Court Declines to Expand Experimental-Drug Access

Jan 16, 08:25 AM

The U.S. Supreme Court turned away an appeal that sought to give terminally ill people greater access to experimental drugs that may save their lives.

The justices, without comment, rebuffed a patient-advocacy group that said the Food and Drug Administration is placing unconstitutional obstacles in the way of people who have exhausted their approved treatment options.

"Huge numbers of Americans die each year after being denied access to developmental drugs that might have prolonged their lives - - drugs that, in many instances, later received FDA marketing approval," argued the group, the Abigail Alliance for Better Access to Developmental Drugs.

The Bush administration and the FDA urged the court not to hear the case, saying the appeal sought to "revive a brand of judicial intervention that this court foreswore long ago."

The case involved people who aren't included in the clinical trials conducted by pharmaceutical companies or the expanded access programs that drug makers offer for some experimental treatments.

Under federal law, people who aren't in those groups and want access to experimental treatments must convince the FDA that the benefits outweigh the risks, a process that requires what Abigail Alliance calls a "mountain of regulatory paperwork."

As a practical matter, those patients also must get the support of the drug company, according to Scott Ballenger, a Washington lawyer representing the Abigail Alliance. He said only about 70 patients a year successfully navigate the process.

The administration told the court that "nearly all" individual patient applications are approved.

The Abigail Alliance is named after Abigail Burroughs, who died in 2001 at age 21 after an 18-month battle with head and neck cancer. In the months before Abigail died, her family unsuccessfully sought access to Erbitux, an ImClone Systems cancer drug that was undergoing clinical testing and had been recommended by her oncologist. The FDA approved the drug in 2004.

Abigail's father, Frank Burroughs, is president of the Charlottesville, Va., group.

A federal appeals court in Washington ruled against the patient group in August on an 8-2 vote.

"There is no fundamental right 'deeply rooted in this nation's history and tradition' of access to experimental drugs for the terminally ill," the majority said, quoting from a 1997 Supreme Court case concerning doctor-assisted suicide.

The appeal focused on drugs that are in the second and third phases of testing required under FDA rules. Phase 2 testing can involve several hundred patients, while Phase 3 testing often includes several thousand subjects.

The drugs are "safe and promising enough to be tested in substantial numbers of human subjects," the appeal argued.

The administration argued that a so-called investigational drug "may be wholly ineffective," and "taking it may sicken the patient or even kill him."

The government also said wider disbursement of investigational medicines might undermine clinical testing. That would especially be the case if drug makers could sell those products at a profit -- something they currently can't do -- because companies would have less incentive to pursue regulatory approval, the U.S. said.

In other U.S. Supreme Court news:

High court may review severance agreements

The court signaled it may hear business arguments in a case that would decide whether companies can require employees receiving severance packages to promise they won't sue under the Family and Medical Leave Act.

The justices on Monday asked the Bush administration for advice on a dispute between utility owner Progress Energy and a woman who gave up her right to sue for violations of the law when she accepted $11,718 in severance pay. Progress Energy is appealing a ruling that said a federal regulation bars that type of waiver without court or Labor Department approval.

Business groups say the decision by the 4th U.S. Circuit Court of Appeals threw tens, if not hundreds, of thousands of existing agreements into legal uncertainty. The decision also created a disincentive for employers to offer severance packages in the future, according to the U.S. Chamber of Commerce and other groups.

"Because the 4th Circuit's rule devalues releases of employment- related claims, businesses invariably will reduce or eliminate the benefits offered to affected employees," the Chamber of Commerce argued in a court filing in Washington.

The former Progress worker, Barbara Taylor, urged the Supreme Court not to hear the case, saying the company should not be able to "avoid its obligations and responsibilities" under the 1993 law.

The law requires employers to give workers up to 12 weeks of unpaid leave during a one-year period to take care of a newborn child or sick relative or to deal with their own serious health condition.

The justices directed their request Monday to U.S. Solicitor General Paul Clement, the Bush administration's top courtroom lawyer.

The ruling by the 4th Circuit, which is based in Richmond, Va., came over the administration's objection. The Labor Department argued unsuccessfully that its regulation, which says employees "cannot waive" their rights under the law, bars only a surrender of future rights, not a waiver of the right to sue over a past violation.

The 2-1 ruling conflicted with a 2003 decision by the New Orleans- based 5th Circuit. The Supreme Court often intervenes to clear up lower court disagreement.

Taylor began working for Progress's CP&L unit in 1993 as a technical aide at the Brunswick Nuclear Plant in North Carolina. Her lawsuit centers on roughly two months of work she missed in 2000 and 2001 while doctors were diagnosing and treating her for leg pain and swelling. Doctors eventually removed an abdominal mass that was causing the problem.

Taylor contends that the company was wrong not to designate all her health-related absences as leave under the federal law. She says the absences were the reason she received a poor 2000 job evaluation and then lost her job as part of a May 2001 layoff.

Progress, which is based in Raleigh, N.C., owns utilities in the Carolinas and Florida.

Oil, power industries rejected on ozone rule

The court refused to consider a bid by the oil, chemical and power industries to loosen some of the rules governing ozone, a pollutant that can cause shortness of breath and aggravate asthma.

The justices, without comment, let stand a 2006 federal appeals court decision that was a victory for environmental advocates and several East Coast states and a setback for industry groups and the Bush administration.

The dispute centered on a Clean Air Act provision designed to ensure that parts of the country don't "backslide" on their anti- pollution regulations during the implementation of new federal air- quality standards.

The Bush administration in 2004 revised the way the anti- backsliding rule applied to a change the Clinton administration had made in the standard for measuring ground-level ozone. Industry groups said the Bush rule was too strict, while environmentalists and states led by Massachusetts contended it was too lax.

The U.S. Court of Appeals for the D.C. Circuit largely agreed with the environmental groups and states, telling the Environmental Protection Agency to modify its approach.

Industry trade associations then asked the Supreme Court to intervene, saying the D.C. Circuit ruling would increase "the burdens of multiple sets of overlapping and potentially inconsistent requirements." Those groups included the National Petrochemical & Refiners Association, the American Chemistry Council, the American Petroleum Institute and the Utility Air Regulatory Group.

The Bush administration urged the high court not to hear the appeal. U.S. Solicitor General Paul Clement argued that, while some aspects of the D.C. Circuit ruling were wrong, the reasoning wasn't likely to have a broad impact.

Massachusetts Attorney General Martha Coakley, representing the states and environmental groups, told the justices that the lower court had issued an "unremarkable decision" in accord with the goals of the Clean Air Act.

Ozone is formed when nitrogen oxides, emitted by power plants and factories, mix with volatile organic compounds. While a necessary part of the upper atmosphere, ozone is dangerous at ground level.

Originally published by Greg Stohr, Bloomberg News.

(c) 2008 Daily Record and the Kansas City Daily News-Press. Provided by ProQuest Information and Learning. All rights Reserved. Court Declines to Expand Experimental-Drug Access
Back to Current Headlines