ONE-LINE Rx FORM LEGISLATION PASSES NEW YORK STATE ASSEMBLY
ONE-LINE Rx FORM LEGISLATION PASSES NEW YORK STATE ASSEMBLY April 29, and has been forwarded to the state senate. Sponsored by Assemblyman Alexander Grannis, the legislation provides that Rx forms contain a single line for the prescribing MD's signature and that generic substitution is allowed unless the MD specifies "DAW" (dispense as written) on the form. Under current state law, Rx forms contain two signature lines; the MD must sign on the left one to indicate that the brandname must be dispensed or on the right to permit substitution. The proposal, which is expected to facilitate generic substitution in New York, is part of a broad pharmaceutical assistance for the elderly legislative package. Assembly debate on the legislation sparked correspondence between the bill's sponsor and U.S. Rep. Waxman (D-Calif.) regarding the merits of the FDA approval process for post-1962 generic drugs under the patent/ANDA bill. In an April 8 letter to Waxman, Assemblyman Grannis maintained that representatives of the Pharmaceutical Mfrs. Assn. (PMA) and several brandname drug mfrs. lobbied against the state bill by questioning the therapeutic equivalence of generics. Waxman replied on April 25: "I was quite surprised to learn that representatives of the PMA and some pharmaceutical companies are arguing that generic drugs approved under the act by FDA are in any way unsafe, ineffective, or not therapeutically equivalent." Noting that negotiations, which lasted eight months, gained support for the bill from PMA, FDA, generic drug mfrs., consumer and elderly organizations, and labor unions; Waxman continued: "If representatives of the PMA or major brandname drug companies are now claiming that the quality, safety, or therapeutic equivalence of generic drugs is doubtful, they are directly contradicting their position of seven months ago and they are wrong." Waxman said he views "with skepticism any complaint by the PMA or its member companies that our generic drug approval system is unsound or jeopardizes consumer safety." Brandname drug mfrs. "have an economic interest in dissuading consumers from using generic durgs," he pointed out, adding: "I am confident that the Congress and the President did not fail the American public."
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth
Sign in to continue reading.
Need a specific report?
1000+ reports available
New to Pink Sheet?
Start a free trial today!
Register for our free email digests: