Margaret "Peggy" Dotzel

Partner

Office
Washington, DC
Tel.
202.778.1998
Fax.
202.822.8106
Others
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Peggy Dotzel focuses her practice on complex regulatory issues and provides strategic advice to companies and public interest organizations. Also trained as a pharmacist, she primarily handles all aspects of food and drug law, including litigation, administrative actions, and legislative and policy matters. 

Prior to joining Zuckerman Spaeder, Peggy served as Acting General Counsel and Deputy General Counsel at the U.S. Department of Health and Human Services (HHS).
 


As Acting General Counsel at HHS, Peggy managed over 500 attorneys and support staff and oversaw all legal advice provided by the Office of General Counsel, which is responsible for all litigation and ensuring that decisions in the program areas – which include Medicare, Medicaid, the Affordable Care Act, the FDA, the National Institutes of Health and the Centers for Disease Control – are consistent with the law. She also provided legal counsel directly to the Secretary and other senior level Department officials. From 2011-2016, in her role as deputy general counsel, Peggy oversaw litigation and legal advice provided by the Office of General Counsel on matters related to, among other things, generic drugs and biosimilars, the Indian Health Services, the 340B program, Ryan White, community health centers, the Substance Abuse and Mental Health Services Administration, Medicare program integrity, and implementation of the Affordable Care Act. She also served as the Department liaison with the HHS Office of the Inspector General. 

Peggy served as counsel at Zuckerman Spaeder from 2006-2011. From 2000-2003, she served as Associate Commissioner for Policy at the Food and Drug Administration, where she oversaw the development of major FDA policy initiatives and worked with HHS, the White House, and Congress on issues relating to FDA’s regulatory policy. From 1999-2000, Peggy was the Acting Associate Commissioner for Policy, and from 1995-1999 she was a Senior Policy Advisor at the Food and Drug Administration. She started her legal career as a law clerk to Judge Jerry Buchmeyer in the Northern District of Texas. Following her clerkship she spent five years at a large Washington, DC law firm. Prior to attending law school, Peggy practiced as a hospital pharmacist.

Peggy received her B.S., summa cum laude, from Temple University School of Pharmacy and earned her J.D., with honors, Order of the Coif, at the University of Texas School of Law.


Education
  • University of Texas School of Law, J.D., with honors, 1989 Order of the Coif 
  • Temple University School of Pharmacy, B.S., summa cum laude, 1983
Bar admissions
  • District of Columbia
  • Texas (inactive)
Court admissions
  • U.S. District Court, District of Columbia
Clerkships
  • Hon. Jerry Buchmeyer, U.S. District Court for the Northern District of Texas
Government service
  • Acting General Counsel
    • U.S. Department of Health and Human Services
       
  • Deputy General Counsel
    • U.S. Department of Health and Human Services
       
  • Associate Commissioner for Policy
    • U.S. Food and Drug Administration
       
  • Acting Associate Commissioner for Policy
    • U.S. Food and Drug Administration
       
  • Senior Policy Advisor
    • U.S. Food and Drug Administration
       

Representative matters
  • Worked extensively on regulations implementing the Affordable Care Act and litigation involving the Act, as well as regulations and litigation related to HRSA, SAMHSA, FDA and other HHS programs.
  • Represented a generic drug manufacturer in the U.S. Supreme Court in a case addressing whether federal laws preempted state failure to warn actions against generic manufacturers.
  • Represented a generic drug manufacturer in a challenge to the FDA’s approval of its drug under the Hatch-Waxman Amendments to the Food, Drug, and Cosmetic Act (FDCA). The action for a preliminary injunction was brought against the FDA by a competitor who claimed that the client had forfeited its 180-day generic exclusivity under the FDCA, and Zuckerman’s client intervened. In the first case addressing the generic exclusivity forfeiture provisions of the FDCA, the court refused to enjoin FDA from approving the drug, allowing Zuckerman Spaeder’s client to continue marketing its drug.
  • Represented a biotech company in connection with litigation brought by a brand company challenging the FDA’s approval of a generic product co-developed by our client.
  • Represented a generic drug manufacturer in a challenge to FDA’s grant of 180-day exclusivity that would have blocked approval of that manufacturer’s generic drug for 180 days.
  • Represented a leading public health group in legislation to give the FDA jurisdiction over tobacco products.

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Margaret "Peggy" Dotzel

Partner

Office
Washington, DC
Tel.
202.778.1998
Fax.
202.822.8106
Others
Send an Email
vCard