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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.

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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.

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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in the United States written for lower-cost generics, they worry that many drugs that Americans take every day may have outdated safety information.

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“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.

  • I was taking the generic drug Simvastatin and it caused blindness in my left eye and left me with permanent vision loss in both eyes. After thousands of dollars in diagnostic tests it was found that the Generic drug caused the vision loss and damage to my optic nerves. AND THERE WAS NOT ONE WORD IN THE ADVERSE SIDE EFFECTS PAPER I GOT WITH THE MECICATION THAT SAID ANYTHING ABOUT VISION PROBLEMS AT ALL!. I tried to sue the drug maker NorthStar but the FDA blocked it stating that Generic drug makers do not have to list the dangerous side effects of their drugs and the FDA stands behind them. ” big money protects big money” and Now I sit here with permanent vision loss with no compensation while the while the poison maker poison make ran off with part of my vision and my money like a thief in the night. IN LIGHT OF THIS, I have dumped all my medications and will NEVER again take another pill. NOR will the hosp. put another big pharma drug in me. I WILL DIE FIRST!. If I need drugs again I will look on the street for them as I have never heard of a street drug causing blindness.

  • Hi Kathleen,
    Thanks for the note. Not sure I follow, though, why you think this oversimplifies things. The FDA is still struggling with a backlog of generic applications. So it’s unclear how the agency could quickly devote resources needed for executing labeling changes. Presumably, the FDA would still be involved and oversee changes so they are synchronized.
    Regards
    ed

  • This article over-simplifies the situation. We cannot have a variety of different labels for the same drug. The generics are reporting adverse events, and due to GDUFA, the FDA has a lot more resources to stay on top of the situation. And yes, the paper insert is a waste. MD’s check for prescribing information online now, and updated inserts are posted immediately upon implementation, rather than waiting for the next lot of drug product to be manufactured and labeled with the updated information, while there is still product on the market with the old information.

    • ALL PI inserts must be approved by the FDA before being used anywhere, whether online or in the packaging. Not sure what you are getting at. As far as having different labels for generics from different manufacturers? Simple answer: once the FDA approves a safety change for one maker’s label, all makers must then adopt that change. If they are all notified when a safety change is requested, they can all have their say before the FDA rules. They all know who their competitors are; requiring them to shoot a copy of the proposed PI change as they sumbit it to the FDA is no burden at all, on sender or receiver.

  • Very, very few, including doctors, pharmacists and patients, EVER reads drug “labels” (ie, package inserts). 99.999% are thrown away. The only ones reading them are attorneys. So it is if no concern whether or not generics list “all” the side effects (which is impossible, anyway). I have personally created and read hundreds of inserts with the full knowledge that all they are is a waste of paper.

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