Competitive Enterprise Institute | 1899 L ST NW Floor 12, Washington, DC 20036 | Phone: 202-331-1010 | Fax: 202-331-0640
Contact: Jody Clarke, 202.331.2252
Washington, D.C., May 23, 2007—Since the biotechnology revolution for pharmaceuticals began 25 years ago, nearly 325 million patients have been helped by these life-enhancing and life-saving advancements in medical technology. Now, the Competitive Enterprise Institute argues in a new study, Healthy Competition: The Case for Generic and Follow-On Biologics , that another "revolution" is needed to kick-start the approval process for generic versions of these products.
Because biopharmaceuticals are regulated differently than conventional drugs, the Food and Drug Administration does not currently have a procedure for approving generic, or "follow-on," versions of most biotech medicines. Some critics argue that generic versions of biopharmaceuticals cannot be made safely. But study author Gregory Conko, a senior fellow at CEI, notes that "although it is more difficult to reproduce biopharmaceuticals than conventional drugs, today’s sophisticated technology allows it to be done without sacrificing safety or efficacy."
Introduction of generic drugs typically brings down the cost of prescription medicines, making them more accessible to patients. And, while the savings are likely to be much smaller with generic biopharmaceuticals, patients, insurers, and taxpayers are likely to reap a sizeable benefit.
This spring, Congress has been considering the Access to Life-Saving Medicines Act, which would establish an abbreviated regulatory process for generic and other follow-on biologics. The bill is scheduled for mark-up next month by the Senate Health, Education, Labor, and Pensions Committee.
"Consumers would see tremendous benefits from an abbreviated approval process for generic biotech prescription drugs," says Conko. "In addition to the cost savings, the competition that these approvals would generate could spur even more improvements in the quality of biopharmaceuticals."
CEI is a non-profit, non-partisan public policy organization dedicated to the principles of free enterprise and limited government.