The “Access to Life-Saving Medicine Act” was introduced in the U.S. Senate today. The act, which Senator Susan Collins has cosponsored, would give the Food and Drug Administration (FDA) the express legal authority to approve safe, lower cost copies of biotech drugs, also known as biologics or biopharmaceuticals. Biotech drugs, which are produced from living cell cultures rather than being synthesized chemically, are among the fastest growing and most expensive components of the nation’s drug bill. Currently there is no statutory pathway for generic versions of biotech drugs to enter the market, even after all patents have expired. As a result, the manufacturers of biotech drugs can charge monopoly prices, indefinitely.
“Biologic drugs provide effective treatments for some of our most devastating diseases,” said Senator Collins. “Unfortunately, however, these drugs are often prohibitively expensive and can cost tens of thousands of dollars a year. It is my hope that by creating a process to bring safe and effective generic versions of biologic drugs to the market, we will increase access and dramatically reduce costs for patients, employers, and federal and state health programs.”
Biotech drugs can cost tens of thousands of dollars a year, imposing financial burdens on patients, employers, insurers, and federal and state governments. The “Access to Life-Saving Medicine Act” would authorize FDA to approve abbreviated applications for biological products that are “comparable” to previously approved brand name biological products and it gives the FDA the authority to require any additional clinical information it deems necessary.
This bill comes in response to years of recognition of the need for a new statutory pathway for approval of generic versions of biotech drugs. These products are not subject to the 1984 law that first authorized FDA to approve generic drugs. The EMEA, which is Europe’s equivalent of the FDA, has had a legal framework in place for approval of “biosimilars” since 2004. In letters received recently, both the AARP and the Coalition for a Competitive Pharmaceutical Market — composed of employers, health plans, generic drug companies, pharmacy benefit managers, and pharmacists — agree that legislation creating a pathway for approval of generic biologics is critically important to assure access to more affordable drugs.
Demonstrating that a generic version of a biotech drug is the same as the brand name product raises more complicated scientific issues than for traditional drugs. The bill therefore establishes a rigorous, case-by-case scientific process for approving these products to make sure they are as safe and as effective as their brand name counterparts. Recent approvals by FDA of similar products, like Omnitrope (a human growth hormone drug approved on the basis of abbreviated tests), show that this approach is scientifically feasible.
This bipartisan legislation is sponsored by Senator Charles Schumer and Senator Hillary Clinton. In addition, Senators David Vitter, Debbie Stabenow, and Patrick Leahy are original cosponsors.
The bill has been endorsed by Aetna, the AFL-CIO, the Coalition for a Competitive Pharmaceutical Market, Consumer’s Union, General Motors, Generic Pharmaceuticals Association, Express Scripts, Inc. and National Organization of Rare Disorders.
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