This weekly column offers opinions on the latest pharmaceutical industry news.
Most Americans may assume their prescription medicines are packaged with the latest, up-to-date safety information. But that may not always be true when it comes to generic drugs.
The companies that make brand-name medicines can change their product labels when they learn about new side effects that may harm patients. But federal regulations prevent generic companies from doing the same thing, unless a change has already been made to the corresponding brand-name drug.
Generic drug manufacturers don’t mind having their hands tied in this way because it helps shield them from potential lawsuits over side effects not mentioned on their medicines’ labels. But it potentially jeopardizes patient safety. With generic drugs now prescribed the vast majority of the time, side effects often are first noticed in patients taking these medications.
So three years ago, the US Food and Drug Administration proposed a rule that would allow generic drug makers to update their labeling if new side effect information is detected.
The pharmaceutical industry, fearing rising litigation costs, has lobbied hard to thwart the agency and has won delays and allies in Congress. Earlier this month, the House Appropriations Committee proposed a spending bill that would prevent the FDA from using its funding to enact the rule as early as this summer.
Consumer advocacy groups are protesting. With eight of every nine prescriptions in the United States written for lower-cost generics, they worry that many drugs that Americans take every day may have outdated safety information.
“New risks posed by drugs are often discovered after a medicine is sold as generic,” said Allison Zieve, director of litigation at Public Citizen, which five years ago petitioned the FDA to devise a new rule about generic labeling. “It really doesn’t make sense for crucially important products such as drugs not to have updates.”
For their part, generic drug makers have been battling the FDA over concerns that they will face an untold number of lawsuits filed by consumers who claim they were harmed by the medicines. Right now, a generic drug maker cannot be sued for not warning about potentially dangerous side effects, since federal regulations only require their product labels match brand-name drugs.
The Generic Pharmaceutical Association, an industry trade group, argues that the added regulatory requirements and litigation costs could eventually add $4 billion to the nation’s health care bill. And it asserts that the new rule would create confusion if only some generic drug makers adopt language about a side effect, leading to a potpourri of potential labels.
The generics industry is not alone in sharing such concerns. Two weeks ago, more than a dozen companies and organizations reiterated these points in a letter to the FDA. Among them: the CVS and Rite Aid drug-store chains; trade groups representing health insurers, pharmacists, and pharmaceutical wholesalers; and the health plan for retired auto workers.
Opponents of the FDA proposal are doing more than just complaining.
Last year, brand-name and generic drug makers jointly made a proposal. Their idea was for brand-name manufacturers to remain responsible for updating product labeling when they learn about new safety hazards. But this would only apply when there are no generic versions available. Otherwise, the FDA would be responsible for mandating label changes for all drugs, including generics.
This idea amounts to a stalking horse.
The proposal places nearly all responsibility for label changes on the FDA, but the agency is unlikely to be able to act quickly enough on new information. Moreover, there are a few hundred generic drugs for which brand-name versions are no longer sold — which suggests the agency may be overwhelmed.
Objections aside, the FDA rule would fill a needed void. The House ought to abandon this effort and the Senate should not pursue it. The industry alternative may be good for drug makers, but not for patients — and by supporting industry efforts, Congress risks perpetuating the widespread perception that our lawmakers are in the pocket of corporate interests.
That’s a label worth changing.