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Court ruling finds terminally ill patients have right to unapproved drugs


Pharmaceutical Executive

Pharmaceutical ExecutivePharmaceutical Executive-05-10-2006
Volume 0
Issue 22

Judges' decision finds constitutional right to experimental drugs when no other options are available

Terminally ill cancer patients have a constitutional right to access treatments before they receive regulatory approval, a federal appeals court ruled last week.

The ruling reinstates a lawsuit brought by the Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation, a public interest law firm, against FDA.

"The problem right now is that compassionate use programs can be very difficult to get into," said Richard Samp, chief counsel for WLF. "Our concern was the unnecessary roadblocks that the FDA [has set] for terminally ill patients who have no other options."

Writing for the majority, circuit Judge Judith Rogers argued that a patient has a "right to make the decision about her life free from government interference," and that it is only in recent years that FDA has blocked access to experimental drugs.

She cited as precedent the decision that gives patients the right to refuse treatment.

One of the three judges on the panel dissented. "Balancing the risks and benefits found at the forefront of uncertain science and medicine has been, for good reason, the historical province of the democratic branches," wrote Judge Thomas Griffith, who noted that FDA already expedites the commercialization of certain drugs through Fast Track and Accelerated Approval programs.

Samp estimated that thousands of terminally ill patients who cannot enter into expanded access (also known as compassionate use) programs would be affected by the ruling. These patients would be able to access drugs after the first phase of clinical trials, unless FDA can prove a compelling interest in curtailing that right.

"The whole burden of proof changes," Samp said.

He stressed that the decision would not compel drug companies to offer investigational compounds or expand their compassionate use programs.

"This case doesn't force companies to do anything; it just allows them to do something if they so choose," he said.

He also noted that under current compassionate use programs, companies are prevented from charging for drugs; the new ruling could even reverse that provision to provide incentives to companies to expand those programs for terminally ill patients.

FDA can now appeal the decision, but as of Monday, would not say whether it would do so.

In a statement, Dr. Scott Gottlieb, FDA's deputy commissioner for medical and scientific affairs, noted that the agency is studying the opinion and consulting with the Department of Justice.

"We remain sympathetic to the desire of terminally ill patients to gain access to experimental treatments when they have exhausted other therapeutic options," he said, "and we are exploring a number of new efforts to improve how we make investigational drugs available through expanded access programs."

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