As reported in Kaiser Health News, the personal drug importation cause had a little victory recently. A bill focused on the opioid crisis, H.R. 6, slated for final passage, includes language that is protective of individuals who import medicines for their own use, even illegally.
H.R. 6 reforms drug importation laws that have nothing to do with opioids but empowers the FDA to stop imports of prescription drugs considered by the FDA to be misbranded (which can mean prescription drugs that have a Canadian not U.S. label). Those reforms will make it more difficult on people and business engaged in illegal, wholesale prescription drug importation. An earlier version of H.R. 6, from the House, included language that exempted imports for personal use. That language was quietly removed in a Senate version, which passed in that chamber. Then, apparently there was some protest among certain members of Congress and the language was put back in during conference – and is now in the final law.
Now I’m getting a lot of questions about the law and personal drug importation. There are several parts of law, regulation and policy very favorable to personal (but not wholesale) importation, which have yet to be compiled and addressed in one article. I endeavor to do that here. The gist is that Congress doesn’t want the FDA to unnecessarily stop Americans from buying medication from Canada and many other countries – even if it’s technically illegal. The position of Congress is clear in law if you look comprehensively and closely.
What is personal drug importation?
Personal drug importation is the practice of individuals buying a medicine from a pharmacy in another country and importing it for their own use (not re-sale). For millions of Americans, personal importation has been a lifeline of savings for decades due to lower drug prices in Canada and other countries. Detractors of the practice say it’s not safe due to counterfeit and substandard drugs, but most of these people are getting paid directly or indirectly from pharmaceutical companies.
The fact is, and commonsense dictates, that importing medicine from licensed pharmacies with high quality medicines in other countries is exceedingly safe. Despite the best interest of public health, personal importation is under most circumstances technically illegal. However, within the law and regulations, personal importation is clearly recognized as permissible and even necessary under certain circumstances, including because of cost.
This post identifies and discusses those parts of law, regulation and practice that are strongly in favor of personal drug importation.
FDA’s Personal Drug Importation Policy
It’s not uncommon for advocates, or even opponents, of personal importation to cite the U.S. Food and Drug Administration’s Personal Importation policy in explaining that the FDA essentially permits personal importation. See FDA’s Coverage of Personal Importation. While this policy does not (and cannot) make personal drug importation legal, it generally allows FDA employees to not enforce the law when it comes to stopping imports of small quantities of medicine that will not be resold and do not represent a serious risk to the importer, who is the patient:
“FDA personnel may allow entry of shipments when the quantity and purpose are clearly for personal use, and the product does not present an unreasonable risk to the user.”
By itself, that language is very open-ended and that’s what Congress wants. However, the FDA provides narrower guidance, going beyond what Congress called for and in ways that are wrongly used by personal importation opponents.
The FDA’s policy states that the enforcement discretion given to its personnel “should not be interpreted as a license to individuals to bring in such shipments.” Since this is simply guidance, the use of the word “license” must only be a reminder to FDA personnel tasked with enforcement that permitting imports doesn’t make it legal.
The policy then goes on to specify imports for which the FDA may use its enforcement discretion. FDA personnel “may consider a more permissive decision” when:
1) the product’s use is clearly identified and not for treating a serious condition and the product is not known to “represent a serious health risk;”
2) the intended use is unapproved and for a serious condition for which there are no available domestic treatments;
the people selling the drug didn’t promote it to the individual;
the product doesn’t “represent an unreasonable risk”; and
the patient attests in writing that the drug is for personal use only and provides the name and address of the licensed healthcare provider responsible for treatment.
This policy describes how the FDA uses enforcement discretion to allow imports for personal use of medicines that are otherwise illegal. Enforcement discretion is when a federal agency decides on a case-by-case basis or through regulation not to enforce the law, but it does not change the law, which can only be done by Congress.
This guidance on specific conditions for permitting illegal imports, namely for unapproved drugs that are not available in the U.S., does not mean that the FDA can’t permit an otherwise illegal import due to cost. The language of the law very specifically allows the FDA to use enforcement discretion to permit any type of personal drug importation that does not represent an unreasonable risk to public health.
Prescription Drug Import Fairness Act of 2000 – Section 746
The Prescription Drug Import Fairness Act of 2000 was passed into law as Section 746 of an appropriations bill for the FDA and other agencies in 2000 (H.R. 4461). In this law, Congress articulates these findings:
“Patients and their families sometimes have reason to import into the United States drugs that have been approved by the Food and Drug Administration (“FDA”).”
This is not about Congress’ intent but its position on personal drug importation. These findings were identified because some Americans who imported medication because of cost were receiving letters from the FDA —instead of their prescription order— which “failed to inform the individual of the reasons underlying the decision to send the notice.” In Section 746, Congress instructs the FDA that it must provide “to the individual involved a statement of the underlying reasons.”
The language is specific to individuals importing for personal use, not people in the business of importing and/or reselling prescription drugs. It appears that this law is the basis for the letters currently sent by the FDA to patients when they refuse an import. It forces the FDA to give them an explanation. The FDA must find that the drug “appears to be adulterated, misbranded” or “otherwise in violation of Federal law.”
