Advocacy & Government Relations

FDA Regulatory Counsel's Washington, DC practice provides subject matter expertise to government relations teams supporting stakeholders in FDA-regulated industries. As regulatory lawyers, we are uniquely able to educate legislators and regulators on developing laws, regulations, public policy and enforcement guidelines.

FDARC is particularly focused on innovative life sciences and emerging industries. We have counseled lawmakers on the precedent and implications of changing regulation, including:

 

  • Medical device 510(k) overhaul

  • Dietary Supplement Health and Education Act (DSHEA)

  • 503B Compounding Pharmacy Act

  • Advertising, off-label claims and scientific exchange policies

  • Mobile and TeleHealth development

  • Food Safety Modernization Act (FSMA)

  • Tobacco Deeming Rule (e-cigarettes/vape)

  • 2018 Farm Bill

  • Hemp, CBD and cannabis policy

Representative Matters

  • Liaise with government and regulatory bodies, including FDA, on regulated products, scientific information, formal and informal inquiries, and legislative and regulatory policies.

  • Draft comments and responses to regulatory dockets, proposed laws and regulations, FDA guidance documents, and industry group policy positions.

  • Inform and shape advocacy before Congress, FDA, and other federal and state bodies and agencies with respect to existing and emerging regulatory policies.