Thursday, May 7, 2015

J&J Teams With NYU to Revise Review Process for Compassionate Care

by Ed Silverman

In a bid to change the contentious dynamics surrounding compassionate use, Johnson & Johnson JNJ +0.49%has formed a partnership with the New York University School of Medicine, which will form an independent committee to evaluate requests by seriously ill patients who seek experimental medicines.
The move comes amid a growing furor over compassionate use as a growing number of people attempt to obtain a drug under development, even though they are not enrolled in a clinical trial. Requests must be approved by both the FDA and drug makers.
Frustrated by rejection, some patients and their families have increasingly turned to social media to pressure drug makers to change their corporate minds. More recently, 16 states have passed ‘Right to Try’ laws designed to leapfrog the bureaucratic process created by the FDA.
The process, however, will still require patients and their doctors to obtain approval from the FDA. The agency has a strong track record of approving requests–to date, the FDA has signed off on 99.5% of nearly 1,900 requests made. More than half of those were considered emergencies.
Thank You Mr Silverman and WSJ

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