Tuesday, August 30, 2005

Drug Stabbing Time

Over the counter morning after pills to be made available in the US?! In a statement that I thought would receive more press, the FDA have announced that they are considering a request to allow Plan B contraception (aka the morning after pill) to be sold over the counter as opposed to the current arrangement where a prescription is required. The FDA are claiming that "the questions we were asked to answer were unprecedented for this agency."

They say that they've been asked to put an age restriction of 16 in place, i.e. a girl under 16 would still need a prescription for the drug, therefore packaging becomes an issue as does age-enforcement. Also a precedent would be set to allow many other, currently prescription-only, drugs available to sub populations over the counter.

The FDA Commissioner states that "[the proposal] could be a positive public health step, and one that I would support as the agency’s Commissioner, if it means we could safely make many more effective medicines more easily available. We believe these novel regulatory issues should be considered in an open, public process." He goes on to state that "We need to resolve these policy and regulatory questions before we can reach a final decision on the underlying science that was presented to us. FDA is both a scientific and a regulatory agency. And what we are saying today is that there are unique regulatory issues that need to be addressed before we can take a final action on the application."

There is something odd going on here. The proposal is indeed a fundamental change of policy. To allow a particular drug to be available over the counter, yet restricted to prescription-only for a sub-population, is a departure from current practice (where, if a drug needs to be restricted to prescription-only for a sub-population, it's restricted for the whole population). Yet why such a discussion needs to be "public" in the manner described is not clear. The FDA are a professional, scientific, regulatory body. They are supposed to have the knowledge and expertise (despite issues that crop up unexpectedly like Vioxx). If the morning after pill is safe, which it is, then there are no potential healthcare issues. The decision is one of policy - should medicines be over the counter for one sub-population but not another. That's a decision for government and healthcare professionals, surely, not the general public.

However the FDA are, in my opinion, passing the buck. The test case drug is the morning after pill and, given the current conservative climate in the US, the FDA have decided to drop this one like a hot snot. There's no way they want to be seen to be the ones green lighting a proposal that many religious and social conservatives would view as promoting promiscuity. Personally, as someone who feels that the point should never be reached where a woman feels compelled to seek an abortion, I believe the morning after pill should be freely available (and free).

The Commissioner does say, in fairness, that "as an agency, and as its Commissioner personally, I want to say that FDA remains committed to making safe and effective contraceptive products available to women and men who choose to use them." He just doesn't want to say how, when or to who.
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