Todd H. Halpern

Partner
Halpern Todd

Todd Halpern focuses on issues related to federal and state regulation of companies in the life sciences industry including manufacturers and marketers of pharmaceuticals, medical devices, food, dietary supplements, and cosmetics. Todd brings to his practice a comprehensive understanding of Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), Federal Trade Commission (FTC), and Consumer Product Safety Commission (CPSC) regulations that affect his clients. He has significant experience counseling business leaders on the risks associated with regulated activities and defending companies accused of regulatory violations.

Todd’s practice includes:

cGMP Compliance – Drugs, Biologics, Dietary Supplements, and Combination Products

  • Drafting responses to regulatory enforcement letters and agency audit reports (e.g., FDA 483s)
  • Supporting site management of Board of Health (e.g., FDA) inspections
  • Addressing questions related to regulatory notifications (e.g., field alert reports and biological product deviation Reports)
  • Managing product recalls, including the health hazard assessment; recall strategy; and communications to regulators, customers, and the media
  • Supporting significant transactions involving acquisition or divestiture of manufacturing sites, including due diligence and issues related to DEA and state licensing requirements
  • Negotiating and drafting quality agreements
  • Interpreting new legislation, regulations, and FDA policies

DEA Regulation

  • Drafting corporate standards governing the development of manufacturing site procedures, and supporting site management of regulatory inspections
  • Drafting responses to administrative enforcement letters, and addressing a wide range of issues related to regulatory compliance

Medical Devices and Mobile Medical Applications

  • Assessing whether proposed technologies are subject to FDA regulation as medical devices
  • Drafting PMA submission documents
  • Advising on issues related to quality system regulations, adverse event reporting, and field actions

Rx-to-OTC Switch, New Drug Applications, and Drug Safety

  • Providing key advice on a wide range of issues related to efforts to obtain FDA approval to switch a drug from prescription to OTC use, such as clinical study compliance, Hatch-Waxman exclusivity, and preapproval communications
  • Working on complex regulatory matters emanating from drug safety concerns, issues related to the Pediatric Research Equity Act (PREA), and FDA decisions regarding proposed drug names

Prior to joining Venable, Todd served as assistant general counsel, Regulatory Law for Pfizer Inc. As a member of the Chief Regulatory Counsel’s leadership team and lead regulatory attorney to Pfizer Consumer Healthcare, he addressed a variety of issues stemming from the manufacture and promotion of leading over-the-counter brands that include Advil®, Centrum®, Emergen-C®, and Nexium® 24HR. In addition, Todd provided regulatory counsel to Pfizer Global Supply, advising colleagues hosting regulatory inspections, responding to FDA Form 483s, and managing other product quality matters arising in the context of private litigation and corporate transactions.

Insights

Credentials
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Education

  • J.D. Fordham University School of Law 1996
  • Dean's List
  • B.A. University of Wisconsin-Madison 1992

Bar Admissions

  • District of Columbia
  • New York