III 111th CONGRESS 1st Session S. RES. 287 IN THE SENATE OF THE UNITED STATES September 24, 2009 Mr. Brown submitted the following resolution; which was referred to the Committee on the Judiciary RESOLUTION Honoring the 25th anniversary of the enactment of the Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act).

Whereas, on September 24, 1984, the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98–417; 98 Stat. 1585), commonly known as the Hatch-Waxman Act, was signed into law by President Ronald Reagan, at which time President Reagan indicated that generic drugs might save American consumers $1,000,000,000 over the next 10 years; Whereas this landmark law created the regulatory mechanism under which the Food and Drug Administration approves safe and affordable generic drugs; Whereas each year for the past quarter century, the generic pharmaceutical industry has delivered billions of dollars in savings on the purchase of prescription drugs, far exceeding the original estimate; Whereas a May 2009 report showed that during the preceding 10-year period, the use of generic drugs has saved the American health care system more than $734,000,000,000, with the most-recent annual average exceeding $121,000,000,000; Whereas generic drugs accounted for more than 72 percent of all prescription drugs dispensed, yet accounted for only 17 percent of the spending on all prescription drugs, a differential that reflects the dramatically lower prices paid for generic drugs, which not only reduces consumer and taxpayer spending but also increases patient access to needed medicines; and Whereas while the Hatch-Waxman Act does not have an explicit pathway for approval by the Food and Drug Administration of lower-priced versions of cutting-edge biologic medicines, which account for a rapidly growing portion of prescription medicine spending, the Act does provide a solid framework for such a pathway: Now, therefore, be it

That it is the sense of Senate that— (1)enactment of the Hatch-Waxman Act (Public Law 98–417; 98 Stat. 1585) in 1984 served to create the modern generic pharmaceutical industry, which has provided consumers with access to affordable drugs, yielding significant health and economic benefits for the Nation’s health care system; (2)Senator Orrin Hatch and Representative Henry Waxman deserve the Nation’s gratitude for authoring and championing this landmark bipartisan legislation; and (3)Congress should build on the work of these dedicated policymakers and enact legislation to create a pathway for approval by the Food and Drug Administration of safe and affordable generic versions of biologic medicines.