A large group of House Republicans is once against raising questions about the U.S. Food and Drug Administration’s (FDA) 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.”
As explained by Regulatory Focus, the FDA’s meetings related to the development of the rule has drawn criticism from Republican legislators due to the possible influence of trial lawyers on the FDA’s decision-making. This is 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 feasible 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 did not meet with anyone from the generic drug industry, which stands to be affected most by the proposed rule, yet ultimately had no input during its development.
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.
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.