Zoe Lofgren

Washington, D.C. Admission Act

United States · United States Congress · 3 January 2025

Washington, D.C. Admission Act This bill provides for the establishment of the State of Washington, Douglass Commonwealth, and its admission into the United States. The state is composed of most of the territory of the District of Columbia (DC), excluding a specified area that encompasses the U.S. Capitol, the White House, the U.S. Supreme Court building, federal monuments, and federal office buildings adjacent to the National Mall and the U.S. Capitol. The excluded territory shall be known as the Capital and serve as the seat of the government of the United States, as provided for in Article I of the Constitution. The state may not impose taxes on federal property except as Congress permits. The bill provides for the DC Mayor to issue a proclamation for the first elections to Congress of two Senators and one Representative of the state. The bill eliminates the office of Delegate to the House of Representatives. The bill applies current DC laws to the state. DC judicial proceedings and contractual obligations shall continue under the state’s authority. The bill also provides for specified federal obligations to transfer to the state upon its certification that it has funds and laws in place to assume the obligations. These include maintaining a retirement fund for judges and operating public defender services.  The bill establishes a commission that is generally comprised of members who are appointed by DC and federal government officials to advise on an orderly transition to statehood.

Dental Care for Veterans Act

United States · United States Congress · 6 January 2025

Dental Care for Veterans Act This bill expands eligibility for veterans for dental care provided by the Department of Veterans Affairs (VA). Specifically, the bill makes all veterans who are enrolled in the VA health care system eligible for VA-provided dental services. Currently, only veterans who have a service-connected dental issue or meet other narrow criteria are eligible for certain dental services. The bill phases in eligibility over four years based upon existing eligibility, degree of service-connected disability or other disability, prisoner of war status, award of a Purple Heart, financial need, or VA health care eligibility.

Improving Menopause Care for Veterans Act of 2025

United States · United States Congress · 7 January 2025

Improving Menopause Care for Veterans Act of 2025 This bill requires the Government Accountability Office (GAO) to study and report on the medical services furnished by the Department of Veterans Affairs (VA) for veterans experiencing perimenopause, genitourinary syndrome of menopause, and menopause stages. The VA must also report to Congress on a strategic plan to (1) implement any recommendations GAO makes in its report, (2) improve the quality of menopause care, and (3) improve the access of veterans to menopause care.

Veterans Infertility Treatment Act of 2025

United States · United States Congress · 7 January 2025

Veterans Infertility Treatment Act of 2025 This bill requires the Department of Veterans Affairs (VA) to furnish infertility treatments, standard fertility preservation services, or both to a covered veteran or partner of a covered veteran. A covered veteran is a veteran who is enrolled in the VA health care system and has infertility or is at risk of having infertility, as determined by a licensed physician. The VA may furnish up to three completed in vitro fertilization cycles that result in live birth, or 10 attempted cycles, whichever occurs first. Additionally, the VA may furnish in vitro fertilization treatment using donated gametes or embryos. The VA must receive consent to furnish an in vitro fertilization cycle from the covered veteran, the partner of a covered veteran, and the third-party donor (if applicable). For purposes of paying travel expenses for treatment or services to the partner of a covered veteran, the VA must deem the partner to be a veteran receiving treatment or care. The VA must prescribe regulations related to the provision of infertility treatments and standard fertility preservation services as required by this bill. Prior to the enactment of such regulations, the VA must ensure that (1) counseling and treatment furnished under existing authority is available to a veteran and the veteran's partner, regardless of whether they are married; and (2) treatment under existing authority may be furnished using donated gametes or embryos.

Health Care Affordability Act of 2025

United States · United States Congress · 9 January 2025

Health Care Affordability Act of 2025 This bill makes permanent temporary changes enacted by the American Rescue Plan Act of 2021 (ARPA) and the Inflation Reduction Act of 2022 (IRA) that generally expand eligibility for and increase the amount of the premium tax credit. Currently, eligible taxpayers may be able to claim the premium tax credit, which applies toward the cost of obtaining health insurance through health insurance exchanges. To be eligible for the premium tax credit, a taxpayer’s household income must meet or exceed 100% of the federal poverty level (FPL) and, after 2025, may not exceed 400% of the FPL (maximum income limit). For 2021-2025, the ARPA and IRA eliminated the maximum income limit, which generally expands eligibility for the premium tax credit. Further, under current law, the amount of the premium tax credit is (1) generally the plan premium (conditions apply), minus (2) the taxpayer’s household income multiplied by the applicable percentage. The applicable percentage is a specific percentage that varies depending on which of six income ranges (adjusted for inflation after 2025) the taxpayer’s household income falls within. For 2021-2025, the ARPA and IRA lowered the applicable percentages and eliminated the adjustment of the applicable percentages for inflation, which generally increases the amount of the premium tax credit. The bill makes permanent the elimination of the 400% maximum income limit, the lower applicable percentages, and the elimination of the inflation adjustment for the applicable percentages.

