On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance of body weight in patients with obesity or who are overweight. Notably, this draft guidance includes recommendations with respect to the clinical assessment of weight reduction drugs in both adults and pediatric patients, revising and replacing the draft guidance for industry “Developing Products for Weight Management” issued in February 2007. Obesity presents significant implications for patients, public health and our nation’s health care system as annual obesity-related medical care costs in the United States are estimated to be nearly $173 billion. The issuance of this draft guidance comes against the backdrop of ongoing policy considerations related to the coverage of anti-obesity medications and how best to tackle chronic disease. The FDA has requested comments be submitted by April 8, 2025.

FDA Unveils Draft Guidance on Developing Drugs and Biological Products for Weight Reduction
January 14, 2025

Previous Entries
Eye on FDA
June 5, 2025
Over the weekend, the Department of Justice (DOJ) did not file an appeal of the U.S. District Court for the Eastern District of Texas’ decision to vacate and set aside the agency’s final rule on the regulation of laboratory developed tests (LDTs), titled Medical Devices; Laboratory Developed Tests (the LDT Rule). The LDT Rule would have required laboratories to ensure that their offered LDTs met medical device requirements under a multistage phase out of Food and Drug Administration’s (FDA) enforcement discretion policy. While the government’s decision not to appeal this ruling may not have been a surprise, questions remain as to how FDA plans to clarify its policy towards lab test offerings going forward.
Eye on FDA
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On May 30, 2025, the Department of Health and Human Services released additional information regarding the Trump administration’s Fiscal Year (FY) 2026 budget request. The release of these FY26 budget materials is timely as Secretary Kennedy and the Food and Drug Commissioner Dr. Makary have started to testify before Congress on the FY26 budget and the House and Senate Appropriations Committees are moving forward with their annual appropriations work. Further still, the House Appropriations Committee’s Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies is scheduled to markup their FY26 Ag-FDA Approps bill later this week.
Eye on FDA
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Yesterday, the White House’s Make America Healthy Again (MAHA) Commission, led by the Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. released its inaugural health report titled, Make Our Children Healthy Again, delivering one of the first widely anticipated deliverables from the MAHA Commission Executive Order issued earlier this year and noted in our prior alert. The 72-page assessment examines the rising rates of childhood chronic disease in the country—including obesity, heart disease and diabetes—and explores potential contributing factors. Specifically, the report identifies and focuses on four potential drivers:
Eye on FDA
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On May 9, 2025, the U.S. Food and Drug Administration (FDA) granted three color additive petitions, approving two new colorings and expanding one existing approval. These approvals come after the agency’s announcement last month to phase out all petroleum-based synthetic dyes in food by the end of 2026 and transition to natural alternatives (see our post here). Under section 721 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), color additives (unless exempt from batch certification) are subject to FDA approval to determine their safety for use in food. The agency evaluates the safety of color additives based on multiple factors including projected human dietary exposure to the additive, toxicological data, and other relevant information. Once FDA approves a color additive petition, any manufacturer can use the additive in foods for the approved intended uses.
Eye on FDA
May 8, 2025
In the last two weeks, the Department of Health and Human Services (HHS) has filled key artificial intelligence (AI) positions at HHS and the U.S. Food and Drug Administration (FDA). These appointments, as well as recent statements from HHS and FDA leadership, align with the Trump administration’s intention to use AI to improve regulatory efficiency at HHS and beyond.
Eye on FDA
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This week, the U.S. Food and Drug Administration (FDA), in collaboration with the Department of Health and Human Services (HHS), announced a series of new measures to phase out all petroleum-based synthetic dyes in food by the end of 2026. This initiative is part of the broader “Make America Healthy Again” (MAHA) agenda aimed at bolstering food safety. Citing growing concerns about the potential role of petroleum-based food dyes in childhood diabetes, obesity, depression and attention-deficit/hyperactivity disorder (ADHD), the agency plans to establish a national standard and timeline for the food industry to transition to natural alternatives.
Eye on FDA
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Eye on FDA
April 2, 2025
On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA. Judge Jordan’s decision vacates and sets aside the Food & Drug Administration’s (FDA) final rule, Medical Devices; Laboratory Developed Tests (the LDT Rule).1 The LDT Rule would have required laboratories offering LDTs to meet medical device requirements. The preamble to the LDT Rule provided a multi-stage phase out of FDA’s enforcement discretion policy, under which the first set of regulatory requirements would have been actively enforced beginning May 6. While many labs are breathing a sigh of relief after the publication of this order, questions remain as to how the agency will proceed and the broader implications for regulation of lab tests and in vitro diagnostics generally.