Bill introduced to give all combination drug products five years market exclusivity

WASHINGTON — Rep. Jason Chaffetz, R-Utah, last week introduced a bill that would extend to new combination drugs containing molecules already approved by the Food and Drug Administration the same five-year market exclusivity as a drug product containing an entirely new set of active ingredients. 

 

“As the law is currently written, virtually all combination new drugs are excluded from the five years of market exclusivity and therefore are not being developed,” said Chaffetz. “A new drug that has been created using one or more existing molecules should not be required to go through the same rigorous, lengthy and expensive FDA new drug approval process.”

 

According to a Wall Street Journal article on the bill, FDA once awarded only three years of market exclusivity to combination products that contained one medicine that had already been approved by the FDA. However, the agency agreed to extend five years of exclusivity to combination drugs containing older components in October. Though that ruling was not retroactive to include combination drugs already approved by the FDA. Chaffetz's bill would change that. 

 

The legislation is supported by a coalition consisting of large research-based pharmaceutical companies like Sanofi and Boehringer Ingelheim, small innovators like Pozen, and independent generic companies like Teva. "This may well be the first time ever that the research-based and generic pharmaceutical companies have joined on an issue involving market exclusivity," Chaffetz noted.