The FDA has drafted a proposed rule to facilitate wholesale importation of lower-cost drugs from Canada, pursuant to Section 804 of the Food, Drug and Cosmetic Act. Importation from Canada is legal under this section of U.S. law, but only if the Secretary of Health and Human Services (HHS) certifies, as stated in Part L, that such importation would pose “no additional risk” to the public and would help save the American consumer money. It’s a major milestone that the FDA is willing to and on the cusp of finally providing that certification – but that’s only for wholesale importation. What about personal drug importation? Wholesale drug importation is when people or companies import drugs for re-sale, usually described as commercial quantities. Personal drug importation is when a consumer fills a prescription in Canada or another country and imports it either carrying it across the border or through the mail.
Section 804, as clearly stated in Part J (1), treats personal drug importation differently, and this is of paramount importance for policymakers and the general public to understand. Section 804 doesn’t legalize it across the board but affirms that Americans should be permitted to import prescription drugs for personal use, as long as it doesn’t represent an “unreasonable risk” to the patient. This more liberal standard is fundamentally different from Part L of Section 804, which mandates “no additional risk” to the public health, the standard necessary for the overall section to become effective. Where does that leave us in terms of law and policy?
In FDA’s proposed rule last week, as I see it, the agency implied they are required to do something affirmative to “implement” the personal importation provisions of Section 804, which are found in Part J, in order to make them effective. I’m no stranger to this thinking. Prescription Justice, the organization I founded, published a whole paper on this very topic, recommending that the Trump administration use its executive authority to permit personal importation under Section 804. However, the language of this statute already tells the FDA what it “should” do even in the absence of any type of implementation: permit Americans to import lower-cost medicine.
In its proposed rule – and in its announcements over the past 18 months relating to drug importation – the agency is clearly not creating rules for personal drug importation. Nonetheless, the agency essentially admitted in the proposed rule that millions of Americans are compelled to import medicines for personal use because of lower prices in other countries. The FDA states:
“Contributing to public frustration on this issue is the disparity between prices that Americans pay for brand name medications as compared with other developed countries…For instance, in 2017, Canada’s Patented Medicine Prices Review Board (PMPRB) found that patented medicines (i.e., drug products to which patents apply) cost on average three times more in the United States than Canada (Refs. 15 and 16). As a result of these price differentials, some American consumers have sought to import drugs from other countries in an effort to obtain treatments that may be otherwise inaccessible to them because of cost. According to a national poll, millions of Americans have purchased prescription drugs from other countries (Refs. 17 and 18).”
The FDA’s recognition of the benefits of personal drug importation is itself a step in the right direction. Still, the proposed rule states: “FDA is not proposing to implement the personal importation provisions in section 804(j) through this rulemaking.” As I’ll explain, the FDA could implement new personal drug importation rules – but the fact that it’s choosing not to do so doesn’t weaken the importance of Part J, which already protects Americans who choose to import medicine for personal use from enforcement actions against them.
Part J is broken up into three subparts. In summary:
J(1) articulates Congress’ position that the FDA should allow personal importation and not take enforcement actions against it accept where there’s a “significant” threat to the public.
J(2) stipulates that the FDA can permit personal imports with specific waivers or by general regulation.
J(3) is specific to Canada and basically tells the FDA to permit personal importation from licensed pharmacies that require a valid prescription.
Below, you’ll find part J in its entirety with my quick analysis/reiteration under each subpart in bold.
“(j)Waiver authority for importation by individuals
(1) Declarations. Congress declares that in the enforcement against individuals of the prohibition of importation of prescription drugs and devices, the Secretary should—
(A) focus enforcement on cases in which the importation by an individual poses a significant threat to public health; and
(B) exercise discretion to permit individuals to make such importations in circumstances in which—
(i) the importation is clearly for personal use; and
(ii) the prescription drug or device imported does not appear to present an unreasonable risk to the individual.
Don’t take people’s personal prescription drug imports away from them or take other kinds of enforcement against them even if the import violates federal law.
(2) Waiver authority
(A) In general
The Secretary may grant to individuals, by regulation or on a case-by-case basis, a waiver of the prohibition of importation of a prescription drug or device or class of prescription drugs or devices, under such conditions as the Secretary determines to be appropriate.
