AAM Statement on CBO CREATES Score
WASHINGTON DC (September 20, 2018) – “The Congressional Budget Office (CBO) has released its score, estimating that the CREATES Act would save taxpayers $3.9 billion by accelerating the use of more affordable generic and biosimilar medicines. By establishing a limited, legal pathway for generic and biosimilar developers to efficiently resolve disputes with brand drug companies […]
The 180-Day Rule Supports Generic Competition. Here’s How.
The Hatch-Waxman Act, signed into law by President Ronald Reagan in 1984, created a pathway for patient access to affordable medicines, balancing competition in the pharmaceutical sector with innovation and giving rise to the generic drug industry as we know it. As a result, the majority of brand drugs today face competition from lower-priced generic […]
Learn to manage the GDUFA landscape at our CMC Workshop
The FDA’s Office of Pharmaceutical Quality (OPQ) describes its mission as “the closer integration of review, inspection, surveillance, policy, and research for the purpose of strengthening pharmaceutical quality on a global scale,” with a motto of “One Quality Voice.” Every year, our Chemistry, Manufacturing & Controls (CMC) workshop helps participants to stay on top of the latest […]
FDA Approvals: Good News for Patients, More Work to Do (Part 2)
Continued from Part 1… We greatly appreciate the FDA’s efforts to increase the number of generic drug approvals and take action on applications in the backlog. What some people also might not understand is that not all generic medicines approved by the FDA make it to market. There are several reasons a company could decide […]
FDA Approvals: Good News for Patients, More Work to Do (Part 1)
We greatly appreciate the FDA’s efforts to increase the number of generic drug approvals and take action on applications in the backlog. In fact, the agency approved a record number of generic applications in 2017, including 843 full approvals and 184 tentative approvals. We also are very encouraged by FDA Commissioner Scott Gottlieb’s comments that he […]
AAM Position Paper: HHS 180-Day Exclusivity Proposal
Our position paper addresses the HHS FY19 Budget as released on Feb 19, 2018. AAM holds: The 180-day exclusivity provision is critical to promoting earlier entry of generic competition. The HHS proposal could reduce generic drug competition by undermining the main incentive for generic drug companies to challenge weak or questionable patents. The HHS proposal […]
FDA Meeting: Administering The Hatch-Waxman Amendments
Excerpts of Chester “Chip” Davis, Jr.’s Remarks WHITE OAK, MD (JULY 18, 2017) – Chester “Chip” Davis, Jr. CEO of the Association for Accessible Medicines, today testified before a panel of FDA officials considering the Hatch Waxman Amendments, specifically how to ensure the intended balance between innovation and access. On the Challenges Facing the Generic […]
AAM Applauds Nomination of Dr. Scott Gottlieb to Lead the Food and Drug Administration
Statement of Chester “Chip” Davis Jr., President and CEO of the Association for Accessible Medicines on the Nomination of Dr. Scott Gottlieb as Commissioner of Food and Drug Administration. (March 11, 2017) WASHINGTON, DC – “President Donald Trump’s nomination of Dr. Scott Gottlieb to lead the Food and Drug Administration signals he is serious about […]
