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CONFERENCE BRIEFING MATERIALS
National State Attorney General Program at Columbia Law School
May 10-11, 2007
On this page you will find key background articles. We encourage you to download and read the articles of interest to you. We will continue to update this page with relevant articles as we receive them.
Dr. Mark McClellan, former Administrator for the Centers for Medicare and Medicaid Services, former Commissioner of the Food and Drug Administration, visiting fellow at AEI-Brookings Joint Center for Regulatory Studies (click for full bio)
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Moderator: Attorney General Mike McGrath, Montana
This session introduced participants to some of the approaches and challenges of pharmaceutical-related litigation specific to the areas of consumer protection, Medicare fraud, and anti-trust.
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Evidence Based Medicine and Counter-Detailing
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Moderator: Attorney General Marc Dann, Ohio
Dr. Mark Gibson started this panel with a description of evidenced-based medicine (EBM), and how the Drug Effectiveness Review Project (DERP) applies EBM principles to the selection of drugs for state Medicaid formularies. Dr. Tim Carey’s presentation addressed some of the challenges inherent in applying EBM principles to drafting clinical guidelines, including the need to provide actionable recommendations when there is insufficient high quality evidence to establish a comfortable level of certainty.
Tom Snedden presented the experience of Pennsylvania’s PACE program as an example of an academic detailing program that uses EBM principles to educate prescribers, including a discussion of the PACE process, its effect on drug utilization, and future steps for the program. Marcia Hams provided an overview of the role of the Prescription Project in reducing conflict of interest and increasing the use of EBM in pharmaceutical prescribing, as well as collaborations with other consumer advocacy organizations, and related activities being undertaken in states other than Pennsylvania.
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State litigation over innovative state laws
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Moderator: Attorney General Bill Sorrell, Vermont
Sharon Treat opened this panel with a roundup of the three areas of current state legislative activity that are currently experiencing momentum across the country, including action on pricing (leveraging discounts with bulk purchasing, causes of action to lower cost, AWP and price disclosures), public health initiatives (action against drug substitution, kickbacks, and pharmaceutical marketing practices), and consumer protection.
The panel then engaged in a debate about the constitutionality of some recently enacted state legislation. David Ogden presented the pharmaceutical industry’s constitutional objections to Washington D.C.’s unconscionable pricing law on the grounds that it represents an extraterritorial violation of the commerce clause, and violates the supremacy clause by regulating the price of patented goods. Sean Flynn addressed the constitutional issues raised by Washington D.C.’s law and then concluded the presentations with a discussion of the legal and constitutional concerns that have been raised about pharmacy benefit management (PBM) and prescription privacy suits.
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Direct to Consumer Advertising and Counter-Advertising
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Moderator: Attorney General Lawrence Wasden, Idaho
Dr. Meredith Rosenthal presented a brief history of direct-to-consumer (DTC) advertising, including spending trends, the FDA’s role, and what is known about the public health impact of DTC advertising. Carlton Wessel of Pfizer followed with a discussion of the pharmaceutical industry’s perspective on DTC advertising as encapsulated in PhRMA’s voluntary guidelines for DTC advertising standards. Representing a consumer advocacy organization, Dr. Marvin Lipman presented the perspective of Consumer Reports on DTC advertising, including Consumer Reports’ recommendations on how to curb the influence of the marketing practice. Pat Molino closed the panel presentations with a discussion of Johnson and Johnson’s perspective on the value of DTC advertising as a means of educating consumers.
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Marketing to Doctors: payments to gain loyalty
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Moderator: Attorney General Steve Rowe, Maine
Dr. Jerry Kassirer introduced the basic issues surrounding conflict of interest in medicine, including how payments to doctors can influence clinical judgment and guideline formulation, and denigrate the medical profession; and the ineffectiveness of disclosure. Dr. David Rothman then presented recommendations to address conflict of interest that have been proposed by academic journals, academic institutions, and the state of Washington, as examples of possible solutions to the problem. Julie Brill rounded out the presentations by discussing state legislative remedies that attempt to disclose payments that present a conflict of interest, including laws in Minnesota, California, Vermont, and Maine.
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Marketing to Doctors: presenting truthful information
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Moderator: Attorney General Wayne Stenehjem, North Dakota
Dr. Aaron Kesselheim opened this panel with a summary of cases illustrating that pharmaceutical manufacturers have not always presented important clinical information to prescribers, especial when it pertains to safety and side effects, as demonstrated by recent litigation. Shirley Stark followed, using New York State’s case against the SSRI antidepressant Paxil as an example of the use of litigation to enforce transparency into the reporting of pharmaceutical clinical trial findings. Among the remedies sought in this case was use of a clinical trial registry by the manufacturer. Dr. Deborah Zarin then discussed the challenges, goals, and current state of the National Institutes of Health’s clinical trial registry site www.clinicaltrials.gov. Included in Dr. Zarin’s presentation was a clarification of the differences between prospective registries and results databases, the implications of pending federal legislation, and the role of state litigation and legislation in promoting effective use of such databases. |
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Formularies and Bulk Purchasing
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Moderator: Attorney General Patrick Lynch, Rhode Island
Dr. Gerard Anderson began with a summary of the overarching themes and challenges facing state Medicaid bulk purchasing initiatives. Richard Cauchi discussed current multi-state bulk purchasing consortia, their similarities and differences, and the savings that have been realized. Michael Valentino used the Veterans Administration as an example of a proven, well-established pharmacy benefit system that combines EBM, bulk purchasing, and formularies to provide high quality pharmacy benefits at a low price relative to other purchasers in the United States. Dr. Kevin Gorospe returned the discussion to the state level with a presentation on the lessons learned from California’s Medicaid pharmacy program.
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State and Federal Pharmaceutical Pricing Systems
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Moderator: Attorney General Mark Shurtleff, Utah
Lew Morris discussed concerns and issues related to the current system of pharmaceutical pricing, as seen from the Federal Office of the Inspector General, and the Medicare and Medicaid programs. Mr. Morris discussed specific cases, prospective administrative remedies for illegal price manipulation, and alternative pricing solutions. Pat Lupinetti focused on state-level pricing concerns faced by New York State, including justifications for replacing AWP with alternate pricing systems. Dr. Gerard Anderson capped the presentations by summarizing the larger themes and economic forces influencing the pricing debate.
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