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Stakeholders Offer Some Hatch-Waxman Creativity, Highlight Limits Of FDA Action

 
• By Michael Cipriano

Other proposals were broad in nature, and did not provide the agency with specific mechanisms to consider.

A few public stakeholders tried to offer creative solutions in FDA's Hatch-Waxman comment docket to foster a more competitive generic marketplace, but the inventive thinking has so far just underscored the difficulty of finding a solution within the agency's jurisdiction to address the issue.

In comments from Harvard Medical School and Brigham & Women’s Hospital signed by Harvard Medical School professors Aaron Kesselheim and Ameet Sarpatwari, George Washington University Law School Professor Dmitry Karshtedt, and Rutgers Law School Professor Michael

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