Submits formal statement for the record for hearing on drug pricing in support of proposed protections to ensure patients have access to safe and affordable generic medicines and biosimilars
WASHINGTON (May 21, 2024) — The Association for Accessible Medicines, the leading trade association for generic and biosimilar manufacturers, and the Biosimilars Council, a division of AAM, submitted a formal statement for the record for the Senate Committee on the Judiciary hearing on drug pricing held today. AAM applauds and thanks the Committee for its efforts to provide a safe harbor for skinny labeling and supports legislation being considered by the Senate Judiciary Committee that will protect patients and the health care system. The full statement is linked below.
“The Association for Accessible Medicines and its Biosimilars Council greatly appreciate the work of the Senate Judiciary Committee in seeking to find broadly agreed upon ways to expedite access to generic and biosimilar medicines. As AAM notes in its full written statement, we support legislation being considered by the Senate Judiciary Committee that would provide a statutory safe harbor for generic companies using the well-established skinny labeling regime that ensures that a patented method of using of a drug will not block all generic competition on that drug. Since the passage of the Hatch-Waxman Amendments, skinny labels have expedited access to lower-cost generic medicines—generic medicines that save patients and the health care system billions each year. The legislation—which is part of the Food and Drug Administration’s FY2024 budget proposals—would reverse a mistaken decision by the U.S. Court of Appeals for the Federal Circuit which, according to the federal government, ‘threatens significant harm to competition and to consumers.’ AAM applauds the Senate Judiciary Committee’s effort to protect patients and the health care system and looks forward to working with the Committee on these important issues.”
For media inquiries, contact the Communications department at media@accessiblemeds.org.
About AAM
The Association for Accessible Medicines, your generics and biosimilars industry, is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers of finished generic pharmaceuticals and biosimilars, manufacturers of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 17.5 percent of total drug spending.
About the Biosimilars Council
The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.
