“New” Plan B Emails Say FDA’s “Novel” Concerns Were Not Novel – Waxman

Internal emails suggest FDA began addressing legal issues pertaining to "dual marketing" of Plan B in early 2004; these documents could strengthen the Center for Reproductive Rights' suit against the agency over the delay in considering OTC status for the drug.

Several "new documents" released March 9 by Rep. Henry Waxman (D-Calif.) indicate that agency officials began as early as April 2004 to consider the legality of marketing the emergency contraceptive over-the-counter to women age 16 and older and by prescription to those under 16.

"These documents show that policy staff both analyzed and outlined potential solutions for the regulatory questions at least 15 months before FDA claimed that the questions were so 'novel' that they required an indefinite delay," Waxman says in a March 9 letter to Acting Commissioner Andrew von Eschenbach.

Waxman maintains FDA "appears to be seriously mischaracterizing its analysis of the regulatory issues" surrounding Plan B. The documents show that the agency's Office of Chief Counsel "repeatedly brushed aside" requests from FDA officials for a legal analysis, the congressman says.

The timing of FDA's legal concerns may undermine any perceived legitimacy of the agency's 2005 decision to pursue a rulemaking to address Plan B regulatory issues.

An Rx-to-OTC switch application for the drug was submitted in April 2003, which the agency deemed "not approvable" in May 2004. Sponsor Barr submitted an amended application including an age restriction in March 2004, and revised that submission in July 2004.

In August 2005, the agency announced it would issue an advance notice of proposed rulemaking to address "novel" issues surrounding the switch - such as the legality of the dual marketing scheme.

CRR's suit, originally filed in January 2005, alleges the agency's delays are arbitrary and capricious. One element of CRR's case depends on establishing that the agency's ANPR represents an "unreasonable" delay (¹ (Also see "FDA Topsiders Must Testify In Plan B Case – Judge" - Pink Sheet, 6 Mar, 2006.), p. 3).

Waxman cites a redacted April 1, 2004 Deputy Division Director review stating agency counsel would have to review any "restricted distribution program."

The lawmaker also points to a May 2004 email from Office of New Drugs Director John Jenkins following the issuance of the "not approvable" letter. Jenkins emailed then Acting Director of CDER Stephen Galson and Acting Deputy Commissioner for Operations Janet Woodcock in order set out a schedule for review of the amended application.

Noting the agency would have a six-month PDUFA deadline to address the new proposal, Jenkins suggested asking OCC "to agree to complete their review by the end of month 3 or month 4 at the latest, so that there will be time in the review cycle to complete any negotiations about any changes needed to the labeling (assuming they find the proposal legal)."

Jenkins asked Galson and Woodcock to coordinate with then Chief Counsel Dan Troy to initiate an OCC review. Waxman notes "a conclusive review apparently did not occur."

Waxman calls for an explanation of the agency's actions, including all documents from CDER's regulatory analysis and "an account of why the OCC apparently failed to respond to repeated requests for a timely legal analysis of Barr's amended application."

The lawmaker asks for a response by March 27.

CRR is expected to depose Galson, Woodcock and two former commissioners in April.

Waxman also follows up on concerns about possible FDA violation of records management laws that were raised by the Government Accountability Office's investigation of Plan B last fall (² (Also see "FDA Disagrees With GAO’s “Unusual” Findings Regarding Plan B Decision" - Pink Sheet, 21 Nov, 2005.), p. 4)

GAO said its investigators were told they could not have access to emails relevant to the investigation because they were deleted every 16 days - a statement FDA later amended to say they were deleted every 16 weeks, GAO said. Waxman wrote a letter at the time to HHS Secretary Leavitt, calling for an investigation into whether FDA disposed of any correspondence in violation of federal law (³ (Also see "Investigation Into McClellan Plan B Memos Sought By House Democrats" - Pink Sheet, 21 Nov, 2005.) p. 7).

In his recent letter, Waxman counters an FDA response dated Jan. 27 denying there was any violation of law, stating that "even if, as the agency later claimed, backup files were retained for 16 weeks, the practice would not approach the standards required by the Federal Records Act nor FDA's document retention policy."

- Christopher Walker