The contradiction between Congress’ position on personal importation and the law is clear. It is inconsistent with good policy-making to assert that Americans have reason to import medicine for their own use, yet the action is technically subject to prosecution, including fines and jail time.
The language of Section 746 is found in the notes of Section 801 of the Food, Drug and Cosmetic Act (U.S. Code 381), the main statute governing imports and exports. Generally, Section 801 states which drug imports are allowed (801a). It also includes what is famously known as the ban on re-importation, which notably excludes manufacturers, who can reimport their own drugs (801d). The United States imports – legally – many if not most of the medicines sold in U.S. pharmacies in accordance with Section 801, a process controlled almost entirely by pharmaceutical companies.
That system, which does help keep substandard or counterfeit drugs out, also blocks access to more affordable high-quality drugs, and is one of the reasons we’re in a crisis of high drug prices. What speaks volumes in favor of personal importation is that, at the end of the statute governing drug imports and banning reimports, are notes to articulate Congress’ position that Americans have reason to import for personal use, despite the prohibitions.
The Medicine Equity and Drug Safety Act of 2000 – Section 745 (MEDS Act)
The Medicine Equity and Drug Safety Act of 2000 (MEDS Act) was also passed into law as part of H.R. 4461. You’ll notice that it comes right before Section 746, discussed above. The MEDS Act amended the law to make importation of lower-cost medicines legal from several high-income countries (Australia, Canada, Israel, Japan, New Zealand, Switzerland, or South Africa; or countries of the European Union), ones known to have adequately strict pharmaceutical drug safety regulations, but only if the Secretary of Health and Human Services (HHS) certifies that such importation poses “no additional risk” to the public’s health and the new importation would result in “significant savings.” No HHS Secretary has done so, however.
The MEDS Act envisioned an elaborate regulatory framework to create new wholesale channels for safe importation of medications for re-sale. It is language that comes in the findings of the Act and what is absent from the Act that is relevant to personal importation and our discussion.
Notable findings from the MEDS Act, 3-5:
“(3) Many life-saving prescription drugs are available in countries other than the United States at substantially lower prices, even though such drugs were developed and are approved for use by patients in the United States.
(4) Many Americans travel to other countries to purchase prescription drugs because the medicines that they need are unaffordable in the United States.
(5) Americans should be able to purchase medicines at prices that are comparable to prices for such medicines in other countries, but efforts to enable such purchases should not endanger the gold standard for safety and effectiveness that has been established and maintained in the United States.”
That these findings and this section come right before Section 746 further demonstrates the extent to which Congress recognizes that Americans are buying medications outside the country because of the lower cost on the same products sold here. Yet the MEDS Act does nothing to expressly allow personal drug importation, such as buying medication directly from a pharmacy in Canada. It instead seeks to bring those lower prices to U.S. pharmacy wholesalers. That explains why Congress viewed Section 746 as necessary: there’s reason for Americans to import medicines for personal use.
Medicare Modernization and Improvement Act of 2003 – Section 1121
The legislation that gave birth to a pharmacy benefit in Medicare, or Part D, also included changes to the law that affect importation. Section 1121 (U.S. Code §384). Much of Section 1121 is similar to the MEDS Act, except for three key features:
One, a new Section 804 would only make it legal to import lower-cost medicines from Canada, whereas MEDS listed several countries.
Two, it makes personal drug importation from Canada expressly legal.
Three, it allows the Secretary of Health and Human Services to permit personal importation on a case-by-case basis or through regulation. There are no limitations on Congress’ license to the Secretary to permit such importation.
Congress declares that enforcement against individuals involving drug importation prohibitions should:
“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.”
Like in the MEDS Act, it appears that for the new importation regulations to go into effect, the Secretary needs to certify “no additional” safety risk. Upon a close read, you’ll notice two competing safety standards within this section, which are subject to debate. Part (l) states that the Section doesn’t become effective unless the Secretary certifies that implementation will:
(A) pose no additional risk to the public’s health and safety; and
(B) result in a significant reduction in the cost of covered products to the American consumer.
This could be used to argue that the entire section is meaningless without such certification, but that doesn’t make sense. Congress was clear in its instruction to the Secretary to permit personal imports that do “not appear to present an unreasonable risk to the individual” not “pose no additional risk”. The latter, stronger, standard, clearly applies only to the new regulations in that section that affect lawful wholesale and personal imports from Canada, not personal drug imports permitted through “enforcement discretion.” What else explains Congress’ specific carve out for “enforcement discretion” on personal drug importation?
Customs and Border Patrol Cannot Use Funds to Stop Personal Imports Carried by Patients
For several years, a provision has usually been included in Homeland Security appropriations bills that prohibit funds from going toward preventing individuals from importing medicine for personal use.
The imports must be FDA-approved drugs: those would include medications made in the U.S. and those made in foreign manufacturing plants registered with FDA, which are also sold in the U.S. However, many generic drugs and foreign versions of FDA-approved drugs would not technically be allowed under this policy.
