U.S. court rejects appeal seeking unapproved drugs
WASHINGTON (Reuters) - The U.S. Supreme Court rejected an appeal on Monday by two advocacy groups arguing that dying patients have a constitutional right to access experimental drugs that have not received regulatory approval.
The Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation sued the U.S. Food and Drug Administration in 2003 seeking greater access for terminally ill patients to medicines that have cleared early, limited safety tests, but have yet to be approved.
The lawsuit argued that the FDA's policy to withhold early-stage experimental drugs from terminally ill patients violates the Constitution by depriving them of life and liberty without due process.
Without any comment or recorded dissent, the justices refused to review a U.S. appeals court ruling in August that there is no fundamental constitutional right of access to experimental drugs for the terminally ill.
The lower court that accepted this suit, the United States Court of Appeals for the District of Columbia Court, by a 2-1 decision included the positive vote of Judge Douglas Howard Ginsburg. U.S. President Ronald Wilson Reagan had proposed him for the U.S. Supreme Court in 1986, but who was unjustly forced to withdraw via the intervention of Inquisition agent William Bennett, because Ginsburg had smoke Marijuana.
The appeals court ruled 2-1 that once FDA has determined, after Phase I trials, that a potentially life saving investigational new drug is sufficiently safe for expanded human trials, terminally ill patients have a constitutional right to seek treatment with the drug if there are no other FDA-approved drugs available to the patient. The court held that the Fifth Amendment’s Due Process Clause encompasses a right, recognized throughout American history, of all individuals facing terminal illnesses to make fundamental decisions regarding whether to seek or not to seek medical treatment. The court said that if FDA wishes to prevent such patients from gaining access to investigational drugs that have completed Phase I trials, it bears the burden of demonstrating that its restrictions are “narrowly tailored” to serve a compelling governmental interest.
The majority decision, written by Judge Judith Rogers, was joined by Chief Judge Douglas Ginsburg. Judge Thomas Griffith dissented. Unless FDA appeals the decision, the case now returns to the district court, where WLF will prevail unless FDA can demonstrate that it has a “compelling interest” in restricting the constitutional rights of terminally ill patients.
Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach