Politics Corrupts Scientific Process at FDA: Videotape Confirms Long-Standing Allegations
WASHINGTON, DC — In a stunning admission, Dr. David Hager confirmed that he was asked to write and submit a memo that sought to derail FDA approval of over-the-counter sales of Plan B emergency contraception (EC).
According to The Washington Post, Hager's memo flew in the face of comprehensive scientific evidence that shows that EC is safe and effective for all women at risk of unintended pregnancy, regardless of age.
In an overwhelming majority vote (23 to 4) in December 2003, two blue-ribbon panels of women's health and drug advisory experts recommended that the FDA grant over-the-counter status for Plan B, the only branded EC product currently on the market.
"Anti-choice fingerprints have been all over emergency contraception since day one," Planned Parenthood Federation of America (PPFA) Interim President Karen Pearl said. "It's hard to say which is more appalling, Dr. Hager's blatant attempt to interfere with the scientific approval process or the FDA's willingness to compromise its credibility and public health mandate. Both are deeply troubling."
EC is the best way to prevent unintended pregnancy in the case of rape, incest, or contraceptive failure. Experts estimate that wider access to EC could prevent 1.7 million unintended pregnancies and 800,000 abortions each year.
The FDA advisory panels' recommendation that EC be made available over-the-counter without prescription was based on overwhelming scientific evidence proving the drug is safe and effective.
Today's Washington Post reports that Dr. Hager delivered a sermon last October at Asbury College chapel in Wilmore, Kentucky, in which he said he was asked to write a "minority opinion" for the commissioner of the FDA.
Hager further claimed his memo was central in convincing the FDA not to abide by the recommendation of its own advisory committees, only the second time in five decades in which the FDA has done so.
Dr. Hager co-authored a book that recommends scriptural passages and prayers for treating premenstrual syndrome, and he is opposed to prescribing contraceptives for unmarried women. His claims that increased access to EC would result in irresponsible behavior is unsubstantiated.
Legitimate studies show that women use EC responsibly, that they do not rely on it as a regular method of contraception, and that greater EC access does not increase sexual activity among teens. The FDA advisory panels concluded that EC meets all FDA requirements for over-the-counter status.
May 13, 2014