Referred to the Committee on the Judiciary. (text: CR S580-581)

Original title: “SRES 604: A resolution recognizing that it is the duty of the Federal Government to develop and implement a Transgender Bill of Rights to protect and codify the rights of transgender and nonbinary people under the law and ensure their access to medical care, shelter, safety, and economic security.”

The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.

Original title: “Moderna’s Outright Flu Refusal Just the Latest Case of Crossed FDA Signals”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AUCATZYL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

Original title: “Determination of Regulatory Review Period for Purposes of Patent Extension; AUCATZYL”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ALYFTREK and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

Original title: “Determination of Regulatory Review Period for Purposes of Patent Extension; ALYFTREK”

The Clinical Center (CC), an institute/center of the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is giving notice of the license opportunity for the invention listed below, which is owned by an agency of the U.S. Government and is available to achieve expeditious commercialization of results of federally-funded research and development.

Original title: “Government Owned Inventions Available for License: Gait Assistance Systems and Methods of Control Thereof”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BLUJEPA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

Original title: “Determination of Regulatory Review Period for Purposes of Patent Extension; BLUJEPA”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ATTRUBY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

Original title: “Determination of Regulatory Review Period for Purposes of Patent Extension; ATTRUBY”

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #273 entitled "Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals." This guidance document provides recommendations on how sponsors may voluntarily establish defined durations of use for certain antimicrobial new animal drugs used in or on the medicated feed of food-producing animals that are currently approved with one o

Original title: “Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals; Guidance for Industry; Availability”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for RYTELO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

Original title: “Determination of Regulatory Review Period for Purposes of Patent Extension; RYTELO”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for KEBILIDI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

Original title: “Determination of Regulatory Review Period for Purposes of Patent Extension; KEBILIDI”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AMTAGVI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

Original title: “Determination of Regulatory Review Period for Purposes of Patent Extension; AMTAGVI”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CRENESSITY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

Original title: “Determination of Regulatory Review Period for Purposes of Patent Extension; CRENESSITY”

The Office of Community Services (OCS) is requesting a reinstatement with changes to the collection and reporting of administrative household beneficiary data from state Low Income Home Energy Assistance Program (LIHEAP) grant recipients. The LIHEAP Residential Energy Consumption Survey (RECS) Data Match request is completed approximately every five years, to support research and analysis of LIHEAP program impacts. Office of Management and Budget (OMB) approved the original collection under #: 0

Original title: “Proposed Information Collection Activity: 2024 Low Income Home Energy Assistance Program (LIHEAP) Residential Energy Consumption Survey (RECS) Data Match”

The act was passed in 1983 and has contributed to increased research and development on treatments for rare diseases. More than 30 million Americans have a rare disease, and “the passage of the Orphan Drug Act (ODA) in the United States in 1983 represented a launching point for a rare disease drug development revolution for these patients,” the study authors wrote. “Funding of basic and translational science for rare disease drug development should continue in order to bring therapies to the millions of affected patients who remain without treatment options.” ... Fermaglich LJ and Miller KL. A comprehensive study of the rare diseases and conditions targeted by orphan drug designations and approvals over the forty years of the Orphan Drug Act. Orphanet J Rare Dis. Published online June 23, 2023. doi:10.1186/s13023-023-02790-7 · Stay ahead of policy, cost, and value—subscribe to AJMC for expert insights at the intersection of clinical care and health economics. Prior to the law’s passage, only around 2 drugs per year had been approved by the FDA for rare diseases. However, the ODA provided financial incentives through the Orphan Drug Designation Program that helped accelerate development. These incentives include a 25% tax credit on research and development costs, waived FDA user fees, and the potential for 7 years of marketing exclusivity for an approved orphan-designated indication. The legislation and scientific advances in the last 4 decades have led to the approval of hundreds of “orphan” drugs for use in the 7000 to 10,000 diseases and conditions that are considered rare, the researchers said. “Our results also suggest significant concentration in orphan drug designations and approvals: Only 5% (n = 54) of orphan-designated diseases account for nearly 50% of all orphan drug designations and 37% of initial orphan drug approvals,” the authors wrote. The high number of single designation rare diseases suggests ongoing activity across a wide spectrum of previously overlooked conditions, they added. This finding “could be interpreted as a hopeful sign for patients diagnosed with these diseases.”

Original title: “Assessing the Impact of the Orphan Drug Act 40 Years Later | AJMC”

Vinay Prasad, the FDA's Center for Biologics Evaluation and Research head, is accused of interpersonal impropriety as pushback builds against his decision to reject Moderna’s influenza vaccine candidate.