Proxy Voting for New Parents Resolution

United States · United States Congress · 9 January 2025

Proxy Voting for New Parents Resolution This resolution authorizes proxy voting in the House of Representatives for a Member who has given birth or whose spouse has given birth and pregnant Members who are unable to travel safely or have a serious medical condition. Under the resolution, a qualifying Member may designate a proxy to cast a vote in a committee, the Committee of the Whole, or on the House floor; however, proxies will not be counted for purposes of establishing a quorum. The proxy designation is valid for up to 12 weeks. To designate a proxy for House and Committee of the Whole votes, the Member must submit a signed and dated letter to the Clerk stating the Member’s qualifying circumstances and the name and state of the Member who has agreed to be designated as proxy. A Member who has designated a proxy according to these requirements may also designate a proxy for committee votes. To designate a proxy for committee votes, the Member must provide the committee chair and ranking minority member with a signed and dated letter specifying another member of the committee to cast a proxy vote.  The resolution further provides that a Member may revoke the proxy authorization by (1) casting the Member’s own vote; (2) recording the Member’s own presence in the House or in the Committee of the Whole; or (3) in a committee, by submitting a signed letter to the chair and ranking minority member.

Goldie’s Act

United States · United States Congress · 13 January 2025

Goldie's Act This bill expands enforcement provisions under the Animal Welfare Act (AWA). Specifically, the bill directs the Department of Agriculture (USDA) to document and record detailed descriptions of violations of the act observed during inspections and investigations. USDA must provide a copy of all records documenting violations to state, local, and municipal animal control or law enforcement officials within 24 hours of such inspections or investigations. Inspections must be held at least once a year of each research facility, the premises of each animal dealer, and each exhibitor of animals. If violations are found during inspections, then USDA must conduct any necessary follow-up inspections until all the violations are corrected. Inspectors must confiscate or destroy in a humane manner animals found to be suffering physical or psychological harm as a result of failure to comply with the AWA. Violators are subject to civil penalties as outlined in the bill.

Paycheck Fairness Act

United States · United States Congress · 25 March 2025

To provide technical and financial assistance for groundwater recharge, aquifer storage, and water source substitution projects.

United States · United States Congress · 13 January 2025

This bill modifies the Infrastructure Investment and Jobs Act to allow unobligated balances of amounts made available to the Bureau of Reclamation for western water infrastructure to be made available to Reclamation for FY2026-2031 to provide financial or technical assistance for (1) groundwater recharge projects, (2) aquifer storage and recovery projects, or (3) water source substitution for aquifer protection projects.

Richard L. Trumka Protecting the Right to Organize Act of 2025

United States · United States Congress · 5 March 2025

John R. Lewis Voting Rights Advancement Act of 2025

United States · United States Congress · 5 March 2025

John R. Lewis Voting Rights Advancement Act of 2025 This bill establishes new criteria for determining which states and political subdivisions must obtain preclearance before changes to voting practices may take effect. Preclearance is the process of receiving preapproval from the Department of Justice (DOJ) or the U.S. District Court for the District of Columbia before making legal changes that would affect voting rights. A state and all of its political subdivisions shall be subject to preclearance of voting practice changes for a 10-year period if, during the previous 25 years: 15 or more voting rights violations occurred in the state; 10 or more violations occurred, at least 1 of which was committed by the state itself; or 3 or more violations occurred and the state administers the elections. A political subdivision as a separate unit shall also be subject to preclearance for a 10-year period if three or more voting rights violations occurred there during the previous 25 years. States and political subdivisions that meet certain thresholds regarding minority groups must preclear covered practices before implementation, such as redistricting. States and political subdivisions must notify the public of changes to voting practices. The bill authorizes DOJ to require states or political subdivisions to provide certain documents or answers to questions for enforcing voting rights. The bill outlines factors courts must consider when hearing challenges to voting practices, such as the extent of any history of official voting discrimination in the state or political subdivision.

