House Oversight and Government Reform Committee Chairman Darrell Issa (R-Calif.), Subcommittee on Economic Growth, Job Creation, and Regulatory Affairs Chairman Jim Jordan (R-Ohio), and Rep. Rob Woodall (R-Ga.) late yesterday requested that the U.S. Food and Drug Administration (FDA) provide information on a proposed rule to change long standing policy on drug labeling, which was developed in sole consultation with trial lawyer lobbyists in order to override a 2011 Supreme Court decision. If implemented, the rule will increase the costs consumers pay for generic drugs, without any corresponding public health benefit.
“FDA developed the proposed rule to ensure manufacturers of generic drugs would face liability, and resulting litigation, by establishing a process for generic drug manufacturers to change their label without prior FDA approval,” the lawmakers wrote in the letter. “It seems to us that the proposed rule is not designed to address a health or safety related concern, instead it is designed to placate special interests groups and increase lawsuits.”
The letter notes that on February 15, 2013, the American Association of Justice, formerly known as the Association of Trial Lawyers of America, “met with senior level FDA staff, including Daniel Sigelman, Senior Policy Advisor to the Commissioner and former trial lawyer.” The FDA failed to meet with any other key stakeholders.
“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 lawmakers write.
The letter also notes that FDA failed to provide an economic analysis of the increased cost of lawsuits on the prices consumers face, despite private sector analysis which indicates the cost of litigation could be billions of dollars.
In addition to a briefing, the lawmakers requested that the FDA provide the following:
1. All documents and communications referring or relating to failure-to-warn liability for drug manufacturers.
2. All documents and communications referring or relating to FDA’s February 15, 2013, meeting with the American Association for Justice.
3. All documents and communications to or from Daniel Sigelman and any other FDA staff that attended the February 15, 2013 meeting with the American Association for Justice referring or relating to the “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products” proposed rule.
4. All documents and communications referring or relating to the content of the Preliminary Economic Impact Analysis for the proposed rule.
5. All documents and communications referring or relating to Pliva v. Mensing or Mutual Pharmaceutical Company v. Bartlett.
6. All documents and communications referring or relating to alternative methods of regulating generic drug labels considered by FDA during the course of the rulemaking
To see the full letter, click here.