NEW YORK (WWTI) — The United Department of Health and Human Services and the Food and Drug Administration is working to make prescription drugs more affordable.
HHS and the FDA took action to make these drugs more safe, effective and affordable through the Safe Importance Action Plan.
The Plan allows states to import certain prescription drugs from Canada, fulfilling aspects of an Executive Order passed in July.
According to the FDA, the rule implements a federal law provision allowing FDA-authorized programs to import these drugs from Canada.
Drug manufacturers must follow guidance to import prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country.
Additionally, any state, including the District of Columbia and territories, tribes, pharmacists and wholesalers can submit importation program proposals to the administration for review. Any of the listed proposers can co-sponsor an importation program which will then manage the program.
These proposals will authorize the FDA to facilitate the importation of approved Canadian drugs, and meet the conditions of an FDA-approved drug application.
“Today’s action is an important part of FDA’s priorities to promote choice and competition. The Safe Importation Action Plan aims to clearly describe procedures to import drugs that would lower prices and improve access while also maintaining the high quality and safety Americans expect and deserve,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA will continue to assess and act on opportunities to increase competition in the prescription drug market and help reduce the cost of medicines.”
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