Bill to Make Generic Drugs More Accessible

      WASHINGTON - U.S. Reps. John Baldacci, D-Maine, and Tom Coburn, R- Okla., have introduced bipartisan legislation aimed at increasing consumer access to affordable prescription medicine. The Greater Access to Affordable Pharmaceuticals Act, HR 5247, would close many of the loopholes that allow pharmaceutical companies to delay the introduction of lower-cost, FDA-approved generic medicines.

      "Promoting access to safe generic medication should lower the overall cost of prescriptions in this country. Currently, generics account for 45 percent of all medication sales but amount to just 10 percent of the money spent by consumers on prescriptions. Our legislation will encourage greater competition from generics and lead to lower prescription prices for the American people," Baldacci said.

      "As a practicing physician I prescribe many generic drugs which are just as effective as brand-name drugs even though they can be purchased for half the price," Coburn said. "For example, the widely used ulcer medication Prilosec costs $134.69 but its generic version costs only $52.53. Congress has a duty to combat the collusion in the drug industry that has kept these drugs off the market and away from consumers."

      The GAAP Act has gained support from Rep. Henry Waxman, a leader of the prescription drug patent issue in Congress. The Hatch-Waxman Act of 1984 expedited access of generics into the market. Since its enactment, however, brand-name pharmaceutical companies have found ways to hinder generic drug competition.

      The GAAP Act, for example, addresses a problem identified by the Federal Trade Commission in which makers of brand-name medicines pay generic companies to apply for the rights to a brand patent but not actually produce the drug, which keeps the cheaper generic alternative off the market. Such practices prevent competition for an extended time after the brand patent has ended. The GAAP Act states that if this kind of collusion is identified, other generic companies could apply for the rights of the brand-name product.

      The Baldacci-Coburn bill retains the requirement that generic companies must obtain FDA approval for the development of their product, but eliminates barriers erected by some manufacturers of brand-name medicines. The bill originally was introduced as S. 3051 in the Senate by Charles Schumer, D-New York, and John McCain, R- Arizona.

      Baldacci and Coburn added that this legislation will complement their medicine re-importation amendment, which would allow Americans to purchase FDA-approved drugs at much lower costs from Canada and Mexico.

     

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