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Drug Pricing and Intellectual Property Law: A Legal Overview for the 116th Congress [April 4, 2019]
From the Document: "Intellectual property (IP) rights play an important role in the development and pricing of pharmaceutical products such as prescription drugs and biologics. In order to encourage innovation, IP law grants the rights holder a temporary monopoly on a particular invention or product, potentially enabling him to charge higher-than-competitive prices. IP rights, if sufficiently limited, are typically justified as necessary to allow pharmaceutical manufacturers the ability to recoup substantial costs in research and development, including clinical trials and other tests necessary to obtain regulatory approval from the Food and Drug Administration (FDA). However, because they may operate to deter or delay competition from generic drug and biosimilar manufacturers, IP rights have been criticized as contributing to high prices for pharmaceutical products in the United States."
Library of Congress. Congressional Research Service
Hickey, Kevin J.; Shen, Wen S.; Ward, Erin H.
2019-04-04
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Executive Order 13927 on Economic Recovery from the COVID-19 Emergency and the Endangered Species Act [Updated January 28, 2021]
From the Document: "On June 4, 2020, President Trump issued Executive Order (E.O.) 13927 on 'Accelerating the Nation's Economic Recovery from the COVID-19 [coronavirus disease 2019] Emergency by Expediting Infrastructure Investments and Other Activities.' The President declared the COVID-19 outbreak a national emergency that threatens national security on March 13, 2020 (Proclamation 9994). The E.O. seeks to facilitate the nation's economic recovery from the national emergency by directing selected federal departments and agencies to use emergency and other authorities to expedite regulatory compliance for infrastructure and other projects."
Library of Congress. Congressional Research Service
Crafton, R. Eliot; Sheikh, Pervaze A.; Ward, Erin H.
2021-01-28
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Testing, Testing, (Phase) 1-2-3: Legal Considerations for Clinical Trials of Potential COVID-19 Vaccines [June 2, 2020]
From the Document: "In the race to develop a Coronavirus Disease 2019 (COVID-19) vaccine, several pharmaceutical companies, governments, and educational institutions around the world have begun testing their potential COVID-19 vaccines in clinical trials. Clinical trials are used to assess whether a new pharmaceutical product, such as a vaccine, is safe for humans and effective in achieving its intended purpose. Companies must generally test new pharmaceutical products on humans through clinical trials to obtain U.S. Food and Drug Administration (FDA) approval to market the product. But using human subjects to test these novel products exposes them to unknown health and safety risks, raising ethical considerations for FDA and for the sponsors and Institutional Review Boards (IRBs) overseeing the investigations. These stakeholders--sponsors, IRBs, and FDA--aim to balance the need to ensure that the product is safe and effective against the desire to bring the product to market quickly, tensions that are heightened during a worldwide pandemic. Existing law requires FDA and IRBs to weigh these considerations when evaluating proposed clinical trial designs for COVID-19 vaccines. This Sidebar describes the legal and regulatory framework that governs clinical trials for pharmaceutical products, such as vaccines, and some avenues researchers and Congress may consider for accelerating that process during the COVID-19 pandemic. (For ease of reference, this Sidebar uses the term 'drugs' includes both traditional drugs and biological products, including vaccines.)"
Library of Congress. Congressional Research Service
Ward, Erin H.
2020-06-02
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Final Rules Changing Endangered Species Act Regulations [Updated August 27, 2019]
From the Document: "On August 27, 2019, the Trump Administration published three final rules that change the implementation of the Endangered Species Act (ESA; 16 U.S.C. §§ 1531 et. seq.). The final rules concern Section 4 (listing of endangered and threatened species) and Section 7 (consultation with federal agencies) of ESA. The final rules are effective on September 26, 2019. The federal agencies that implement ESA include the U.S. Fish and Wildlife Service (FWS) and the National Oceanic and Atmospheric Administration through the National Marine Fisheries Service (NMFS). (FWS and NMFS are referred to as the 'Services' in this In Focus, and the term 'Secretary' refers to the Secretary of the Interior or the Secretary of Commerce, as applicable.) The final rules are summarized below, including some of the Services' explanations for the changes."
