Reports Raise Questions Over Who Was Involved in Drafting FDA’s Proposed Change to Generic Drug Labeling

March 31, 2014

Health Subcommittee to Hear from FDA, Stakeholders at Hearing TOMORROW

The Washington Examiner reports that there are “new concerns that the administration is doing the bidding for trial lawyers who want access to generic firms.” This is not the first time Members of Congress have raised concerns about the proposal. House Energy and Commerce Committee Chairman Fred Upton (R-MI) earlier this year led a group of House and Senate lawmakers in a letter to the Food and Drug Administration regarding the agency’s proposed changes to generic drug labeling. Members are concerned about how FDA’s proposed changes would affect patients and providers. Moreover, they question why FDA would propose this change that directly contradicts the “sameness” requirements that have been in place for decades and is also at odds with statements the agency made in an earlier Supreme Court brief. FDA responded to the committee’s letter earlier this year but the committee’s questions remain.

SCHEDULING NOTE: The Health Subcommittee will hear from FDA and other stakeholders at a hearing tomorrow at 3 p.m.

March 27, 2014

Trial Lawyers Helped FDA with Rule Opening Generic Drug Firms to Lawsuits

The association that represents America's trial lawyers played a special role in the Food and Drug Administration's process of developing a new rule that opens the door to suits against generic drug makers, a potential financial bonanza to lawyers -- and a $4 billion hit to consumers and the government.

In a letter to a House committee, the FDA singled out the trial lawyers group, the American Association for Justice, as the only one officials met with as they drew up the rule. In the same letter, the FDA said that it typically doesn’t meet with stakeholders while drawing up new regulations. …

The admission raised new concerns that the administration is doing the bidding for trial lawyers who want access to generic firms.

The rule change follows a Supreme Court decision barring suits against generic drug firms accused of providing insufficient label warnings. The 5-4 decision restricted suits for so-called design defect or drug-safety complaints, arguing that generic makers have to use the same labeling as the original drug maker. As a result, only the makers of brand-name drug can be sued. …

But the shift to let generic firms change safety labels could be costly. The Generic Pharmaceutical Association recently released a study that said the rule could cost $4 billion, mainly because generic firms would have to expand their legal teams to fight product liability lawsuits. …

Read the complete story online here.