Pharmaceuticals - Health Law and the Regulation of Drug Pricing and Marketing

Venable’s healthcare attorneys represent all aspects of the $1.3 trillion health care industry in the United States. This diverse representation permits our attorneys to focus on the legal and regulatory issues facing participants in the industry with a broad understanding of the dynamics of how healthcare is actually delivered. In the case of pharmaceuticals, the requirements, roles and financial interests of the important players are very different. Venable attorneys have worked with and know the specific needs of the following health care entities:

  • prescribers (physicians and extenders);
  • direct buyers and sellers (mainly hospitals, other institutional health care providers, the federal government, and the retail pharmacy business);
  • payors (Medicaid, insurers, such insured plans using PBMs, VA and DOD, and, to a limited extent, Medicare);
  • intermediaries (wholesalers, group pricing organizations, specialty service providers, and disease management);
  • generic and branded manufacturers; and
  • regulators – Office of the Inspector General of the Department of Health and Human Services, FBI, Medicaid Fraud Control Unit, state and federal prosecutors.

Venable has represented or advised each of these segments of the healthcare industry. Our attorneys prevent potential problems (particularly in reviewing marketing, pricing  and distribution proposals) and respond to regulatory inquiries and investigations.

In any regulatory/criminal/civil investigation or challenge, Venable’s approach is to assemble a team of white-collar litigators, attorneys skilled in FDA regulations and healthcare attorneys who can respond to highly individualized issues. Venable has negotiated successful settlements and corporate integrity agreements for many of the participants in the healthcare field. Venable has also used the team approach to thwart a state Medicaid plan’s payment strategy for prescription medication.