{"id":5636,"date":"2015-09-01T00:00:00","date_gmt":"2015-09-01T00:00:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/index.php\/2015\/09\/01\/pmn1406-article03\/"},"modified":"2019-02-18T20:38:49","modified_gmt":"2019-02-18T20:38:49","slug":"pmn1406-article03","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn1406-article03\/","title":{"rendered":"The Power of Patient Input: How FDA Learned to Love & Approve Addyi"},"content":{"rendered":"

The Power of Patient Input How FDA Learned to Love & Approve Addyi
\"PatientPatients are beginning to play a much bigger role in all aspects of the pharmaceutical enterprise from drug discovery to clinical trials to FDA approval to post-approval marketing. Sanofi, for example, utilizes patients’ input to get a better sense of their needs, so it can design and deliver solutions that help fulfill those needs.<\/p>\n

But there is another side to patient-centricity: fulfilling the needs of pharma companies to get drugs approved. “We have heard from pharma and bio that — and they’re using the term ‘science of patient input’ — is one of the most important items of discussion for the reauthorization of PDUFA [the Prescription Drug User Fee Act],” said Theresa Mullin, director of the Office of Strategic Programs at the FDA Center for Drug Evaluation and Research. “They’re identifying this as a high-priority area.” <\/p>\n

This article presents a case study of how patient input has the power to change the course of drug approval. The case is Sprout’s ground-breaking patient campaign that played a major role in getting Addyi, a female sexual dysfunction drug, approved by the FDA. <\/p>\n

Topics (partial list)<\/b>:<\/p>\n