significant departure from Bush administration positions on controversial health-care issues since President Barack Obama took office.

An FDA spokeswoman said the agency is reviewing the judge's decision.

A spokeswoman for the Family Research Council, a conservative advocacy group, said the ruling "jeopardizes girls' health and the ability of parents to care for their daughters' physical and emotional well-being."

The court ruling came in response to a lawsuit filed in 2005 by the Center for Reproductive Rights, a women's health-advocacy group. The FDA had announced it wanted more time to review the safety of Plan B, despite support for over-the-counter sales by the FDA's outside experts.

Then-FDA official Susan Wood resigned in protest over the move, saying science had been ignored in favor of politics at the agency. "I feel I've been vindicated," Dr. Wood said Monday.‹