FDA Delay of Plan B Triggers Complaints

The FDA is in hot water. Not long ago the agency was under scrutiny for its handling of the Vioxx problem. Critics charged that the Food and Drug Administration was more concerned about the health of the pharmaceutical industry than about patient safety.
Now the FDA is on the hot seat again because it has put off its decision on whether emergency contraception should be sold over the counter.
The morning-after pill (Plan B) has been sold by prescription since 1999. It consists of the hormone levonorgestrel, a common ingredient in birth control pills.
Plan B is effective in preventing pregnancy after unprotected intercourse. But the sooner it is taken, the more likely it is to work. That is why British regulators allow emergency contraceptives to be sold without prescription. Some states also permit ready access to morning-after contraception.
In 2003 the maker of Plan B asked FDA to allow OTC sale of the drug. An expert panel overwhelmingly recommended approval. The agency’s own professional staff agreed with this conclusion.
Normally, the agency follows such recommendations. But in this case management overruled both its outside experts and its own staff. FDA leadership objected that OTC availability of emergency contraception might not be safe for young teenagers and could encourage sexual promiscuity.
After promising a final ruling by this September, FDA has again delayed a decision. As a result, Dr. Susan Wood, Director of the FDA’s Office of Women’s Health, has resigned. She protested that postponing a decision indefinitely was not based on scientific or clinical evidence.
Critics complain that politics has again trumped science at the FDA. They suggest that the professed concern about safety in adolescents is a smokescreen for abortion politics. People who oppose abortion maintain that emergency contraception may prevent implantation of a fertilized egg.
The FDA is caught on the horns of a dilemma. If over-the-counter safety is truly the issue, then the agency may need to re-evaluate many other products.
New research suggests that regular use of popular pain relievers, such as acetaminophen and ibuprofen, can raise blood pressure in women. Aspirin and drugs like ibuprofen and naproxen can cause life-threatening ulcers. Dextromethorphan, the DM in many OTC cough medicines, can be abused.
Yet all of these medicines are widely available to the public, including teenagers, without prescription.
One solution to the morning-after pill problem might also solve other safety concerns. Many countries permit behind-the-counter sale of various pharmaceuticals. In England, for example, people can buy the cholesterol-lowering drug simvastatin (Zocor) without a prescription. But they first have to discuss the drug with a pharmacist.
The FDA has been unwilling to consider pharmacist supervision for drugs such as Plan B or the herpes medicine acyclovir (Zovirax). Even pain relievers like ibuprofen, naproxen or codeine might be sold from behind the counter. This approach would allow easier access to some drugs but still improve safety through counseling.
The FDA may not like this idea, but until it finds a way out of its current predicament, it will continue to take criticism from all sides.