WASHINGTON, D.C. – U.S. Representatives John Baldacci (D-ME) and Tom Coburn (R-OK) have introduced bipartisan legislation aimed at increasing consumer access to affordable prescription medicine. The Greater Access to Affordable Pharmaceuticals Act (GAAP), H.R. 5247, would close many of the loopholes which 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.

"The reason many Americans have to choose between buying food or medicine is because a lack of competition in the pharmaceutical industry allows drug companies to charge ridiculously high prices for prescription drugs. Promoting access to generic drugs is a common sense market-based solution that will promote competition, and could save consumers as much as $71 billion over the next 10 years," Coburn 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. For example, the widely-used ulcer medication Prilosec costs $134.69 but it's generic version only costs $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," Coburn said.

The GAAP Act has gained support from Congressman 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 (FTC) 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.

This Baldacci-Coburn bill retains the requirement that generic companies must obtain FDA approval for the development of their product, but eliminates barriers that have been erected by some manufacturers of brand-name medicines. This legislation would restore the balance sought in the Hatch-Waxman Act. The measure also clarifies definition of bioequivalence in FDA testing methods and codifies in law the FDA standards and testing methods for bioequivalence.

This bill was originally 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 compliment their medicine reimportation amendment, which would allow Americans to purchase FDA-approved drugs at much lower costs from Canada and Mexico. Taken together, these two bipartisan bills could provide substantial relief to seniors and others burdened by excessive prescription prices.