By Christine S. Moyer, amednews staff. Posted Aug. 30, 2010.
When ella is available later this year, physicians will have to decide if prescribing the drug is right for them and their patients.
When the Food and Drug Administration approved Plan B in 1999, some doctors objected on moral grounds to prescribing the emergency contraceptive.
Much of the controversy faded when Plan B went to over-the-counter status in 2006, taking the prescribing decision largely out of doctors’ hands. Today, the drug is available OTC for women 17 and older, but younger patients still need a prescription.
Now that the FDA has approved ella (ulipristal acetate), a prescription-only emergency contraceptive, the debate about whether to prescribe such drugs is moving back to the doctor’s office. With it comes ethical and legal questions for physicians, particularly those who object to emergency contraception for various reasons.
“There will be plenty of doctors who won’t provide the drug because it probably does cause abortion,” said Gene Rudd, MD, senior vice president of the Christian Medical and Dental Assns. He said approval of ella “raises the issue of right of conscience and whether … a patient or health care system can tell a doctor he no longer has the right to exercise his moral [belief].”
Dr. Rudd said he heard that some employed physicians were pressured by their employers to offer Plan B when it was a prescription-only drug.
On Aug. 13, the FDA approved ella for use in the U.S. The drug probably will be available by the end of the year. The progesterone agonist/antagonist prevents pregnancy when taken orally within 120 hours after a contraceptive failure or unprotected sex. Emergency contraceptives now on the market, including Plan B, are indicated for use up to 72 hours after sex.
Ella works by blocking progesterone activity, and in doing so, inhibits or delays ovulation. The drug’s patient information notes the possibility that the medication also might prevent implantation of a fertilized egg in the lining of the uterus.