Plan B - Lancet has a go at the FDA

May 21 2006

A well known international medical journal has called on the acting FDA Commissioner Andrew von Eschenbach to adopt an independent stance and follow the best judgment of it's expert staff and scientific advisers, even when that means incurring the wrath of patients' groups, industry, Congress, and even the White House.

The Lancet says that the emergency contraception Plan B, should be available without a prescription in the United States.

The respected medical journal says the acting commissioner Andrew von Eschenbach must make an independent decision on Plan B if he is to lead the agency on a permanent basis.

For over a year, the FDA has stalled on the decision over an application to make the emergency contraceptive Plan B available to women older than 16 years without a prescription.

This is despite the FDA's scientific advisory board voting almost unanimously for such approval and is viewed by many as an attempt to avoid offending anti-abortion supporters of President Bush, who claim that the contraceptive is an abortifacient (a substance that induces abortion).

U.S. President George W. Bush nominated von Eschenbach to run the agency full-time earlier this year, but supporters of Plan B in the U.S. Senate, two Democrats have blocked any vote pending a decision on the drug.

As acting FDA commissioner he has refused to do so and his failure says the Lancet undermines both his credibility and that of the agency.

The Lancet says von Eschenbach should move quickly to approve Plan B in order to demonstrate the independence needed to be an effective leader of the FDA.

Editors at the Lancet, published in London, say von Eschenbach's failure to act indicates he may not be independent enough to run the FDA.

Plan B is a set of two pills containing higher levels of a hormone used in regular birth control pills, as contraception. If taken within 72 hours, it can prevent pregnancy, unlike the abortion pill RU-486 regimen which ends an established pregnancy.

It has been available with a doctor's prescription since 1999, but a growing number of pharmacists in some states have refused to fill the orders.

The Lancet's comments are just the latest in a long list of media editorials calling on the FDA to make a decision.

Only last August, former FDA Commissioner Lester Crawford ruled the drug was safe and effective over-the-counter but said other regulatory issues remained, he then resigned rather abruptly a month later.

Many women's groups and other supporters say easier access is crucial for women and will help reduce the number of abortions and a bipartisan group consisting of 62 members of Congress has also called for wider availability.

Opponents of the drug believe making the drug easier only serves to promote promiscuity and encourage the spread of sexually transmitted diseases.