GENERIC DRUGS: Bill Would Standardize State Laws
In a move to combat the rising cost of prescription drugs, Rep. Frank Pallone (D-NJ) last week introduced a measure that would guarantee access to FDA-approved generic equivalents of brand- name drugs (Pallone release, 2/24). The "Generic Drugs Access Act of 1999" (HR 805) would amend the Federal Food, Drugs and Cosmetic Act to mandate that a generic be deemed the therapeutic equivalent of a name-brand drug when "all of its active ingredients are the same, it is of the same dosage form, it has the same route of administration, it is identical in strength or concentration [and] ... it is expected to have the same clinical effect and safety profile." Moreover, the bill would prohibit states from establishing different requirements for therapeutic equivalence than the proposed federal standard (bill text). In a "Dear Colleague" letter sent Jan. 25, Pallone wrote that a generic can lower the price of a treatment by as much as 60% to 70%, a fact that does not sit well with "the brand name producer trying to maintain and protect monopolistic pricing. ... It is for this reason that brand name companies launch aggressive campaigns to block or delay generic competition," particularly in state Legislatures. Pallone writes that if "these tactics are successful with the states, generic manufacturers could end up having to comply with 50 different sets of state laws before their products ever reach the consumer. ... The Access to Generic Drugs Act would prevent drug companies from gaming the system. ... Most importantly, it will ensure that generic drugs get to the market in a timely fashion and provide consumers with access to low cost alternatives at the earliest possible time" (letter, 1/25). Dr. Alice Till, president of the Generic Pharmaceutical Industry Association, said, "The FDA is the chief scientific authority and we believe it is appropriate for Congress to ensure that there is national uniformity of the agency's therapeutic equivalence determinations. State laws and regulations should not undermine FDA's findings on safety and efficacy" (Pallone release, 2/24).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.