Brad Thompson Quoted on ‘Unique’ Case Over Access to Experimental DrugPinksheets Weekly September 4, 2008
Brad Thompson, a Member of the Firm in the Health Care and Life Sciences Practice in the Washington, DC office, was quoted in an article in Pinksheets Weekly about a judge's decision to order PTC Therapeutics to provide an experimental drug for a teenage boy with Duchenne Muscular Dystrophy.
New Jersey federal judge William Martiniissued a preliminary injunction on August 21 for PTC Therapeutics to provide access to PTC124, now in Phase II testing, to 16-year-old Jacob Gunvalson.
Advocacy groups and judges are well aware of the dangers in encouraging people to use the courts to get access to new drugs instead of participating in placebo-controlled trials, said Thompson. He added that the case is "unique," because the plaintiff was not arguing a statutory right to the medication or challenging FDA regulations; instead, the case involves a quasi-contract through a set of communications between the patient and the company.
"The case could have a chilling effect on companies talking to patients if they had to fear that somehow they were creating an expectation about access to a drug," he said.