AAM applauds Senate Judiciary Committee efforts to protect patients, skinny labeling
The Association for Accessible Medicines, 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 recently.
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 healthcare system.
The statement reads, “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."
[Read more: Challenges continue, but generics companies see a bright future with biosimilars]
The statement continues, "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 healthcare system and looks forward to working with the Committee on these important issues.”