Lawmakers ask White House to Review FDA Rule for Generic Label Changes

Originally posted on Pharmalot


A pair of Republican lawmakers has written the White House to question the authority the FDA has to issue a rule allowing generic drug makers to independently provide updated safety warnings about their medicines.

The proposed rule, which the agency released last fall, has become controversial as generic drug makers argue the FDA is on a misguided mission to close what consumer advocates call a safety loophole in the national medicine chest. The generic industry, however, funded awhite paper that maintains the rule would add $4 billion to the nation’s health care bill, mostly due to higher litigation costs that may ensue.

The generic industry has now caught the ear of U.S. Sen. Lamar Alexander of Tennessee and Bob Goodlatte of Virginia, who chairs the House Judiciary Committee. In their June 25 letter, they also caution the rule is troubling and asked the White House Office of Management and Budget to review the legality of the proposed rule and what they call a “flawed” cost-benefit analysis by the FDA.

As we have written previously, the rule would allow generic drug makers to independently add new side effect information to product labeling, something that only brand-name drug makers are currently allowed to do before receiving FDA permission. The rule was proposed in response to a 2011 U.S. Supreme Court ruling that generic drug makers are unable to make such changes independently and, therefore, should not be held accountable for a failure to warn against any risks.

The court ruling prompted criticism from consumer groups that generic labeling would be insufficient to warn patients about the risks associated with numerous medications, especially at a time when generic drugs are so widely prescribed. But the FDA explained its decision by saying the rule was an attempt to “create parity” between brand-name and generic drug makers.

How so? Since the passage of the 1984 Hatch-Waxman Act, generic drug makers have not been required to run tests to prove their medicines are the same as brand-name drugs and, as a result, have also not had to upgrade labels with new risk information. The FDA maintains that there is nothing in that law preventing the agency from issuing its proposed rule.

This is the second time this month that the rule has come under fire from members of Congress. A June 4 report from the House Appropriations committee questioned the premise by stating its “unaware of evidence of a need to change existing regulations.

“The proposed rule has the potential to threaten public health by creating unprecedented patient and provider confusion by having multiple labels for the same product, therefore undermining the longstanding policy” of having the same label on both brand and generic versions of a drug, the committee wrote on page 61.

“The committee urges FDA to maintain a system where prescription drug labels on the market are FDA-approved, grounded in scientific evidence, and information between the name brand drug and the generic version drug present no opportunity for mismatched dispensing” or usage information between brand and generic copies.

To buttress this last point, the Generic Pharmaceutical Association recently released a survey of 450 physicians, physicians assistants and pharmacists, who said the rule would require additional time to keep current with labeling changes; FDA approval should be required before any safety information is changed on labeling, and are concerned legal liability would rise. The survey was conducted by Fairleigh Dickinson University’s PublicMind.