Lawmakers call upon FDA to approve Plan B

Share this article:
A bipartisan group of 62 U.S. lawmakers are calling on the new acting commissioner of the FDA to allow OTC sales of Barr Pharmaceuticals' Plan B (levonorgestrel).
Although the letter stops short of accusing the FDA of allowing politics to interfere with a ruling on OTC status for emergency contraceptive, it chides officials for ignoring evidence.
"We believe this new delay does not truly reflect valid scientific or regulatory concerns," the lawmakers, including six Republicans and one Independent, wrote in a letter dated Oct. 7. "By further delaying the FDA's decision to expand access to EC (emergency contraception), you are seriously hindering efforts to reduce abortions across the U.S.," lawmakers wrote. The letter also called on acting FDA commissioner Andrew von Eschenbach to approve Plan B "without further delay."
Barr has sought OTC status for Plan B for more than two years.
An FDA advisory panel overwhelmingly supported non-prescription sales of the drug, but early last year the FDA rejected Barr's proposal citing concerns about use among girls under 16. Barr re-filed its bid, proposing OTC sales for only those over 16.
Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Business Briefs

Monday Moves: September 15

Hires and promotions for manufacturers, regulatory and agencies

Kantar acquires Evidências, expands Brazilian presence

The company's acquisition signals the growing importance of understanding the Brazilian healthcare market and evidence-based healthcare management services.

Study says statins not enough for diabetic hearts

Researchers using an experimental test have discovered that the 50% of surveyed diabetics may also have undetected heart muscle damage.