Pharmaceutical Safety: Equal Opportunity or Double Standard?

NCHC Writer
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August 11, 2011

By Shelley Jazowski

With pharmaceutical companies hitting the “patent cliff,” the floodgates of generic competition are opened. An influx of generics into the market means patients can experience the same medical and health outcomes, but at a more affordable price. Although brand-name medicines and their generic counterparts are comprised of the same active pharmaceutical ingredients (APIs), they are held to different regulatory standards. A recent Supreme Court decision (cases: Pilva v. Mensing, Actavis v. Mensing and Actavis v. Demahy)highlighted the discrepancy between brand-name and generic drug safety. In a 5-4 ruling, the Court stated that if generic manufacturers updated their labels in accordance with state “failure to warn” laws, they would be in violation of federal law, which requires generics producers to mimic the packaging inserts used by brand-name pharmaceutical manufacturers. Simply put, this case highlights a conflict between state and federal law.

Under state statutes, pharmaceutical manufacturers are required to warn consumers about new dangerous side effects. Lack of “failure to warn” lays the foundation for many, if not all, product liability lawsuits, in which the plaintiff claims that drug manufacturers are aware of the potential dangers of their product but do not provide adequate information about such dangers. Conversely, federal regulations require generic drugs to carry the exact same label information as the brand-name medicines they imitate. Under this scenario, generic manufacturers cannot update their labels with up to date safety information. Justice Clarence Thomas summed it up best, “State law imposed a duty on the manufacturers to take a certain action, and federal law barred them from taking that action.”

This Supreme Court ruling follows the standard of preemption, where federal law takes precedent over state law, but also brings to light the controversial issue of pharmaceutical safety, specifically highlighting a drug labeling double standard. On the one hand, the decision protects generic producers from being sued for not providing information warning consumers about side effects. On the other hand, brand-name pharmaceutical manufacturers are held to a higher standard of product labeling, and thus accountable for continually updating these labels with safety information and adverse events. In essence, were the Justices proponents for a drug safety double standard?

There is no denying the fact that generic medicines are as, and if not more, safe and effective as brand name pharmaceuticals. Numerous studies have demonstrated that the low cost alternatives, or generics, are as effective in lowering cholesterol as the blockbuster drug Lipitor. Moreover, in the area of diabetes, generics have proven to be safer than brand name drugs like Avandia, which was issued a black box warning due to the increased risk of cardiac arrest. Affordability coupled with efficacy has propelled a surge of generic sales. It is for these reasons that the generic market share reached 78 percent in 2010, which was a four percent increase compared to 2009.

With generics accounting for a disproportionate share of the pharmaceutical market, policymakers should address the current double standard in pharmaceutical product labeling. If generics are comprised of the same ingredients and clinical studies suggest equivalent quality, then why are manufacturers not accountable for abiding with state “failure to warn” laws? Although federal lawmakers have proposed legislation to increase access to generics, as well as introduced policies set on eradicating anticompetitive practices within the industry, they have yet to address the product labeling issue. There is no time like the present to address the discrepancy between state and federal laws.

To gain entry to market, generics must demonstrate bioequivalence, so if in all respects these drugs are “equal” to their brand name counterparts, shouldn’t the laws regulating safety and labeling also be equivalent?