FDA gives OK to over-the-counter Plan B

Age restrictions will be applied to the drug's purchase.

By Victoria Stagg Elliott — Posted Sept. 11, 2006

Print  |   Email  |   Respond  |   Reprints  |   Like Facebook  |   Share Twitter  |   Tweet Linkedin

Nearly three years after two Food and Drug Administration advisory committees recommended that emergency contraception be available over the counter, the agency has approved the switch with certain restrictions.

Plan B, also known as the morning-after pill, will be available from pharmacists, without a prescription, to women 18 and older. A prescription will still be required for those younger. Duramed Pharmaceuticals, the product's distributor and a subsidiary of Barr Pharmaceuticals, has agreed to educate health care professionals and consumers about appropriate use. The company also will set up a toll-free hotline to answer questions, monitor the effectiveness of the age restriction and ensure that the drug is available only through clinics and pharmacies.

"While we still feel that Plan B should be available to a broader age group without a prescription, we are pleased that the agency has determined that Plan B is safe and effective for use by those 18 years of age and older as an over-the-counter product," said Bruce L. Downey, Barr's chair and CEO.

Debate about this step has been controversial. Because it is unusual for the agency to take so long to act on an advisory committee recommendation, the timeline prompted some women's health activists to accuse the agency of unreasonably delaying its final decision because of politics.

Most major medical societies, including the American Medical Association, support the switch because it would allow more women to access the medication during the 72-hour time window when it is most effective.

"The [AMA] applauds the recent FDA approval of Plan B emergency oral contraceptive as an over-the-counter option," said AMA Trustee Joseph M. Heyman, MD.

Reproductive rights organizations also have promoted OTC status and greater access as a way to reduce unintended pregnancies and abortion.

"This is a historic event in the struggle for women's reproductive health and rights," said Sharon L. Camp, PhD, president and CEO of the Guttmacher Institute.

But opponents lobbied against the status change because they say using the medication can be a form of abortion. They also expressed concerns that repeated long-term use may not be good for women's health. Additionally, some physicians opposed the shift because they say it will result in lost opportunities to provide medical care.

"Removing this high dose of hormones from a doctor's oversight removes a vital safety protection [for] women," said David Stevens, MD, executive director of the Christian Medical Assn.

Back to top



Read story

Confronting bias against obese patients

Medical educators are starting to raise awareness about how weight-related stigma can impair patient-physician communication and the treatment of obesity. Read story

Read story


American Medical News is ceasing publication after 55 years of serving physicians by keeping them informed of their rapidly changing profession. Read story

Read story

Policing medical practice employees after work

Doctors can try to regulate staff actions outside the office, but they must watch what they try to stamp out and how they do it. Read story

Read story

Diabetes prevention: Set on a course for lifestyle change

The YMCA's evidence-based program is helping prediabetic patients eat right, get active and lose weight. Read story

Read story

Medicaid's muddled preventive care picture

The health system reform law promises no-cost coverage of a lengthy list of screenings and other prevention services, but some beneficiaries still might miss out. Read story

Read story

How to get tax breaks for your medical practice

Federal, state and local governments offer doctors incentives because practices are recognized as economic engines. But physicians must know how and where to find them. Read story

Read story

Advance pay ACOs: A down payment on Medicare's future

Accountable care organizations that pay doctors up-front bring practice improvements, but it's unclear yet if program actuaries will see a return on investment. Read story

Read story

Physician liability: Your team, your legal risk

When health care team members drop the ball, it's often doctors who end up in court. How can physicians improve such care and avoid risks? Read story

  • Stay informed
  • Twitter
  • Facebook
  • RSS
  • LinkedIn