Scarsdale, N.Y – New Hampshire resident Karen Bartlett developed a debilitating skin disease after taking a generic drug for shoulder pain, prompting her to sue the pharmaceutical company that made the drug. Bartlett was awarded $21 million but the Supreme Court overturned that lower court decision, deciding that the drug company was not at fault.

New York Assemblywoman Amy Paulin (D-88th District) introduced legislation (A8057) late in the spring 2013 session that could help people like Bartlett before they take any generic drugs. This legislation would require the Commissioner of Health to establish and publish a list of generic drug products approved by the FDA. Manufacturers would be required to provide the Commissioner with detailed information on the drugs, including any adverse events.

This information would be made publicly available on the Department of Health website, allowing doctors, pharmacists and research groups the opportunity to examine the ingredients in each drug to determine whether they would be harmful to certain individuals.

Since the Supreme Court ruled in 2011 that generic drug manufacturers could not be held accountable for failing to place warnings on labels, there is currently no easy way for patients to find out how a generic version of a drug may differ from the name brand. This legislation would fill in that gap so patients can make an informed choice with their doctors to take a generic drug or a name brand.

“There is not enough information available for doctors, pharmacists, and especially patients, about the ingredients in generic drugs and how the drugs actually work in the body,” Paulin said. “This bill would provide that information. While a person can never know if a specific ingredient will cause an adverse reaction, people have a right to know what is in a drug.

“There are many advocacy groups that would be able to conduct research based on knowing what ingredients were in certain medications. By publishing the results of those tests, doctors and pharmacists could issue warnings. Who knows? Had Karen Bartlett know that there was a chance she would have developed this skin disease she might not have taken the drug that caused it.”

Paulin had 16 bills which she sponsored passed by the Assembly and the Senate during the spring session. She will be making A8057 a priority once session resumes this winter.