Senators Schumer and Clinton Secure Commitment on Generic Versions of Biologic Medications
Senators Charles Schumer and Hillary Rodham Clinton announced that they have secured a commitment that the FDA Revitalization Act, currently under consideration on the Senate floor, will include a pathway for the FDA to approve generic versions of biologic medications before it is sent to the President later this year. In making this commitment, Senator Edward Kennedy, Chairman of the Health, Education, Labor and Pensions Committee (HELP) committee -- which has jurisdiction over the bill and of which Senator Clinton is a member -- announced that legislation on follow-on biologics will receive a mark-up in the HELP Committee on June 13.
"Biologics treat some of the most devastating diseases around and no one should be denied access to them because they're too expensive," said Senator Schumer. "Today's news is a significant step toward providing safe and affordable generic biologics drugs. It is high time for these vital treatments to become more affordable - our legislation is just what the doctor ordered."
"We must provide the FDA with the authority and flexibility to approve biopharmaceuticals subject to a workable, abbreviated approval pathway that is efficient, effective, and scientifically grounded. We must also include measures to ensure timely resolution of patent disputes as well as adequate incentives for continued innovation," said Senator Clinton on the Senate floor.
Senators Schumer and Clinton in February joined with Representative Henry Waxman to introduce the "Access to Life-Saving Medicine Act," which would give the 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.
"Patients who rely on biologic drugs spend as much as tens of thousands of dollars a year, yet there is currently no clear pathway for lower-cost competitors to enter the market, as there is for generic versions of traditional chemical drugs. Biologic drugs are at the cutting edge of treatment, and it's time our regulations caught up," said Senator Schumer.
"In 1984 when the Waxman-Hatch drug law was written, very few biologic drugs existed and there wasn't any need at that time to empower the FDA to approve lower cost versions of existing biologic drugs. This, as we know, is no longer the case, and it is time to enact legislation that will allow the FDA to approve safe and effective follow-on versions of biotech drugs," noted Senator Clinton on the Senate floor.
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.