The U.S. Food and Drug Administration plans to begin issuing authorization documents for contraceptive devices to doctors as early as this week, allowing them to recommend and sell the devices to all men and women, according to the New York Times.
A pill, known as Ella, uses progestin pills in the morning and a second pill, known as Depo-Provera, in the afternoon and evening to help prevent pregnancy for three weeks before being replaced by an older morning-after pill. A second, most-commonly sold, prescription product, called Plan B, is a similar method of preventative pregnancy in which one dose of a hormone is taken, then taken again an hour or two after intercourse. (Planned Parenthood has said the NDA package is not actually the same as an NDA, which means Pfizer isn’t actually submitting papers for the device yet.)
In most cases, patients are turned away when a doctor thinks the device is not suitable for their needs or they have concerns about side effects, ranging from acne and acne in newborns to vaginal bleeding and ectopic pregnancies. In some cases, doctors may have to turn people away altogether.
The director of the FDA’s Center for Devices and Radiological Health, Dr. Jeffrey Shuren, said at a press conference Tuesday that the FDA had been thinking about “the families who are concerned that they don’t have insurance. And so they’re going to have a choice,” he said. “Are they going to go to their health plan provider who may or may not know about this? Do they need to go to a Planned Parenthood provider who may or may not have trained medical staff who can actually offer them this advice?
“This is an important issue for people around the country to be aware of.”
The F.D.A. has taken a proactive role in the issue. The agency moved to notify physician groups about the prospective approval, which would also be discussed in a brochure to be distributed at clinics and doctors’ offices, as part of a larger effort to expand access to contraceptive devices to all women, the Wall Street Journal reported.
And the White House’s Center for Women’s Health Policy said in a statement Tuesday that it would support the NDA action, based on “the compelling scientific and medical evidence” that has “explained why this tool will help women take charge of their own reproductive health.”
Doctors and patient groups have for years urged the government to expedite the process to issue an NDA so that more women have access to the product. The FDA will decide in June whether to issue such an NDA.