Topline
The Food and Drug Administration on Thursday approved the first ever over-the-counter birth control daily pill, a major development amid a heightened debate over contraception in the wake of the Supreme Court’s momentous decision last summer to overturn Roe v. Wade.
The FDA approved Opill for nonprescription use.
Key Facts
The FDA approved drug maker HRA Pharma’s daily pill norgestrel, marketed as Opill, the agency announced in a statement on Thursday, 50 years after the drug was first approved for prescription use.
Patrizia Cavazzoni, FDA drug evaluation and research director, said the approval makes the pill available for millions of Americans, calling the contraception “safe and expected to be more effective” than available nonprescription contraceptive methods.
Shares of Perrigo Company, which acquired HRA Pharma last year, jumped nearly 6% in pre-market trading Thursday morning, to $34.90.
Crucial Quote
The American Medical Association lauded the decision, calling it a “monumental step in providing broader access to safe and effective reproductive health care for millions of patients,” while urging the FDA to “consider a variety of oral contraceptive options for over-the-counter use.”
Tangent
The approval comes nearly three months after the Supreme Court blocked a controversial lower court decision challenging U.S. women’s access to the abortion pill mifepristone, one of two commonly-used pills in U.S. abortions. The lower court sought to restrict access to mifepristone, after District Court Judge Matthew Kacsmaryk ruled to toss the FDA’s approval of the drug, which had been approved for more than 20 years.
Key Background
In one of its biggest decisions in years, the Supreme Court ruled last June to overturn Roe v. Wade, giving states license to impose bans and restrictions on abortions. Since the decision, which overturned almost 50 years of precedent, 14 states have imposed full or nearly-full bans on abortions, while Georgia reinstated a ban at six weeks into a woman’s pregnancy, and five other states put into effect bans at 12-18 weeks.
Further Reading
Roe V. Wade Overturned One Year On: Here’s Where The Money’s Going (Forbes)
Mifepristone: Supreme Court Keeps Abortion Pills Legal—At Least For Now—Blocking Ruling (Forbes)