The RAPS store will be under maintenance Saturday, 17 April between 5 AM and 12 PM EST. Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.

Regulatory Focus™ > News Articles > House Legislators Want FDA to Discuss 'Alternatives' to Generic Labeling Rule

House Legislators Want FDA to Discuss 'Alternatives' to Generic Labeling Rule

Posted 23 April 2014 | By Alexander Gaffney, RAC

A large group of House Republicans is once against raising questions about the US Food and Drug Administration's development of a rule that would change the way generic drug labels are regulated, saying it has "significant questions" about the involvement of a group of trial lawyers in the process and is interested in proposing its own "alternative approaches."

Interested in learning more about FDA's generic drug labeling rule? Check out our Regulatory Explainer on the issue, which contains everything you need to know about the rule, how generic drug labels are regulated, and the arguments for and against the rule.

A Suspect Meeting

As explained in our "Explainer," the Generic Pharmaceutical Association and Republican legislators have both expressed concerns that FDA consulted only one group during its development of the proposed rule: a trade association composed of and representing trial attorneys.

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) 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."

Outside Involvement

The meeting has raised the hackles of Republican legislators-no fans of trial lawyers to begin with-in large part because of FDA's apparent violation of Executive Order 13563, which regulates how the executive branch is supposed to manage public participation. That order reads in part:

"Regulations shall be adopted through a process that involves public participation. To that end, regulations shall be based on the extend deasible and consistent with law, on the open exchange of information and perspectives among State, local and tribal officials, experts in relevant disciplines, affected stakeholders in the private sector, and the public as a whole.

… Before issuing a notice of proposed rulemaking, each agency, where feasible and appropriate, shall seek the views of those who are likely to be affected, including those who are likely to benefit from and those who are potentially subject to such rulemaking."

The problem, according to lawmakers, is that FDA apparently met with no one other than the AAJ, meaning the generic drug industry, which stands to be affected most by the proposed rule, had no input on it whatsoever.

In a new letter to FDA, Republican legislators said it is "not at all clear why plaintiffs lawyers would have any role in the development and review of the proposed rule." The legislators cited FDA's own past statements indicating that it has a vested interest in maintaining its sole status as "gatekeeper" in the labeling process.

"We share these longstanding views, and in fact are very concerned that the result of this proposed rule would be therapeutically equivalent products with different warnings and contraindications based on companies taking actions to mitigate litigation risks-not based on communicating genuinely new risks to patients," the legislators wrote.

Legislators asked FDA to turn over all documents, communications and meeting minutes related to its 15 February meeting with the AAJ and other trial attorneys, presumably to see if points raised by the attorneys made their way into the rule or otherwise influenced FDA's thinking.

Talking About Alternatives

The letter goes on to state that legislators are interested in opening a "dialogue" with FDA on the "timeframes by which generic manufacturers must make conforming changes to ensure consistency," and opening up further discussions on "alternative approaches" to regulating generic drug labels "consistent with the statute."

While never saying so explicitly, it would appear that legislators have formulated one or more alternatives to FDA's proposed rule and are prepared to play hardball to get the agency to back off.

Republican Letter to FDA


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.