ReputationRx

FDA's messaging on morning-after pill debate hurts its scientific credibility

FDA's messaging on morning-after pill debate hurts its scientific credibility

There is nothing particularly earth shattering about the so-called morning-after pill. It is simply a higher dose of a hormone that has been used for decades to prevent pregnancy.

Yet the fight to increase access to this unremarkable product has been a blot on the Food and Drug Administration's credibility and reputation. And the longer it drags on, the greater the hit that the FDA's image will take.

What should be a science-driven discussion has become a social science debate - and one that advocacy groups are now trying to exploit.

The FDA is not stalling over the safety of the product (which was never in question), but over whether pharmacists will be able to keep it out of the hands of teens, who will still need a prescription to use it.

But the regulatory agency has failed to convincingly communicate to critics why it has hemmed and hawed about making a decision on the product. Instead, the delay smacks of political pandering.

It doesn't help that there has been considerable divisiveness within the FDA. When Dr. Susan Wood resigned from her position as the head of the Office of Women's Health, she left no doubt about why she was leaving the post.

"Scientific and clinical evidence," she wrote in an e-mail that pro-choice advocates sent to The Associated Press, "has been overruled."

The FDA is also acting at odds with its own scientific advisory body as well as with the views of prominent physicians in private practice and academia. It has been roundly criticized by medical organizations, including those representing obstetrician/gynecologists and pediatricians.

The only voices speaking out in support of the FDA are those that are very clearly at the far right of the abortion debate, and oppose easier access to Barr Labs' Plan B on moral grounds - not just for teens, but for all women.

It's no wonder then that the messages from the FDA have done little to quell criticism. The agency claims that its act on the best available scientific evidence, but studies in major medical journals - as well as outcomes in countries where the pill is more widely available - contradict the fears of Plan B opponents.

In addition, several states have already taken matters into their own hands, allowing over-the-counter sales of the morning-after pill without age restrictions.

Meanwhile the FDA is considering questions that have traditionally been beyond its purview, including how to ensure that age restrictions are enforced in pharmacies. There are many age-restricted products on the market, and the agency has yet to explain what distinguishes the morning-after pill from, say, the nicotine patch.

The FDA needs to decide on an issue that has been unresolved for too long. It cannot stall it away, or continue to pass the buck by calling for extended comment periods.

The agency certainly has some explaining to do to address why it has split from its trusted advisors and - seemingly - the medical community at large.

But outreach is just one piece of the equation. Communication is a key step for the FDA to reclaim its good name. Speedy action, however, is absolutely essential.

 

 

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