Library of Congress. Congressional Research Service
Ward, Erin H.; Crafton, R. Eliot
2019-08-27
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Drug Pricing and the Law: Regulatory Exclusivities [May 17, 2018]
From the Document: "The Food and Drug Administration (FDA) generally must approve pharmaceutical products, such as drugs and biologics, before they can be marketed in the United States. To obtain approval of a new drug or biologic (i.e., the brand-name or reference product), the sponsor must submit to FDA data from clinical investigations demonstrating that the underlying product is safe and effective for its intended use. Conversely, a follow-on product, such as a generic drug or biosimilar, via an abbreviated process by relying upon the data generated to support approval of the reference product. In order to balance interests in competition with the countervailing interest in encouraging innovation, federal law establishes periods of regulatory exclusivity that limit FDA's ability to approve applications to market pharmaceutical products under certain circumstances."
Library of Congress. Congressional Research Service
Ward, Erin H.
2019-05-17
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Tenth Circuit Ruling May Limit Availability of Small Refinery Exemptions from the Renewable Fuel Standard: Implications for Congress [March 10, 2020]
From the Document: "A recent appeals court decision may limit the availability of small refinery exemptions (SRE) from the Clean Air Act's renewable fuel standard (RFS) going forward. These exemptions have garnered attention from stakeholders and Congress as the number of exemptions sought and granted has increased significantly the last few years."
Library of Congress. Congressional Research Service
Ward, Erin H.
2020-03-10
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Executive Order 13927 on Economic Recovery from the COVID-19 Emergency and the Endangered Species Act [June 22, 2020]
From the Document: "On June 4, 2020, President Trump issued Executive Order (E.O.) 13927 on 'Accelerating the Nation's Economic Recovery from the COVID-19 [coronavirus disease 2019] Emergency by Expediting Infrastructure Investments and Other Activities.' The President declared the COVID-19 outbreak a national emergency that threatens national security on March 13, 2020 (Proclamation 9994). The E.O. seeks to facilitate the nation's economic recovery from the national emergency by directing selected federal departments and agencies to use emergency and other authorities to expedite regulatory compliance for infrastructure and other projects."
Library of Congress. Congressional Research Service
Crafton, R. Eliot; Sheikh, Pervaze A.; Ward, Erin H.
2020-06-22
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COVID-19: Legal Considerations for Bringing a New Vaccine to Market [March 24, 2020]
From the Document: "As the number of confirmed COVID [coronavirus disease]-19 cases increases at an accelerating rate, interest has grown in developing a COVID-19 vaccine as an avenue for addressing the pandemic. Media reports indicate that a number of countries and companies are working on developing a vaccine. The National Institute of Allergy and Infectious Diseases (NIAID) and the biotechnology company Moderna, Inc., recently initiated the first clinical trials of a potential vaccine in the United States at a hospital in Seattle. However, developing a new vaccine and obtaining approval to market it can take a long time. This Sidebar discusses the licensure (i.e., approval) process for vaccines under the Public Health Service Act (PHS Act) and the federal Food, Drug, and Cosmetic Act (FD&C Act), as well as potential legal avenues for expediting that process to bring a new vaccine to market sooner."
Library of Congress. Congressional Research Service
Ward, Erin H.
2020-03-24
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Legal Issues in COVID-19 Vaccine Development [June 8, 2020]
From the Summary: "Private companies, universities, and governmental entities are working to develop a vaccine for coronavirus disease 2019 (COVID-19). Vaccines are biological products regulated under the Public Health Service Act (PHSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). New vaccines must generally be licensed by the U.S. Food & Drug Administration (FDA) before they can be marketed and used in the United States. To obtain licensure, the vaccine must be tested in human subjects through clinical trials. The clinical trials inform the dosing schedule and labeling that will be used for the approved vaccine. Sponsors use the data from clinical trials, along with other information, to prepare a biologics license application (BLA) to submit to FDA. FDA approves the BLA if it determines that the vaccine is safe, potent, and pure. Because the development and review process can be lengthy, the FD&C Act provides several avenues to accelerate this process for pharmaceutical products intended to treat or prevent serious diseases or conditions. FDA may grant fast track product and breakthrough-therapy designation at the sponsor's request for products that are intended to fill an unmet need or improve on existing therapies. Both designations entitle the sponsor to increased communication with FDA regarding the clinical trial design and data collected, as well as rolling review of the BLA. Products may also qualify for accelerated approval based on intermediate or surrogate endpoints likely to predict a clinical benefit. In addition, FDA may designate products for priority review."
Library of Congress. Congressional Research Service
Hickey, Kevin J.; Ward, Erin H.
