Letter Questions FDA Delay on Plan B Application
Rep. Henry Waxman (D-Calif.) on Thursday sent a letter to acting FDA Commissioner Andrew von Eschenbach saying that the agency "appears to be seriously mischaracterizing" its analysis of regulatory issues regarding Barr Laboratories' application for nonprescription sales of the emergency contraceptive Plan B for women ages 17 and older, CQ HealthBeat reports. According to Waxman, agency documents show that FDA for at least a year had considered issues it cited in its August 2005 decision to delay its ruling on the application (CQ HealthBeat, 3/9).
FDA in May 2004 issued a "not approvable" letter in response to Barr's original application to authorize nonprescription sales of Plan B -- which can prevent pregnancy if taken up to 72 hours after sexual intercourse -- citing inadequate data on its use among girls under age 16. The decision contradicted the recommendations of two FDA advisory panels.
The agency in January 2005 delayed a ruling on Barr's revised application, which would allow Plan B to be sold without a doctor's prescription only to women and girls ages 17 and older.
Former FDA Commissioner Lester Crawford in August 2005 opened a 60-day public comment period on Barr's application and said that science supports giving nonprescription access to Plan B to women ages 17 and older but added that the application presented FDA "with many difficult and novel policy and regulatory issues," including how to keep girls ages 16 and younger from obtaining the drug.
The comment period expired in November 2005, and the agency did not indicate when it might make a decision on the application (California Healthline, 11/15/05).
Waxman, the ranking member of the House Government Reform Committee, in his letter said FDA told Barr in August 2005 that the application presented "three difficult and novel issues," including whether FDA can authorize prescription and nonprescription sales of the same drug based on age, whether both prescription and nonprescription sales could be sold in the same package and how an age restriction could be enforced (Waxman letter, 3/9).
According to the letter, Jane Axelrad, associate director for policy at FDA's Center for Drug Evaluation and Research, said that allowing Plan B to be sold in the same package for prescription and nonprescription sales would be "consistent with precedent" and would comply with "applicable statutory and regulatory provisions," Knight Ridder/San Jose Mercury News reports (Pugh, Knight Ridder/San Jose Mercury News, 3/9).
Another document, written by an unnamed FDA deputy division director and dated April 1, 2004, said former agency Commissioner Mark McClellan and senior management had asked the agency's Office of Chief Council to review whether age-based restrictions on nonprescription sales would be legal.
In addition, John Jenkins, director of the Office of New Drugs, in a May 14, 2004, letter to colleagues wrote that a six-month schedule should be set to review issues raised by limiting nonprescription access to Plan B to girls and women ages 16 and older (Waxman letter, 3/9).
"In essence, the agency was well aware of the regulatory questions that would arise when it suggested age restrictions, but simply did not resolve them in a timely manner," Waxman wrote (Knight Ridder/San Jose Mercury News, 3/9).
The letter asks Von Eschenbach by March 27 to provide documents from CDER's analysis of possible age restrictions for Plan B nonprescription sales, as well as "an account of why the Office of Chief Counsel apparently failed to respond to repeated requests for a timely legal analysis of Barr's amended application."
Waxman adds that if OCC attorneys "did in fact prepare an analysis," Von Eschenbach should explain "why FDA announced in August 2005 that it was unable to resolve the key regulatory questions by that time" (Waxman letter, 3/9).
FDA officials had no comment on the letter, according to CQ HealthBeat (CQ HealthBeat, 3/9).
Daniel Troy, former head of OCC, also did not comment on the documents, and Waxman's office would not disclose the source from which they were obtained. Barr spokesperson Carol Cox would not comment on the documents but said, "We continue to seek approval from the FDA of Plan B as a [nonprescription] product" (Knight Ridder/San Jose Mercury News, 3/9).