Posted 18 July 2014
By Alexander Gaffney, RAC
A new group of House legislators is calling on the US Food and Drug Administration (FDA) to answer questions about a plan to overhaul the way in which generic drug labels are updated to reflect new safety risks, saying the plan appears to have been improperly influenced by a special interest group.
In November 2013, FDA unveiled a new proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. The rule would, among other things, permit a sponsor of a generic drug to immediately change the label on its product to reflect any new or probable safety risks known to the company. Those changes would later be reviewed by FDA and the owner of the non-generic (i.e. original) product, and either adopted for all drugs, or rejected.
For an extremely thorough explanation of the rule, please read Focus' regulatory explainer, Understanding the Regulation of Generic Drug Labels.
But since the release of the proposed rule, legislators have found that FDA consulted with only one group during the entire lead-up to its release: an organization of trial lawyers.
In response to questions by Republican legislators, FDA said that while it "generally does not participate in a dialogue during the development of proposed rules," it had made an exception in this case and met with representatives from the American Association for Justice (AAJ) (formerly the Association of Trial Lawyers of America) and two additional law firms (Forcey LLC and Blizzard, McCarthy & Nabors).
The February 2013 meeting involved top FDA officials, including Elizabeth Dickinson, FDA's chief counsel; Leslie Kux, associate commissioner for policy; Donald Beers, one of FDA's top generic drug legal experts; Denise Esposito, deputy chief counsel for drugs and biologics; and Daniel Sigelman, a senior regulatory policy analyst.
The meeting was described only as a "Mensing follow-up," referring to the prominent Supreme Court case of Pliva vs. Mensing. FDA officials later clarified to legislators that it was a "listen-only session."
Republican legislators—no friends to the trial lobby in general—said they had concerns that the meeting had violated Executive Order 13563, which regulates public participation in the rulemaking process. Per the order, the process should either be closed to everyone, or based on an "open exchange of information," especially among those expected to be affected by the rule. Because FDA met with no one other than the AAJ, legislators with the House Energy and Commerce Committee said they were "very concerned," and asked FDA to turn over all related documents.
New Legislators Take Note
And now, another group of legislators has turned its eye on the agency's meeting, citing the appearance of improprieties.
"The Committee is concerned with several dubious aspects of this rulemaking," three legislators from the House Committee on Oversight & Government Reform wrote in a letter to FDA Commissioner Margaret Hamburg on 17 July 2014.
"Given the intent of the rule is to create an environment for increased litigation, the Committee finds it troubling that the FDA consulted only with trial lawyers, but no other major stakeholder likely to be affected," the legislators wrote.
The legislators, including House Oversight Chairman Darrell Issa and Reps. Jim Jordan and Rob Woodall, demanded FDA grant them access to all documents related to the formulation of the rule, including documents and communications surrounding the agency's meeting with the AAJ.
The legislators also requested a meeting with FDA to discuss the allegations and related documents, which must be turned over by 30 July 2014.
Whether or not the letter turns into a formal investigation—and what that could mean for the future of FDA's generic drug labeling proposal—remains to be seen.
Letter to FDA