Bradley Thompson Quoted on Impact of Gunvalson Case on Medical Trials

The Regulatory Affairs Journal

Bradley Thompson, a Member of the Firm in the Health Care and Life Sciences Practice in the Washington, DC office, was quoted in The Regulatory Affairs Journal about a decision by a US appeals court to put on hold a district court judge's order to PTC Therapeutics to provide an experimental drug for a teenage boy with Duchenne Muscular Dystrophy.

The district court had ordered that the terminally ill patient have access to the drug, despite objections by the drug manufacturer. Drug sponsors fear that they may have to revise their "compassionate use" policies to accommodate patients, even those who do not meet criteria to participate in a clinical trial.

In the article, titled, "US court Suspends Patient's Access to Experimental Medicine," Thompson said that drug companies should use greater caution when interacting with patient groups.

"The Gunvalson case is an illustration of the risks that are out there," he said. "The pharma companies need to be on guard about how they talk to patients. In all their correspondence, they must emphasize that they do not intend to provide access to an investigational drug [outside of the trial]. The order could distance the patient groups from the industry."

Thompson said, however, it is too early for drug companies to revise their compassionate use policies on the basis of this case. The Gunvalson case is unique because the family's argument is based on the company's alleged contract assuring access to the experimental drug rather than a drug being provided as a statutory right to the terminally ill patient.