The Colorado House of Representatives this week passed HB 1212, which would give pharmacists the authority to prescribe the drug Plan B, the so-called “morning-after” contraceptive.
Although I believe that women should have access to every resource to control their own reproductive systems, I couldn’t completely dismiss critics who argued against this bill because it was unprecedented for pharmacists to have the authority to write prescriptions, since that power is reserved for physicians.
Like most people, I knew only the headlines and sound bites of the emergency contraception issue. I saw it merely as an extension of the abortion debate, and didn’t pay close attention to the nuances of the issue itself. So I didn’t understand exactly how Plan B worked, its status according to the FDA or what had prompted the Colorado Legislature to take up this issue.
So I went to the websites of the FDA, American Medical Association (AMA) and American College of Obstetricians and Gynecologists (ACOG). After reading their public statements on this issue, I understand why our legislature felt compelled to act.
According to the AMA, Plan B is a Barr Laboratories drug that was first approved for use in 1999, and it contains levonorgestrel, “a synthetic hormone used in birth control pills for more than 35 years.” It prevents pregnancy by stopping an egg from being released from the ovaries, delaying ovulation, keeping the sperm from reaching the egg or keeping the fertilized egg from implanting in the womb. The pill works best if taken within 72 hours of intercourse. Several years ago, the AMA recommended that the FDA approve Plan B as an over-the- counter drug.
ACOG said that 40 studies and 15,000 pages of clinical data have made it clear that emergency contraception is “safe … does not increase promiscuity or unprotected sex among teenaged women, nor does it cause women to abandon their regular birth control methods.” ACOG also recommended that the FDA approve Plan B for over-the-counter use.
The FDA reports that in December 2003 its two advisory panels voted 23-4 in favor of making Plan B available without a prescription. But, despite all of the scientific evidence of the drug’s safety, in May 2004, Dr. Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research, issued a “Not-Approvable” letter that rejected Barr Laboratories’ application for over- the-counter status.
Critics of the decision argued that Galson had ignored science and had made a purely political ruling. The fact that he had personally signed the “Not-Approvable” letter fueled the suspicions about his motives.
In a New York Times article a few days after the announcement, Dr. Raymond Lipicky said, “I can’t ever remember the center director ever signing a nonapproval letter.”
The FDA’s official question-and-answer page regarding Plan B includes this query and response: “Dr. Steven Galson signed the letter FDA sent to the sponsor. Does Dr. Galson usually sign such letters? Why did Dr. Galson sign the letter?”
Answer: “No, Dr. Galson does not usually sign regulatory action letters. However, his opinion of the adequacy of the data in young adolescents differed from that of the review staff. He believes that additional data are needed … .”
So on the basis of “his opinion,” Dr. Galson has, single-handedly, set the national policy on Plan B to match his beliefs. ACOG called the decision “morally repugnant,” and the AMA said it was opposed to “the unprecedented actions” of the FDA.
This is what spurred the Colorado legislature into action. Yes, it is unprecedented to give pharmacists the power to issue prescriptions, but this authority will be extremely limited. They can prescribe only Plan B, which will achieve the recommendations of the AMA, ACOG and FDA advisory boards in the handling of this drug.
Former Bronco Reggie Rivers is the host of “Global Agenda” Wednesdays at 9:30 p.m. on KBDI-Channel 12. His column appears every Friday.
