A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is equivalent in performance compared to their performance at the time when they were patented drugs. A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, color, taste, and packaging.
Prescription drug list prices in the United States continually rank among the highest in the world. The high cost of prescription drugs became a major topic of discussion in the 21st century, leading up to the American health care reform debate of 2009, and received renewed attention in 2015. One major reason for high prescription drug prices in the United States relative to other countries is the inability of government-granted monopolies in the American health care sector to use their bargaining power to negotiate lower prices, and the American payer ends up subsidizing the world's R&D spending on drugs.
Patrick Joseph Leahy, is an American politician and attorney who represented Vermont in the United States Senate from 1975 to 2023. A member of the Democratic Party, he also served as the president pro tempore of the United States Senate from 2012 to 2015 and from 2021 to 2023. During his tenure he chaired the Senate Appropriations Committee, the Senate Judiciary Committee and the Senate Agriculture Committee. Leahy is the third-longest-serving U.S. senator in history, with 48 years served, and is the longest-serving member of the United States Congress to solely serve as a U.S. senator.
The Medicare Prescription Drug, Improvement, and Modernization Act, also called the Medicare Modernization Act or MMA, is a federal law of the United States, enacted in 2003. It produced the largest overhaul of Medicare in the public health program's 38-year history.
Budget reconciliation is a special parliamentary procedure of the United States Congress set up to expedite the passage of certain federal budget legislation in the Senate. The procedure overrides the Senate's filibuster rules, which may otherwise require a 60-vote supermajority for passage. Bills described as reconciliation bills can pass the Senate by a simple majority of 51 votes or 50 votes plus the vice president's as the tie-breaker. The reconciliation procedure also applies to the House of Representatives, but it has minor significance there, as the rules of the House of Representatives do not have a de facto supermajority requirement. Because of greater polarization, gridlock, and filibustering in the Senate in recent years, budget reconciliation has come to play an important role in how the United States Congress legislates.
Medicare Part D, also called the Medicare prescription drug benefit, is an optional United States federal-government program to help Medicare beneficiaries pay for self-administered prescription drugs. Part D was enacted as part of the Medicare Modernization Act of 2003 and went into effect on January 1, 2006. Under the program, drug benefits are provided by private insurance plans that receive premiums from both enrollees and the government. Part D plans typically pay most of the cost for prescriptions filled by their enrollees. However, plans are later reimbursed for much of this cost through rebates paid by manufacturers and pharmacies.
The Biodefense and Pandemic Vaccine and Drug Development Act of 2005, nicknamed "Bioshield Two" and sponsored by Senator Richard Burr, aims to shorten the pharmaceutical development process for new vaccines and drugs in case of a pandemic, and to protect vaccine makers and the pharmaceutical industry from legal liability for vaccine injuries. The proposed bill would create a new federal agency, the Biomedical Advanced Research and Development Agency (BARDA), that would act "as the single point of authority" to promote advanced research and development of drugs and vaccines in response to bioterrorism and natural disease outbreaks, while shielding the agency from public Freedom of Information Act (FOIA) requests. BARDA would be exempt from long-standing open records and meetings laws that apply to most government departments.
The Public Readiness and Emergency Preparedness Act (PREPA), passed by the United States Congress and signed into law by President of the United States George W. Bush in December 2005, is a controversial tort liability shield intended to protect vaccine manufacturers from financial risk in the event of a declared public health emergency. The part of PREPA that actually affords such protection is now codified at 42 U.S.C. § 247d-6d. The act specifically affords to drug makers immunity from actions related to the manufacture, testing, development, distribution, administration and use of medical countermeasures against chemical, biological, radiological and nuclear agents of terrorism, epidemics, and pandemics. PREPA strengthens and consolidates the oversight of litigation against pharmaceutical companies under the purview of the secretary of Health and Human Services (HHS). PREPA provides $3.8 billion for pandemic influenza preparedness to protect public health in the case of a pandemic disease outbreak.
