Four Former FDA Commissioners: Drug Importation to Reduce Costs is 'Complex and Risky'

Regulatory NewsRegulatory News | 20 March 2017 |  By 

As Congress looks to address the problem of rising prescription drug prices, four former US Food and Drug Administration (FDA) commissioners told members in an open letter from last week that importing cheaper medicines from Canada and elsewhere is "a complex and risky approach."

Former commissioners Robert Califf, MD, Margaret  Hamburg, MD, Mark McClellan, MD, PhD and Andrew Von Eschenbach, MD, write that although in some shortage cases, importation of generic drugs may be necessary, "none of us, acting in our roles as former FDA Commissioners, were able to conclude that a wider policy of routine importation would increase access to safe and effective drugs for the American public."

The position aligns the former commissioners with industry group PhRMA, which has warned of patient safety concerns and law enforcement burdens. And though other experts have contended that drugs approved by Health Canada and other regulators are no less safe or effective than US-approved ones, the bills introduced in March that would begin allowing such importations without providing any more funding to FDA or other federal agencies to track and evaluate the tweaks to the system.


One of the issues that the former commissioners point to is the tracking of such imports if there were safety or efficacy issues.

"Allowing importation of drugs purported to be manufactured overseas in FDA-inspected facilities and drugs purported to be manufactured domestically for export to other countries and reimported from those countries to the United States can not meet the requirements under the existing closed drug manufacturing and distribution system because the drugs could not be tracked and certified by the manufacturer," they write.

The burden on FDA and other federal agencies to ensure the safety of such products would also likely be high.

"Given the enormous volume and complexity of imports to the U.S., obtaining sufficient resources and expertise to screen and verify the authenticity of every product destined for American consumers presents enormous challenges," the former commissioners write.

"Even if spot-checking discovered a dangerous or counterfeit product, in the absence of the closed system currently in use, there would be no way to trace that product to its origin or intervene to protect other consumers before irreparable harm occurs… The FDA lacks the resources needed to oversee a major importation program. It is conceivable that if extraordinary new resources were allocated to the FDA, it might oversee a major program of drug importation. But there are many far more urgent priorities for FDA reform that would have much greater benefits for Americans, including more effective ways to improve access to safe drugs."



© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy