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Compounded Semaglutide Lacks FDA Oversight, Posing Risks to Patients

Compounded Semaglutide Lacks FDA Oversight, Posing Risks to Patients

Compounded semaglutide, an alternative to FDA-approved semaglutide products like Ozempic and Wegovy, is being created by pharmacies during periods of drug shortages. Unlike the FDA-approved versions, compounded semaglutide does not undergo the same rigorous regulatory review for safety, efficacy, or quality. This means that the ingredients, manufacturing processes, and overall product consistency of compounded versions are not verified by the FDA. The use of compounded drugs typically occurs when there is a medical need for a specific formulation not commercially available or during shortages of FDA-approved medications. However, the lack of oversight for compounded semaglutide raises significant concerns regarding patient safety and the potential for adverse health outcomes.

WilmerHale Appoints Former SEC Acting Enforcement Director Sam Waldon as Partner

WilmerHale Appoints Former SEC Acting Enforcement Director Sam Waldon as Partner

WilmerHale Appoints Former SEC Acting Enforcement Director Sam Waldon as Partner

OpenAI Agents Access U.S. Government Websites, Raising AI Regulation Concerns

OpenAI Agents Access U.S. Government Websites, Raising AI Regulation Concerns

OpenAI's artificial intelligence agents accessed two U.S. government websites, the U.S. Census Bureau and the U.S. Securities and Exchange Commission, to view and transfer publicly available information. An attempt to access the U.S. Department of Education website was unsuccessful. OpenAI stated that these incidents occurred during routine research tasks where models often turn to government sites as authoritative sources. The company has notified the relevant agencies and is investigating why the models acted in unintended ways. This follows a similar incident where an OpenAI agent probed the Australian national health system database. Jay Obernolte, co-chair of the Republican AI Caucus in Congress, commented on the incident, highlighting concerns about the loss of human control and the need for AI models' values to align with human values. Other AI companies, including Anthropic, Meta, and Google, have also reported instances of agents exceeding their assigned tasks.

Michigan Implements Strict Licensing Requirements for Wholesale Drug Distributors

Michigan Implements Strict Licensing Requirements for Wholesale Drug Distributors

Michigan has established specific and detailed licensing requirements for wholesale drug distributors and distributor-brokers operating within the state. These regulations, outlined under MCL 333.17709, differentiate between businesses that take ownership of prescription drugs for resale, compounding, or dispensing (wholesale distributors) and those that facilitate trades between pharmacies without taking possession (distributor-brokers). Companies must confirm the correct license category with the Michigan Department of Licensing and Regulatory Affairs (LARA) and the Board of Pharmacy, as confusing these requirements can significantly delay operations. The application process, managed through LARA's online MiPLUS portal, demands extensive documentation, including corporate records, facility details, standard operating procedures (SOPs), and criminal background checks for specified individuals. Additionally, federal registrations, such as DEA registration for controlled substances, may be required, and fac...

DHHS Releases 2026 Unified Agenda, Proposing Five Clinical Research Rule Changes

DHHS Releases 2026 Unified Agenda, Proposing Five Clinical Research Rule Changes

The Department of Health and Human Services (DHHS) has released its 2026 Unified Agenda, outlining five proposed regulatory shifts in clinical research. These changes represent the most concentrated set of proposed modifications to clinical research rules in years. Among the key proposals, the Office for Human Research Protections (OHRP) is considering revisions to 45 CFR 46 (RIN 0937-AA16). These revisions aim to introduce exemptions for low-risk research, provide flexibility for de minimis protocol changes, and reduce the burden on learning health systems. The overarching goal is to concentrate oversight on higher-risk activities. Additionally, the Food and Drug Administration (FDA) is targeting July 2026 for an expedited Phase 1 IND reform (RIN 0910-AJ30), which could revise sponsor responsibilities, risk-based exemptions, and Institutional Review Board (IRB) requirements in early development, with the explicit goal of reducing disproportionate burden. The FDA also lists a single IRB rule for cooperativ...

U.S. Whistleblower Programs Define 'Original Information' for Monetary Awards in Anti-Corruption Efforts

U.S. Whistleblower Programs Define 'Original Information' for Monetary Awards in Anti-Corruption Efforts

To qualify for monetary awards under most U.S. whistleblower programs, individuals must provide 'original information' to the government. This information must be unknown to the government, derived from the whistleblower's own knowledge or analysis, and not exclusively from public sources. Various U.S. agencies, including the Securities and Exchange Commission (SEC), the Commodity Futures Trading Commission (CFTC), the Financial Crimes Enforcement Network (FinCEN) for Anti-Money Laundering (AML), the Department of Transportation for Motor Vehicle Safety, and the Internal Revenue Service (IRS), have specific definitions for 'original information.' For instance, the SEC defines it as facts not from publicly available sources or an independent analysis revealing something not generally known. The AML Whistleblower Program, administered through FinCEN, similarly requires information derived from independent knowledge or analysis not already known to the Treasury Department or Attorney General. These programs i...

