AAM Applauds Senate Bill to Protect Patient Access to Affordable Medicines
Skinny labels allow quicker market entry of generic and biosimilar competition, reducing prices across the healthcare landscape WASHINGTON (December 19, 2024) — Since the passage of Hatch-Waxman 40 years ago, skinny labeling has saved patients and the health care system billions of dollars. Today, the Association for Accessible Medicines, the leading trade association for generic […]
Congress Should Pass Legislation to End the Shenanigans That Allow Brand-Name Drug Manufacturers to Delay Generic Competition and Charge Higher Prices for Longer Periods
The history of pharmaceutical competition in the U.S., especially as it concerns competition from high-quality and lower-cost generic drugs, is littered with instances in which branded manufacturers have attempted—with some success—to delay the Food and Drug Administration’s (FDA’s) approval of generic drugs in an effort to maintain monopoly pricing of their own branded products. This […]
AAM Urges Congress to Pass Key Bills Considered by the Senate HELP Committee This Week
Congress encouraged to stop patent abuses and eliminate biosimilar misinformation WASHINGTON (September 24, 2024) — On the anniversary of the enactment of the Hatch-Waxman Act forty years ago today, the Association for Accessible Medicines and its Biosimilars Council today commended the slated mark up by the Senate Health, Education, Labor and Pensions Committee of two […]
Statement Regarding Senate Judiciary Committee Markup of the PREVAIL Act and the PERA Act
WASHINGTON, DC (September 13, 2024) — The Association for Accessible Medicines and its Biosimilars Council released the following statement concerning the upcoming markup of S. 2220, the PREVAIL Act, and S. 2140, the PERA Act in the Senate Judiciary Committee. The Association for Accessible Medicines and its Biosimilars Council oppose passage of the PREVAIL Act […]
AAM and the Biosimilar Council Host Patent Abuse Congressional Briefing: What’s Truly Preventing Low-Cost Medicines from Getting to Patients: A Look at the Broken Patent System
Letter sent to Congressional leaders Imploring Prompt Legislative Action WASHINGTON (September 10, 2024) — The Association for Accessible Medicines and its Biosimilars Council today hosted a policy briefing: What’s Truly Preventing Low-Cost Medicines from Getting to Patients: A Look at the Broken Patent System, for Congressional staff regarding ways to expedite patient access to lower-cost […]
The Hatch-Waxman 180-Day Exclusivity Incentive Accelerates Patient Access to First Generics
Congress should preserve – not limit – 180-day generic exclusivity Before the enactment of the landmark Hatch-Waxman Amendments in 1984,1 FDA generally required generic drug manufacturers to conduct human clinical trials and submit full marketing applications to obtain approval. Those requirements made it cost-prohibitive to develop lower-cost generic versions of previously approved brand drugs. Congress […]
GLAXOSMITHKLINE LLC and SMITHKLINE BEECHAM (CORK) LIMITED v. TEVA PHARMACEUTICALS USA, INC.
Unless corrected, the Federal Circuit’s ruling in GSK v. Teva widely threatens the ability of generic and biosimilar developers to deliver more affordable medicines to patients in as timely a manner as possible. View Brief
AAM Statement on The Protecting Access to Affordable Medicines Act
WASHINGTON, D.C. (April 29, 2021) — “The Association for Accessible Medicines endorses The Protecting Access to Affordable Medicines Act, which helps ensure patients maintain uninterrupted access to low-cost medicines by fixing the misguided application of the Medicaid rebate to generic medicines. We thank Representatives Butterfield (D-NC) and Long (R-MO) for introducing the act. We appreciate […]
Letter from AAM: Mr. President, Block the BLOCKING Act!
The Lower Health Care Costs Act, under consideration in both the House and Senate, includes a provision (Section 407 — the BLOCKING Act) that would significantly harm the competition that lowers prescription drug prices for America’s patients and taxpayers. AAM CEO Chester “Chip” Davis, Jr. wrote to President Trump to urge him to oppose the BLOCKING […]
AAM Statement on the Introduction of the Protecting Access to Affordable Medicines Act of 2020
WASHINGTON, DC (October 7, 2020) — The Association for Accessible Medicines (AAM) applauds U.S. House of Representatives members G. K. Butterfield (D-NC), Billy Long (R-MO) and Tony Cardenas (D-CA) for protecting patient access to affordable medicines by introducing bipartisan legislation to fix the misguided Medicaid penalty against affordable generics. The Medicaid Generics Penalty, as imposed […]
AAM Issue Brief: Inter Partes Review (IPR)
Inter Partes Review (IPR) Is Necessary to Lower Drug Prices by Ensuring that PTO Only Grants Patents that Reflect True Innovation The problem remains: patients are paying too much for brand-name drugs. Generic and biosimilar medicines are a proven solution to high drug prices and policies that continue to foster generic access are needed. Maintaining […]
White Paper (Part 1) Failure to Launch: Patent Abuse Blocks Access to Biosimilars for America’s Patients
As prescription drug costs continue to increase, biosimilar medicines represent hope for patients seeking access to more affordable treatment. Biosimilars are lower-priced versions of brand medicines used to treat debilitating and life-threatening diseases, such as Crohn’s disease, ulcerative colitis, cancer and psoriatic arthritis. Patients and physicians can rely on FDA-approved biosimilar medicines just as they […]
