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Recent court decisions and proposed regulatory actions have fueled the legal debate over the right of terminally ill patients to use experimental drugs. The U.S. Food and Drug Administration (FDA) in December 2006 released new proposed guidelines that would allow seriously ill patients to get easier access to experimental drugs. The proposed guidelines, which are subject to comment for 90 days, follow a handful of lawsuits in recent years in which patients have sued for access to unapproved drugs. Also, a three-judge panel of the U.S. Circuit Court of Appeals for the District of Columbia ruled in May that terminally ill patients had a constitutional right to potentially life-saving drugs. The full court will rehear the case en banc in March. Abigail Alliance for Better Access to Developmental Drugs v. Von Eschebach, 445 F.3d 470 (D.C. Cir. 2006). “When we’re talking about a terminally ill patient who has no other effective treatment options, the FDA should stand out of the way and let private parties decide for themselves,” said Richard Samp, chief counsel at the Washington Legal Foundation and co-lead counsel in Abigail. Ruling blasted FDA attorneys declined to comment. But in court documents, government attorneys blasted the ruling, saying it “struck an unprecedented blow” to the FDA’s drug regulatory system. “It has done so by holding that terminally ill patients who lack treatment alternatives have a fundamental constitutional right to use unapproved experimental drugs that they believe to be potentially lifesaving. Other courts have rejected attempts to constitutionalize access to experimental drugs in the past, and no court of appeals has ever given its imprimatur to such an effort-until now,” the government filing said. The FDA added that by “placing the FDA’s and Congress’s regulatory authority in a constitutional straitjacket, the decision jeopardizes their ability to balance the competing interests that surround clinical testing of experimental drugs.” Samp, however, argues that people have a Fifth Amendment due process right to make “essential decisions” about their personal health and their “right to live.” He noted that, currently, patients can access unapproved drugs, but only if the FDA gives the OK. “The only right we’re seeking is to have the FDA step aside,” Samp said. But lawyers representing drug companies are concerned about eliminating the FDA’s role in decisions involving access to experimental drugs. “I’m a little bit nervous about taking the Food and Drug Administration completely out of the picture and leaving it entirely up to the patient,” said Mark Gately of the Baltimore office of Washington-based Hogan & Hartson, who represents drug companies in products liability cases. Last year, Gately won two lawsuits on behalf of Thousands Oaks, Calif.-based Amgen Inc., a biotech company that was sued over a Parkinson’s drug experiment and a blood-disorder drug. The plaintiffs in both cases wanted continued access to an experimental drug, but the judges in both ruled that the company had the right to terminate a drug trial that it considered potentially harmful. Abney v. Amgen, No. 5:05-CV-254 (E.D. Ky.); Suthers v. Amgen, No. 05-CV-4158 (S.D.N.Y.). Under the FDA proposal, expanded access to experimental drugs would be available to individual patients, small patient groups and larger populations under a treatment plan when there is no satisfactory alternative therapy to diagnose, monitor or treat the disease or condition.

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