Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

ASHP URGES PHYSICIAN GROUP NOT TO BE SWAYED BY ANTIGENERIC CAMPAIGNS

Executive Summary

ASHP URGES PHYSICIAN GROUP NOT TO BE SWAYED BY ANTIGENERIC CAMPAIGNS that are not based on "objective scientific data." In a Sept. 6 letter to the American Academy of Family Physicians, American Society of Hospital Pharmacists Exec VP Joseph Oddis said ASHP members "hope that the AAFP Congress of Delegates will seriously deliberate this matter as an important professional and public policy issue and will not be influenced by parties with a proprietary interest in the generic drug use debate," Oddis said. ASHP was responding to an AAFP board recommendation that the physicians academy adopt a policy opposing "blanket approval of generic substitution." AAFP's Congress of Delegates was scheduled to vote on the recommendation at its annual meeting, Sept. 16-18 in Los Angeles ("The Pink Sheet" Aug. 14, T&G-7). The delegates were expected to hear presentations from FDA Center for Drug Evaluation & Research Director Carl Peck, MD, and representatives of the Generic Pharmaceutical Industry Association, the American Pharmaceutical Association, the American Society of Hospital Pharmacists and the American Association of Retired Persons. "Drug product selection should be based on objective scientific data and individual patient-specific criteria, "ASHP maintained. AAFP's"broad-based criteria . . . are not scientifically based." Oddis added that drug product selection decisions are appropriately made by physicians and pharmacists working together. Pharmacists' "primary responsibility" of selecting suppliers of multiple-source prescription drugs "is recognized in the pharmacy practice acts of all states and is well accepted in the everyday practice of most physicians and pharmacists," ASHP said. Consequently, "it is puzzling why there is no mention in your statement of pharmacists and their role in drug product selection." Physicians' concerns about generic drug suppliers "would be best resolved at the local level through communications between the prescriber and the pharmacist," the association continued. Pharmacists, "by virtue of their education and experience, are qualified to aid in the evaluation of therapeutic response to specific drug products." ASHP does "not believe that it is in the best interest of the patient to obtain multisource drug products simply at the lowest price," Oddis noted. Association guidelines advise pharmacists to evaluate 30 factors when selecting drug products. The factors include quality information, such as analytical control, sterility testing, bioavailability data, and testing procedures; product recall history; compliance with compendial standards; and availability of therapeutic, biopharmaceutic, and toxicologic information. In short, physicians and pharmacists "have applied scientific principles to the objective selection of multisource drug products in a manner that has lowered patient-care costs," ASHP said. "Because of this record of success, it is astonishing to read the strongly negative attitude toward generic drug products reflected in AAFP's statement." "Rational drug product selection entails far more than simply consulting the FDA's 'Orange Book' ]of therapeutically equivalent drug products[ or looking at the price catalog," Oddis said. ASHP "data indicate that nearly 60% of the nonfederal short-term hospitals in this country have a well controlled formulary system" and that "approximately 65%" of those hospitals participate in group buying of pharmaceuticals, Oddis noted. Group purchasing includes "a formal approval process for suppliers of multisource drug products," he pointed out.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

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 Skin Infections Guidance Spurs Debate On Endpoint Relevance

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

Shire Hopes To Sow Future Deals With $50M Venture Fund

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

Latest Headlines
See All
UsernamePublicRestriction

Register

PS016237

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel