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Report Card Research Background

Pharmaceutical Company HIV/AIDS Report Card

Research Methodology and Scoring

 

Research Methodology

 

ATAC’s Drug Development Committee completed its independent review of the pharmaceutical industry in June 2009.  The information in the HIV/AIDS Report Card was gathered from interviews with pharmaceutical companies and data taken from publicly-available sources.  Each company was assigned an ATAC representative who led the data collection and reporting for that company.  All voting ATAC Drug Development Committee members then suggested a grade for each company in each of the five areas (drug development portfolio and plans, access to drugs, pricing, community relations and marketing practices), all of which were averaged.

 

Criteria Used for Scoring Each Report Card Category

 

Drug Development Portfolio and Plan

·         has active development pipeline for HIV-- including new targets

·         has active development of treatments for viral hepatitis

·         treatment development plans are rational, ethical and expeditious

·         drug development plans  include both naïve and treatment experienced patients

·         provides access to researchers who clearly describe the company’s development plans

·         complies with all FDA required post marketing studies

·         initiates and supports wide range of company-sponsored and investigator-led postmarketing studies that increase knowledge about drugs used in clinical practice

·         makes efforts to accrue and retain women, people of color, and people with common comorbid conditions (such as coinfection with viral hepatitis) in all phases of research and in numbers representative of the U.S. epidemic

·         has an active pediatric R&D program

·         includes community representatives in DSMBs, investigator meetings, reviewing informed consent documents, etc.

 

Access to Drugs

·         has effective patient drug assistance program (PAP); inclusive co-pay and relevant patient support programs

·         expanded access program(s) initiated in a timely manner

·         has worked to improve formulations of existing treatments

·         has shown willingness to cooperate with other drug manufacturers in combination trials and coformulations

·         has provided free drugs to the ACTG and other networks for research purposes

Pricing

·         has not broken industry precedents for pricing within a drug class

·         has not priced new drugs substantially higher than the other drugs in the same class

·         has not used price hikes or other predatory practices to protect market share of its drugs

·         does not increases drug prices frequently (eg. more than once per year)

 

Community Relations

·         provides access to scientists, marketing executives, community liaisons

·         seeks input from a diverse range of opinions and voices in the U.S. HIV community

·         seeks timely community input and implements community recommendations

·         responds to correspondence in writing

·         supports unrestricted educational grants for ASOs

 

Marketing Practices

·         does not use scare tactics in advertising

·         models used in advertising are representative of  individuals living with HIV in the U.S.

·         has not received warnings about improper advertising practices from the FDA

·         advertises and actively informs communities about patient assistance and co-pay programs

 

Definitions for Each Letter Grade

 

A = Excellent performance, demonstrates corporate leadership in this area.

 

B = Very Good, demonstrates actions beyond the expected.

 

C = Acceptable, within expectations.

 

D = Poor, performance subpar compared with peers.

 

F = Failure, performance significantly falls below minimal expectations of corporate performance.