Pharmaceutical Regulatory and Compliance

Pharmaceutical and medical product manufacturers are among the most highly regulated and closely scrutinized industries today—making regulatory compliance and documentation of such compliance a priority for every industry participant. Experienced in the wide range of health care issues that impact the pharmaceutical and medical device industry, we help our clients to file applications for FDA approval and address complex FDA compliance issues; comply with Medical Device Reporting requirements; resolve clinical research issues, including preparation and negotiation of clinical trial agreements and informed consents; obtain licenses; and resolve HIPAA issues. If the need arises, we also advise clients with adverse event reporting issues.

Dykema lawyers are well versed in the federal and state consumer protection statutes and other laws governing product marketing in the pharmaceutical and medical products industry. Along with compliance advice in this area, we provide our clients preventative counseling and proactive risk avoidance strategies that save clients not only time and money, but business disruption and anguish. 

When the need arises, we competently represent clients in state and federal agency investigations, as well as defend them throughout enforcement and other regulatory proceedings. We work closely with our clients to bring such matters to an expeditious, cost-effective resolution. We also have an exemplary track record defending clients against allegations of white-collar crime that can arise in this closely watched industry.

Experience Matters

  • Assisted medical device manufacturer to submit Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act to determine whether its product was subject to FDA regulation.
  • Assisted medical device manufacturer in analysis of state laws relating to the regulation of the sale, distribution and use of the device.
  • Successfully represented biotechnology manufacturer in an FDA audit and investigation.
  • Counseled industry participants regarding compliance with FDA requirements, including obtaining required clearances and approvals, labeling, informed consent and IRB. 
  • Advised biotechnology manufacturers and distributors regarding reimbursement, HIPAA and tax issues related to clinical research. 
  • Conducted 50 state survey on application of state laws on the manufacture, sale and distribution of medical devices.
  • Represent clients in response to enforcement actions by the FDA, DEA and OIG, including warning letters, web site alerts, cease and desist notices and corrective action plans.
  • Represented client in filing 513(g) request from FDA.
  • Represented Illinois retail pharmacy chain in significant Medicaid overpayment audit by the State of Illinois.