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The Scoop – Implications of FDA Draft Guidance on Reprints | Pulling Back on Doctor Payments | What Are You Giving Up? March 5, 2014

Filed under: Corporate — CMI/Compas @ 4:41 pm

Mike Miller, SVP Healthcare and Clinical Content Services shared what the FDA’s release of revised draft guidance on reprints means (and what it means is big): “The FDA revised guidance regarding Scientific Medical Articles will enable our clients to continue to responsibly educate the healthcare professional community to the findings of well-controlled clinical studies, which ultimately will have a direct benefit to patients and the overall healthcare system.”

Several Scoop readers shared this story from ProPublica that many pharma companies have begun to pull back on payment to doctors for speaking and other KOL services, likely because of the Sunshine Act.

An OpEd in the Wall Street Journal this week criticizes FDA for not approving InterMune’s pirfenidone, which has been shown to be effective in treating some forms of lung disease but FDA felt there were not sufficient enough clinical trial results. The highly critical OpEd begins scathingly: “Government power can ruin fortunes, reputations and businesses, but at least the targets usually escape with their lives. Not so with the Food and Drug Administration, whose culture of political control is often lethal.” Yeek.

Thanks to Director of Supplier Partner Relations Gazelle Afshari who shared this timely story – Lent begins today, and social networking is among the top ‘vices’ that people will choose to give up.

-Carly Kuper, VP, Strategic Marketing & Corporate Communications
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