Pharmacy Law: Do Patients Have a Right to Investigational Drugs?

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

Issue of the Case

Ordinarily, patients have access tomedications only after they havereceived premarketing approval fromthe FDA based on that agency?s reviewof safety and efficacy data for the pharmaceuticalproduct. Does the USConstitution supersede the FederalFood, Drug, and Cosmetic Act andextend to terminally ill patients a constitutionallyprotected right of access toexperimental medications?

Facts of the Case

The case was filed by an advocacyorganization known as the AbigailAlliance for Better Access to DevelopmentalDrugs that represents terminallyill patients and those who supportthem. That entity was represented inthe case by the Washington LegalFoundation, a public interest law firmthat has taken on the FDA in the past onother issues. Its argument was thatpatients with terminal illnesses shouldhave access to medications earlier inthe drug-product approval systemadopted by FDA. They based this viewon an interpretation of the FifthAmendment to the Constitution.

Following issuance of an investigationalnew drug approval to ship thedrug product across state lines forresearch purposes, the product?s sponsorlaunches the clinical trial process forthe study medications, which is usuallydivided into 3 phases?sometimes afourth is added. Phase 1 testing uses arelatively small number of research subjects(eg, 20-80), who are administeredthe medication in an attempt to ascertainhow it is metabolized, its possiblepharmacologic activity, the relationshipof increasing the dosage to developmentof side effects, and perhaps evenan early indication of effectiveness for aparticular disorder. Although this multitudeof purposes can exist, the primaryfocus of phase 1 testing is on assessingthe safety of the drug product for furthertesting in humans. The alliancesought to have medications that havecompleted only phase 1 evaluationavailable to terminally ill patients.

The alliance based its legal argumentson the Due Process clause of the FifthAmendment, which provides, in part:"No person shall be ... deprived of life,liberty, or property, without due processof law...." Through a long series of decisions,the Supreme Court has expandedmeaning of the wording to mean muchmore. This provision has been interpretedby the court to create an expandedprotection of citizens against interferenceby the government with certain"fundamental rights and liberty interests."Based on case decisions over theyears, these include ?the right to marry,to have children, to direct the educationand upbringing of one?s children, tomarital privacy, to use contraception, tobodily integrity, and to abortion.? Theissue in question: Should that list beexpanded to include a Due Process rightto have access to experimental medications?

The federal trial court had ruled theanswer was no, dismissing the casebefore a trial was held. Following an initialreview by a 3-judge panel of theCourt of Appeals, the court settled on anopposite view and ruled that the caseshould be sent back to the trial court forfurther proceedings. The alliance did notagree with everything in that decisionand requested a review of the case bythe full Court of Appeals bench (10judges).

The Court?s Ruling

The Court of Appeals? judges en banc(in full court) considering this case ruledby an 8-2 vote that no such constitutionallyprotected right exists and that thetrial court judge was correct in his decisionthat the case should be dismissed.

The Court?s Reasoning

The majority of the judges pointed outthat the expansion of the list of protectionsfalling under Due Process shouldnot be added to lightly. Because the protectedrights added to the list are notspecified in the Constitution, theSupreme Court "has cautioned againstexpanding the substantive rights protectedby the Due Process clause." Thisis so because "guideposts for responsibledecision making in this unchartedarea are scarce and open-ended."

The judges did an extensive review ofboth the historical evolution of thenation?s drug-regulation schema and thelong line of cases interpreting the wordingof the Constitution relevant to thiscase. They assigned great weight to thelack of proof that there exists "evidenceof a right to procure and use experimentaldrugs that is deeply rooted in ournation?s history and traditions." The 2dissenting judges wrote strong decisionstaking exception to both the approachused and the conclusions reached bythe majority.

This case was decided on August 7,2007. On September 28, 2007, thealliance petitioned the Supreme Court totake the case. On January 14, 2008, theSupreme Court declined to take up thecase, meaning that the ruling of the nextlower court stands. In doing so, theSupreme Court issued no statementabout why it declined to hear the case.