FDA Relaxes Abortion Pill Restrictions
The Food and Drug Administration (FDA) as decided to loosen restrictions on use of the abortion pill Mifeprex, giving American women cheaper and easier access to abortion by medication. The decision was announced on Wednesday to relax restrictions that were in place for over a decade.
The FDA eased access to Mifeprex by updating the prescribing information on the drug’s label – expanding use to 70 days of gestation from the current 49 days, cutting the recommended dose of the drug and reducing the number of mandatory visits to a doctor.
Many abortion providers (an estimated 83%) had already moved away from the previous restrictions over the years but states like Texas, North Dakota and Ohio have laws that restrict medication abortions by requiring prescription of the drug strictly according to the old label.
The revision opened another front in the fight over abortion that has spilled into the U.S. presidential election campaign and come up again in the Supreme Court. Anti-abortion campaigners condemned the expanded access to the drug, which was in response to an application and clinical data submitted by the manufacturer, Danco Laboratories.
Under the new label, women will take one 200 mg tablet of Mifeprex on day 1 instead of 3 200 mg tablets. They will take 800 mcg of misoprostol 24-48 hours after taking Mifeprex. Previously they took 400 mcg on day 3. Under the old label, women were asked to return to their doctor 14 days after taking Mifeprex for an examination. The new label recommends that they return between 7 and 14 days for an assessment.