by Maria Vitale Gallagher
LifeNews.com Staff Writer
March 18, 2005
Washington, DC (LifeNews.com) — The Bush Administration’s pick to head the Food and Drug Administration is defending the agency’s delay in deciding whether to approve the morning-after pill for over-the-counter sale.
Lester Crawford made the comments in a confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions.
Crawford told the committee the agency plans to create a new drug-safety oversight board to debate conflicts over new drugs. But he said he’d also consider making the Office of Drug Safety a separate entity.
“An independent office of drug safety is something I’m certainly open to discuss," Crawford said. Senators Charles Grassley (R-Iowa) and Christopher Dodd (D-CT) are writing legislation to set up an independent drug safety office.
Committee Chairman Michael Enzi (R-WY) said the committee had received 100 letters of support for Crawford and only one opposing his appointment. The opposition letter came from the Consumers Union, Consumer Federation of America and U.S. Public Interest Research Group, which claim that Crawford is lax in recognizing the FDA’s shortcomings.
"Though he claims to have a bold vision for the FDA, the question is whether or not Dr. Crawford is committed to achieving substantive rather than symbolic drug safety reform," the joint letter said.
However, Crawford told lawmakers drug safety would be his top concern and said he wanted to increase staff and funding for drug safety, saying it was “the one thing we are vulnerable” on.
Crawford, a veterinarian, is in his second stint as acting FDA commissioner. Crawford formerly chaired the physiology and pharmacology department at the University of Georgia. He has been serving as acting commissioner since March, 2004.
Sen. Hillary Rodham Clinton (D-NY), a vocal supporter of abortion, said the FDA’s inaction on the morning-after pill, or Plan B, was the result of “political interference in a scientific process” by religious conservatives who argued the drug encourages premarital sex and causes abortion.
Crawford denied any political motive, saying the delay was the result of a complicated and unique application. Barr Pharmaceuticals wants to sell Plan B, which sometimes acts as an abortion drug, without a prescription to women age 16 and older, while maintaining the prescription for girls 15 and younger.
The discussion about Plan B comes at a time when some lawmakers are calling for a ban on sales of RU-486, a drug used for abortion.
Last year the FDA strengthened its black box warning labels on the RU 486 drug, making them the most severe the agency issues. The abortion pills have been blamed for the deaths of three women.
Crawford has said the FDA is concerned that infections leading to a woman’s death could be brought on without the normal indicators. A California woman, Holly Patterson, died in September 2003 after a sudden infection brought on by the abortion drug.
"We believe that physicians may not be as aware as they might be that these infections can occur without the usual signs," Crawford said.
The committee vote on Crawford’s nomination is expected to take place in April.