AAM white paper highlights generics savings, hurdles
A recent white paper from the Association for Accessible Medicines highlights the savings from generics and biosimilars — and highlights needed policy to keep the savings rolling. “Ensuring the Future of Accessible Medicines in the U.S.: Avoiding Shortages & Ensuring Competition for America’s Patients” notes that generics prices are headed downward faster than ever, with the prices they settle at also marking historic lows.
The paper also notes that continued savings are dependent on a lack of artificial barriers to entry coming from branded drug makers, as well as a regulatory environment that doesn’t make low-margin products unprofitable. Among the barriers that AAM identified were drug makers “gaming” Food and Drug Administration regulations to delay a generic from hitting the market, as well as using patents for existing drugs to delay entry and a lack of clarity from the FDA with regard to complex generics.
AAM also noted that there are real challenges to staying in the generics markets, with state regulations, Medicaid’s generics penalty, unincentivized generic use counting among the issues that generics makers face as price deflation continues.
As a result, the organization uses the paper to call for the enactment of legislation to stop regulatory gamesmanship, sustained regulatory focus on approving complex generics, modifying the Medicaid generic penalty and increased use of generics for Medicare patients with low incomes, among others.
“Patient health and well-being depend on the uninterrupted availability of lower-cost generic and biosimilar medicines,” the report says. “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.”
The paper also notes that continued savings are dependent on a lack of artificial barriers to entry coming from branded drug makers, as well as a regulatory environment that doesn’t make low-margin products unprofitable. Among the barriers that AAM identified were drug makers “gaming” Food and Drug Administration regulations to delay a generic from hitting the market, as well as using patents for existing drugs to delay entry and a lack of clarity from the FDA with regard to complex generics.
AAM also noted that there are real challenges to staying in the generics markets, with state regulations, Medicaid’s generics penalty, unincentivized generic use counting among the issues that generics makers face as price deflation continues.
As a result, the organization uses the paper to call for the enactment of legislation to stop regulatory gamesmanship, sustained regulatory focus on approving complex generics, modifying the Medicaid generic penalty and increased use of generics for Medicare patients with low incomes, among others.
“Patient health and well-being depend on the uninterrupted availability of lower-cost generic and biosimilar medicines,” the report says. “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.”