GPhA Statement on Reps. Eshoo-Barton Biologics Bill
ARLINGTON, VA, March 14, 2008 -- Generic Pharmaceutical Association President and CEO Kathleen Jaeger today issued the following statement on the introduction of the “Pathway to Biosimilars Act†(H.R. 5629):
“‘The Pathway for Biosimilars Act’ is a pathway to the wrong destination for patients in need of safe and affordable biogenerics. This new bill, at best, is a disappointing distraction that does nothing to advance legislation. At worst, it’s a step backwards that puts brand company profits before patient needs. For a pathway to work, it must ensure patient access. Unfortunately, this new proposal creates a pathway filled with needless roadblocks to access.
“To increase competition and ensure timely patient access, Congress needs to enact a workable pathway without barriers. This workable pathway must spark innovation by brand and generic companies without requiring unwarranted and unprecedented market exclusivity or patent extension provisions. Unfortunately, this new proposal contains just such barriers including an unjustifiable 14.5 years of market exclusivity beyond the years companies already have under their existing patents. This is in stark contrast to the current system which works exceedingly well in bringing generics to the markets while fostering innovation. It also means that it will be decades before patients have access to affordable biogeneric medicines. For the countless patients who are choosing between paying for their medicines and putting food on their tables, waiting decades is simply not an option.
“Nearly 25 years ago, Congress faced this same dilemma when debating the Hatch-Waxman Act. It worked hard to strike a balance between innovation and consumer access. This balance provides for a reasonable five-year period of market exclusivity for novel medicines and three years for new products or new dosage forms. Thanks to Hatch-Waxman, millions of Americans are able to afford safe and effective generic medicines, saving consumers and our health care system billions of dollars annually. At the same time, the brand pharmaceutical industry has continued to innovate and produce significant profits in return.
“What was possible then is possible now. However, we must all work together like we did in 1984 to make this happen. BIO and PhRMA say they will compromise, but this new proposal is anything but a compromise. It is a step backwards that puts power in the hands of the pharmaceutical and biotech industries instead of in the hands of patients.
“The generic industry and organizations representing consumers, labor, business and older Americans have worked hard to support bipartisan House legislation sponsored by Representatives Waxman, Emerson and Pallone that brings timely access to safe and affordable biogenerics to patients. Our goal must be to move forward on legislation that does not cut patients out. We cannot support a bill that provides for a pathway in name only.â€
GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic drug industry. Generics represent 65% of the total prescriptions dispensed in the United States, but only 20% of all dollars spent on prescription drugs.