Lawmakers To Reintroduce Bill Legalizing Terminally Ill Patients' Access To Experimental Medications

Main Category: Public Health
Also Included In: Pharma Industry / Biotech Industry
Article Date: 21 Aug 2007 - 19:00 PDT

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Lawmakers likely will reintroduce legislation that would require FDA to allow terminally-ill patients to purchase experimental drugs with the recommendation of their physician, CongressDaily reports. Sen. Sam Brownback (R-Kan.) and Rep. Christopher Shays (R-Conn.) last session introduced the Access, Compassion, Care and Ethics for Seriously Ill Patients Act, but the bill "did not gain traction," according to CongressDaily. This session the bill likely will be introduced by Brownback and Rep. Diane Watson (D-Calif.) (Edney, CongressDaily, 8/15).

The U.S. Court of Appeals for the District of Columbia Circuit earlier this month ruled that terminally ill patients do not have the right to obtain access to unapproved prescription drugs that potentially are lifesaving, even if their physicians say the treatments offer the best chance of improved health. In 2003, the Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation filed a lawsuit against FDA to obtain access to experimental medications for terminally ill cancer patients.

The lawsuit asked FDA to provide a special initial approval of experimental medications that appear effective and allow their sale and distribution to terminally ill patients who have no other approved treatment options. FDA argued that programs currently exist to provide experimental medications to terminally ill patients and that increased access to such treatments would lead to unacceptable risk (Kaiser Daily Health Policy Report, 8/8).

Frank Burroughs, founder of the alliance, believes that the increased media attention of the appeals case will bolster the bill's chance of passage. "It was a devastating decision for the Abigail Alliance, but the upside of it is it's generated media coverage and that coverage is definitely positive," Burroughs said (CongressDaily, 8/15).

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