For the second time in a week, the Food and Drug Administration on Thursday is scheduled to consider a controversial request to convert a prescription drug into an over-the-counter product.
And if you thought last week's FDA advisory committees' ruling about a cholesterol drug provoked headlines, wait until you hear the reaction after the agency acts on a contraceptive product.
The FDA is scheduled to rule on an application by
to permit an emergency contraceptive -- known as Plan B or, more colloquially, the morning-after pill -- to be sold without a prescription for women age 16 and older. If taken within 72 hours of unprotected sex, Plan B can reduce the risk of pregnancy by 89%. Plan B is 95% effective when taken in the first 24 hours after intercourse.
Last week, two FDA advisory committees soundly rejected an attempt by
and its marketing partner
Johnson & Johnson
to turn the prescription cholesterol drug Mevacor into an over-the-counter medication. The two committees, meeting jointly, said the companies failed to show that patients could safely take the drug without a doctor's prescription. This was the second time in four years that Mevacor had been rebuffed as an OTC product.
But Plan B is a more complicated and more politically incendiary story.
In December 2003, two FDA advisory committees voted 23 to 4 to support the sale of Plan B as a nonprescription product for all women. In May 2004, however, the FDA, in a rare move, overruled the committees and rejected Plan B.
The agency said Barr didn't provide "adequate data to support a conclusion that Plan B can be used safely by young adolescent women" for emergency contraception without a doctor's prescription.
In this instance, a top FDA official, Dr. Steven Galson, signed the rejection letter. The agency noted that he "does not usually sign regulatory action letters," but he did so for Plan B because "his opinion of the adequacy of the data in young adolescents differed from that of the review staff."
The FDA gave Barr two choices: (a) Provide more data showing that Plan B can be used safely by women under 16 years old without a doctor's care, or (b) Supply information that shows Plan B could be sold over the counter to women 16 years and older and sold by prescription to younger adolescents.
Barr chose the latter, filing its amended request with the agency in July.
Politics, Economics, Medicine
Plan B has become the focal point for a national debate on morality, unwanted pregnancies and family planning.
That's quite an achievement for a product that, analysts say, will have little economic impact on Barr. Even if the FDA allows Plan B to go over the counter for some women, annual sales might rise to $25 million or $30 million a year, up from about $10 million a year as a prescription-only product. Barr is expected to generate almost $1.1 billion worth of revenue for the fiscal year ending June 30.
Analysts say investors should focus more on Barr's balanced portfolio of generic drugs and proprietary products, its leadership in women's health care products, its strategic acquisitions and its skill in filing patent challenges. A check of recent analyst reports by
shows few comments about Plan B for a company rated among the best of the specialty pharmaceutical manufacturers. Barr now has 13 buy recommendations and seven hold recommendations, according to Thomson First Call.
Plan B's minimal economic impact is overshadowed by its prominent effect on public policy debates. Supporters, such as Planned Parenthood Federation of America, say the product is a safe way to prevent unwanted pregnancies. Opponents, such as the Concerned Women for America, say easier access will cause more unprotected sex and more sexually transmitted disease.
These debates were further stirred when the
Journal of the American Medical Association
published a study earlier this month that refuted critics' contentions that easier access to emergency contraception would promote sexual misconduct.
"Given that there is clear evidence that neither pharmacy access nor advance provision
of contraception compromises contraceptive or sexual behavior, it seems unreasonable to restrict access to emergency contraception to clinics," said the study.
The study was conducted by the Center for Reproductive Health Research and Policy at the University of California-San Francisco, a Planned Parenthood chapter in San Jose, Calif., and the San Francisco Department of Public Health. The study surveyed 2,117 San Francisco-area women who were assigned to a clinic (as a control group for the study), given emergency contraception on their own or told to seek emergency contraception at a pharmacy.
The percentage of women in the pharmacy group and in the clinic group using emergency contraception were essentially the same. Women given the contraceptive product in advance were almost twice as likely to use the drug as were women in the clinic, even though their rates of unprotected sex were similar.
The authors also found that women in the pharmacy group and the self-medication group "did not experience a significant reduction in pregnancy rate." Supporters of over-the-counter Plan B say greater access to the product will reduce unwanted pregnancies. The study said the pharmacy and self-medication groups didn't experience an increase in sexually transmitted infections.
If the FDA rejects Plan B as an over-the-counter product, analysts expect Barr to work with pharmacies and states on so-called collaborative agreements that allow pharmacists to sell emergency contraception without an advanced prescription from a physician. Six states now permit this practice.
It's also possible that the Plan B verdict will stimulate more discussion about creating a third type of drug: a "behind-the-counter" product. A patient could buy this drug without a prescription, but he or she would first need to talk to a pharmacist.
This third option is available in some countries, including Britain, and the subject came up recently during the FDA advisory panels' review of Merck's Mevacor. It is unclear, however, whether the FDA could take action directly; the new drug category probably would require action by Congress.