News Feature | February 20, 2014

Generic Drug Companies Battle Proposed FDA Regulation

Source: Pharmaceutical Online

By Marcus Johnson

Generic drug companies sell the medications that ultimately reach the majority of Americans. Generic companies are being put at risk by a new proposed FDA regulation that would require them to warn patients of all potential health risks that their products carry. Industry trade groups and lobbyists are fighting hard against the proposed regulation, with Ralph G. Neas, the President of the Generic Pharmaceutical Assn. trade group, calling it “nothing short of catastrophic.” Generic companies claim that the new regulation would do more harm than good by causing healthcare costs to rise and by offering confusing and possibly contradicting information to doctors and patients.

The 2009 US Supreme Court ruling that stated that brand-name drug producers could face legal action if they didn’t disclose their drugs’ health risks opened the door for the same legal interpretation to be applied to generic companies. However, when offered the opportunity, the Supreme Court ruled that generic companies are not liable for serious injuries caused by generic drugs because generic companies are bound by law to make “exact copies” of brand name drugs and cannot “revise or update warning labels.”

The FDA’s proposed regulation would close the loophole applied to generic drugs and bring their legal status in line with brand name products. The FDA believes that generic companies should be able to update their warning labels as new information arises about their products. “