• Big Pharma Flunks Legal Compliance Test

    Posted November 14, 2015: by Bill Sardi

    A team of university-based medical ethicists has given Big Pharma an “F” grade on reporting requirements for new drugs. [Medical Express]

    Their research report said: “It may seem difficult to understand failures to comply with federal law, now eight years old, whose origins track back to 1997, and even more difficult to understand failures to meet the over-riding ethics obligation that human research be designed to contribute to generalizable knowledge.”

    jennifer-miller

    Jennifer E. Miller, PhD, assistant professor of medical ethics at New York University Langone Medical Center led the ethics review, published in BMJ Open.

    The ethics team fingered the feckless Food & Drug Administration for lack of enforcement. Under the Food & Drug Administration Amendments Act (FDAAA) that empowers the FDA to impose a $10,000/day penalty for non-compliance, no penalty has ever been imposed.

    The research report said only “two-thirds of clinical trials supporting new drugs approved by the FDA in 2012 were publicly disclosed,” which they said may “perhaps be encouraging, but below both legal and ethics standards.”

    Studies have shown that roughly 30–50% of clinical trials remain unpublished, often years after their completion and most fail to meet legal disclosure requirements. Partial rather than full disclosure of all human clinical trials can “distort the medical evidence and challenge physicians, prescription guideline writers and payers of medical care” said the authors. “Transparency may be essential to ensure the integrity and trustworthiness of the clinical research enterprise,” they added.

    Almost half of the newly approved drugs in 2012 had at least one undisclosed trial. Only 67% of new drug new drugs were fully FDAAA compliant.

    Only 2 of our 10 reviewed companies disclosed all trials and complied with legal disclosure requirements for their 2012 approved drugs. — ©2015 Bill Sardi, Knowledge of Health

    Scorecard Of Drug Company Compliance Reporting Requirements
    Under The FDA Amendments Act

    DRUG

    COMPANY

    INDICATION

    FDAAA Compliance

    Controlled trials

    Interventional trials

    Elelyso Pfizer/Protalix Gaucher disease

    0%

    0%

    Stivarga Bayer Colorectal cancer

    0%

    0%

    Perjeta Genentech/Roche Breast cancer

    0%

    0%

    Signifor Novartis Cushing’s disease

    0%

    0%

    Erivedge Genentech/Roche Basal cell carcinoma

    0%

    0%

    Zioptan Merck/Santen Eye pressure, glaucoma

    17%

    14%

    Eliquis BMS Anticoagulant

    33%

    33%

    Aubagio Sanofi Multiple sclerosis

    71%

    71%

    Zaltrap Sanofi Colorectal cancer

    67%

    78%

    FDAAA – Food & Drug Administration Amendments Act
    Source: British Medical Journal OPEN Nov. 13, 2015
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