FDA rejects citizen's petition on Plan B

After a week of arguments and protests, the FDA has denied a citizen's petition from the Center for Reproductive Rights on allowing greater access to generic versions of the Plan B contraceptive for girls under 17.

The news comes a week after HHS Secretary Kathleen Sebelius' decision to trump the FDA on expanding access to the Plan B contraceptive. At issue was whether Teva Pharmaceutical Industries' ($TEVA) product should be taken out from behind the pharmacists' counter, making it available outside pharmacy hours--and without a prescription for girls younger than 17 for the first time. The FDA was inclined to approve, but the HHS intervened, overruling that decision.

In a letter explaining its actions to the center, the agency points out that the application to approve access to girls 16 and younger without a prescription was denied because the drugmaker provided data for Plan B One-Step, a single-dose tablet, not Plan B.

Plan B One-Step is an OTC pill for women ages 17 and older and is available by prescription for those under the age of 17. Plan B, on the other hand, uses a two-dose regimen, as Pharmalot notes.

"In particular, because Plan B One-Step consists of a single tablet, the dosing data for Plan B One-Step could not provide support for an OTC switch of Plan B as that data would not adequately address the ability of subjects to correctly follow the directions related to the timing of a second dose that is required for proper use of Plan B," the letter, a copy of which is available at Pharmalot, states.

The rejection comes as the FDA faces a contempt of court hearing. Judge Edward Korman is slated to hear arguments today over whether it is constitutional for the government to block the OTC sale of the emergency contraception to younger girls, NY1 reports. In March 2009, Korman lambasted the agency for putting politics above public health and ordered the FDA to let 17-year-olds have access to Plan B.

"On the eve of a contempt hearing, the FDA has once again come up with an excuse to treat the approval of contraceptives differently from any other drug," said Nancy Northup, president and CEO of the Center for Reproductive Rights, in a statement. "It is truly stunning the lengths to which the agency will go to deny women access to emergency contraceptives that have been proven safe and effective for years."

After Sebelius' ruling on Plan B, there was a firestorm of criticism, including from New York City Mayor Michael Bloomberg. "We've had many, too many, unwed births in this country," he said, as quoted by Bloomberg. "It would be much better if these young girls didn't get pregnant. I agree with Hamburg."

However, not all may be lost for Teva. Sebelius, who made the decision to overrule the FDA last week on access to the contraceptive, said the drugmaker can always come back with more information in support of its application for younger girls. "There are always opportunities for the company to come back with additional data," she said, as quoted by Bloomberg. "Subsequent discussions can take place."

- read the Center for Reproductive Rights' release 
- see more from Bloomberg
- get this Bloomberg report
- read the Pharmalot post
- get the NY1 report (with video)

Suggested Articles

While Lilly's 2018 launch Emgality is approved to prevent migraines, Reyvow is intended to treat them as they occur.

ICER's new draft review of RA drugs takes a different approach, reflecting how physicians treat the disease and the time horizon that's considered.

Johnson & Johnson is facing multibillion-dollar liabilities in thousands of talc and opioid cases. But that's not such a bad thing, one analyst said.