North Carolina Takes Steps toward Protecting Drugmakers
April 22, 2011
North Carolina lawmakers moved a step closer yesterday to passing a bill that would protect drugmakers and those selling medications from liability in lawsuits, so long as the medication was approved by the Food and Drug Administration (FDA), reports Pharmalot.
- Opponents say the provisions are among the most restrictive in the nation and would, effectively, prevent state citizens from recovering damages from any harm.
- The only exceptions refer to drugmakers that continue to sell a med after a government agency ordered a withdrawal or altered the med in a way that would have avoided an alleged injury, intentionally withheld or misrepresented info that led to approval by a government agency, or bribed a government official in order to obtain product approval.
At issue is preemption, which is the notion that FDA approval of a drug supersedes state law claims challenging safety, efficacy or labeling. Drugmakers and the FDA unsuccessfully argued two years ago before the U.S. Supreme Court that preemption exists by maintaining the agency's actions are the final word on safety and effectiveness. Opponents of the legislation argue that North Carolina citizens will lose the right to recover damages from harm that citizens elsewhere are allowed to pursue.
Source: Ed Silverman, "North Carolina Preemption Bill Is Closer To Reality," Pharmalot, April 15, 2011.
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