12:00 AM
Jan 21, 2008
 |  BioCentury  |  Politics, Policy & Law

Abigail's next steps

Patient groups looking for easier access to experimental medicines were dealt a setback last week when the U.S. Supreme Courtrefused to hear a case brought against FDA and HHS by the Washington Legal Foundation (WLF) and Abigail Alliance for Better Access to Developmental Drugs. Based on their track record at FDA and on Capitol Hill, the plaintiffs believe they are more likely to achieve their goals through legislative means than through administrative solutions.

WLF and the alliance filed the suit in the U.S. District Court for the District of Columbia in 2003, arguing terminally ill patients had a constitutional right to have access to experimental compounds that have successfully completed Phase I testing.

The government countered that "there is no fundamental right to obtain unapproved drugs, and the government's restriction on access to such drugs serves a legitimate interest in protecting the public health."

The district court sided with FDA and HHS in 2004, but in May 2006, the U.S. Court of Appeals for the District of Columbia Circuit reversed the decision. Last August, the appeals court reheard the case en banc and ruled 8-2 for FDA and HHS.

The plaintiffs used the constitutional argument because there is no law that says FDA must provide patients access to experimental medicines. "If we thought FDA had violated a law, then we would have gone that route, but we had nothing to hang our hat on," Richard Samp, chief counsel for WLF, told BioCentury.


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