PhRMA’s Lawsuit Against Section 804 Ignores Statute’s Permissive Position on Personal Importation
In its lawsuit to stop wholesale drug importation programs that could help lower U.S. drug prices, the Pharmaceutical Researchers and Manufacturers of America (PhRMA) may be stepping on its toes in helping to allow more personal drug importation. Last month, along with co-plaintiffs Partnership for Safe Medicines (PSM) and Council for Affordable Health Coverage (“CAHC”), PhRMA sued the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) to invalidate the certification by the HHS Secretary Alex Azar that drug importation from Canada is safe and will achieve savings for the American consumer.
In late September, Secretary Azar, in a final rule, certified that importing drugs from Canada, subject to Section 804 of the Food, Drug and Cosmetic Act (Section 804), 21 U.S.C. 384, Part L, poses “no additional risk to the public’s health and safety” and will “result in a significant reduction in the cost of covered products to the American consumer.” Those were the two certifications needed to allow a new wholesale drug importation channel.
Section 804 clearly distinguishes between wholesale (“commercial”) importation (subsections b-h) and personal importation (subsection J). As explained below, the standard for allowing personal importation is different. While PhRMA does not want either wholesale or personal importation to lead to lower drug prices, certain legal arguments it employs in its lawsuit may help the cause of expanding personal drug importation. Namely, personal drug imports can be permitted if they don’t pose an “unreasonable risk” to the patient; not so for wholesale imports (drugs that are resold). PhRMA ignores this.
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