Holland & Knight Health Dose: February 10, 2026

Looking Ahead

U.S. Congress will largely return to normal operations this week, following passage of an appropriations package on February 3, 2026, that will fund the vast majority of federal agency operations through the end of 2026. However, funding for the U.S. Department of Homeland Security (DHS) remains the final hurdle for Congress to address, with DHS funding set to run out on February 13, 2026. Republican and Democratic leadership continued negotiations over the weekend regarding a path forward for DHS, though the outcome could be another short-term funding solution; the parties remain far apart on funding the DHS through the year's end.

The U.S. House of Representatives will consider a variety of bills on the floor. Although none are squarely focused on healthcare policy, the bills include a major housing package, legislation focused on financial services and foreign affairs, and a bill on election security. The U.S. Senate will vote on judicial and other nominations.

Upcoming Events

Congress

The House Committee on Energy and Commerce Subcommittee on Health will hold a hearing on February 11, 2026, titled "Lowering Health Care Costs for All Americans: An Examination of the Prescription Drug Supply Chain." Witnesses will include representatives from associations representing drug and biotechnology manufacturers, pharmacy benefit managers (PBMs), generic drug manufacturers, distribution companies, employer-sponsored healthcare, community pharmacists and a professor of law who focuses on prescription drug pricing policy.

The House Committee on Veterans' Affairs will hold a full committee oversight hearing on February 11, 2026, titled "Opportunities with VHA Reorganization."

The Senate Committee on Veterans' Affairs will hold a hearing on February 11, 2026, titled "Building a 21st Century VA Health Care System: Assessing the Next Generation of VA's Community Care Network."

The Senate Select Committee on Aging will hold a hearing on February 11, 2026, titled "The Doctor is Out: How Washington's Rules Drove Physicians Out of Medicine." Witnesses include representatives from an academic medical center, healthcare companies, a nonprofit focused on healthcare provider well-being and a trade association representing medical professions.

Federal Agencies

The U.S. Food and Drug Administration (FDA) will host a town hall for interested stakeholders on February 18, 2026, at 1 p.m. ET to discuss final guidance that was issued on December 18, 2025. The webinar is titled "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices."

Administrative Updates

Executive Order Updates

The Trump Administration has continued to release wide-ranging executive orders (EOs). For the latest updates, see our "Trump's 2025 Executive Orders: Updates and Summaries" tracking chart.

Trump Rx Launches

The Trump Administration announced the launch of TrumpRx.gov on February 5, 2026. The website will enable patients to access discounts on prescription drug products, including products manufactured by companies that struck drug pricing agreements with the White House to offer their products at most-favored nation (MFN) pricing levels. The website is intended to allow cash-paying patients with prescriptions to access coupons to use for purchase of prescription drugs. Notably, the platform disclaims that upfront payments on direct-to-consumer (DTC) purchases won't count toward deductibles or out-of-pocket maximums.

Congressional Updates

Senate Democrats Release Agenda for Drug Pricing Plan

In response to the launch of TrumpRx.gov and the Trump Administration's broader drug pricing initiatives, Democrats on the Senate Committee on Finance released their own effort on February 4, 2026, to lower prescription drug costs. Ranking Member Ron Wyden (D-Ore.), along with Sens. Catherine Cortez Masto (D-Nev.), Peter Welch (D-Vt.) and Ruben Gallego (D-Ariz.), laid out their plan in a letter to other members of the Senate Democratic Caucus, with goals being to lower the prices drug manufacturers charge, including through an expansion of the Medicare Drug Price negotiation program, as well as reduce out-of-pocket costs paid by consumers and bolstering innovation.

Chair Grassley Sends Letter to CMS Urging Action Following HHS OIG Report

Senate Committee on the Judiciary Chair Chuck Grassley (R-Iowa) wrote to the Centers for Medicare & Medicaid Services (CMS) Administrator on February 4, 2026, urging CMS to take action following a report published by the U.S. Department of Health and Human Services (HHS) Office of the Inspector General (OIG) regarding suicide follow-up care provided to children enrolled in Medicaid. The report found that among half of unique hospitalizations or child emergency room visits related to suicidal ideation or behaviors in 2023, children did not receive follow-up visits after being discharged. In just over 20 percent of cases, children did not receive any follow up visits up to 60 days after discharge. The letter requests that CMS provide additional information by February 28, 2026.

