WEDNESDAY, April 7, 2004 (HealthDayNews) -- In a strongly worded editorial, a leading medical journal is criticizing the U.S. Food and Drug Administration's postponement of a decision to give the emergency contraception known as Plan B over-the-counter status.
The postponement, the New England Journal of Medicine editorial stated, "suggests that the FDA's decision-making process is being influenced by political considerations."
"A treatment for any other condition, from hangnail to headache to heart disease, with a similar record of safety and efficacy would be approved quickly," the editorial added.
An FDA spokeswoman only said the issue was "under review," adding the agency "will base its decision on science and the available data."
Carol Cox, vice president of corporate communications for Barr Laboratories, which markets the pill, said, "Clearly, this [editorial] was independent of Barr. We are still in an ongoing discussion with the FDA."
According to the journal's editor-in-chief, Dr. Jeffrey Drazen, a co-author of the editorial, the publication takes a public stand on different issues about four or five times a year.
This time, the journal hopes the FDA will take notice.
"We would hope that the people who are responsible for making these decisions will have a chance to read this and think them over," Drazen said. "Until now, the FDA has had a very sterling reputation worldwide as being science-driven. What we're concerned about is that this decision appears to be driven by politics.... We're hoping the agency could stay as apolitical as possible. If people aren't happy with the decision, that's why we have the legislative branch."
The FDA originally approved Plan B, or levonorgestrel, as a prescription drug in 1999. In 2001, a coalition of more than 60 health groups petitioned the federal government to make emergency contraceptives available without a prescription. In December 2003, an FDA advisory committee concluded that Plan B was both effective and safe and overwhelmingly recommended that the agency make Plan B available without a prescription.
The FDA usually follows the advice of its expert committees, but, in February of this year, it told Barr Laboratories that it was delaying a decision.
Cox said the date for Barr's "user fee" to the FDA was delayed by 90 days and now takes effect May 21.
"The FDA should be back to Barr with some sort of ruling by May 21, that's my experience," she said.
Plan B consists of two tablets of levonorgestrel that need to be taken within 72 hours of unprotected intercourse, but the sooner the better. Essentially, the drug prevents pregnancy by delaying ovulation. It does not interrupt an already implanted pregnancy.
According to the journal editorial, using Plan B after a single act of unprotected intercourse results in a pregnancy rate of about 1 percent, versus 8 percent without treatment.
Efficacy rates drop the longer after intercourse the pills are taken, with better results within 24 hours of sex. "If a woman does not have the medication on hand when needed, the delay entailed in obtaining a prescription -- and thus in initiating therapy -- can seriously reduce its efficacy," the editorial stated. And many instances of unprotected sex take place at night and on weekends when health-care professionals who might be able to provide a prescription are unavailable, according to the editorial.
The editorial also questioned whether the FDA's action would affect physicians' and patients' view of future drug approvals: Are they based on efficacy and safety data or on political considerations?
The last time Drazen recalls an approval with such a high political profile was RU 486, the so-called "abortion pill." It was approved in 2000, while President Clinton was in office.
"There were a lot of politics," Drazen recalled. "But the FDA made a decision that was scientifically correct, and I think that was an appropriate thing to do."
More information
For more on Plan B, visit its official site. For more on emergency contraception, visit Planned Parenthood.