2020-06-08
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Supreme Court Preview of 2020-2021 Environmental and Energy Law Cases and Review of 2019-2020 Rulings [Updated February 11, 2021]
From the Summary: "The Supreme Court 2019-2020 term, which started on October 1, 2019, was historic in unexpected ways. The Coronavirus Disease 2019 (COVID-19) pandemic resulted in the Court indefinitely closing its building to the public, postponing oral arguments, and conducting telephonic oral arguments for the first time in history. Beyond the effects of the pandemic, the 2019-2020 Term was notable for the substantive opinions that the Supreme Court issued on environmental, energy, and natural resources (EENR) law issues. [...] The Supreme Court's 2020-2021 term, which began on October 5, 2020, features cases relating to states' competing claims to several interstate rivers, disclosure of agency documents produced during an Endangered Species Act consultation, the appropriate court to decide climate change liability suits, the small refinery exemptions under the Clean Air Act's renewable fuel standard, the relationship between separate CERCLA [Comprehensive Environmental Response, Compensation, and Liability Act] provisions for recouping cleanup costs, eminent domain authority under the Natural Gas Act, and other areas of EENR law. [...] This report reviews some the major EENR decisions from the Supreme Court's 2019-2020 term and previews the legal disputes and arguments in selected EENR cases and petitions for certiorari in the 2020-2021 term. The report also highlights the broader implications of these decisions and cases for Congress."
Library of Congress. Congressional Research Service
Tsang, Linda; Bowers, Kate R.; Holmes, Eric N. . . .
2021-02-11
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Compensation Programs for Potential COVID-19 Vaccine Injuries [March 22, 2021]
From the Document: "Following the Food and Drug Administration's (FDA) emergency authorization of the Pfizer/BioNTech [hyperlink], Moderna [hyperlink], and Janssen Biotech/Johnson & Johnson [hyperlink] vaccines against COVID-19 [coronavirus disease 2019], millions of Americans [hyperlink] have received at least one dose of a COVID-19 vaccine regimen. Based on months-long clinical trials (including safety monitoring) of each vaccine candidate involving tens of thousands of participants, FDA did not [hyperlink] identify any [hyperlink] safety concerns for these vaccines that would preclude FDA emergency use authorization. As with most vaccines, however, a very small percentage of inoculated individuals experienced adverse reactions to a COVID-19 vaccine. Anecdotal reports [hyperlink] from early in the COVID-19 vaccination campaign include several cases of anaphylaxis--a severe and potentially life-threatening allergic reaction--following vaccination. [...] Federal law has two distinct vaccination compensation regimes that may compensate individuals harmed by adverse reactions. In general, the National Vaccine Injury Compensation Program [hyperlink] (VICP) may provide compensation for injuries or deaths associated with most vaccines [hyperlink] routinely administered in the United States (such as pediatric and seasonal influenza vaccines). During certain public health emergencies, the Countermeasures Injury Compensation Program [hyperlink] (CICP) may provide compensation for injuries and deaths resulting from the administration of 'covered countermeasures' under the Public Readiness and Emergency Preparedness Act [hyperlink] (PREP Act), which may include vaccines."
Library of Congress. Congressional Research Service
Hickey, Kevin J.; Ward, Erin H.
2021-03-22
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Drug Pricing and Intellectual Property: The Legislative Landscape for the 117th Congress [March 31, 2021]
From the Summary: "Intellectual property (IP) rights play an important role in the development and pricing of pharmaceuticals, such as prescription drugs and biological products (biologics). To provide incentives for research and development (R&D), IP law grants innovators exclusive rights that may prevent others from making generic or biosimilar versions of a drug or biologic, enabling makers of brand-name pharmaceuticals to charge higher prices in some circumstances. In the pharmaceutical context, such higher-than-competitive prices are intended to allow pharmaceutical manufacturers an opportunity to recoup substantial R&D costs, including clinical trials and other tests necessary to obtain regulatory approval from the Food and Drug Administration (FDA). Although many factors other than IP rights contribute to the cost of prescription drugs and biologics, pharmaceutical products are frequently protected by IP rights, and IP rights are often among the most important factors driving high drug prices. [...] [T]his report summarizes legislative proposals introduced in the 116th Congress that concern drug pricing and relate to patent and regulatory exclusivity rights in drugs and biologics. Among other things, this report classifies bills by legislative status and type, and analyzes and compares bills addressing similar subject matter."
Library of Congress. Congressional Research Service
Hickey, Kevin J.; Richards, Kevin T.; Ward, Erin H.
2021-03-31
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