Rosie the Riveter Commemorative Coin Act

United States · United States Congress · 15 January 2025

Rosie the Riveter Commemorative Coin Act This bill directs the Department of the Treasury to mint and issue coins in recognition and celebration of the women who contributed to the U.S. home front during World War II. All sales of coins issued under this bill must include a surcharge to be paid to the Rosie the Riveter Trust to support the National Park Service in maintaining and repairing the Rosie the Riveter WWII Home Front National Historical Park.

Chiropractic Medicare Coverage Modernization Act of 2025

United States · United States Congress · 16 January 2025

Chiropractic Medicare Coverage Modernization Act of 2025 This bill expands Medicare coverage of chiropractic services to include all services provided by chiropractors, rather than only subluxation corrections through manual manipulation of the spine.

BEACH Act of 2025

United States · United States Congress · 21 January 2025

Beaches Environmental Assessment and Coastal Health Act of 2025 or the BEACH Act of 2025 This bill reauthorizes through FY2029 and expands an existing program of the Environmental Protection Agency (EPA) that awards grants to states and local governments to (1) monitor the water quality of coastal recreational waters adjacent to beaches or similar points of access that are used by the public; and (2) notify the public, local governments, and the EPA when the water is not safe for recreational activities. Specifically, the bill expands the program to allow the EPA to award grants for identifying sources of contamination (i.e., pathogens) for coastal recreation waters. It also allows grants to be used for monitoring and notification of contamination in (1) shallow waters upstream from recreational waters, and (2) recreational waters on beaches.

Protecting First Responders from Secondary Exposure Act of 2025

United States · United States Congress · 22 January 2025

Protecting First Responders from Secondary Exposure Act of 2025  This bill expands the allowable uses of grant funds under the Comprehensive Opioid, Stimulant, and Substance Use Program administered by the Department of Justice. Specifically, the bill allows grants to be used for purchasing containment devices for first responders and training first responders on the use of containment devices to prevent secondary exposure to fentanyl and other potentially lethal substances.

Neighbors Not Enemies Act

United States · United States Congress · 22 January 2025

Neighbors Not Enemies Act This bill repeals provisions authorizing the President to apprehend and remove from the United States the citizens of a particular nation, if the United States has declared war against that nation or that nation has threatened an invasion against the United States.

Public Lands in Public Hands Act

United States · United States Congress · 23 January 2025

Tim’s Act

United States · United States Congress · 28 January 2025

Tim Hart Wildland Firefighter Classification and Pay Parity Act or Tim's Act This bill increases compensation and establishes additional benefits and programs for federal wildland firefighters. (These individuals are employed by the Department of Agriculture, the Department of the Interior, or tribal governments.)  The bill increases the minimum rate of basic pay for wildland firefighters at General Schedule (GS) levels 1 through 15 by percentages specified in the bill, with smaller increases for higher GS levels. The bill also requires comparable increases to the hourly rates paid to prevailing rate employees who are wildland firefighters. It also establishes premium pay for wildland firefighters who respond to certain prolonged fire incidents and are deployed outside of their normal duty stations or to an area adjacent to the incident. These changes take effect after other temporary pay increases for wildland firefighters expire. The bill also (1) establishes paid rest and recuperation leave; (2) allows certain prior service to be credited for retirement purposes; and (3) provides housing allowances, tuition assistance, and other benefits for wildland firefighters. Further, the bill directs the Office of Workers' Compensation Programs within the Department of Labor to ensure that psychological stress-related injuries and illnesses correlated to fire response are compensated and to expedite related claims. The bill also establishes programs to (1) assist the next-of-kin of wildland firefighters and fire support personnel who are critically injured or killed while in the line of duty, and (2) support the mental and physical health of wildland firefighters.

Foreign Anti-Digital Piracy Act

United States · United States Congress · 28 January 2025

Foreign Anti-Digital Piracy Act or FADPA This bill establishes a process for copyright owners and exclusive licensees to petition U.S. district courts to block access to foreign websites or online services that engage in copyright infringement.  Specifically, the bill allows a copyright owner or an exclusive licensee of a copyright owner to file a petition in a U.S. district court for the issuance of a preliminary order declaring that a foreign website or online service is engaging in copyright infringement. The petition must show that (1) the transmission through a foreign website or online service of a copyrighted work or live event likely infringes on the exclusive right of the owner or licensee to reproduce, distribute, publicly perform, or publicly display such work; and (2) the owner or licensee is likely to suffer irreparable harm as a result of the infringement. The bill outlines the process and the time frame for the court to issue a preliminary order. After obtaining a preliminary order, the copyright owner or licensee may request for the court to issue a blocking order that requires certain broadband service providers to take measures to prevent their users from accessing the foreign website or online service identified in the order. The bill outlines the terms and conditions of such an order. The court may require the copyright owner or licensee to pay the reasonable costs and expenses directly incurred by the service provider to comply with the order.  The bill includes liability protections for service providers.

