Megan Howard draws on her nearly 10 years of FDA policy and political experience to counsel clients on a range of complex legal, regulatory, and policy issues. She provides strategic advice to companies and trade associations on pharmaceutical, biotechnology, medical device, and cosmetics product related issues. Megan’s practice particularly focuses on counseling clients regarding sensitive or complex political challenges necessitating engagement with FDA, HHS, the White House, or Congress.
From May 2021 to September 2023, Megan served as the Senior Advisor for Medical Products and Cosmetics to FDA’s Deputy Commissioner of Policy, Legislation, and International Affairs. Megan was responsible for advancing hundreds of policy proposals for consideration by the Administration, including as part of the President’s Budget development process. During Megan’s tenure, she was involved with all major legislative and policy initiatives before the Agency, including the Food and Drug Omnibus Reform Act (FDORA) of 2022, ongoing work related to women’s health issues, and competition policy. Prior to serving in this role, Megan was detailed to then-Chairman Frank Pallone’s House Energy & Commerce Committee professional staff. While there, Megan assisted with drafting and negotiating the Orange Book Transparency Act, the Purple Book Continuity Act, numerous other pieces of competition legislation, and the Cosmetic Safety Enhancement Act. Prior to her House detail, Megan served as FDA’s lead legislative staffer for numerous high-profile legislative proposals, including GDUFA II authorization and the riders to the Food and Drug Administration Reauthorization Act (FDARA), the MODERN Labeling Act, and the CREATES Act. Megan was hired into FDA’s Office of Legislation as a Presidential Management Fellow and completed a rotation as a health policy fellow on then-Ranking Member Patty Murray’s Senate HELP health policy staff during final negotiations of the 21st Century Cures Act.
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