Evergreening is any of various legal, business, and technological strategies by which producers extend the lifetime of their patents that are about to expire in order to retain revenues from them. Often the practice includes taking out new patents, or by buying out or frustrating competitors, for longer periods of time than would normally be permissible under the law. Robin Feldman, a law professor at UC Law SF and a leading researcher in intellectual property and patents, defines evergreening as "artificially extending the life of a patent or other exclusivity by obtaining additional protections to extend the monopoly period."
Heather Bresch is an American business executive. In 2012, she was named as the chief executive officer (CEO) of Netherlands-based pharmaceutical company Mylan, becoming the first woman to run a Fortune 500 pharmaceutical company. Bresch retired in 2020, upon the closing of Mylan’s combination with Upjohn. Bresch has been a central figure in two controversies: a 2007 accusation of inflating her resume with an unearned MBA degree, and as the CEO of Mylan during the 2016 controversy over pricing of the company's EpiPen products. In 2015, she was listed as #22 in Fortune magazine's “Most Powerful Women” list.
Some authors advocating patent reform have proposed the use of prizes as an alternative to patents. Critics of the current patent system, such as Joseph E. Stiglitz, say that patents fail to provide incentives for innovations which are not commercially marketable. Stiglitz provides the idea of prizes instead of patents to be awarded in order to further advance solutions to global problems such as AIDS.
Kirsten Gillibrand is the junior United States senator from New York and a member of the Democratic Party. Formerly a member of the United States House of Representatives from the generally conservative 20th congressional district, she was appointed to the Senate in 2009, representing a generally liberal state.
The Continuing Appropriations Resolution, 2014 is a bill that was introduced into the United States House of Representatives on September 10, 2013. The original text of the bill was for a continuing resolution that would make continuing appropriations for the fiscal year 2014 United States federal budget. Though versions of the bill passed each house of Congress, the House and Senate were not able to reconcile the bills and pass a compromise measure.
Cory Booker is the junior United States senator from New Jersey and a member of the Democratic Party. He was previously the 36th mayor of Newark from 2006 to 2013. Before that Booker served on the Newark City Council for the Central Ward from 1998 to 2002.
The Further Continuing and Security Assistance Appropriations Act, 2017 is a continuing resolution that extended fiscal year 2017 funding for the United States federal government from December 9, 2016 until April 28, 2017. The bill contains a boost to defense spending as well as bipartisan health programs.
The following is a list of plans which were considered to replace the Affordable Care Act during the Donald Trump administration. The plans were considered after the Republican Party gained a federal government trifecta in 2016. "Repeal and replace" has been a Republican slogan since March 2010 when the ACA was signed into law and had been adopted by former President Donald Trump.
The United States federal budget for fiscal year 2018, which ran from October 1, 2017, to September 30, 2018, was named America First: A Budget Blueprint to Make America Great Again. It was the first budget proposed by newly elected president Donald Trump, submitted to the 115th Congress on March 16, 2017.
Amy Jean Klobuchar is an American lawyer and politician serving as the senior United States senator from Minnesota. A member of the Minnesota Democratic-Farmer-Labor Party, Minnesota's affiliate of the Democratic Party, she previously served as the Hennepin County Attorney. She ran for the Democratic nomination for President of the United States in the 2020 election, before pulling out in March and endorsing Joe Biden.
The United States federal budget for fiscal year 2020 ran from October 1, 2019 to September 30, 2020. The government was initially funded through a series of two temporary continuing resolutions. The final funding package was passed as two consolidated spending bills in December 2019, the Consolidated Appropriations Act, 2020 and the Further Consolidated Appropriations Act, 2020. A series of supplemental appropriations bills was passed beginning in March 2020 in response to the COVID-19 pandemic.
The Elijah Cummings Lower Drug Costs Now Act is proposed legislation in the 117th United States Congress. The bill is designed to lower prescription drug costs in the United States. Notably, the law gives the federal government the power to negotiate prescription drug prices. The legislation takes the name of late Maryland Representative Elijah Cummings.
