Another Federal Court Rejects a Drug Importation Plan

Author: Joseph L. Fink III, BSPharm, JD

Issue of the Case

The county government of a mid- Atlantic state filed a lawsuit against the US Department of Health and Human Services (HHS), along with its subsidiary, the FDA, after those agencies denied the county's request for a waiver under federal law to permit the county to implement a program to import medications from Canada.

Facts of the Case

The chief executive officer of the county had filed a petition with the federal agencies requesting that permission be granted for the residents of that county, as well as the government itself, to import Canadian medications. The petition made arguments that some residents of the county were being forced to "choose between their health and putting food on the table," and that it is "fundamentally unfair that people living in Canada pay a fraction of what Americans pay for the same prescription."

The Medicare Prescription Drug Improvement Act of 2003 contains a provision stating that the FDA may implement a program enabling wholesalers and pharmacists to import medications only if the secretary of HHS first certifies that creating such an exception to the general law would "(1) pose no additional risk to the public health and safety and (2) result in a significant reduction in the cost of drugs to the American consumer."One issue presented here was whether such an exception would need to extend to the entire nation or could the county get a "carve-out"limited exception. The FDA took the position that the former approach was the only permitted one. In fact, the FDA had engaged in a number of communications with the county government before the lawsuit was filed, all of which emphasized that the programs proposed by the county would violate the Federal Food, Drug, and Cosmetic (FDC) Act.

The county sought to have the court order the agency to authorize the project by granting mandamus (ie, entering a mandate that something be done). The county's position was that the federal officials had failed to discharge their official duties.

Two months later, the defendants (the 2 federal agencies) filed a motion with the federal trial court to dismiss the action, arguing that the lawsuit failed to state a claim on which relief could be granted.

The Court's Ruling

The US District Court granted the motion of the federal agency defendants to dismiss the lawsuit. It is noteworthy that the dismissal occurred before any trial proceedings.

The Court's Reasoning

The court concluded that, before any program to allow importation could be put in place, the secretary of HHS must make the specified certifications about lack of risk and cost-effectiveness. This ruling said that this is the case for all exceptions to allow importation. The court emphasized the FDA's jurisdiction and authority to regulate the manufacturing, marketing, and sale of medications in the United States.

The plaintiff county government had also argued that the FDA failed to enforce the importation restrictions of the FDC Act in all cases, such as when patients were permitted to bring into the country limited supplies of medications for their own use. In the view of the county, this lapse by the FDA equated to a de facto certification of safety and cost-effectiveness by the secretary. That argument also was rejected by the judge, citing a long-standing doctrine that governmental agencies have absolute discretion in making enforcement decisions, sometimes referred to as "prosecutorial discretion."The court emphasized that those decisions as to whether to act in a given situation may be "selective enforcement,"but they "cannot be used as an argument for de facto blanket certification."

As a general notion, if one wants to challenge a decision of an administrative agency, as was done in this case, 3 basic arguments can prove successful—mistake of law; abuse of discretion; or arbitrary or capricious action. The county's case failed on the first argument because the court agreed with the agencies'interpretations of the relevant statutes.

The local government also had argued that the decision to deny the request for a waiver to permit importation was "arbitrary, capricious, or an abuse of discretion."The judge disagreed.

Finally, the court ruled that judicial review of the agency head's decision not to issue the required certifications was not available because the wording of the statute was not mandatory. Congress did not mandate that the secretary must issue such certifications, nor did it establish any deadline. Until such certifications are issued, "the current policy, which views as illegal almost all importation of prescription drugs, remains effective and the status quo remains intact."

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