FDA’s Generic Drug Warning Labeling Rule Change

The New York Times recently published an editorial in support of the FDA’s generic drug labeling rule. AAJ (American Association for Justice) released an editorial board memo on generics and Katie Gommel (AAJ Press Secretary) did an outstanding job working behind the scenes with Public Citizen to shape this editorial.

Late last year, the Food and Drug Administration proposed new regulations  that would authorize the makers of generic drugs to update safety labels without waiting for F.D.A. approval, to warn of newly discovered risks. The change is strongly opposed by the manufacturers of generic drugs out of fear of being held liable for damages to patients harmed by their products. But the change is an important one, to give both patients and doctors more timely warning of possible risks and to enable patients to sue.

The current law, enacted in 1984, requires the labeling for a generic drug to be the same as the labeling already approved for the brand-name drug it had copied. The proposed rule change is important for two reasons. One is that a Supreme Court ruling in 2011 said that “because makers of generic drugs do not control the labeling, they cannot be sued under state law for failure to warn of new dangers”. So basically, patients could sue a brand-name drug manufacturer for such a failure, but consumers harmed by the generic version of the same drug were left without recourse. This important rule change would advocate consumer safety measures and allow both generic and non-generic drug companies to be held responsible for any adverse reactions.

The use of generic drugs account for 80 percent of all prescriptions filled in the United States today. Typically, once a generic drug enters the market, the brand-name drugs drop in popularity or disappear altogether; there are many generic drugs for which there is no brand-name drug still on the market whose label can be changed to indicate new risks.

With that in mind, the F.D.A.’s proposed changes would allow makers of generics to use the same process as brand-name drug makers to update safety information in the product labels. The F.D.A. is now considering a final rule.

The changes are strongly opposed by the Generic Pharmaceutical Association, a trade group, which argues that exposing makers of generics to product liability lawsuits will drive up their costs by at least $4 billion annually, increase the price of generic drugs, and cause confusion if different warnings are put on different versions of the same drug.

Public Citizen, a consumer advocacy group based in Washington that has been pushing the agency to make the change, believes there will be little or no confusion and suggests that the liability costs will not be large because prompt safety updates should help to prevent injuries from occurring in the first place.

Now that generics constitute the vast majority of prescriptions, their manufacturers should be made responsible for alerting the public to risks discovered after their drugs are on the market.

If you or a family member believe you may be a victim of a defective drug, contact The Yost Legal Group for help. You can speak with an attorney for free about your situation.

The Baltimore defective drug lawyers at The Yost Legal Group are here to help you get the justice you deserve. We have years of experience holding negligent pharmaceutical companies accountable and know exactly what needs to be done in these cases to get maximum compensation for our clients.

A formal review of FDA policies is a step in the right direction, but not enough to help current victims. We are here to take your case and fight for you, helping you get the true compensation you deserve.

To schedule your free consultation with an experienced Baltimore defective drug attorney, contact The Yost Legal Group today at 1-800-Yost-Law. (1-800-967-8529)