Original title: “FDA’s Prasad Weathers Personal Controversy, Internal Strife Amid Moderna Imbroglio”

The American Journal of Managed Care provides insights into the latest news and research in managed care across multimedia platforms. Often the price tag that it came to market with, because it was orphan, is what gets used then for more highly prevalent conditions. Peter L. Salgo, MD: Right. Maria Lopes, MD, MS: This makes the drug even more unaffordable. Peter L. Salgo, MD: Right, that’s a problem. Maria Lopes, MD, MS: That is a problem. Peter L. Salgo, MD: That wasn’t addressed early on in that legislation, but at some point we probably should take another look at that. In orphan conditions, there often are no other options. But as the indications expand—and now you’re in a disease state that maybe has generic options, or 2 other agents—it forces us to manage that drug by indication much more closely. Stay ahead of policy, cost, and value—subscribe to AJMC for expert insights at the intersection of clinical care and health economics. Peter L. Salgo, MD: If we had to pick, there it is. There was an attempt to address all this with Congress, right? In fact, they passed something called the Orphan Drug Act of 1983. That’s been around for quite a while. What is it? When does it kick in? And what does it mean? Prior to that act, many pharmaceutical companies didn’t see the benefit of creating drugs to treat orphan diseases because there was more of an incentive to create drugs that treated common diseases so that they would be guaranteed a return on their money.

Original title: “Defining Rare Diseases and Orphan Drug Act | AJMC”

The Break Up Big Medicine Act aims to address structural conflicts of interest. The Break Up Big Medicine Act aims to address these structural conflicts of interest, which allow companies to put profits over the interests of patients, taxpayers, employers, and independent providers. On February 10, 2026, Senators Elizabeth Warren (D-Mass) and Josh Hawley (R-Mo) introduced the Break Up Big Medicine Act, a bipartisan bill that, if passed, would address rampant consolidation in the health care industry that sponsors of the bill say “drives up prices, squashes competition, and fuels corporate greed.”1,2 Allow the FTC and DOJ to review and block future actions that would recreate the conflicts of interest prevented by the bill.

Original title: “Bipartisan Legislation Introduced to Control Drug Prices, ‘Corporate Greed’ Within Health Care | Pharmacy Times”

This report describes the public health response to a Purpureocillium lilacinum keratitis outbreak in New York City associated with an ophthalmology clinic.

Original title: “Purpureocillium lilacinum Keratitis Outbreak Associated with an Ophthalmology Clinic — New York City, 2024”

In a long-debated move, the NIH will no longer characterize basic experimental studies involving humans as clinical trials. The change on basic experimental studies involving humans, or BESH, is welcomed by some but raises transparency concerns. In a long-debated move, the National Institutes of Health will no longer characterize basic experimental studies involving humans as clinical trials, a step that was cheered by many researchers, but is also raising transparency concerns because the work will no longer have to be registered with — or reported to — a government database. So the agency defined a clinical trial as a research study in which one or more human subjects are given a medication to evaluate its “health-related biomedical or behavioral outcomes.” But its definition quickly prompted controversy over whether basic research on humans should follow the same rules and requirements as studies for testing medicines. The agency made this decision, which was disclosed in late January, after years of discussion about the definition of a clinical trial that was established in 2014.

Original title: “NIH redefines 'clinical trials,' as shift divides researchers”

On February 3, 2026, Congress enacted the Consolidated Appropriations Act, 2026, marking a watershed moment in the regulation of pharmacy benefit managers (PBMs). With the passage of United States Hou… One of the most significant changes takes effect in 2028: Medicare Part D plans will be required to compensate PBMs solely through flat, bona fide service fees, payments that reflect fair-market value for actual services performed. By restricting remuneration to fixed-dollar amounts, the legislation aims to eliminate the perverse incentives created by rebate-linked compensation structures. This move is designed to curb the preference for high-list-price drugs to lower costs for patients and payers. On February 3, 2026, Congress enacted the Consolidated Appropriations Act, 2026, marking a watershed moment in the regulation of pharmacy benefit managers (PBMs). With the passage of United States House Bill 7148, incorporating robust PBM reform language crafted in collaboration with the Senate Finance Committee, the federal government has taken a decisive step toward increasing transparency, accountability and fairness in the prescription drug supply chain. These reforms promise to reshape the landscape for employer health plans, independent pharmacies and, most importantly, patients across the country. The new legislation also introduces a robust “Any Willing Pharmacy” provision. Starting in 2028, prescription drug plan sponsors must allow any pharmacy meeting standard contract terms and conditions to participate in their networks. PBMs must now provide employer health plans with detailed, semiannual reports on net drug spending, rebates and “spread pricing” arrangements. These reports will also explain benefit designs that may steer patients toward PBM-affiliated pharmacies, arming employers and plan sponsors with critical information to evaluate the true value of their pharmacy benefit.

Original title: “Sweeping PBM Reforms Arrive: What the 2026 Federal Legislation Means for Pharmacies, Patients and Employers | Buchanan Ingersoll & Rooney PC”