Healthy Skepticism Library item: 19422

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Silverman E
The Supreme Court, Generic Labels & Preemption
Pharmalot 2011 Mar 28
http://www.pharmalot.com/2011/03/the-supreme-court-generic-labels-preemption/

Full text:

Should generic drugmakers be required to strengthen product labeling if alerted to side effects, even when the same change has not been made to the labeling for the branded med? This question goes to the heart of a pair of state lawsuits filed by two women, who claim generic drugmakers should be held liable for failing to warn of serious side effects.
However, the drugmakers, which include Actavis and Pliva, claim federal law preempts the lawsuits, because they would be required to offer labeling that is different from what appears on the label of the brand-name drug. The generic drugmakers further maintain that permitting such lawsuits to proceed in state courts would raise their costs, which would, ultimately, be passed on to consumers.
This complicated issue will be heard this coming Wednesday by the US Supreme Court, which is being asked to decide this question: should a generic drugmaker, which has complied with federal requirements to provide labeling similar to a brand-name med, be held liable under state failure-to-warn claims on the grounds that its product labeling was inadequate?
The case began with a lawsuit filed by Gladys Mensing, a Minnesota woman who took a version of Wyeth’s Reglan heartburn med and developed a neurological disorder known as tardive dyskinesia, which causes involuntary muscle movements (read the lawsuit). 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.
What arguments do the generic drugmakers face? For instance, when it ruled against the generic drugmakers, the 8th US Circuit Court of Appeals cited the closely watched 2009 Supreme Court decision against Wyeth, which is now owed by Pfizer, that ruled FDA regulations do not protect drugmakers from being sued under state law over labeling (here is some background on that case). In explaining its decision, the 8th Circuit said Congress could have crafted a provision to preempt such lawsuits against generic drugmakers but had not done so (see the ruling).
The women argue generic drugmakers would create uncertainty about the safety of their meds if they are not held liable under state laws and update labeling in the face of evidence of serious side effects. The American Medical Association agrees. In an amicus curiae brief, the organization maintains doctors rely on drugmakers to provide accurate and current info on the benefits and risks of their meds. “It would disrupt the established patient care system to adopt a policy pursuant to which one member of the healthcare community – generic drug manufacturers – was permitted to absolve themselves of their unique and vital role in ongoing drug safety,” the AMA wrote (read the brief).
For their part, the drugmakers insist they can not comply with both state and federal laws simultaneously, because the Food, Drug and Cosmetic Act and the FDA require generic labels to be the same as labeling for the brand-name med. Their trade group, the Generic Pharmaceutical Association, meanwhile, maintains creating liability may increase costs as generic drugmakers assume the task of tracking the latest scientific research.
“Generic drugs are required to be exact copies of brand name drugs that already have been subjected to the thorough testing process required by FDA. Generic manufacturers cannot change their labeling under federal law; only FDA can do that,” GPHA executive director Bob Billings writes us. “Generic companies cannot reinvent the expensive research and testing FDA required to approve the brand drug. Recreating that wheel would eliminate the key benefit of generic drugs – they are lost cost without new risks. Upsetting this regulatory balance by exposing generic manufacturers to state tort liability will drive up costs for no salutary purpose.”
And in a supporting amicus curiae, Morton Grove Pharmaceuticals, another generic drugmaker, wrote that, if the women prevail, warnings would ultimately be controlled by the “most warning happy state,” instead of the FDA and federal law. Moreover, if the FDA is “flooded with unneeded information,” the brief continues, “then (FDA) decision making will slow down – and it will take even longer for generic drugs to reach consumers” (read here).
But in a brief filed by the US Solicitor General, the Obama administration contends that, if the Supreme Court rules state tort claims are preempted by federal law, it will diminish the incentive for generic drug manufacturers to provide the most current safety information to the FDA.