(B) Guidance on case-by-case waivers
The Secretary shall publish, and update as necessary, guidance that accurately describes circumstances in which the Secretary will consistently grant waivers on a case-by-case basis under subparagraph (A), so that individuals may know with the greatest practicable degree of certainty whether a particular importation for personal use will be permitted.
Through general guidance or in specific cases, the Secretary can waive importation prohibitions to permit imports of drugs by patients.
(3) Drugs imported from Canada. In particular, the Secretary shall by regulation grant individuals a waiver to permit individuals to import into the United States a prescription drug that—
(A)is imported from a licensed pharmacy for personal use by an individual, not for resale, in quantities that do not exceed a 90-day supply;
(B)is accompanied by a copy of a valid prescription;
(C)is imported from Canada, from a seller registered with the Secretary;
(D)is a prescription drug approved by the Secretary under subchapter V;
(E)is in the form of a final finished dosage that was manufactured in an establishment registered under section 360 of this title; and
(F)is imported under such other conditions as the Secretary determines to be necessary to ensure public safety.”
The Secretary will create regulations specifically to permit personal drug importation from Canada.
To sum up my main point here: Subpart 1 is Congress’s declaration on its position about personal drug importation. So, when the FDA wrote that it’s not implementing “Part J” – the agency must have meant subparts 2 and 3. Also, the fact that certifications under Part L, which really focus on legalizing wholesale importation, have yet to be made doesn’t detract from the law’s overall position on personal imports, which admittedly is ironic: the FDA should allow people to break the law by using its “enforcement discretion” to permit personal drug importation.
As the agency gets closer to providing certification under L, even if it’s only focused on legalizing wholesale drug importation, Part J should be getting a lot more attention. And the FDA knows that and apparently, while noting the millions of Americans who already buy lower cost medicines from other countries, doesn’t want that attention to be too favorable.
In the proposed note, the agency implies that the Internet is the reason it’s not implementing J. It raises the problem of “rogue online pharmacies” that sell drugs at “deeply discounted prices.” That is a problem. Rogue online pharmacies could be viewed as a public health threat. But, again, as the FDA admits, much lower pharmacy prices in other countries are the reason Americans already access them. Those pharmacies aren’t rogue. They are just not based in the U.S. And of course that’s where we come in: the online pharmacies accredited by PharmacyChecker are properly vetted and proven to sell drugs that are approved by the FDA or lawful, foreign versions of FDA-approved drugs and require valid prescriptions.
After identifying the problem of rogue online pharmacies, instead of focusing on the tens of thousands of unverified and dangerous online pharmacies out there, such as those that don’t require a valid prescription and sell opioid drugs, the FDA brings up Canada Drugs to defend the agency’s position against personal drug importation. It states:
“Canada Drugs Ltd. (“Canada Drugs”) was an internet-based pharmacy corporation located in Winnipeg, Manitoba, Canada, which purchased drugs from questionable sources that were outside FDA’s closed supply chain (Refs. 21 and 22).”
The reason Canada Drugs, Ltd. was brought up is because they got busted for illegal drug importation, which included two counterfeit batches of Avastin; but the irony is overwhelming here: Canada Drugs, Ltd., was prosecuted for illegal wholesale drug importation, not for personal drug importation. Its consumer-facing, retail online pharmacy, CanadaDrugs.com, was never found to have sold a bad drug after processing millions of prescription orders over almost 20 years. Per the guilty pleas of its owners, through various wholesale subsidiaries and partners, the company, between 2007-2011 was distributing wholesale quantities of drugs into the U.S., in violation of federal law. It was within those wholesale supply chains that two batches of counterfeit Avastin were distributed in the U.S. While that prosecution was not about personal drug importation, as part of the plea deal, Canada Drugs, Ltd, agreed to forfeit its retail online pharmacy.
In considering the FDA’s statements about personal drug importation in the rule and its narrative on Canada Drugs, please read What Really Happened With CanadaDrugs.com.
One point to close with is to note that CanadaDrugs.com was allowed to continue operating for three months after the plea deal, which meant exporting medicines into the U.S. to American patients who imported them. Apparently, the FDA allowed this transition period because it recognized that American customers of CanadaDrugs needed a heads up that the online pharmacy would be closing. That permission to import for personal use seems to be recognition by the FDA that such imports are not an “unreasonable risk” to the importing consumers. Any other way of looking at it would be…unreasonable.