US Capitol Capsule: Power to the people: Patients' influence over FDA
This article was originally published in Scrip
Executive Summary
An unusual statement posted on the FDA's website late on 30 October not only gives insight into the sometimes miscommunication that goes on between regulators and drug makers – in this case Sarepta Therapeutics – it also reflects the growing power the patient advocacy community wields through public pressure and influence those groups have over the agency’s decision-making process.