Security Bill Introduced to Protect Synthetic DNA Sequencing

The Biosecurity Modernization and Innovation Act, introduced by Sens. Tom Cotton (R‑Ark.) and Amy Klobuchar (D‑Minn.), aims to strengthen U.S. biodefense by tightening oversight of synthetic DNA. The bill would require DNA providers to screen orders for potentially hazardous genetic sequences and verify customer identities – key steps designed to prevent misuse of emerging biotech tools. In the announcement, Sen. Klobuchar commented, "While access to genetic material allows scientists to study diseases, develop lifesaving medicine, and improve crops, without safety standards it could be misused, including to create bioweapons. Our bipartisan legislation will enhance biosecurity efforts and reduce the risk of genetic material being used to cause harm by ensuring that the companies selling these products know who their customers are and how they will use genetic material."

Regulatory Updates

CMS Releases Explanations for MFPs for IPAY 2028

CMS released explanations on February 5, 2026, for how it arrived at the maximum fair prices (MFPs) for drugs selected for Medicare Drug Price Negotiation for Initial Price Applicability Year (IPAY) 2028. In each explanation document, CMS shares its perspective on the data that had the greatest impact on the CMS' formulation and determination of offers, as well as CMS' consideration of counter offers consistent with the law. The explanations also outline details specific to each drug, as well as information on the data received, exchange of offers and counteroffers, and the negotiation meetings.

FDA Approves Natural Color Additives and Outlines Enforcement Approach for Certain Products

The FDA approved a new color option on February 5, 2026, and approved the expanded use of an existing color additive. The approval of beetroot red and spirulina extract follow the filing of two petitions that sought to advocate for their approval and furthers the agency's work to shift away from synthetic or petroleum-based dyes to alternatives.

In addition, the FDA also released a letter that was sent to certain manufacturers, signed by Commissioner Martin Makary and Deputy Commissioner for Human Foods Kyle Diamantas. The letter provides notice that the FDA intends to shift its regulatory approach regarding food labeling claims related to artificial colors. Manufacturers may now use the claims "no artificial colors," "made without artificial food colors" and "no added artificial color" (with slight variations allowed based on the number of colors or colorings) on product labels if the products do not contain petroleum-based dyes but contain other natural colors. This represents a shift, as previously the FDA only permitted these claims to be made on a label if no added colors were present, regardless of whether they were synthetic or natural. Specifically, the FDA highlights it intends to exercise "enforcement discretion" when entities use these voluntary labeling claims, meaning the FDA will not take enforcement action should an entity make a claim. However, the enforcement discretion does not expand to include foods that contain colors certified under the Federal Food, Drug, and Cosmetics Act (FDCA).

FDA Issues Guidance on Computer Software Assurance, Cybersecurity in Medical Devices

The FDA released two final guidance documents on February 3, 2026, titled "Computer Software Assurance for Production and Quality Management System Software" and "Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions." Both guidance documents supersede final guidance documents that had previously been issued in 2025.

The final guidance on computer software assurance provides recommendations for computers and automated data processing systems used as part of medical device production or quality management systems. The recommendations are intended to promote product quality and patient safety, as well as correlate to higher-quality outcomes. The final guidance lays out an approach to assist manufacturers in establishing a risk-based framework for computer software assurance that can be applied to automation, data analytics and artificial intelligence/machine learning (AI/ML) tools, along with cloud computing, when used as part of the production of a quality management system.

The final guidance on cybersecurity in medical devices describes recommendations for cybersecurity information to be submitted for devices under certain pre-market submission types, including 510(k), de novo, premarket approval applications, biologics license application and investigational new drug. The guidance also applies to devices that meet the definition of a biological product regardless of whether they require pre-market submission.

GDUFA, PDUFA Reauthorization Meeting Minutes Released

Following a January 7, 2026, meeting between FDA officials and generic drug industry representatives, the FDA proposed waiving annual facility fees for new domestic manufacturers. The meeting was part of the process to reauthorization of the Generic Drug User Fee Amendments (GDUFA), which is slated to expire September 30, 2027. The fee waiver would apply for the first three years a facility would incur a facility fee under GDUFA after it is first referenced in an approved abbreviated new drug application (ANDA). Industry representatives in attendance pushed back, noting there are other ways to more quickly support domestic manufacturing.

