ENZI SAYS APPROVING BIOLOGICS “PATHWAY” MUST ENSURE SAFETY, INNOVATION; AVOID RACE TO SIMPLY CUT COSTS

Washington, D.C. - U.S. Senator Mike Enzi (R-WY), Ranking Member of the Senate Health, Education, Labor and Pensions (HELP) Committee, today said the rush to open a new regulatory pathway for the Food and Drug Administration (FDA) to approve generic biologics creates a monumental regulatory challenge that should not be a race to cut drug costs alone, but one that also includes a careful effort to protect and promote innovation in the marketplace while still ensuring patient safety. “Biologics are the skyscrapers of the drug world. They are towering monuments to medicine, science and biotechnology that can’t be duplicated without exact blueprints and precision engineering,” Enzi said. “Allowing drug makers to duplicate these giants will create an unprecedented regulatory and safety challenge for the FDA. If Congress grants that authority in haste, the results could be disastrous.”Biologics are protein-based, highly-engineered drugs derived from a complicated process. Biologics in common use today include: Humulin, a replacement insulin for diabetics; Procrit, an anemia treatment for cancer patients; and Avonex, a therapy for persons with Multiple Sclerosis. “Biologics are making it possible for thousands of Americans to live productive lives, while others are changing the way we treat deadly diseases like cancer and infectious diseases,” Enzi said, in a HELP Committee hearing to examine proposals to expand FDA’s biologics authority. “We need to move diligently and earnestly, but we must not short-circuit safety, leave patients at risk or sacrifice protections that will encourage the drug industry to innovate.” Enzi said he favors taking time to fully consider a range of framework options for allowing generic biologics, such as the European model for follow-on, or generic, biologics. The system already adopted in Europe created an abbreviated approval pathway for biologic drugs but also required due consideration of safety, innovation and savings while also leaving decisions about critical scientific issues to scientists. Enzi rejected calls to link biologics legislation to the package of FDA-related bills currently being prepared by the HELP Committee, including the “Enhancing Drug Safety and Innovation Act,” the “Prescription Drug User Fee Act” reauthorization, and the “Medical Device User Fee and Modernization Act” reauthorization, which Senators have tagged as must pass bills and targeted for final approval before Congress goes to its August recess. “There are several must-pass FDA-related reauthorizations that Congress must have approved and sent on their way to the President’s desk by August 3rd,” Enzi said. “Due to the scientific complexity and uncertainty regarding biologics, premature and ill- considered solutions should not be included in the discussion of those must pass bills.” “If we get this balance wrong, then we face two potential undesirable outcomes – either no new biologics will be available to provide the next cure for the most horrid diseases; or individuals will die as we rush products to market without considering their safety implications,” Enzi added. Over 20 years ago, Congress enacted legislation that provided a framework for the creation of generic drugs. In creating that initial framework, Senator Orrin Hatch (R- UT) and Congressman Henry Waxman (D-CA) and others wrote watershed legislation, which balanced safety and savings in creating an abbreviated pathway for the approval for most prescription drugs. That legislation, referred to as the Hatch-Waxman Act, was the product of careful drafting and consideration over many years. ###