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.
This week, the Trump administration formally announced support for not only state prescription drug importation programs, but also HHS Secretary Alex Azar’s own importation plan. Until this week, it was known that Trump had instructed Secretary Azar to work with Republican Governor Ron DeSantis of Florida to help implement its new law to permit wholesale drug importation from Canada for public payers, which also includes importation from other countries for the private market. Now, there is real movement.
Before diving into Trump’s drug importation plan more fully, please take note that this plan actually allows for the importation of what the FDA has called “foreign unapproved drugs,” ones that they have said they don’t want Americans ordering online and importing for their own use. These drugs, as explained below, are safe and effective foreign brand versions of the same drugs sold here. This recognition of equivalent brand drug safety is a step in the right direction.
Earlier this week, a report (the
“FGI Report”) opposing prescription drug importation proposals was released
by the law firm of Freeh, Sporkin and Sullivan LLP and the Freeh Group International.
Both organizations are headed by former FBI Director, Louis Freeh. I’m hesitant
to criticize reports authored by dedicated Americans who spent years in public
service protecting the safety of the American people in federal law enforcement.
On the other hand, the intent of tacking the name of a venerated American
patriot on a report that mirrors
the lobbying agenda of the pharmaceutical industry is clearly being used to
deter voices opposed to that agenda.