FDA official denies politics delaying Plan B decision

Share this article:
The FDA’s acting director refuted concerns that politics are delaying the agency’s review of an OTC switch petition for Plan B, the AP reports. Andrew von Eschenbach told House members that the decision on the morning-after contraceptive pill, marketed by Barr Labs, would be based on science. "That process will be carried out in the appropriate fashion," he said, while appearing before a House Appropriations subcommittee to go over the agency's budget. House Democrats pressed von Eschenbach on the issue, saying the agency has had ample time to reach a decision. Under Barr’s revised application—the FDA rejected its initial OTC petition in 2004—Plan B would become available over the counter to patients 16 and above but remain a prescription drug for younger ones. Those age limits create a novel situation for the FDA, which has not considered the same product as both a prescription and OTC drug. Von Eschenbach declined to say when the agency might rule, adding that it was reviewing public comment.
Share this article:
close

Next Article in Business Briefs

Email Newsletters

More in Business Briefs

Illumina inks deal with J&J, AstraZeneca, Sanofi

The goal is to develop companion diagnostics to match patients with cancer treatments.

Abbott deal highlights inversion inaction

Political furor over the recent spate of tax inversions is having little influence on how the government chooses its partners.

Allergan reported to seek out Salix deal

The Wall Street Journal says the deal would add "another layer of intrigue" to the Allergan-Valeant hostilities.