U.S. probe sought of memo on “morning-after” pill

	Tweet

Two U.S. Senate Democrats called for an investigation on Thursday into whether a memo from a Christian doctor influenced regulators’ rejection of over-the-counter sales of a “morning-after” contraceptive.

Sens. Hillary Rodham Clinton of New York and Patty Murray of Washington said reports about the memo added to concerns that politics was trumping science in the government’s review of Barr Pharmaceuticals Inc.’s Plan B contraceptive.

The memo’s author, Dr. David Hager, is a Bush administration appointee to a Food and Drug Administration advisory panel that voted 23-4 in December 2003 to urge approval for Barr’s bid to sell Plan B without a prescription.

The FDA ruled against that advice in May 2004, citing concern that young girls might not be able to use Plan B safely. It is unusual for the FDA to reject such a decisive vote.

The FDA now is considering a new application from Barr for over-the-counter sales of Plan B, a set of pills that can prevent pregnancy if taken within 72 hours after intercourse.

Hager, one of the dissenting votes at the December 2003 meeting, confirmed in an e-mailed response to questions on Thursday that he wrote a memo to the FDA expressing the “minority opinion” of the panel. He did not elaborate on the memo’s contents and said he did not keep a copy of it.

The Nation magazine, which first reported the memo’s existence, quoted Hager as saying last October that the memo was written from a scientific perspective, not a Christian one.

The Washington Post reported on Thursday that Hager gave reporters conflicting accounts about who asked for the memo, at one point saying the request was from an FDA staff member and another time saying it came from outside the agency.

“Due to confidentiality, I am not at liberty to say who encouraged that this opinion be written,” Hager said in an e-mail to Reuters.

An FDA spokeswoman said Hager sent the letter “as a private citizen” and that the agency does not ask for “minority opinions” from advisory committees. She said she could not release the letter, but that it might become public in response to a Freedom of Information Act request.

Hager is a practicing obstetrician and gynecologist and a professor at the University of Kentucky. He has been open about his Christian beliefs as a spokesman for the Christian Medical Association. He also co-wrote a book that emphasizes the healing power of Jesus and prayer.

Conservative opponents of Barr’s request to sell Plan B over the counter have argued that wider availability could lead to more promiscuity and sexually transmitted diseases, particularly among teenagers.

Murray and Clinton asked Health and Human Services Secretary Mike Leavitt to immediately investigate reports about Hager’s memo and whether it swayed any FDA decisions. Neither senator has seen the memo, their spokeswomen said.

“If substantiated, these allegations seem to leave little doubt that the process for considering Barr Laboratories’ application was based not on science, but on personal beliefs,” the senators wrote in a letter to Leavitt.

Bill Hall, a spokesman for Leavitt, said he could not comment on how the secretary would respond to the request.

Murray and Clinton have vowed to block the nomination of Acting FDA Commissioner Lester Crawford as permanent commissioner until the agency rules on Barr’s current application for Plan B. 

RELATED STORIES:
Obesity May Reduce Brain Gray Matter in Postmenopausal Women   Exercise boosts teen girls’ bones   Investigative Osteoporosis Drug Eases Symptoms of Vaginal Atrophy   Viagra May Help Women With Rare Heart Problem   Why Women Get More Migraines Than Men   Health risks fade after hormone therapy stops   Hospitals best for vaginal birth after C-section   Cancer drug plus the Pill relieves endometriosis   Judge rules against ‘partial-birth’ abortion law   US starts women’s meeting with anti-abortion stand   Greater seizure frequency seen in women with epilepsy during anovulatory cycle   Very small mice are bad mothers

Comments

[ + Post Your Own ]

Now you're in the public comment zone. What follows is not Armenian Medical Network's stuff; it comes from other people and we don't vouch for it. A reminder: By using this Web site you agree to accept our Terms of Service. Click here to read the Rules of Engagement.

There are no comments for this entry yet. [ + Comment here + ]