Patients Sue the US Government to Allow Drugs from Canada

Issue of the Case

The case for this month addresses avery timely topic related to the law andpublic policy.A husband and wife living inChicago filed a legal challenge to provisionsfound in the Federal Food, Drug,and Cosmetic (FDC) Act and theMedicare Prescription Drug Improvementand Modernization Act that prohibitthe reimportation of prescription medicationsfrom Canada by consumers. Thelawsuit named as defendants the USDepartment of Health and Human Services(HHS); the US FDA, a subdivision ofHHS; and Tommy Thompson, secretary ofHHS at the time.

Facts of the Case

Both plaintiffs were 75 years of agewith multiple chronic health conditions.Their medications for treating these conditionscost them about $1100 permonth. They alleged that they have nearlydepleted their life savings to pay forthe medications, forcing them to resumeworking to supplement their retirementincomes and to qualify for health insurancebenefits. They estimated that if itwere lawful for them to purchase theirmedications from Canada, they wouldsave $400 to $500 per month, but theyhave not done so because that wouldconstitute unlawful activity under theFederal FDC Act.

The Court's Ruling

The US District Court for the District ofColumbia ruled that the provisions in federalstatutes that prohibit reimportationof prescription drugs did not violate thesubstantive due process rights of theplaintiffs arising under the FifthAmendment to the US Constitution. Inaddition, the refusal of the secretary ofHHS to issue certifications to Congressthat such importations may be safelydone, a prerequisite for lawful importationof such drug products, was notviewed by the court as arbitrary andcapricious action, one of 3 general basesthat a court can use to overturn an actionof an administrative agency.

The Court's Reasoning

The court ruled that the role of the USFDA in ensuring the safety of medicationsdistributed in this country is done infurtherance of a legitimate governmentpurpose. The statutes being challengedin this case work to further that goal byprotecting the American public fromreimported medications that may beadulterated or otherwise unsafe. Thecourt stated that the right to purchasemedications from a preferred source orat a preferred price is not a fundamentalright of US citizens, and, as a result, agovernment agency has some leeway inworking to discharge its administrativeresponsibilities.

Turning to the reluctance of the secretaryto issue the required certifications toCongress, the court emphasized that aprovision in the Medicare statute authorizesthe secretary to lift the prohibition ofreimportation of drug products fromCanada for either individuals or groupson a case-by-case basis. Before he doesthat, however, he must first certify 2things—(1) that doing so would "pose noadditional risk to the public's health andsafety," and (2) that the reimportationwould "result in a significant reduction inthe cost of covered products to theAmerican consumer." The Medicarestatute specified that the secretary cannotmake such certifications unless,"after a hearing on the record," he makesa series of findings as outlined in thestatute.

HHS had conducted no such hearing,and the secretary of the department hadmade no findings as required by thestatute. He had received written inquiriesincluding a letter signed by 16 US senators.Moreover, the governor of Illinoishad written to him requesting a waiver.The secretary had uniformly responded,however, that he was "unable to makethe determinations" the statute specifiedas a prerequisite to lawfully authorizedreimportation. The court viewed theseresponses to communications from avariety of groups to be far from "finalagency action" that would be reviewableby a court. One of the requirements thatmust exist before a court will hear a challengeto an action by an administrativeagency is that the case must be "ripe," ie,fully developed. That was not the situationhere; the department had not issueda final decision on the matter.

This case was before the court on amotion made by the attorneys for thedefendants (government agencies andpersonnel) to dismiss the lawsuit. Thecourt granted that motion because thelawsuit failed to state a claim uponwhich the court could grant relief and,therefore, the lawsuit could not bemaintained.

Dr. Fink is professor of pharmacylaw and policy at theUniversity of KentuckyCollege of Pharmacy,Lexington.