After more than a year of waiting for over-the-counter (OTC) access to emergency contraception, also known as the morning-after pill, the issue is again before the FDA, which has twice delayed a decision on the product.
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NOW activists protest the FDA's delay in approving emergency contraception for over-the-counter use. |
Politics at Odds With Science
It has become clear that the FDA's failure to allow OTC access is due to politics rather than science. Dr. Susan F. Wood, director of the Office of Women's Health, resigned in protest over the decision, saying that "the scientific staff [at the FDA] were shut out of this decision." A month later, Dr. Frank Davidoff, a former member of the Nonprescription Drugs Advisory Committee, also resigned in protest of the decision. The New England Journal of Medicine issued its second editorial on the subject, charging the agency with making "a mockery of the process of evaluating scientific evidence."
"This is just another in a long line of decisions that make women's health secondary to right-wing politics," said NOW President Kim Gandy. "This administration is determined to turn the FDA into an arm of the Republican Party — carrying out the fondest desires of Bush allies who oppose women's use of contraception."
Following the FDA announcement and Wood's resignation, several U.S. senators issued a statement saying that "this turn of events leaves the strong impression that concerns about politics have overridden concerns about public health in this process." They also called on the Government Accounting Office (GAO), which had opened an investigation into the FDA’s decision-making process on Plan B, to release the results of their investigation to the public.
Report Calls Delay "Highly Unusual"
The General Accounting Office (GAO) released a draft of its report on the decision in October. According to the Washington Post, the draft GAO report concludes that "the decision was highly unusual, was made with atypical involvement from top agency officials, and may well have been made months before it was formally announced."
Sen. Hillary Clinton (D-N.Y.) commented that the draft report "appears to confirm what we have suspected for some time: Science was compromised in the FDA's decision-making process on Plan B."
History of Plan B and the FDA
Originally approved for prescription use in 1999, Plan B was submitted by its manufacturer, Barr Laboratories, for OTC status with the FDA in April 2003. Two FDA advisory committees, the Reproductive Health Drugs committee and the Nonprescription Drugs committee, reviewed the application and data from more than 40 studies and unanimously agreed in December 2003 that Plan B was safe and effective. Twenty-three of 27 committee members recommended Plan B for OTC use. In addition, the FDA's professional staff, including the head of the FDA's Office of New Drugs John Jenkins, agreed with the recommendation.
In May 2004, however, the FDA issued a "not approvable" letter to Barr Laboratories, citing concerns about young women's health and sexual behavior, in spite of studies indicating that use of Plan B did not increase promiscuity or alter women's use of other birth control methods. The FDA recommended that Barr Laboratories submit a revised application seeking OTC access to Plan B only for women 16 years of age or older (young women under 16 would still need a prescription).
The move by the FDA to ignore scientific data and expert opinions drew fire from the scientific community. The American College of Obstetricians and Gynecologists called the decision "morally repugnant" and "a dark stain on the reputation of an evidence-based agency like the FDA."
Barr Laboratories submitted a revised application in July 2004, conforming to the FDA's recommendation to seek OTC status only for women aged 16 and older. By January 2005, however, the FDA still had not made a decision on the application. Pending the decision, Sens. Clinton (D-N.Y.) and Patty Murray (D-Wash.) placed a hold on the nomination of Lester Crawford to serve as Commissioner of the FDA. Their hold was released in July only after a promise from Secretary of Health and Human Services Mike Leavitt that the FDA would deliver a decision on Plan B by Sept. 1, 2005.
But instead of announcing a decision in September, the FDA indefinitely postponed its decision. Although officials acknowledged that "the available scientific data are sufficient to support the safe use of Plan B as an over the counter product," they still failed to allow OTC access, instead choosing to postpone the decision again, this time for a 60-day public comment period. They claimed that the implications of a "dual label" product (sold over the counter in certain circumstances but by prescription in other circumstances) raised administrative and practical concerns that warranted further study. This issue was raised by FDA appointees, in spite of the fact that the dual label product application had been submitted at the agency's own recommendation. The 60-day comment period ended on Nov. 1 with no decision from the FDA.
Changes at the FDA
Nearly a month after the FDA's announcement of its postponed decision, Crawford resigned as FDA commissioner. It has since been reported that Crawford declined to cooperate with the GAO inquiry into the Plan B decision.
Tapped to replace Crawford and serve as Acting Commissioner was Andrew von Eschenbach, a friend and former physician of George H. W. Bush. Von Eschenbach currently serves as director of the National Cancer Institute which, under his tenure, published a fact sheet erroneously linking abortion and breast cancer.
"The FDA has shamefully put this decision off time and again for almost two years now, even though women's lives are on the line," Gandy said. "The FDA is responsible for protecting women's health — not protecting the ideology of the right wing."
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