Carcieri fights for biologics protections

Gov. Donald L. Carcieri has joined his counterparts from Massachusetts, Maryland, Colorado, Delaware and North Carolina in a letter to President Barack Obama urging him not to let health care reform undermine the rights of biotech firms that make biological drugs, such as Amgen.
At stake is how soon developers of “biosimilar” drugs could start selling cheaper or generic versions of biologics such as Amgen’s arthritis drug Enbrel. The laws and regulations governing such drugs are different than for traditional drugs.
While both the House and Senate reform bills offered 12-year data exclusivity for developers of biologics, recent discussions have considered reducing the term to eight years.
In their joint letter, the governors argued against limiting the period of data exclusivity for biologics and against any revision to the “evergreening” language in both the House and Senate bills.
“Data exclusivity serves as an important complement to patents, which may expire during the lengthy (10-15 years) pre-clinical and clinical research period required to get FDA approval,” they wrote.
“With biotechnology products in particular,” they added, “data exclusivity provides a critical incentive for innovation, as patent protections may be limited by the highly complex nature of these products which are produced from living cells. Economic modeling has shown that a provision of at least 12 years of non-patent data exclusivity allows innovator companies to recover their original investment in the marketed therapy.”
Revenue from successfully marketed biologics also offset biotech firms’ huge investments in research and development, the governors wrote, supporting pipeline drug candidate development and investments in “costly and complex manufacturing facilities.”
The bioscience industry is “one of our nation’s strongest economic engines,” the governors argued, and the sector “continues to invest billions of dollars annually into the research and development of new life-saving medicines, making the U.S. a global leader in addressing unmet medical needs.”
For states, they said, those investments “generate vital revenues and expand highly valued, technology-based job markets.” The U.S. biopharmaceutical and life sciences work force “is nearly 700,000 strong,” they added, “and supports more than 3.2 million total jobs in associated sectors of our nation’s economy.”
In Rhode Island, about 5,000 people work in biopharmaceutical manufacturing, biotextiles, medical device design and manufacturing, and biomedical research and development, according to the governor’s office. The average salary in that sector is nearly $65,000 a year, significantly higher than Rhode Island’s average private-sector salary of $41,000.