Stop Stalling Access to Affordable Medications This bill makes it an unfair method of competition to submit an objectively baseless petition to the Food and Drug Administration (FDA) in an attempt to interfere with a competitor's application for market approval of a drug. The bill authorizes the Federal Trade Commission to sue an individual or entity that submits such a petition to the FDA. A party found liable in such a lawsuit shall be subject to civil penalties, such as a fine of up to $50,000 for each day that the FDA spent reviewing the baseless petition.
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 This bill prohibits product hopping by drug manufacturers and authorizes the Federal Trade Commission to sue in court or institute administrative proceedings to enforce this prohibition. Generally, product-hopping describes a situation where, when the patents on a reference drug (or biological product) expire, the manufacturer switches to a follow-on product that is covered by a later-expiring patent. Under this bill, a follow-on product is a changed, modified, or reformulated version of the reference drug that shares an indication (what the drug is used for) with the reference drug. The bill presumes product hopping has occurred when a reference drug manufacturer engages in a hard switch or a soft switch . A hard switch occurs when, after receiving notice of an application for Food and Drug Administration (FDA) approval to market a generic (or biosimilar) version of the reference drug, the manufacturer markets a follow-on product and (1) the FDA withdraws approval of the reference drug at the manufacturer's request, or (2) the manufacturer announces the withdrawal or discontinuance of the reference drug or destroys the drug's inventory in a manner that impedes generic competitors. Furthermore, the bill presumes that a soft switch occurred if a reference drug manufacturer (1) markets a follow-on product, and (2) takes actions that disadvantage the reference drug relative to that follow-on product in a way that impedes competition from a generic drug. A drug manufacturer may rebut these presumptions by demonstrating that its conduct was not intended to limit competition.
Preserve Access to Affordable Generics and Biosimilars Act This bill authorizes the Federal Trade Commission (FTC) to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement is presumed to have anticompetitive effects and is a violation of this bill if the filer of the generic drug or biosimilar application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar. An agreement is exempted if the only consideration granted to the generic manufacturer is (1) the right to market its product prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on any claim that the generic drug or biosimilar infringes a patent. An agreement is also exempt if the agreement's pro-competitive benefits outweigh the anticompetitive effects. When a generic or biosimilar drug manufacturer enters into an agreement with another drug manufacturer related to the manufacturing, marketing, or sale of a drug, the manufacturers must certify that the material they have given the FTC concerning the agreement contains the complete agreement and any agreements related to that main agreement, including descriptions of any oral agreements or representations. The bill imposes penalties for violations of this bill, including the forfeiture of the 180-day marketing exclusivity period for a generic drug.
This resolution supports the designation of National Voter Registration Day.
This resolution recognizes the importance of ending the stigmatization of substance use disorder.
Performing Artist Tax Parity Act of 2021 This bill modifies the tax deduction for the expenses of performing artists (including commissions paid to managers or agents) to provide for a phaseout of such deduction for taxpayers whose adjusted gross income exceeds $100,000 ($200,000 for joint return filers). The $100,000 phaseout threshold is adjusted for inflation annually for taxable years beginning after 2021.
Rewarding Efforts to Decrease Unrecycled Contaminants in Ecosystems Act of 2021 or the REDUCE Act of 2021 This bill imposes an excise tax on any taxable virgin plastic resin. The bill establishes a Plastic Waste Reduction Fund to carry out reduction and recycling activities, plastic waste and marine debris reduction, detection, monitoring, and cleanup activities, and address environmental justice and pollution impacts from plastic products.
Cancer Patient Equity Act of 2021 This bill provides for coverage of certain cancer diagnostic and laboratory tests under Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). Specifically, the bill provides for coverage of microarray analysis, DNA and RNA sequencing, whole-exome sequencing, and other next-generation sequencing for individuals diagnosed with cancer. Additionally, the Department of Health and Human Services must establish an education and awareness program for physicians and the public about genomic testing and the role of genetic counselors.
Unemployment Insurance Improvement Act This bill expands the list of requirements a state unemployment compensation system must follow to be compliant under federal law. Specifically, the bill requires the maximum benefit period available to an individual be at least 26 weeks. The base period used to determine unemployment eligibility must consist of at least four completed calendar quarters preceding the claim and must include the most recently completed calendar quarter. Further, compensation must not be denied to an otherwise eligible individual who earns at least $1,000 during the highest quarter and at least $1,500 during the entire base period. Finally, compensation must not be denied under an ability to work, active search for work, or refusal to accept work provision solely on the basis of the number of hours of work the individual is seeking, so long as the individual is seeking at least 20 hours of work or half the hours the individual typically worked. Employers that pay unemployment taxes to a noncompliant state system cannot claim amounts paid into the state system as a credit against federal unemployment tax due. The bill also requires states to meet specified online claim system accessibility requirements and to ensure that offline means of filing are available. A state that does not comply cannot receive federal funds for administration of its state unemployment system.
Providing Officers With Electronic Resources Act or the POWER Act This bill authorizes the Office of Community Oriented Policing Services within the Department of Justice to make grants to law enforcement agencies to purchase a chemical screening device and to train personnel to use, and interpret data collected by, such device.
Unclaimed Savings Bond Act of 2021 This bill establishes requirements and procedures for the Department of the Treasury to transfer ownership of certain matured, unredeemed savings bonds and related records to states.
Helping Students Plan for College Act of 2021 This bill requires certain statements related to the impact of nonfederal financial assistance (e.g., private scholarships, grants, and loans) on financial-aid awards from an institution of higher education (IHE). Specifically, the bill requires an IHE that participates in federal student-aid programs and adjusts its financial-aid awards based on students receiving such other financial assistance to provide enrolled and prospective students with a statement about (1) its policies on adjusting awards, and (2) how receipt of such other financial assistance may impact student eligibility for and the amount of financial-aid awards from the IHE. The Government Accountability Office must study and report on the relationship between such other financial assistance and eligibility for and the amount of financial-aid awards from IHEs.
