Issue of the Case

The case for this month addresses a very timely topic related to the law and public policy.A husband and wife living in Chicago filed a legal challenge to provisions found in the Federal Food, Drug, and Cosmetic (FDC) Act and the Medicare Prescription Drug Improvement and Modernization Act that prohibit the reimportation of prescription medications from Canada by consumers. The lawsuit named as defendants the US Department of Health and Human Services (HHS); the US FDA, a subdivision of HHS; and Tommy Thompson, secretary of HHS at the time.

Facts of the Case

Both plaintiffs were 75 years of age with multiple chronic health conditions. Their medications for treating these conditions cost them about $1100 per month. They alleged that they have nearly depleted their life savings to pay for the medications, forcing them to resume working to supplement their retirement incomes and to qualify for health insurance benefits. They estimated that if it were lawful for them to purchase their medications from Canada, they would save $400 to $500 per month, but they have not done so because that would constitute unlawful activity under the Federal FDC Act.

The Court's Ruling

The US District Court for the District of Columbia ruled that the provisions in federal statutes that prohibit reimportation of prescription drugs did not violate the substantive due process rights of the plaintiffs arising under the Fifth Amendment to the US Constitution. In addition, the refusal of the secretary of HHS to issue certifications to Congress that such importations may be safely done, a prerequisite for lawful importation of such drug products, was not viewed by the court as arbitrary and capricious action, one of 3 general bases that a court can use to overturn an action of an administrative agency.

The Court's Reasoning

The court ruled that the role of the US FDA in ensuring the safety of medications distributed in this country is done in furtherance of a legitimate government purpose. The statutes being challenged in this case work to further that goal by protecting the American public from reimported medications that may be adulterated or otherwise unsafe. The court stated that the right to purchase medications from a preferred source or at a preferred price is not a fundamental right of US citizens, and, as a result, a government agency has some leeway in working to discharge its administrative responsibilities.

Turning to the reluctance of the secretary to issue the required certifications to Congress, the court emphasized that a provision in the Medicare statute authorizes the secretary to lift the prohibition of reimportation of drug products from Canada for either individuals or groups on a case-by-case basis. Before he does that, however, he must first certify 2 things—(1) that doing so would "pose no additional risk to the public's health and safety," and (2) that the reimportation would "result in a significant reduction in the cost of covered products to the American consumer." The Medicare statute specified that the secretary cannot make such certifications unless, "after a hearing on the record," he makes a series of findings as outlined in the statute.

HHS had conducted no such hearing, and the secretary of the department had made no findings as required by the statute. He had received written inquiries including a letter signed by 16 US senators. Moreover, the governor of Illinois had written to him requesting a waiver. The secretary had uniformly responded, however, that he was "unable to make the determinations" the statute specified as a prerequisite to lawfully authorized reimportation. The court viewed these responses to communications from a variety of groups to be far from "final agency action" that would be reviewable by a court. One of the requirements that must exist before a court will hear a challenge to an action by an administrative agency is that the case must be "ripe," ie, fully developed. That was not the situation here; the department had not issued a final decision on the matter.

This case was before the court on a motion made by the attorneys for the defendants (government agencies and personnel) to dismiss the lawsuit. The court granted that motion because the lawsuit failed to state a claim upon which the court could grant relief and, therefore, the lawsuit could not be maintained.

Dr. Fink is professor of pharmacy law and policy at the University of Kentucky College of Pharmacy, Lexington.