Supreme Court Upholds Restricting Access to Test Drugs
Posted on: Monday, 14 January 2008, 18:00 CST
WASHINGTON -- The Supreme Court today upheld the government's authority to restrict access to test drugs, even if the drugs might help dying patients.
The court decided against hearing the appeal of terminally ill patients, who argued that they had a constitutional right to unproven but promising treatments.
"It's a tragedy," said Frank Burroughs, who has led the fight for expanded access since his 21-year-old daughter, Abigail, died while trying to get an experimental cancer treatment at Johns Hopkins Hospital in 2001. The treatment won approval in 2004.
To protect against dangerous side effects, the government generally bars patients from taking test drugs until scientific studies prove the medicines work safely. Usually, only patients participating in the studies can get the unapproved drugs.
The Abigail Alliance for Better Access to Developmental Drugs argued in its lawsuit that dying patients who can't get into the trials should be able to take unapproved medicines that show promise in preliminary studies.
The Bush administration fought the appeal, asserting that a constitutional right would jeopardize the public health mission of the Food and Drug Administration.
"We are pleased with the Supreme Court's decision," Julie Zawisza, an FDA spokeswoman, said in a statement. "We are committed to making effective therapies available to patients in need and we also will continue to offer access to unproven therapies through our special access programs."
Many in the industry, meanwhile, feared a constitutional right would damage new drug development by encouraging many patients who currently enroll in clinical trials of test drugs to simply ask for access instead.
Source: The Baltimore Sun, Maryland
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