Action from the U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) has been challenged by the Pharmaceutical Research and Manufacturers of America (PhRMA), Partnership for Safe Medicines (PSM) and Council for Affordable Health Coverage (CAHC) for letting drugs from Canada into the country without the authorization of manufacturers' oversight.
“It is alarming that the administration chose to pursue a policy that threatens public health at the same time that we are fighting a global pandemic. FDA has noted it is struggling to keep up with approving medicines while working around the clock to support COVID-19 therapeutics and vaccine development. Despite this, the administration is willing to divert precious FDA resources away from these efforts and to expose Americans to the risks that come with drug importation schemes," PhRMA Executive Vice President and General Counsel James Stansel said in a press release from PhRMA.
He said it's "disturbing" that the administration would allow the drugs into the country without making sure they don't pose a risk to public safety.
"In fact, the Final Rule fails to overcome the well-documented safety concerns regarding importation expressed for nearly two decades by previous HHS Secretaries across party lines or to make any showing that the proposal would result in any—let alone significant—cost savings to American consumers. The bottom line is that the administration has violated federal law by proceeding without proper certification and, in doing so, is putting the health and safety of Americans in jeopardy," Stansel said in the press release.
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