When an advisory panel to the Food and Drug Administration voted overwhelmingly last December to approve the over-the-counter sale of an emergency contraceptive for women, the director of the agency, Mark McClellan, said final approval would be based on “sound science.”
McClellan’s brother, Scott, who is the White House spokesman, said, “The health and safety of American women must always be a priority.”
However, final approval never came, and it wasn’t for a lack of sound science. The reason can be traced to why the White House felt the need to comment in the first place. Plan B, as the morning-after pill is called, is a political issue. Forty-four members of Congress had sent letters to the panel urging it to limit the reach of the pills. Some felt taking the pills was tantamount to abortion. Some felt the pills’ easy availability would encourage young women to be more sexually promiscuous.
The pill works by either preventing the release of an egg from the ovary, by intercepting sperm before it reaches an egg or by preventing a fertilized egg from attaching to the wall of the uterus. Some people believe that the latter scenario is abortion, but nobody can be certain how it works in a specific case. However, there’s no question that Plan B heads off unwanted pregnancies, which often end with abortions.
As for encouraging sex, there’s no evidence of that. Morning-after pills are widely used in Europe, and many countries there have better outcomes on a range of teen health issues, including fewer sex partners and lower rates of abortion and sexually transmitted diseases. Besides, should we limit medications because their use is tied to bad behaviors? Do we crack down on cheeseburgers by limiting anti-cholesterol drugs?
In any event, these are political questions that the FDA should not consider. Its role is to determine whether drugs are safe and effective. The FDA panel of experts felt that emergency contraceptives pass on both accounts. The American Medical Association and the American College of Obstetrics and Gynecology concur. The staff of the acting director of the FDA also agrees (Mark McClellan has moved on to another job). Nonetheless, the acting director, Dr. Steven Galson, turned down the manufacturer’s request for over-the-counter sales.
He said Barr Pharmaceuticals had not adequately proved that women between the ages of 11 and 15 could properly use the product. How such a thing could be proved is difficult to imagine. Galson acknowledges that his rejection of scientific recommendations was unusual. “I’m not trying to convey this decision as being common or usual,” he said.
It is unusual. The FDA typically does not preclude over-the-counter sales of drugs based upon how its youngest users might misuse them. A young teen could just as easily misuse aspirin, cold medicines and a whole host of drugs they can pluck from a shelf. Does that mean the FDA should make them available by prescription only?
In five states, including Washington, Plan B is available over the counter. Women need only ask approved pharmacists, who then deliver the simple instructions. This ruling won’t affect those sales. But it is a shame that a drug that could prevent millions of unwanted pregnancies and head off abortions won’t be more widely available because a science-based agency chose to jettison science.
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