House investigators suspect the Obama administration catered to trial lawyers in the run-up to a proposal that would allow generic drug makers at times to change their labels without FDA approval.
Digging into the matter, skeptical Republicans asked the agency in writing last week how they settled on the plan, because the shift would expose the generic drug makers to lawsuits from which they currently are immune.
“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 interest groups and increase lawsuits,” Rep. Darrell Issa, California Republican and chairman of the House oversight committee, wrote last week with two other congressman.
Even though generic drugs must meet the same safety requirements as brand-name drugs, their makers cannot swiftly change their labels without prior approval to reflect newly acquired safety information. Brand-name drug makers can, however, so the rule would create parity, according to Food and Drug Administration officials.
“The proposed rule would create that pathway for the generic drug application holder to help ensure that safety information reaches prescribers and consumers in a timely way,” Janet Woodcock, an FDA director for drug evaluation, told Congress in April.
But in his letter, Mr. Issa said Republican investigators needed to know why the FDA seemed to consult trial lawyers, and no one else, before issuing the proposal. The cost of litigation could lead to higher prices for consumers, they added, expressing disappointment with the scope of the FDA’s economic analysis before it proposed its rule.
The committee says it is not worried about the merit of the proposal itself but how the FDA conducted its rulemaking.
FDA spokeswoman Stephanie Yao said it is unclear when the proposal will be finalized, but the agency is obtaining a range of feedback while it addresses the lawmakers’ concerns.
“We are reviewing the letter and are working to respond as quickly as possible,” she said. “The FDA has received a great deal of public input from various stakeholders during the comment period on the proposed rule.”
Mr. Issa wants FDA materials from Jan. 1, 2010, to the present relating to failure-to-warn liability for manufacturers, the economic impact of the proposed rule and details of a February 2013 meeting between FDA officials and the American Association for Justice, an organization that supports the work of attorneys.
In 2011, the Supreme Court held in Pliva v. Mensing that generic drug makers were not liable for inadequate labels — although brand-name manufacturers are — because they did not have discretion over their labels.
AAJ said in March it would file comments in support of the FDA’s proposal because it made little sense for there to be separate legal systems for generic and brand-name drugs, particularly when 80 percent of all prescriptions in the U.S. are filled with the generic version.
“The Mensing decision left a glaring safety loophole and the entire generic drug industry unaccountable when their drugs kill and injure Americans,” AAJ spokeswoman Michelle Kimmel told The Washington Times on Friday. “Americans rightfully objected and the FDA responded. The American Association for Justice tirelessly advocates for the safety and accountability of all prescription drugs. If no one is accountable, no one is safe.”