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.
Eliminating a Quantifiably Unjust Application of the Law Act of 2021 or the EQUAL Act of 2021 This bill eliminates the federal sentencing disparity between drug offenses involving crack cocaine and powder cocaine. Currently, different threshold quantities of crack cocaine and powder cocaine (e.g., 28 grams of crack cocaine and 500 grams of powder cocaine) trigger the same statutory criminal penalties. This bill eliminates the lower quantity thresholds for crack cocaine offenses. Under the bill, the same threshold quantities of crack cocaine and powder cocaine trigger the same statutory criminal penalties. The change applies to future cases and cases pending on the date of enactment. With respect to past cases, the bill authorizes a sentencing court to impose a reduced sentence on a defendant who was convicted or sentenced for a specified crack cocaine offense before this bill's enactment. A defendant does not have to be present at the sentence reduction hearing. Finally, the bill prohibits the reduction of a sentence that was previously reduced.
Libya Stabilization Act This bill provides for sanctions and aid related to the conflict in Libya. The bill provides statutory authority for an April 19, 2016, executive order imposing property- and visa-blocking sanctions on persons contributing to the violence in Libya. The President must impose property- and visa-blocking sanctions on any foreign person that (1) knowingly supports or engages in a significant transaction with a foreign person knowingly operating in Libya on behalf of Russia in a military capacity, (2) engages in significant actions threatening peace or stability in Libya, (3) misappropriates Libyan state assets or natural resources, or (4) is knowingly responsible for or complicit in serious human rights abuses in Libya. These sanctions shall expire on December 31, 2026. Further, the President is authorized to expand educational and cultural exchange programs with Libya. The bill urges the U.S. Agency for International Development to provide humanitarian assistance to individuals and communities in Libya, including health assistance, food, shelter, and support for an effective COVID-19 (i.e., coronavirus disease 2019) response. The Department of State must work to strengthen Libya's democratic governance, including by providing assistance to (1) unify Libya's financial and governing institutions, and (2) ensure free and credible future elections in Libya. The Department of the Treasury must vote and argue for international financial institutions to support an economic recovery in Libya that complements the establishment of democratic institutions and rule of law.
This resolution recognizes the importance of education to prevent substance use disorders and expresses gratitude for family members and others who support individuals in recovery.
This resolution supports the designation of National Voter Registration Day.
This bill expresses the sense of the House of Representatives that Congress and the President should examine and support ways to expand access to contraceptives.
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.
This resolution honors the life of Robert Dove, Parliamentarian Emeritus of the Senate, and offers the condolences of the Senate regarding his death.
This resolution designates September 20-September 24, 2021, as National Clean Energy Week.
This resolution condemns and denounces the actions of the Customs and Border Patrol agents who confronted Haitian migrants on horseback using their reins as lashes.
