Federal Judge Orders Access to Experimental Drug

September 1, 2015 by Arkady Bukh

A federal judge has ordered the drug company PTC Therapeutics to give a teenager access to its still-experimental drug PTC124, which the company is developing for treatment of duchenne muscular dystrophy.

This decision would seem to be at odds with the D.C. Circuit Court of Appeals’ ruling in Abigail Alliance v. Eschenbach , unless the legal basis of the argument is different from that in Abigail Alliance.

The New York Times writes:

It was not immediately clear what implications the ruling would have for other patients seeking access to clinical trials of experimental treatments. Drug developers tightly enforce parameters on who can participate in these trials, citing concerns about safety and the validity of the research.

Those who do not meet the guidelines are excluded, often because their cases might alter the results, even if the patients consider the trial a final hope in the face of a devastating illness.

In Wednesday’s ruling, Judge William J. Martini, of the United States District Court in Newark, said that Jacob should be allowed to take the experimental drug even though he does not meet the criteria for eligibility. The details of the order were still being hammered out late Wednesday.