This is yet another example of Congress siding with patients on personal importation.
What about Law Enforcement? No prosecutions for personal importation by patients.
No one has ever been prosecuted for importing small quantities of prescription medicine for their own use. However, the statute covering illegal drug importation includes fines and jail time. For importing a misbranded drug, the penalty is up to one year in jail and a $1000 fine [21 U.S. Code § 333 a1].
Recall that a misbranded drug could be any FDA-approved drug that does not have the U.S. label. There is no carve out for personal or wholesale importation within the law. So, it could apply to wholesale quantities of misbranded drugs with a plan to resell those drugs domestically; or a person who imports a misbranded blood pressure medicine from Canada by mail. Generally, these would be medicines manufactured outside the U.S. [21 U.S. Code § 333 a1]
The penalty for reimporting a drug is much harsher: the guilty party “shall be imprisoned for not more than 10 years or fined not more than $250,000, or both” [21 U.S. Code § 333 (b)(1)(a)]. Again, there is no qualification about quantity, personal or wholesale importation.
People and businesses have been criminally prosecuted for illegal wholesale importation, including jail time. This includes instances where counterfeit drugs were found, but also where there were no problems with the medication in terms of safety; just that the medicines were misbranded and sold within the U.S.
People who import medicine for personal use “get caught” thousands of times per year when the FDA refuses an import at an international mail facility. The importers are warned that the drug is misbranded, unapproved, or reimported. With tens of millions of Americans having imported medicines for their own use, no one has ever been prosecuted. Why?
It’s the general assumption that the FDA would never investigate and recommend for prosecution a patient for illegal personal importation because it would be unethical, and the politics would be awful. It’s also possible that a grand jury would never agree to indict someone for personal drug importation. I believe those are both true.
A potentially more important reason is that Congress has made clear that Americans have reason to import medicines because prices are too high here and that enforcement should focus “on cases in which the importation by an individual poses a significant threat to public health.” [U.S. Code 384 (J)]. Public health means the health and safety of the general public to which a personal drug import cannot pose a significant threat.
Section 708 Not Protective of Personal Importation but Due Process is Invoked
Section 708 of the Food and Drug Administration Safety and Innovation Act of 2012, gave the FDA greater latitude to destroy drug imports that appear to be adulterated, counterfeit, unapproved or misbranded, which are valued at $2500 or less. That is not an example of Congress protecting importation for personal use. However, in Section 708, Congress requires that the FDA give people “due process” to defend such personal quantity imports before such drugs are destroyed.
Against the grain of my general argument about Congress’ support for personal drug importation, Section 708 is mostly a victory for the pharmaceutical industry, which does not want a tolerant position on personal drug importation. To date, however, it has not been used by the FDA to significantly ramp up refusals of personal drug imports, although it could with greater resources now appropriated to the FDA to stop illegal imports of fentanyl and other opioid drugs.
Section 3022 (b) of the Opioid Bill of 2018
October 2018: H.R. 6, “Substance Use–Disorder Prevention that Promotes Opioid Recovery” also called “Treatment for Patients and Communities Act” or the “SUPPORT for Patients and Communities Act”, goes to the president for signature. It contains explicit language to deter enforcement actions related to personal importation.
Section 3022 (b)(2)(D)(ii) empowers the FDA to bar people (prevent them from being in the business of) importing misbranded or adulterated drugs. In the Senate version of this bill, that language was not qualified, therefore it could empower the FDA to bar a patient from continuing to import or, potentially, people in the business of helping that patient. Again, Congress made its intent clear:
“(5) DEFINITION. — For purposes of paragraph (3)(D), the term ‘pattern of importing or offering for import’ means importing or offering for import a drug described in clause (i) or (ii) of paragraph (3)(D) in an amount, frequency, or dosage that is inconsistent with personal or household use by the importer.”
Simply, but importantly, this means that personal or household use imports are not Congress’ target, and people involved in such personal drug importation should not be burdened by this law.
Congress has not made personal drug importation legal, but it has protected people who violate the law by importing more affordable prescription drugs. Congress has stated in law that:
1) Americans have reason to import lower-cost medicines when the prices are too high domestically;
2) The Secretary of Health and Human Services can and should permit personal imports that are not an unreasonable risk to public health; and
3) Personal drug importation should not be targeted for enforcement actions.
While most personal imports reach patients, who have a valid prescription, about 0.5% are refused and some are destroyed. Furthermore, the FDA threatens businesses and people that help Americans import medicines from licensed pharmacies that require valid prescriptions, saving them money and helping them avoid rouge online pharmacies. For some, personal drug importation is their only access to prescribed medicines.
Based on the arguments presented above, it’s time for American consumers to challenge the FDA if the agency refuses their imports, not just administratively but through the courts.
I believe that Americans can prove that when it comes to personal drug importation the law is on their side after all.Tagged with: Congress, enforcement discretion, FDA, personal importation policy