The Campaign for Personal Prescription Importation (CPPI) calls on the Food and Drug Administration (FDA) to clarify personal importation regulations in wake of Commissioner Robert Califf, M.D., M.A.C.C., comments on State prescription drug importation plans, on Friday, April 29.
“Approving a pathway for Americans to personally import safe and affordable medicines directly from licensed Canadian pharmacies is the only way for Americans to receive immediate, much-needed relief from the devastating high costs of prescription drugs,” says Jack Pfeiffer, CPPI executive director. “The FDA and HHS should certify that medications imported from licensed Canadian pharmacies clearly meet the standards for significant consumer cost savings and pose no risk to public health.”
During a conference for the Association of Healthcare Journalists (AHJ), on Friday April 29, in Austin Texas, Califf was asked whether he wants to see the FDA let states import drugs from Canada. Califf declined to say whether he still feels skeptical about wholesale importation now that he serves as FDA Commissioner, and he did not address the future of personal importation, which millions of Americans take advantage of every day, resulting in millions of dollars of direct consumer savings. The question referred to the FDA’s April meeting with five states — Florida, Colorado, Vermont, Maine and New Mexico — which are asking for permission to advance wholesale importation. Florida for example has proposed bulk importation of a short list of medications that would be for institutional use, a plan that would likely have no direct benefit to the general public.
“My opinion is irrelevant. We have a law and a rule and that’s what we will go on,” said Califf at the AHJ Conference. “The FDA is like a referee and the referees go by the rulebook. If a state meets the criteria that are in the rules, we’ll act quickly to approve them … and come up with a system that goes by the criteria laid out not by me but by my predecessors.”
Califf indicated that the FDA will judge State Importation Plans by the standards it set out in the Administration’s Comprehensive Plan for Addressing High Drug Price and the 2020 importation regulation, according to Politico reporter, Alice Miranda Ollstein and StatNews reporter, Nicholas Florko.
“The truth is that only personal importation, which avoids use of pricey middlemen and layers of bureaucracy, can deliver savings for Americans, particularly those on fixed incomes,” says Jack Pfeiffer, executive director of the Campaign for Personal Prescription Importation (CPPI).
CPPI has long argued that wholesale would have the unintended consequence of cutting Americans off from the licensed pharmacies on which they depend. State wholesale importation plans add pricey middlemen that cut into patients’ proposed savings. The state wholesale importation plans are laden with extensive requirements that add layers of bureaucracy, which would take years to implement. Moreover, there is extensive opposition to State and tribal wholesale importation programs. Canadian regulatory restrictions, federal approval, and legal challenges remain obstacles for state wholesale importation programs to become operational.