For Immediate Release - October 17, 2000

ROCHESTER AREA CONSUMERS COULD SAVE OVER $185 MILLION ON PRESCRIPTION DRUGS UNDER NEW SCHUMER-MCCAIN BILL

Generic alternatives could save local residents over $550 annually on Claritin, according to Schumer  survey

Schumer-McCain bill will encourage competition in the pharmaceutical marketplace by leveling playing field for generic drug makers

Underscoring the need for cheaper prescription drugs, US Senator Charles E. Schumer today released data showing that Rochester area residents would see significant savings on their prescription drug expenses if low cost generic alternatives were available under legislation co-authored by Schumer and Senator John McCain (R-AZ).  The Schumer-McCain bill could help save Monroe County consumers over $185 million on their prescription drug costs over the next ten years if passed by Congress, according to Schumer estimates based on a study by the Prime Institute at the University of Minnesota.

Schumer surveyed local pharmacies to determine the costs of five widely prescribed drugs and found that Rochester area residents would see annual savings of hundreds of dollars on a number of prescriptions if generic alternatives are available when the original patents for the brand name drugs are due to expire.  But under current law the pharmaceutical industry regularly seizes upon loopholes to block generic drugs from entering the market.

"In 1984, Congress passed a far reaching pro-consumer law which created a blueprint to allow less expensive generic drugs to enter the market.  In recent years, as the stakes and drug company profits have grown larger, the lawyers have picked this law clean," said Schumer.  "If this pro-consumer law isn't dead, it's dying."

To restore the original purpose of the 1984 generic drug law, also known as Hatch-Waxman, Schumer and McCain this month introduced the Greater Access to Affordable Pharmaceuticals Act (GAAP) to  allow generic drug companies to enter the market promptly after brand name company patents expire.  The bill seeks to speed the approval of generic drugs by the Food and Drug Administration by eliminating legal hurdles and loopholes that have nothing to do with the medication's effectiveness.

"The original law allowed brand name companies to have a set amount of time of market exclusivity rights before a bio-equivalent generic drug could compete on the market.  But when the clock runs out the drug company claims the generic is not bio-equivalent over some frivolous reason like the shape of the pill or the color of the bottle," said Schumer.  "It would be laughable were it not costing individual consumers hundreds of dollars each year."

Under the Schumer-McCain legislation:

• The number of patents that a generic drug company must address for FDA approval would be limited to two categories – how the drug works and how it is taken.  Other frivolous patent challenges on such items as the color and shape of pills and bottles would be barred.\

• It blocks brand name companies from paying generic manufacturers to keep their product off the market.  Recently, Abbott Laboratories admitted to paying Geneva Pharmaceuticals $4.5 million a month to keep its generic equivalent of the hypertension and prostate cancer drug Hytrin off the market.

• It expands the FDA's jurisdiction to allow for approval of generic versions of inhalers and topical treatments like skin ointments.  Currently, only generic oral and intravenous medications can be readily approved by FDA.

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