AAM Commends Senate Q1/Q2 Bill Introduction
Saves more than $800 million over 10 years; brings lower-cost medicines to patients sooner WASHINGTON (April 4, 2025) — The Association for Accessible Medicines today commended reintroduction of Q1/Q2 legislation, S.1302 in the U.S. Senate. The bill was introduced by Senators Hassan of New Hampshire, Paul of Kentucky, Hickenlooper of Colorado, and Lee of Utah. […]
AAM Comments on staff layoffs at FDA
WASHINGTON (April 1, 2025) — The Association for Accessible Medicines today commented on staffing cuts at the Food and Drug Administration, including key personnel responsible for programs funded by user fees from generic and biosimilar manufacturers. “AAM is deeply concerned by reports that key officials within the FDA’s generic drug and biosimilar programs and officials […]
AAM Congratulates FDA Commissioner Makary
WASHINGTON (March 27, 2025) — The Association for Accessible Medicines today congratulated Dr. Marty Makary, MD, MPH on his confirmation as Commissioner of the Food and Drug Administration. “AAM and the Biosimilars Council congratulate Dr. Makary on his confirmation by the Senate as FDA Commissioner,” said John Murphy III, President and CEO of AAM. “Ensuring […]
AAM Statement on the Confirmation of Robert Califf to Lead FDA
WASHINGTON D.C. (February 15, 2022) – The Association for Accessible Medicines (AAM) congratulates Dr. Robert Califf on being confirmed to lead the U.S. Food and Drug Administration (FDA). AAM and its member companies stand ready to work with Dr. Califf to ensure America’s patients have timely access to safe, effective and quality generic and biosimilar […]
GDUFA Reauthorization: A Primer
To help ensure FDA continues to have sufficient resources to carry out its mission, Congress enacted the first Generic Drug User Fee Amendments (GDUFA) in 2012. GDUFA specifies various fees the agency sets and can collect from manufacturers, such as ANDA applications, Drug Master Files(DMF) and facility and program fees. In turn, the fees aid FDA’s […]
The Generic Drug User Fee Amendments (GDUFA III)
GDUFA aims to put FDA’s generic drug program on a firm financial footing by enabling FDA to assess user fees to fund critical and measurable enhancements to the performance of FDA’s generic drugs program, bringing greater predictability and timeliness to the review of generic drug applications. As a direct outcome, the generic drugs program has […]
The Unintended Economics of the BLOCKING Act
The Hatch-Waxman Act established an important incentive for generic drug manufacturers to challenge brand drug patents and bring lower-cost drugs to market. However, legislation known as the BLOCKING Act would significantly weaken the incentive for generics to challenge brand patents and delay patient access to more affordable generic medicines. Matrix Global Advisors conducted a study […]
AAM Reaction to FDA Statement on Patient Access to Generic Drugs
WASHINGTON DC (October 16, 2019) – The Food and Drug Administration (FDA) has made tremendous strides in recent years towards streamlining the approval process for high-quality and more-affordable generic drugs, and the Association for Accessible Medicines (AAM) and its members applaud the FDA’s staff and leadership for their work. That said, despite the FDA’s efforts, […]
35 Year Anniversary of Generic Medicines
On September 24, President Ronald Reagan signed the Drug Price Competition and Patent Term Restoration Act. Better known by the name of its two sponsors, Senator Orrin Hatch (R-UT) and Representative Henry Waxman (D-CA), the Hatch-Waxman Amendments gave rise to the modern generic pharmaceutical industry as we know it. “Fact is,” the president said, “it’s […]
Generic Medicines 35th Birthday Celebration
September 24 marked the 35th anniversary of President Reagan signing into law the Hatch-Waxman Amendments, which provided the framework for the modern generic drug industry and created the proper balance between innovation and access in the pharmaceutical ecosystem. To celebrate this important day, AAM handed out over 1,500 custom-made Georgetown Cupcakes on Capitol Hill. AAM […]
Happy Birthday, Generic Prescription Drugs: 35 Years of Competition
It was September 24, 1984. Amadeus, Places in the Heart and Irreconcilable Differences were playing in theaters, and the number one song in America was John Waite’s “Missing You.” The New York Mets’ Dwight Gooden had just broken the rookie strikeout record, though the rival Chicago Cubs ended up taking the National League East that […]
AAM Statement on FDA Record Generic Approvals
WASHINGTON DC (October 11, 2018) – We appreciate the efforts of the FDA, under the leadership of Commissioner Gottlieb, to lower overall drug prices by seeking to increase the number of generic drug applications on an annual basis. It is important however to recognize that in the current U.S. health care system more generic approvals […]