Stronger Engagement for Indian Health Needs Act of 2025

United States · United States Congress · 28 January 2025

Stronger Engagement for Indian Health Needs Act of 2025 This bill elevates the current position of the Director of the Indian Health Service within the Department of Health and Human Services (HHS) to Assistant Secretary for Indian Health within HHS.

Global Health, Empowerment and Rights Act

United States · United States Congress · 28 January 2025

Global Health, Empowerment and Rights Act This bill establishes that a foreign nongovernmental organization shall not be disqualified from receiving certain U.S. international development assistance solely because the organization provides medical services (including counseling and referral services) using non-U.S. government funds if the medical services do not violate the laws of the country in which they are being provided. Such foreign organizations shall not be subject to requirements relating to their use of non-U.S. funds for advocacy or lobbying activities other than those that apply to U.S. nongovernmental organizations receiving such assistance.

Medicare Patient Access and Practice Stabilization Act of 2025

United States · United States Congress · 31 January 2025

Medicare Patient Access and Practice Stabilization Act of 2025 This bill increases certain payment adjustments under the Medicare physician fee schedule for services furnished between April 1, 2025, and January 1, 2026.

Providing amounts for the expenses of the Committee on Science, Space, and Technology in the One Hundred Nineteenth Congress.

United States · United States Congress · 4 February 2025

This resolution provides amounts for the expenses of the House Committee on Science, Space, and Technology for the 119th Congress.

Expressing support for the continued value of arms control agreements and negotiated constraints on Russian and Chinese strategic nuclear forces.

United States · United States Congress · 4 February 2025

This resolution condemns Russia's nuclear escalatory rhetoric and implied threats on the potential use of nuclear weapons in the context of its invasion of Ukraine. The resolution also (1) condemns Russia's purported suspension of participation in the New START Treaty, (2) emphasizes the value of arms control agreements between the United States and Russia, and (3) calls on the administration to continue pursuing nuclear arms control and risk reduction with Russia and China. 

Rosa Parks Day Act

United States · United States Congress · 4 February 2025

Rosa Parks Day Act This bill designates Rosa Parks Day as a federal holiday.

Access to Counsel Act

United States · United States Congress · 4 February 2025

Access to Counsel Act This bill provides various protections for covered individuals subject to secondary or deferred inspections when seeking admission into the United States. Covered individuals include U.S. nationals, lawful permanent residents, non-U.S. nationals ( aliens under federal law) in possession of a visa, returning asylees, and refugees. The Department of Homeland Security must ensure that a covered individual subject to secondary or deferred inspection has a meaningful opportunity to consult with counsel and certain related parties, such as a relative, within an hour of the start of the secondary inspection and as necessary during the inspection process. The counsel and related party must be allowed to advocate on behalf of the covered individual, including by providing evidence and information to the examining immigration officer. A lawful permanent resident subject to secondary or deferred inspection may not abandon lawful permanent resident status until the individual has had a meaningful opportunity to seek advice from counsel, unless the individual voluntarily and knowingly waives in writing this opportunity to seek counsel's advice.

To award a Congressional Gold Medal to the Freedom Riders, collectively, in recognition of their unique contribution to Civil Rights, which inspired a revolutionary movement for equality in interstate travel.

United States · United States Congress · 4 February 2025

This bill provides for the presentation of a Congressional Gold Medal to the Freedom Riders, in recognition of their contribution to civil rights by fighting for equality in interstate travel.

NO BAN Act

United States · United States Congress · 4 February 2025

National Origin-Based Antidiscrimination for Nonimmigrants Act or the NO BAN Act This bill imposes limitations on the President's authority to suspend or restrict aliens from entering the United States. It also prohibits religious discrimination in various immigration-related decisions, such as whether to issue an immigrant or nonimmigrant visa, unless there is a statutory basis for such discrimination. The President may temporarily restrict the entry of any aliens or class of aliens after the Department of State determines that the restriction would address specific and credible facts that threaten U.S. interests such as public safety. The bill also imposes limitations on such restrictions, such as requiring the President, State Department, and the Department of Homeland Security (DHS) to (1) only issue a restriction when required to address a compelling government interest, and (2) narrowly tailor the suspension to use the least restrictive means to achieve such an interest. Before imposing a restriction, the State Department and DHS shall consult with Congress. The State Department and DHS shall report to Congress about the restriction within 48 hours of the restriction's imposition. If such a report is not made, the restriction shall immediately terminate. Individuals or entities present in the United States and unlawfully harmed by such a restriction may sue in federal court. The bill transfers the authority to suspend the entry of aliens traveling to the United States on a commercial airline that failed to comply with regulations related to detecting fraudulent travel documents from the Department of Justice to DHS. 

