LA Times Shares Committee’s Concerns About FDA’s Proposed Changes to Generic Drug Labels
Health Subcommittee Hearing to Review Proposed Changes Rescheduled for April 1
House Energy and Commerce Committee Chairman Fred Upton (R-MI) recently led a group of House and Senate lawmakers in a letter to the Food and Drug Administration voicing concerns over the FDA’s proposed changes to generic drug labeling requirements. Upton commented, “For years, the ‘sameness’ requirements have made it easier for both patients and providers to understand the benefits and risks, providing peace of mind and encouraging competition in the generic drug market.” The Los Angeles Times editorial board adds that the proposed change “runs counter to the law, which still requires uniform labeling.”
SCHEDULING NOTE: The Health Subcommittee has rescheduled its hearing, Examining Concerns Regarding FDA’s Proposed Changes to Generic Drug Labeling, for Tuesday, April 1, 2014.
March 12, 2014
EDITORIAL: The Labels on Generic Drugs
When Congress gave generic drugmakers a shortcut onto the market 30 years ago, it required them to provide the same warnings as the brand-name medicines they were copying. Two recent Supreme Court rulings applied that stricture in an unexpected way: Even if generic drugmakers learned of a new side effect, they could not be expected to warn about it unless and until the brand-name drug did. In response, the Food and Drug Administration has proposed a rule to let generic makers add new warnings unilaterally — and allow them to be sued if they don’t. One problem with the rule, though, is that it runs counter to the law, which still requires uniform labeling.
When drug manufacturers learn about a bad reaction to one of their products, they have to report it to the FDA — within 15 days if it’s serious, less rapidly if it’s not — so the agency can decide whether to change the drug’s warning label. Brand-name drugmakers have the power to add new warnings temporarily while waiting for the FDA to approve a new label, and to alert physicians about the risk. But the FDA had previously barred generic manufacturers from taking such steps, and the Supreme Court held in 2011 and 2013 that injured patients couldn’t sue them for selling unreasonably dangerous products as long as their labels were the same as those on the branded versions.
Fearing that the rulings left generic manufacturers with little incentive to monitor the safety of their products, the FDA has proposed to reverse its stance and allow all drug makers to add temporary warnings without the FDA’s approval. The goal is the right one: to make sure doctors and patients are adequately warned about newly discovered risks as soon as possible.
The agency’s good intentions, however, don’t outweigh the fact that the law doesn’t allow generic drugs’ labels to vary from the brand-name equivalents’. Allowing each manufacturer of a generic drug to alter its label unilaterally would result in supposedly identical drugs carrying different warnings. That’s not only confusing, it would be counterproductive if consumers gravitated away from the generics that carried more daunting — but more up-to-date — warnings. …
Read the complete editorial online here.