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FDA Expands Transparency, Disclosure of KOL Involvement, Mirroring Pharma Trend

  • May 5, 2010

A recent Pharmaceutical Executive article outlined new US Food and Drug Administration draft guidance that would “expand transparency and disclosure when the agency grants a conflict of interest waiver to permit an individual’s participation at an FDA advisory committee meeting.”

The FDA, much like the many public and private companies that make up the biopharmaceutical industry, relies on the expertise and advice of research scientists and health care professionals as resources for policy-making that affects the public health of the United States.  The draft guidance seeks to implement new guidelines for identifying potential conflicts of interest among the scientists and physicians drafted to help form wide-ranging policy throughout the health care industry.

The FDA’s self-policing initiative mirrors the ongoing trend in the biopharmaceutical industry for greater ethics and transparency.  Pharmaceutical companies are embracing greater disclosure of their activities with thought leaders in the medical community, and they are turning to companies like Thought Leader Select for targeted advice on a variety of fronts where they engage thought leaders. Thought Leader Select’s advisory services span a variety of KOL development areas, including help with advisory boards, conferences, regulatory approval, clinical research, and many other aspects of the development of new medicines.

Thought Leader Select provides an unbiased, third-party perspective that proves vital to evolving pharmaceutical development needs through intensive documentation of the skills and experience of researchers and physicians.  In addition to company’s industry-leading research methodology, Thought Leader Select can develop engagement plans between companies and thought leaders to ensure compliance and transparency with all ethical policies.

Read the full Pharmaceutical Executive article here.

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