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.
A virtuous cycle of innovation and access has served as the foundation for our nation’s prescription drug market since the presidency of Ronald Reagan. When that market worked as Congress originally intended around the time of enactment of the Hatch-Waxman amendments in the 1980s, patients benefited from lifesaving new drugs; they maintained their health with generic medicines; brand drug makers recouped their investments, rewarded shareholders and were incentivized to discover new therapies and cures; and the makers of generics had thriving businesses.
WASHINGTON, DC (April 4) –
“The Association for Accessible Medicines (AAM) and our members who manufacture generic and biosimilar medicines are aligned with the president’s goal of lowering prescription drug prices for patients in the U.S.
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.
The landscape around us looks much different today than it did just one year ago. As our industry changes within the evolving pharmaceutical ecosystem, we must speak with one voice to drive home the message that a robust generic drug and biosimilars marketplace is necessary to sustain affordable health care.
Patient health and well-being depends on the uninterrupted availability of lower-cost generic and biosimilar medicines. Moreover, as patients live longer the importance of a robust and sustainable generic and biosimilar medicines industry becomes only that much more important. Policymakers must act quickly to ensure continued saving and market-based competition, as well as prevent shortages, for future availability of affordable medicines. This requires:
Association for Accessible Medicines is calling on Congress to take meaningful action to lower prescription drug costs with the Prescription for Savings. Patients win when market-based competition from FDA-approved generics and biosimilars deliver savings at the pharmacy counter.
To this end, we recommend these seven policy solutions:
AAM President and CEO Chip Davis testified before the U.S. House of Representatives Energy and Commerce Health Subcommittee December 13 at its hearing, “Examining the Drug Supply Chain.” The oldest standing legislative committee in the U.S. House of Representatives, this body is vested with the broadest jurisdiction of any congressional authorizing committee.
Association for Accessible Medicines files comments with FTC addressing buyer consolidation and anti-competitive tactics