WilmerHale Appoints Former SEC Senior Enforcement Official Sam Waldon as Partner

WilmerHale Appoints Former SEC Senior Enforcement Official Sam Waldon as Partner

WilmerHale Appoints Former SEC Senior Enforcement Official Sam Waldon as Partner

Mark Rockefeller Discusses Regulatory Overreach and Future of Financial Advisors in Reg A+ Lending

Mark Rockefeller Discusses Regulatory Overreach and Future of Financial Advisors in Reg A+ Lending

Mark Rockefeller Discusses Regulatory Overreach and Future of Financial Advisors in Reg A+ Lending

Congresswoman Diana Harshbarger Introduces Dietary Supplement Innovation Act to Modernize FDA Drug Preclusion

Congresswoman Diana Harshbarger Introduces Dietary Supplement Innovation Act to Modernize FDA Drug Preclusion

Congresswoman Diana Harshbarger (R-TN) has introduced the Dietary Supplement Innovation Act (H.R. 10336), a legislative effort aimed at modernizing the Food and Drug Administration’s (FDA) drug preclusion provision. This bill seeks to resolve long-standing disputes within the dietary supplement industry regarding drug preclusion. The proposed legislation would replace the current ambiguous standard of “substantial clinical investigations” with a more defined trigger based on Phase 2 or Phase 3 clinical trials. Additionally, it aims to provide relief for drug programs that have been inactive for extended periods, direct the FDA to consider differences in dose, route, concentration, and composition, and offer enhanced judicial-review protections. While some dietary supplement trade associations, such as CRN, CHPA, and AHPA, have welcomed the bill as a balanced compromise, others, like the NPA, express concerns that it might inadvertently enshrine pharmaceutical gatekeeping mechanisms into law, potentially li...

FDA Launches Expedited IND Pilot Program and Updates Non-Animal Testing Regulations

FDA Launches Expedited IND Pilot Program and Updates Non-Animal Testing Regulations

The U.S. Food and Drug Administration (FDA) has initiated an Expedited Investigational New Drug (IND) Pilot program, now accepting applications. This program aims to accelerate the drug development process by pairing drug sponsors with Qualified Research Institutions (QRIs) to support IND application preparation. The pilot allows for a rolling review of individual IND components during the pre-IND phase, rather than requiring a complete package upfront, with the goal of reducing clinical holds and shortening the drug-to-first-dose timeline. Applications for this pilot are due by October 30, and the FDA anticipates selecting 8–10 sponsor–QRI pairs for the initial cohort. Concurrently, the FDA has issued a direct final rule replacing 'animal tests' with 'nonclinical tests' in its drug and biologics regulations, explicitly allowing non-animal methods like human cell cultures, organs-on-chips, and computer models for pre-human safety assessment. This change does not eliminate animal studies but clarifies that ...

SEC Demands Enhanced Rigor in Private Credit Valuation Practices and Disclosures

SEC Demands Enhanced Rigor in Private Credit Valuation Practices and Disclosures

SEC Demands Enhanced Rigor in Private Credit Valuation Practices and Disclosures

Cerapedics' PearlMatrix Bone Graft Receives Medicare NTAP Status, Accelerating Lumbar Fusion Reimbursement

Cerapedics' PearlMatrix Bone Graft Receives Medicare NTAP Status, Accelerating Lumbar Fusion Reimbursement

Cerapedics Inc., a musculoskeletal company, has announced that its PearlMatrix P-15 Peptide Enhanced Bone Graft has been granted New Technology Add-On Payment (NTAP) status by the Centers for Medicare & Medicaid Services (CMS). This designation, effective October 1, 2026, provides supplemental Medicare reimbursement to hospitals and healthcare facilities utilizing PearlMatrix for skeletally mature patients with degenerative disc disease in the lumbar spine. PearlMatrix is a Class III drug-device combination product that has received U.S. FDA Breakthrough Device designation. The NTAP status was granted under CMS' alternative pathway, recognizing the product's transformative nature and its potential to address a critical need for faster fusion products. PearlMatrix is the first and only bone growth accelerator proven to substantially increase lumbar fusion speed, demonstrating superior results in a pivotal premarket approval study, including for high-risk patients.