Expressing support for the Nation's local public K-12 schools and condemning any actions that would defund public education or weaken or dismantle the Department of Education.

United States · United States Congress · 4 February 2025

This resolution supports federal investment in public K-12 schools, affirms that the Department of Education (ED) plays a vital role in the public education system, and states that public education funding should not be diverted (e.g., through the use of vouchers) to privately run K-12 schools.  The resolution also rejects any claim that the executive branch has the legal authority to (1) dismantle or relocate ED or any of its major offices; or (2) reduce federal funding for public education, block federal grants for education, or transfer funding burdens for education to state and local governments.

Crime Victims Fund Stabilization Act of 2025

United States · United States Congress · 4 February 2025

Crime Victims Fund Stabilization Act of 2025 This bill adds a new source of revenue for the Crime Victims Fund (CVF). Specifically, the bill requires certain civil monetary penalties collected from settlements and judgments in cases involving fraud and false claims against the federal government to be deposited into the CVF through FY2029.  The CVF supports federal, state, and local programs and activities to compensate and assist victims of crimes. Currently, the CVF is funded by deposits from a variety of sources, including federal criminal fines, penalties, and assessments; forfeited bail bonds; and certain other gifts, donations, and bequests. 

Right to Contraception Act

United States · United States Congress · 5 February 2025

Condemning the pardons for individuals who were found guilty of assaulting Capitol Police Officers.

United States · United States Congress · 5 February 2025

This resolution disapproves of pardons for individuals who were found guilty of assaulting U.S. Capitol Police officers.

Love Lives On Act of 2025

United States · United States Congress · 5 February 2025

Love Lives On Act of 2025 This bill extends entitlement for various benefit programs and services for surviving spouses of deceased members of the Armed Forces or veterans. The bill provides that the remarriage of a surviving spouse must not bar the furnishing of dependency and indemnity compensation or special pension benefits to such spouse. Additionally, the Department of Defense may not terminate the payment of an annuity for a surviving spouse under the Survivor Benefit Plan solely because the surviving spouse remarries. The bill also expands the definition of a dependent under TRICARE to include a remarried widow or widower whose subsequent marriage has ended due to death, divorce, or annulment.

Taxpayer Data Protection Act

United States · United States Congress · 6 February 2025

Taxpayer Data Protection Act This bill restricts access to any public money receipt or payment system belonging to the Department of the Treasury. Specifically, access is limited to authorized Treasury officers, employees, or contractors meeting certain performance standards who have held a qualified position for at least a year, or who hold other qualifications as provided by the bill. The bill specifically prohibits special government employees (i.e., temporary appointees hired to perform specific tasks) from having access to such systems. The bill also provides that an individual accessing such systems shall be treated as an executive branch employee for purposes of federal criminal conflict of interest laws.  Treasury's Office of Inspector General must investigate and report on each instance of unauthorized use or other access of such payment systems.

Scientific Integrity Act

United States · United States Congress · 6 February 2025

Scientific Integrity Act This bill requires each federal agency that funds, conducts, or oversees scientific research to adopt and enforce a scientific integrity policy. Under the bill, among other parameters, such policies must (1) ensure that scientific conclusions are not based on political considerations, (2) prohibit the suppression or alteration of findings, and (3) permit researchers to disseminate their findings and engage with the scientific community as appropriate. Scientific integrity policies must also include a mechanism through which stakeholders may report violations of the policy.  Agencies are required to submit their scientific integrity policies to the Office of Science and Technology Policy (OSTP) for approval. Approved policies must be made public, submitted to Congress, and periodically updated. Agencies may use their existing policies provided they satisfy the requirements of the bill. The Government Accountability Office must review implementation of the policies.  Each agency is also required to (1) appoint a Scientific Integrity Officer, (2) establish a process for dispute resolution consistent with the scientific integrity policy, and (3) establish a specified training program for current and new employees.

