Another Federal Court Rejects a Drug Importation Plan

Issue of the Case

The county government of a mid-Atlantic state filed a lawsuit against theUS Department of Health and HumanServices (HHS), along with its subsidiary,the FDA, after those agenciesdenied the county's request for a waiverunder federal law to permit thecounty to implement a program to importmedications from Canada.

Facts of the Case

The chief executive officer of thecounty had filed a petition with the federalagencies requesting that permissionbe granted for the residents ofthat county, as well as the governmentitself, to import Canadian medications.The petition made arguments thatsome residents of the county werebeing forced to "choose between theirhealth and putting food on the table,"and that it is "fundamentally unfair thatpeople living in Canada pay a fractionof what Americans pay for the sameprescription."

The Medicare Prescription Drug ImprovementAct of 2003 contains a provisionstating that the FDA may implementa program enabling wholesalersand pharmacists to import medicationsonly if the secretary of HHSfirst certifies that creating such anexception to the general law would"(1) pose no additional risk to the publichealth and safety and (2) result in asignificant reduction in the cost ofdrugs to the American consumer."Oneissue presented here was whethersuch an exception would need toextend to the entire nation or could thecounty get a "carve-out"limited exception.The FDA took the position that theformer approach was the only permittedone. In fact, the FDA had engagedin a number of communications withthe county government before the lawsuitwas filed, all of which emphasizedthat the programs proposed by thecounty would violate the Federal Food,Drug, and Cosmetic (FDC) Act.

The county sought to have the courtorder the agency to authorize the projectby granting mandamus (ie, enteringa mandate that something be done).The county's position was that the federalofficials had failed to dischargetheir official duties.

Two months later, the defendants(the 2 federal agencies) filed a motionwith the federal trial court to dismissthe action, arguing that the lawsuitfailed to state a claim on which reliefcould be granted.

The Court's Ruling

The US District Court granted themotion of the federal agency defendantsto dismiss the lawsuit. It is noteworthythat the dismissal occurredbefore any trial proceedings.

The Court's Reasoning

The court concluded that, before anyprogram to allow importation could beput in place, the secretary of HHS mustmake the specified certifications aboutlack of risk and cost-effectiveness. Thisruling said that this is the case for allexceptions to allow importation. Thecourt emphasized the FDA's jurisdictionand authority to regulate the manufacturing,marketing, and sale of medicationsin the United States.

The plaintiff county government hadalso argued that the FDA failed toenforce the importation restrictions ofthe FDC Act in all cases, such as whenpatients were permitted to bring into thecountry limited supplies of medicationsfor their own use. In the view of thecounty, this lapse by the FDA equated toa de facto certification of safety andcost-effectiveness by the secretary. Thatargument also was rejected by thejudge, citing a long-standing doctrinethat governmental agencies haveabsolute discretion in making enforcementdecisions, sometimes referred toas "prosecutorial discretion."The courtemphasized that those decisions as towhether to act in a given situation maybe "selective enforcement,"but they"cannot be used as an argument for defacto blanket certification."

As a general notion, if one wants tochallenge a decision of an administrativeagency, as was done in this case, 3basic arguments can prove successful—mistake of law; abuse of discretion;or arbitrary or capricious action.The county's case failed on the firstargument because the court agreedwith the agencies'interpretations ofthe relevant statutes.

The local government also hadargued that the decision to deny therequest for a waiver to permit importationwas "arbitrary, capricious, or anabuse of discretion."The judge disagreed.

Finally, the court ruled that judicialreview of the agency head's decisionnot to issue the required certificationswas not available because the wordingof the statute was not mandatory.Congress did not mandate that thesecretary must issue such certifications,nor did it establish any deadline.Until such certifications are issued,"the current policy, which views as illegalalmost all importation of prescriptiondrugs, remains effective and thestatus quo remains intact."

Dr. Fink is professor ofpharmacy law and policy atthe University of KentuckyCollege of Pharmacy,Lexington.