Managed Care

 

FDA To Regulate Drug Company-Owned PBMs

MANAGED CARE February 1998. © MediMedia USA
Washington Initiatives

FDA To Regulate Drug Company-Owned PBMs

MANAGED CARE February 1998. ©1998 Stezzi Communications
Washington Initiatives

The Food and Drug Administration issued a draft guideline last month that would hold drug manufacturers liable for the activities of pharmacy benefit managers they own. The FDA wants PBMs to adhere to the same truth-in-advertising rules pharmaceutical companies must observe. The idea is to prevent PBMs from making misleading product claims.

PBMs would have to submit promotional materials to the FDA for approval, as drug makers already do. "Pharmaceutical manufacturers should not be permitted to avoid regulation by changing the form through which their communications are accomplished," an FDA official said. The comment period ends April 6.

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4th Partnering With ACOs Summit Los Angeles, CA October 27–28, 2014
PCMH & Shared Savings ACO Leadership Summit Nashville, TN November 3–4, 2014
2014 Annual HEDIS® and Star Ratings Symposium Nashville, TN November 3–4, 2014
Medicare Risk Adjustment, Revenue Management, & Star Ratings Fort Lauderdale, FL November 12–14, 2014
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Healthcare Chief Medical Officer Forum Alexandria, VA November 13–14, 2014
Home Care Leadership Summit Atlanta, GA November 17–18, 2014
HealthIMPACT Southeast Tampa, FL January 23, 2015