(Washington, DC)—The Pharmaceutical Care Management Association (PCMA) issued the following statement today regarding H.R. 1956, “The Patient Protection and Innovative Biologic Medicines Act.” PCMA is the national association representing America’s pharmacy benefit managers (PBMs), which administer prescription drug plans for more than 210 million Americans with health coverage provided through Fortune 500 employers, health insurance plans, labor unions, and Medicare Part D:

“Currently, life-savings biologics lack generic competition because there is no clear regulatory pathway for follow-on biologics, or biogenerics. Bipartisan legislation (H.R.1038/S.623) championed by House Government and Oversight Committee Chairman Henry Waxman (D-Calif.), Representatives Frank Pallone (D-NJ), Jo Ann Emerson (R-MO), and Zack Wamp (R-TN), and Senators Charles Schumer (D-NY), Hillary Clinton (D-NY), David Vitter (R-LA), Susan Collins (R-ME), and Norm Coleman R-MN) among others, seeks to remedy this situation.

“Last year the cost of biologics increased 17.5 percent compared with traditional drugs, which increased 10 percent. The large growth in drug trend in this area is why a diverse group of consumer and employer groups, including the AARP, Consumers Union, the AFL-CIO, Families USA, Caterpillar, Inc., Ford, General Motors and Daimler Chrysler, all support H.R.1038 and S.623.

“PCMA believes H.R. 1956 is flawed because it:

Prohibits FDA from designating any follow-on biologic as therapeutically equivalent to its innovator product;

Guarantees innovator biologic manufacturers up to 15 years exclusivity, as compared to only 5 years with chemical compounds under Hatch-Waxman. Even in the European Union, brand manufacturers are permitted only 10 years of exclusivity to recoup costs and make profits;

Requires FDA to issue guidance before a follow-on manufacturer can submit a biologic application. This was not a requirement of small molecule drugs under the original Hatch-Waxman Act; and

Requires clinical trials for all follow-on products, despite not requiring such for innovator biologics or small molecule drugs. The FDA has raised ethical concerns about mandating unnecessary duplicative human clinical trials for follow-on biologics.

“Instead of micromanaging this process, policymakers should work to ensure that FDA has the necessary resources to determine when a generic version can come to market and in turn when it may be exchanged for another biologic.”

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PCMA is the national association representing America’s pharmacy benefit managers (PBMs), which lower the cost of prescription drugs for more than 200 million Americans with coverage provided through Fortune 500 employers, health insurers, labor unions, and Medicare Part D

Contact Information:
Phil Blando, 202-207-3614
Charles Coté 202-207-3605