Posted 23 November 2015
By Zachary Brennan
The US Food and Drug Administration (FDA) should allow the importation of pharmaceutical products from Canada if they meet certain stipulations, Sens. Chuck Grassley (R-IA) and John McCain (R-AZ) wrote in a letter to Health and Human Services (HHS) Secretary Sylvia Burwell.
The senators call on FDA to “immediately” certify the importation of prescription drugs if they are off patent and are no longer marketed by the drug developer, if there are “significant and unexplained” price increases, if no direct competitor product is currently marketed and the introduction of a new drug will benefit US consumers, or if the drug is “produced in another country by the name brand manufacturer that initially developed the drug or by a well-known generic manufacturer that commonly sells pharmaceutical products in the United States.”
Drugs could also be imported from countries outside of Canada “with similar regulatory regimes related to drug approvals,” McCain and Grassley added.
As far as how FDA could go about allowing such imports, the senators point to the Medicare Prescription Drug, Improvement and Modernization Act of 2003 that allows FDA to permit pharmacists and wholesale retailers to import drugs from Canada.
They also say that with the targeted importation of certain products, FDA could limit the potential safety concerns that have been cited by the agency for a reason to not allow imports in the past.
FDA officials have previously raised questions about allowing the imports from countries like Canada because of the complexity of the pharmaceutical supply chain.
McCain and Grassley also said that if FDA believes it needs additional authority to authorize the use of Canadian drug imports, the agency should provide recommendations of what’s needed.
Grassley and McCain Letter