FOIAengine: FDA Weight Loss Drug FOIA Requests Grow
Leading makers of GLP-1 (Glucagon-Like Peptide-1) weight loss drugs like Ozempic and Zepbound are facing off against domestic compounding pharmacies that import foreign ingredients and make cheaper, non-approved versions of the expensive drugs.
The sale of these substitute drugs was the subject of 14 Freedom of Information Act requests to the Food and Drug Administration during September, according to PoliScio Analytics’ competitive-intelligence database FOIAengine, which tracks FOIA requests in as close to real-time as their availability allows.
Since the FDA’s approval of Wegovy in 2021, GLP-1 drugs have seen explosive demand that has resulted in shortages of supply over the past year. During periods of shortage, the U.S. Food, Drug and Cosmetic Act allows domestic compounding pharmacies to produce unapproved copies of a drug, provided certain conditions are met. For example, the drug’s ingredients must come from sources in compliance with FDA rules and restrictions are imposed on distribution.
Some compounding pharmacies have leveraged that legal space to import active pharmaceutical ingredients (APIs) and create GLP-1 preparations marketed to patients, frequently at lower cost or with more liberal access than branded drugs.
The FDA has raised numerous concerns about compounded GLP-1 products, particularly those made with imported APIs of uncertain provenance. The increased risks, when compared to FDA-approved products, include dosing errors, contamination from incorrect or impure ingredients, and limitations on adverse event reporting to the FDA.
To counter influxes of questionable GLP-1 ingredients, the FDA instituted in early September Import Alert 66-80 allowing detention without physical examination (DWPE) of the ingredients unless the importer can prove FDA compliance. Alongside that, the FDA launched a “green list” of 37 foreign API manufacturers that have already been inspected or deemed compliant. Shipments from those sources are less likely to be automatically detained. The companies are based in 12 countries, with the leading suppliers in China (16), Europe (14), and India (4).
Critics say the green list approach implicitly acknowledges some acceptance of compounding, although with stricter oversight. The tightening of import enforcement has angered compounding interests, who argue it restricts access or raises cost burdens for compounded ingredients.
Earlier, during periods in which GLP-1 drugs were on the FDA’s drug shortage list, the agency granted some enforcement discretion for compounding of copies of those drugs. Patients who had come to rely on cheaper options face disruption if those are restricted or outlawed.
But the FDA now considers those shortages resolved and is reasserting stricter boundaries on compounding. That shift means that compounded versions that were tolerated under shortage may no longer be permitted.
Some state medical centers are now advising that compounding pharmacies must stop production and distribution of compounded GLP-1s now that the shortages are over. Compounding organizations have pushed back, filing lawsuits challenging the FDA’s decisions to curtain compounding.
Major producers like Eli Lilly and Novo Nordisk have mounted aggressive legal and enforcement campaigns against compounding entities, issuing cease-and-desist letters, filing lawsuits, and claiming trademark infringement.
One of the drivers of reliance on compounded GLP-1s is cost and access. Branded therapies are expensive, often require prior authorization, and insurance coverage is uneven.
GLP-1 drugs were the subject of 17 FOIA requests to the FDA during September. Of those, eight inquired about Import Alert 66-80, six were about other compounding pharmacy issues, and three sought documents related to GLP-1 manufacturers.
The Import Alert requests came from compounders, news media, law firms and companies seeking the names of the foreign compliant companies, which were redacted in the Import Alert.
- For example, Pamela Tirado of Empower Pharmacy submitted on September 9 a request seeking “an unredacted copy of Import Alert #66-80 (a.k.a. Green List) showing the names of the companies excluded from the DWPE. As a matter of public health, the public’s interest in knowing this information outweighs the companies’ interest in maintaining their names withheld.”
The issue of compounding also prompted six requests to the FDA seeking information about individual compounding companies, FDA enforcement policy toward compounders, and FDA enforcement documents over the past three years.
- Jhan Ray Barril of Redica Systems on September 3 requested Form 483 inspection reports for five U.S. companies, including Fagron Compounding Services of Wichita, Kansas. Fagron’s inspection reports also were the subject of a September 15 request in which Joanna DiStefano of SCA Pharmaceuticals requested “all documents, communications and/or records related in any way to [the] FDA’s 2025 inspection of Fagron Compounding Services, LLC d/b/a Fagron Sterile Services.”
- Harvinder Bharaj of Xseer Pharmaceuticals submitted a request on September 11 that stated: “a Pre-Operational Inspection on June 9th 2025 and a Pre-Operational Memo was released by the Office of Compounding Quality and Compliance Officer Zachery L Miller. Xseer Pharmaceuticals requests this memo.”
- Julian Gill of the Houston Chronicle, who has published several articles on the issue of compounding, on September 19 requested “a copy of the FDA’s enforcement policies related to 503A and 503B compounding pharmacies that violate guidance around Compounded Drug Products That Are Essentially Copies. If the FDA has multiple versions of internal policies within the specified time frame, please provide all versions. “
- On the same date, Julian Gill also requested “case numbers for all adverse events in the FAERS system related to tirzepatide and semaglutide products produced by Empower Pharmacy in Houston, Texas (both the 503A and 503B products).”
- Noa Metta submitted on September 24 a request for FDA Form 483 inspection reports, warning letters, Establishment Inspection Reports, and adverse event reports relating to “pharmacies conducting unauthorized compounding practices, involving semaglutide, tirzepatide, or similar drugs, between January 1, 2022, and the present.”
Several additional requests addressed non-compounding issues related to GLP-1 drugs, two mentioning Eli Lilly and one mentioning Ozempic and Wegovy.
- Gavin Solomon of Truway Health, Inc. on September 30 requested “records related to Eli Lilly’s terminated Phase IIb Trial (NCT06901349) of Tirzepatide (Zepbound) and Bimagrumab.”
- Kimberly Mason of law firm Morgan & Morgan on September 12 requested documents relating to a specific case involving Eli Lilly and Mounjaro.
- Patrick Wingrove of Reuters submitted two requests on September 3. One asked for “copies of all releasable Form 3911s related to semaglutide or tirzepatide that have been filed since January 1 2024.” A second sought “copies of all drug import waiver applications submitted to the FDA from January 1, 2024, to the present that specifically reference a desire to import semaglutide-containing products, including but not limited to Ozempic and Wegovy.”
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Randy E. Miller, co-creator of FOIAengine, is a Washington lawyer, publisher, and former government official. He has developed several online information products and was a partner at Hogan Lovells, where he founded the firm’s Brussels office and represented clients on international regulatory matters. Miller also has served as a White House trade lawyer, Senior Legal Adviser to the U.S. Mission to the World Trade Organization, policy director to Senator Bob Dole, and adjunct professor at Georgetown University. He is a graduate of Yale and Georgetown Law. FOIAengine is a product of PoliScio Analytics (PoliScio.com), a venture specializing in U.S. political and governmental research, co-founded by Miller and Washington journalist John A. Jenkins. Write to Randy E. Miller at randy@poliscio.com.