April 12, 2002

The Honorable Senator
United States Senate
Washington, D.C.

Dear Senator:

Consumers Union urges you to support the "Greater Access to Affordable Pharmaceuticals Act (GAAP Act) of 2001 (S. 812)." The bill is designed to streamline and improve the generic drug approval process. Companies trying to bring generic drugs to market face many unnecessary obstacles and we believe that the removal of these barriers will increase competition and deliver lower-priced drugs to consumers.

Consumers Union supports greater access to affordable medicines for all Americans, especially the uninsured, the underinsured, the elderly, and the disabled. Today, health care costs are spiraling out of control for consumers and employers. Between 1999 and 2000 alone, prescription drug spending increased by 17.3% -- the sixth year of double-digit increases.

Brand name pharmaceutical companies and some generic companies have engaged in anticompetitive activities that have delayed the introduction of generic drugs and denied consumers significant cost savings. In 2000, the average retail price of a prescription for a brand name drug was more than 3 times the price of a generic drug ($65.29 vs. $19.33). In addition, the top 20 drugs in 2000 by dollar sale were brand name drugs -- which accounted for 29.2% of total drug sales. Increasing the availability of generics could also help make a meaningful Medicare drug benefit an achievable goal.

The legislation would make the following improvements:

· The U.S. Food and Drug Administration ("FDA") has a citizen petition process that can be used to question the safety of drugs before they reach the market. Brand name drug companies often file petitions merely to keep generics off pharmacy shelves. The bill seeks to end abuse of the citizen petition process by requiring that an entity submitting a petition certify that the petition is well grounded in fact, that all relevant information has been included, and that it has not been submitted for an improper purpose. In addition, the bill directs the Federal Trade Commission ("FTC") to investigate citizen petitions that may have been submitted for anticompetitive purposes.

· The bill addresses spurious and inappropriate patent filings designed to prevent generic competition. Under current law, the FDA must stay approval of a generic drug application if a brand name company files a lawsuit claiming that its drug patent will be infringed. Brand name companies have abused this procedure by amending their drug patents just before the original patent is due to expire -- or by suing the generic drug company to challenge non-essential features of the drug (such as color or shape of pill). The legislation requires brand name drug companies to list all relevant patents with the FDA. More importantly, it would end the 30-month stay requirement. The bill would help eliminate the delays caused by brand name drug manufacturers who sue solely to extend their ability to charge monopoly prices. In addition, when a generic drug company has not yet been sued by a brand name drug company, the bill would allow it to seek a court judgment that its product will not infringe on the patent of the innovator drug company.