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.

The final rule identifies in detail the parameters of authorized importation. In summary: wholesale imports of qualified drugs by non-federal entities, such as states and tribes, subject to meeting safety requirements found in Section 804, who have submitted proposals that meet the requirements, are now allowed.

In contrast, the rule stated that it was not implementing personal drug importation provisions of Section 804. The main reason for not doing so, according to the proposed rule, is safety threats from rogue online pharmacies. While evidence shows that prescription drugs ordered from safe international online pharmacies help Americans save money, rogue sites are a real threat. I wish the Secretary had made the distinction, but that’s beyond the scope of this post.

PhRMA argues that Section 804 does not allow the Secretary to permit wholesale importation but neglected to make the same assertion in relation to personal drug importation. The court filing reads:

“Section 804(l)(1) precludes the Secretary from certifying only commercial importation, but not personal importation. By its terms, Section 804(l)(1) requires the Secretary to certify that ‘implementation of this section’ will satisfy the safety and cost criteria in subparagraphs (A) and (B). Secretary Azar did not certify “implementation of this section” but only commercial importation under subsections (b) through (h).”

To this point, Section 804 does not go into effect without the certifications on safety and savings for wholesale and personal importation. PhRMA’s point appears to be that even if wholesale importation did meet the safety threshold (which it argues it does not) required under Section 804, personal importation has to as well. And because it doesn’t, according to the PhRMA, none of Section 804 can effective. Here is where PhRMA fails to mention the different safety thresholds identified in Section 804 between wholesale and personal importation.

Unrelated to the wholesale drug importation provisions of Section 804, Part J states that personal importation, based on enforcement discretion, should be allowed as long as the import does not pose an “unreasonable risk” to the patient. In other words, it doesn’t make personal importation expressly legal like wholesale importation; it permits otherwise illegal importation for individuals.

I believe this part of the law has always been effective in terms of expressing the will of Congress even in the absence of the Secretary’s certification under Part L. However, now that the Part L certifications are satisfied, at least according to PhRMA, Part J, permitting otherwise illegal imports for personal use only, must be in effect.

When Congress passed this law, it recognized that Americans may not be able to afford prescription drugs domestically and should be able to buy them from another country. It set up a standard allowing consumers a fair degree of choice and told the FDA that the standard for its enforcement activity should be stopping an import that is an “unreasonable risk” to the individual. That risk is separate from risks to the “public’s health” from larger-scale, wholesale imports. If Congress wanted there to be “no additional risk” to individuals who import for their own use, then it could have said so.

The thing is that imports for personal use from licensed pharmacies in Canada and many other countries that require valid prescriptions are very safe, not to mention not an “unreasonable risk”. There’s a clear case to be made that Americans should feel emboldened to import prescription drugs for personal use now that Section 804 is in effect, at least according PhRMA!

For those who choose to import lower-cost prescription drugs, and order them online, make sure to stay safe by only ordering from credentialed international online pharmacies.