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Ned Pagliarulo and Andrew Dunn, quoting Rachel Sachs
Biopharma Dive
October 16, 2018

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HHS argues that it has the authority to require price disclosures in ads through the Social Security Act, which tasks it with the "efficient" administration of the Medicare and Medicaid programs. The agency says the rule would help to lower prices and therefore is "necessary" for efficiently managing those government health programs. That's not a shut-and-closed case, though, said Rachel Sachs, an associate professor of law at Washington University in St. Louis. "It's not obvious that including pricing information in ads is necessary for the effective administration of this program," she said in an interview with BioPharma Dive. Sachs also noted the drug industry could argue that Congress gave the FDA authority to regulate drugmaker direct-to-consumer marketing, and not CMS.

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fda   pharmaceuticals   rachel sachs   regulation