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Plan B Decision Overruled
In a controversial and unprecedented move, Health and Human Services Secretary Kathleen Sebelius counteracted a Food and Drug Administration (FDA) decision on December 7, 2011, directing the agency to deny approval of a supplemental drug application. At the direction of Secretary Sebelius, FDA issued a response letter to Teva Women’s Health which informed the company that its February 2011 supplementary application which requested removal of prescription status for its Plan B One-Step product for use by women under age 17 was not approved.
Plan B One-Step is a single-use levonorgestrel tablet which works to prevent pregnancy by preventing a fertilized egg from implanting and subsequently growing. It has been available over-the-counter (OTC) for women aged 17 and older since 2009. Earlier in 2011 it seemed that Teva’s attempt to offer easier access to the product to younger women would be successful. FDA’s Center for Drug Evaluation and Research recommended that the OTC request be approved after concluding that the product met the standards for a nonprescription drug. Secretary Sebelius disagreed, however, overruling the planned approval decision and stating that sufficient data had not been submitted to prove that the product was safe for use in younger women.
The history of Plan B One-Step’s predecessor, simply known as Plan B, has also been controversial. The two-dose Plan B product was approved in 1999 as a prescription product and received the recommendation of an FDA advisory committee for over-the-counter status in 2003. It was not until 2009, however, that the OTC change was finalized. In the end, Plan B was made OTC only for women over age 17, despite a law suit and a U.S. District Court ruling which attempted to force OTC status for Plan B use in all women. The law suit, originated by The Center For Reproductive Rights, has now been reopened and Secretary Sebelius has been added as a defendant.
As this “morning after pill” debate continues, make sure to review our list of relevant documents, including approval documents for Plan B, advisory committee transcripts, and much more.
Novartis/Sandoz Warning Letter
FDA has issued a lengthy warning letter to Novartis citing multiple CGMP violations found at three Sandoz manufacturing facilities owned by the company. Inspections conducted in 2011 at plants in Broomfield, CO, Wilson, NC, and Boucherville, Canada, led to the discovery of a number of violations, including failure to clean equipment, failure to prevent contamination, and failure to investigate batch failures. Many of the violations were repeat observations from 2008 and 2009 inspections. FDA’s November 18 warning letter details the violations and states that the agency “expects Novartis to undertake a comprehensive and global assessment” of its manufacturing operations.
Find out more with our list of related documents, including many of the noted 483s.