FDA To Change Warning Regs Generics

FDA To Change Warning Regs Generics

February 13th, 2013 // 3:43 pm @

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Last year, the US Supreme Court ruled generic drugmakers are not required to strengthen labeling even when alerted to side effects. The decision came in response to lawsuits by two women who claimed changes could have been made under state law and without FDA approval. They argued generic drugmakers would create uncertainty about safety if they are not held liable under state laws and update labeling in the face of evidence of serious side effects.

Under current FDA regulations, however, generic drugmakers cannot update labeling, even if they become aware of a potential risk not mentioned in the labeling. Brand-name drugmakers, though, can update warnings and precautions on product labeling before obtaining FDA approval. In other words, the generic drugmaker is required only to match its labeling to brand-name labeling.

As a result, the FDA was petitioned to revise its regulations so generic drugmakers can update product labeling to warn patients about risks associated with their drugs. And now, there is an indication the agency may do so. How do we know? A footnote in a friend-of-the-court brief that the US Department of Justice filed last month in a somewhat related case concerning the responsbiilty of generic drugmakers and design defects.

This is what the footnotes states: “This office has been informed that FDA is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances. If such a regulatory change is adopted, it could eliminate preemption of failure-to-warn claims against generic-drug manufacturers“ (see page 15 of this brief).

To short, if the FDA were to make such a change in regulations, generic drugmakers could be sued in state courts if they become aware of evidence of serious side effects but do not take action to update the product labeling. We were alerted to this by Bob Pollock, a senior advisor at Lachman Consultants, and a former acting deputy director of the FDA Office of Generic Drugs.

Of course, it is not certain the FDA will follow through or what the language may say. As Pollock notes: “the implications of the agency’s efforts will obviously hinge on what the term ‘appropriate circumstances’ will mean in the proposed regulation. Care must be taken to avoid situations where labeling for the same generic product may have certain differences in labeling, thus making it difficult for consumers and healthcare practitioners to rely on any one product’s label for all appropriate warnings and information for a specific drug” he writes in his blog.

Nonetheless, the possibility that the FDA will revise its regulations will likely cause consternation among generic drugmakers, which cheered the Supreme Court ruling last June. “Assessing liability based on label content that is beyond the control of the generic manufacturer places the generic manufacturer in the impossible position of defending the content of a label that they are required by law to use but prevented by law from changing,” the trade group for generic drugmakers said at the time (read here).

However, Supreme Court Justice Sonia Sotomayor who wrote for the dissenters in the 5-to-4 vote, noted that “a drug consumer’s right to compensation for inadequate warnings now turns on the happenstance of whether her pharmacist filled her prescription with a brand-name drug or a generic… if it agrees that the labels are inadequate, the FDA can initiate a change to the brand-name label, triggering a corresponding change to the generic labels. Once that occurs, a generic manufacturer is in full compliance with both federal law and a state-law duty to warn.”

The petition urging the FDA to make such a change was filed by Public Citizen. “Drug safety would benefit if generic manufacturers – who already have access to real-world information about adverse events – could use FDA procedures currently in place for brand-name manufacturers to revise labeling to warn of risks,” Sid Wolfe, who heads the Public Citizen Health Research Group, said in a statement. “Filling this regulatory gap would help to protect patients” (you can read the petition here).

As we have written previously, the case reviewed by the court began with a lawsuit filed by Gladys Mensing, a Minnesota woman who took a version of Wyeth’s Reglan heartburn drug and developed a neurological disorder known as tardive dyskinesia, which causes involuntary muscle movements. Similarly, Julie Demahy of Louisiana was prescribed Reglan to treat gastroesophageal reflux, developed the same problem and also filed a lawsuit, claiming long-term use of the generic was the cause.

A federal court and an appeals court both ruled in favor of Demahy (read this), while another federal court ruled against Mensing, although an appeals court later overturned that decision. These losses prompted the generic drugmakers to petition the Supreme Court, which consolidated the cases, to hear their argument.

The Justice Department brief, by the way, was made in response to an upcoming review by the US Supreme Court to consider whether personal injury lawsuits can be filed for alleged flaws in the design of their medications. At issue is whether federal law prempts such claims from proceeding in state courts and if generic drugmakers can be held liable if they decline to withdraw their medicines (see this).

As we wrote two months ago, the court agreed to review an appeal by Mutual Pharmaceutical to overturn a $21 million jury award to Karen Bartlett, a New Hampshire woman who in December 2004 had taken its generic non-steroidal anti-inflammatory, or NSAID, called sulindac for shoulder pain. But a few months later, she developed Stevens-Johnson Syndrome and toxic epidermal necrolysis


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