Despite EC Switch Denial, Attorneys See Value In Non-Sponsor Petitions
This article was originally published in The Tan Sheet
The citizen petition filed by the Center for Reproductive Rights and other groups to switch Plan B over the counter failed in part because the petitioners did not sponsor the drug and lacked the necessary data to support a switch.
But that does not mean such petitions from non-sponsors are pointless, attorneys say.
“I do think there are a number of examples where advocacy organizations have moved the needle” and raised issues to FDA that would not otherwise be presented, said Meredith Manning, a partner with Hogan Lovells in Washington.
She pointed to the 2007 petition filed by a coalition of health professionals led by Joshua Sharfstein, later to be FDA principal deputy commissioner, which sought more restrictive labeling for pediatric cough/cold OTCs (Also see "AAP Presses FDA To Eliminate OTC Pediatric Combination Products" - Pink Sheet, 30 May, 2011.).
The agency subsequently began the lengthy rulemaking process for pediatric cough/cold drugs and industry voluntarily relabeled those products to warn against use in children younger than 4.
Citizen petitions filed by health insurance firm WellPoint and law firm Greenberg Traurig between 1998 and 2007 sought the forced Rx-to-OTC switch of antihistamines including Allegra, Claritin and Zyrtec to shift the cost burden for these drugs to consumers (Also see "Antihistamine Forced Switch Proposal Returns In Citizen Petition" - Pink Sheet, 26 Mar, 2007.).
Most of the drugs in the petitions eventually switched at their sponsors’ behest, but “in its heart of hearts, FDA didn’t want to set a precedent of switching based on a citizen petition submitted by a non-sponsor,” said Coleen Klasmeier, a partner with Sidley Austin and former staff attorney at FDA.
Those forced switch petitions were based on commercial interests, but other non-sponsor petitions were based more on risk-management, Klasmeier said. Examples include CRR’s Plan B petition and the frequent filings by Public Citizen seeking market withdrawal of specific drugs for safety reasons.
But excessive risk management by FDA may inspire citizen petitions, too, she said, citing the agency’s requirements for Risk Evaluation and Mitigation Strategies and Medication Guides as components of drug approval that may make health care delivery less efficient.
“I think FDA would really benefit from hearing more from the public about whether the agency is calibrating the risk-management measures in the right way,” Klasmeier said. “You’re going to see more of this rather than less.”