The FDA Succumbs to Political Pressures
Over the summer, the U.S. Food and Drug Administration announced that it was delaying the decision to make Plan B available over the counter.
More commonly known as the morning-after pill, Plan B would have been available to those 16 and over without a prescription, but to those under 16 only with a prescription.
The FDA’s decision to delay approval of Plan B’s over-the-counter proposal was not based on the pill’s safety. In fact, in December 2003, the FDA had reviewed the scientific data of the drug and had concluded that it was indeed safe for women over the age of 16.
FDA Commissioner Lester M. Crawford explained in a statement that the decision to delay approval was due to ‘unique regulatory issues’ that needed to be addressed. He explained the specific questions that the FDA had, such as, ‘If we do use age as the only criterion on which we decide whether a drug is sold as a prescription product, or an over-the-counter product, how, as a practical matter, would such a limitation be enforced?’
The FDA’s reasons were merely excuses. Perhaps a form of identification such as a driver’s license could be used to enforce age limitations. Alcohol and tobacco are sold with a form of identification. Did the FDA conveniently forget that it used and enforced age limitations in order for those harmful substances to be purchased?
On Aug. 31, Susan Wood, director of the FDA’s Office of Women’s Health, resigned because of the FDA’s announcement that it would delay the decision of the Plan B’s over-the-counter status. In her e-mailed letter to the FDA, she wrote, ‘I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled.’
And finally, it all makes sense. Politics is playing a hand in a game it has no business being in.
On Sept. 23, 2005, Crawford resigned as FDA’s commissioner. Although the FDA’s decision of Plan B did not specifically play into Crawford’s resignation, politics did.
The FDA is supposed to be an independent entity, without influences from any political party. If conservatives are so concerned about the sexual lives of Americans, you would think that over-the-counter Plan B would be the way to go: fewer unwanted pregnancies and fewer abortions.
Even something as simple as better sex education in school would be appropriate. From a strictly economical point of view, imagine the money that could be saved from this preventive drug. Health care costs and welfare are just a few of the affected programs.
Even pharmacists are asking for a law that will allow them the right to refuse to fill prescriptions that they are morally against and that will protect them from any harm that results because of the refusal to fill prescriptions. Political beliefs should not get in the way of people’s health and safety.
With the controversy involving non-steroidal anti-inflammatory drugs such as Bextra, increasing the risk of heart attacks, and now a clear disregard for scientific research of Plan B pills, we are forced to question the FDA’s commitment to the health of Americans.