Biotech Therapies Face Disclosure Requirements - Broader transparency in product prices and payments to researchers aim to curb conflicts of interest and rationalize drug expenditures. - BioPharm

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Biotech Therapies Face Disclosure Requirements
Broader transparency in product prices and payments to researchers aim to curb conflicts of interest and rationalize drug expenditures.


BioPharm International
Volume 22, Issue 3

RESEARCH CONFLICTS

The transparency movement similarly seeks to expand disclosure of the financial interests of investigators involved in clinical research on new drugs and biologics to minimize the role of money in shaping R&D and product use. The HHS Office of the Inspector General (OIG) issued a report in January 2009 recommending that sponsors of clinical trials disclose investigator financial information to the FDA before studies begin, instead of when the company files a market application, to improve investigator compliance.1

Grassley is similarly pushing for stricter enforcement of financial disclosure requirements of researchers receiving NIH grants. He has uncovered a number of prominent academics who failed to report millions in industry payments.

In anticipation of additional tracking and disclosure requirements, manufacturers are establishing their own transparency programs. Pfizer (New York, NY) recently joined Eli Lilly, Merck, and GlaxoSmithKline (Middlesex, UK) in posting data on payments to physicians. Academic research centers also are promoting transparency in researcher–industry relationships. Harvard Medical School is reviewing its limits on staff income and stock holdings from drug and medical product companies. The Cleveland Clinic is publicly reporting business relationships between staff and industry, and other prominent universities are adopting stricter conflict-of-interest and disclosure policies.

To comply with multiple state and national reporting requirements, manufacturers are implementing data systems that are able to track payments to health professionals. Information technology vendors have developed programs to compile a company's aggregate spend that can collect all company payments to a physician, which may involve clinical research, consulting, and medical education for different research programs and marketed products.

Meanwhile, physicians are leery of too much disclosure of individual practitioner quality and cost information and have gone to court to prevent consumer groups from using claims data to compile doctor ratings. Such actions reflect the difficulties in establishing disclosure and reporting requirements across the nation's healthcare system. Health reformers, however, regard transparency in healthcare costs, prices, provider practices, and drug and medical product performance as critical to driving down healthcare expenditures and expanding access to affordable care.

Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634,

RESOURCES

1. Levinson DR. The Food and Drug Administration's oversight of clinical investigators' financial information. 2009 Jan [cited 2009 Feb 6]. Available from: http://oig.hhs.gov/oei/reports/oei-05-07-00730.pdf.


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