Also discussed was a proposal to adjust foreign facility fees from $15,000 to $25,000 to account for inflation, a proposal to update prioritization for ANDAs under certain circumstances, and data fidelity. No agreements were made at the time of the meeting. The next meeting took place January 14, 2026, for which minutes have not yet been published.

Similar meetings are being held between the FDA and industry representatives for other user fee agreement (UFA) reauthorization topic areas, including for the Prescription Drug User Fee Act (PDUFA) Reauthorization. A PDFUA Reauthorization meeting was held on January 6, 2026, during which representatives from the FDA and industry representatives met to address questions about ongoing points of discussion including chemistry, manufacturing and controls (CMC) processes. They also discussed a proposal to require additional communications after the issuance of an FDA Form 483, which is issued at the conclusion of an inspection and notes observed violations found during the inspection. The industry proposal involves a 15-day response time following receipt of a Form 483 and an additional 15-day response window for the FDA. New in the proposal would be a scheduled post-inspection meeting upon issuance of a Form 483. The next PDFUA meeting was scheduled for January 13, 2026.

HHS Refers Telehealth Company to DOJ for Potential FDCA Violations

HHS General Counsel Mike Stuart announced on February 6, 2026, that his office had referred a large telehealth company to the U.S. Department of Justice (DOJ) for investigation for producing GLP-1 related products, citing potential violations by the telehealth company of the FDCA and Title 18 provisions that refer to criminal code. The FDA also issued a statement of its own announcing it would take enforcement action against the same telehealth company, along with other pharmacies that produce certain compounded versions of GLP-1s. The FDA's statement also cited potentially misleading DTC advertisements. Action by the DOJ and FDA follows a struggle between large drug manufacturers and telehealth companies regarding the sale of certain compounded and copy-cat GLP-1 products. In September 2025, the FDA previously sent a warning letter to the same telehealth company, among many others, with the telehealth company now facing potential legal risk.

Rule Finalized to Address Cost of Healthcare Services at Military Medical Treatment Facilities

The Defense Health Agency (DHA) on February 5, 2026, finalized a rule as required by the James M. Inhofe National Defense Authorization Act (NDAA) for Fiscal Year 2023 to apply a sliding fee scale or catastrophic fee waiver to medical invoices for certain non-beneficiaries who receive medical treatment at military medical facilities. For non-beneficiaries with health insurance, the U.S. Department of War may accept payments from health insurers as full payment and may not balance bill non-beneficiaries, except for copays, coinsurance, deductibles and for non-covered services. The DHA Director may also now waive the assessment of fees for non-beneficiaries when healthcare provided improves the capabilities of DHA healthcare providers.

Legal Updates

Major PBM Reaches Settlement with FTC

The Federal Trade Commission (FTC) announced on February 4, 2026, that it had reached an agreement with a large pharmaceutical benefit manager (PBM) that will allow the PBM to skirt a lawsuit filed by the FTC against a group of PBMs regarding pricing practices related to insulin. As part of the agreement, the PBM in question agreed to make changes to how it designs drug benefits, including by no longer preferring drugs with higher list prices on standard formularies and delinking compensation paid to manufacturers based on drugs being included in formularies. The PBM also agreed to incorporate enhanced transparency measures. While these actions have been of focus to members of Congress, recent passage of the appropriations package, which included significant PBM reforms, did not extend to the commercial healthcare sector. The FTC will accept public comment on the agreement – called a consent decree – for 30 days.

HHS Backs Off Plan for 340B Rebate Model Pilot Program

The HHS officially backed off a plan to challenge its authority to implement the 340B Rebate Model Pilot Program to provide after-the-fact rebates instead of upfront discounts following legal challenges. The HHS and challengers filed a joint motion for vacatur and remand on February 5, 2026, as opposed to continuing with the litigation. If the HHS proceeds with a new 340B rebate program, the HHS will "issue a new notice, including soliciting new applications." In addition, should HHS proceed with a new 340B rebate program, comments will be solicited, and any effective date for a program will be no earlier than 90 days following the public announcement of approved drug manufacturer applications. Though the 340B rebate program is on pause for now, it is likely the HHS will revisit its program to align the program with Administrative Procedures Act (APA) requirements, which was a key factor in the rulings of various judges to rule in the favor of challengers.

Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your Holland & Knight representative or other competent legal counsel.