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Gerald Masoudi

Gerald (Jerry) Masoudi has more than 20 years of broad experience in the life sciences industry. He served as Chief Counsel of the U.S. Food and Drug Administration (FDA) from 2007 to 2009. Jerry also has held positions in the Antitrust Division at the US Department of Justice; as the general counsel of two large, highly regulated companies; and as a partner in private practice. He provides strategic legal, policy, and regulatory advice to life sciences clients, with a focus on FDA enforcement of manufacturing and promotional rules.

Jerry brings a unique profile and diverse set of experiences to enforcement and compliance work on behalf of clients. These matters are often high-profile and of critical importance to our food, drug, and device clients. He guides clients through significant corporate transactions, litigation, shifting regulatory expectations, and intensive crisis management activities.

From 2015 to 2018, Jerry was the Executive Vice President, General Counsel and Corporate Secretary of Celgene Corporation, a publicly traded biopharmaceutical company now owned by Bristol-Myers Squibb Company. While at Celgene, he was involved in numerous major legal and strategic matters, including IP strategy; two multibillion-dollar corporate acquisitions; a False Claims Act settlement resulting in no Corporate Integrity Agreement; antitrust litigation; congressional and public policy strategy relating to regulatory issues; and corporate governance.

Jerry was a partner and co-chair of Covington’s Food and Drug Practice Group from 2009 to 2015. Before joining Covington in 2009, he served as Chief Counsel of FDA, where he was responsible for supervising FDA’s involvement in civil and criminal litigation and investigations; providing legal review of warning letters, guidances and regulations; and providing advice to the FDA commissioner and senior leadership on matters relating to FDA regulated products. Before joining the FDA, Jerry served as Deputy Assistant Attorney General for international, policy, and appellate matters in the Antitrust Division at the DOJ.

Prior to entering government service, Jerry had a decade of experience in private practice in the areas of antitrust, telecommunications, patent law, and energy.

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On February 19, 2025, President Trump issued an Executive Order titled “Ensuring Lawful Governance and Implementing the President’s ‘Department of Government Efficiency’ Deregulatory Initiative” (the EO). The stated purpose of the EO is to advance the Administration’s policies of focusing executive enforcement actions on regulations “squarely authorized by federal statute” and deconstructing the administrative state in order to achieve the stated goal of “[e]nding Federal overreach and restoring the constitutional separation of powers.” The EO appears to present opportunities for FDA-regulated stakeholders to identify certain regulations, guidance, and enforcement actions for recission or termination. Likewise, certain stakeholders may face changes in the competitive balance with competitors if the EO causes FDA to stop enforcing regulations that currently prohibit the marketing of certain products. 

Key Provisions of the EO

In order to effectuate the stated policy, the EO provides for 1) the rescission of existing regulations across federal agencies, 2) the de-prioritization and termination of certain ongoing enforcement actions, and 3) the review of new regulations by members of the Department of Government Efficiency (DOGE) and the Administrator of the Office of Information and Regulatory Affairs (OIRA):

  1. “Rescinding Unlawful Regulations and Regulations That Undermine the National Interest”: The EO directs agency heads, in coordination with their DOGE team lead and the Office of Management and Budget (OMB) Director, to, within the next 60 days, review all agency regulations and identify regulations deemed to be 1) unconstitutional, 2) unlawful, 3) based on “anything other than the best reading of the underlying statutory authority or prohibition,” 4) implicating “matters of social, political, or economic significance that are not authorized by clear statutory authority,” 5) excessively costly, 6) “harmful to the national interest,” or 7) overly burdensome for small businesses or entrepreneurs. Notably, and consistent with the Administration’s other recent deregulatory actions, the EO defines “regulations” to include guidance documents. The EO states that the Administrator of OIRA, in consultation with agency heads, will then develop a Unified Regulatory Agenda to rescind or modify the identified regulations. Pursuant to this mandate, FDA will likely be expected to conduct a broad review of its regulations and guidance documents over the next 60 days and identify items that may merit rescission.
  2. “Enforcement Discretion to Ensure Lawful Governance”: The EO grants agency heads discretion to “preserve their limited enforcement resources” by 1) de-prioritizing enforcement of regulations that are “based on anything other than the best reading of a statute” or “that go beyond the powers vested in the Federal Government by the Constitution”; and 2) to terminate ongoing regulatory enforcement proceedings which “do not comply with the Constitution, laws, or Administration policy.” This, in turn, could pose significant implications for both future and ongoing FDA enforcement actions. Under the EO, even long-standing precedents that provide the foundation for FDA’s enforcement activities could be scrutinized if the Administration considers them to be not based on the current “best” reading of a statute. In practical terms, this could lead to the truncation or effective deletion of certain long-standing regulatory requirements across all product areas regulated by FDA. 
  3. “Promulgation of New Regulations”: The EO requires that agency heads consult with their DOGE Team Leads and the Administrator of OIRA on potential new regulations as soon as practicable and instructs DOGE Team Leads and OIRA to evaluate potential new regulations against certain criteria outlined in the EO.

Continue Reading Executive Order on Deregulatory Initiative: What it Means for Food, Cosmetic, Drug, and Device Stakeholders