Protect Our Letter Carriers Act of 2025

United States · United States Congress · 6 February 2025

Protect Our Letter Carriers Act of 2025 This bill requires or authorizes certain actions related to the U.S. Postal Service (USPS). The bill requires the Department of Justice to appoint an assistant U.S. attorney in each judicial district to coordinate and supervise the investigation and prosecution of various crimes related to postal services (for example, assault on a postal service employee, breaking into a post office, or obstruction of mails). The bill also requires the U.S. Sentencing Commission to amend sentencing guidelines to provide that the assault or robbery of a postal employee shall be treated the same as the assault of a law enforcement officer. Additionally, the bill authorizes appropriations for the USPS to install high security collection boxes and replace older versions of the universal mailbox key with electronic versions.

Protecting Sensitive Locations Act

United States · United States Congress · 6 February 2025

Protecting Sensitive Locations Act This bill prohibits immigration enforcement actions within 1,000 feet of a sensitive location except in exigent circumstances, such as the imminent risk of death, violence, or physical harm to any person. Sensitive locations include  health care facilities; schools and school bus stops; places that provide assistance for people such as children, pregnant women, and abuse victims; child care facilities; places that provide disaster or emergency services; places of worship; courthouses and lawyers’ offices; facilities used as polling places; certain labor union facilities; and public assistance offices. The prohibition shall apply to Department of Homeland Security officers and agents, as well as state employees pursuing immigration enforcement actions. If an enforcement action is carried out in violation of this prohibition (1) no information resulting from the action may be entered into the record in a resulting removal proceeding, and (2) the affected individual may move to immediately terminate such a proceeding. U.S. Immigration and Customs Enforcement and U.S. Customs and Border Protection shall annually report to Congress about enforcement actions taken at sensitive locations in the preceding year. 

Carried Interest Fairness Act of 2025

United States · United States Congress · 6 February 2025

Carried Interest Fairness Act of 2025 This bill taxes income from carried interest at ordinary income tax rates and makes other changes related to carried interest. (Some exceptions apply.) As background, a general partner in a private equity firm or hedge fund (typically structured as a partnership) generally receives a share of the profits from the assets managed by the general partner (known as carried interest). Under current law, carried interest is characterized (for federal tax purposes) as an interest in a partnership’s capital and, thus, taxed at capital gains tax rates (which may be lower than the applicable ordinary income tax rates).  Under the bill, net capital gain and loss attributable to carried interest is recharacterized as ordinary income and loss and, thus, taxed at ordinary income tax rates. (Some exceptions apply.) The bill also treats as ordinary the money (or fair market value of property) received by a partner in a sale or exchange of carried interest. (Thus, the bill extends what is known as the hot asset rule to include carried interest.) Further, the bill deems distributions of carried interest by a partnership in exchange for interest in other partnership property a sale or exchange of such property and, thus, requires the partner to recognize ordinary gain on the distributed carried interest. Finally, the bill imposes self-employment taxes on carried interest income.

Mikaela Naylon Give Kids a Chance Act

United States · United States Congress · 12 February 2025

Give Kids a Chance Act of 2025 This bill expands the Food and Drug Administration’s (FDA’s) authority with respect to research on rare pediatric diseases, including by permitting the FDA to take enforcement action against drug sponsors that fail to satisfy pediatric study requirements and by reauthorizing programs that support pediatric research.  Specifically, the bill modifies requirements relating to molecularly targeted pediatric cancer investigations to permit research on new drugs in combination with active ingredients that have already been approved, provided certain conditions are met; permits the FDA to take enforcement action against drug sponsors that fail to comply with pediatric study requirements, if such sponsors demonstrated a lack of due diligence in satisfying the requirement; renews the FDA’s authority to award priority review vouchers to sponsors of new products intended to treat rare pediatric diseases through September 30, 2029; and reauthorizes through FY2027 certain funding for the National Institutes of Health to support priority pediatric research.  The bill also provides statutory authority for the FDA’s interpretation of the orphan drug exclusivity period. The bill specifies, consistent with FDA regulations, that the seven-year market exclusivity period for drugs for rare diseases or conditions (i.e., orphan drugs) prohibits the approval of the same drug for the same approved use or indication with respect to the disease or condition. (In Catalyst Pharmaceuticals, Inc. v. Becerra , a court rejected the FDA’s interpretation and held that orphan drug exclusivity extends to all uses or indications for the disease or condition.)

Combating Illicit Xylazine Act

United States · United States Congress · 12 February 2025