The Importation Question
July 24, 2018
To import, or not to import? The question of whether to bring foreign, lower-priced versions of prescription drugs to the United States is back.
The Food and Drug Administration has announced plans for a working group to consider policy solutions to combat high drug prices – solutions that could include drug importation. The announcement came on the heels of several other Trump administration efforts to make prescription drugs more affordable, including the Department of Health and Human Services’ “American Patients First” blueprint and the FDA’s Biosimilars Action Plan.
The FDA envisions importation as a “short-term” response for worst-case scenarios, such as cases of “significant price increases” for drugs with little or no market competition. The move could help maintain patient access, the agency argues, until additional competition in the United States drives down prices.
But would it work? And would it help patients? The answers are unclear.
In 2016, before he was FDA commissioner, Scott Gottlieb, MD, explained that importation would require foreign facilities to either increase their production or redirect supply of the medication away from local distribution. Neither is a given.
He also noted that the scheme would require regulatory oversight to ensure that imported drugs are safe for patients. The costs of that regulation would undermine imported drugs’ potential to reduce overall expenses.
And patient safety concerns linger. Counterfeit drugs are on the rise, and regulators’ ability to ensure the safety of foreign drug manufacturing is limited. Notably, the FDA’s working group will also be tasked with enforcing laws against “unsafe and illegal drug products.”
The FDA wants to address high drug costs, but this proposal invites broader considerations about safety, access and consequences. Foreign drugs may be cheaper, but at what cost to patients?Tags: Biologics, Cost Value, Pharmacovigilance, Regulatory Issues
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