Subject: Federal Food

Direct-to-Consumer Advertising and Promotional Labeling Transparency and Pricing Requirements for Pharmaceutical Manufacturers

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Government and regulatory agencies have recently provided guidelines regarding the importance of transparency in Direct-to–Consumer (DTC) advertising through proposed regulation and guidance documents.

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Impact of President Trump’s Opioid Legislation on Drug Manufacturers

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President Trump recently signed the SUPPORT, or Substance-Use Disorder Prevention That Promotes Opioid Recovery and Treatment, for Patients and Communities Act (the “Act”), aimed at curbing the overuse of opioids in the United States. The Act is far-reaching, and it includes changes to Medicare, Medicaid and other public health efforts. Certain sections, especially those in Title III, “FDA and Controlled Substance Provisions,” will have a direct impact on manufacturers of certain products used to treat chronic pain.

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