PharmExec Blog
Follow Us
RSS
Bookstore
- Image via Wikipedia
FDA on Monday announced that it was looking to withdraw approval for the low-blood-pressure treatment midodrine hydrochloride because the companies manufacturing the drug failed to provide data from post-approval studies.
The kicker: The drug was approved 14 years ago.
FDA gave midodrine hydrochloride—branded by Shire as ProAmatine and produced by a half-dozen generics firms—the green light in 1996 as part of the fast-track approval program designed to speed to market drugs for diseases with no current treatments.
The catch is that FDA requires post-market clinical trials to ensure that the drug is meeting risk/benefit endpoints. In other words, the regulatory body wanted to make sure no hiccups occurred with the treatment when it hit the general population.
Patients Want to Talk. Do You?
It used to be so easy. Patients listened to doctors, doctors listened to pharma and everyone was happy. There was even a time when payers listened to pharma, reimbursing their prices with very few questions asked. Now everyone is asking questions and no-one listens to anyone else.
No-one, that is, except pharma. Branded as the bad guy of healthcare, companies are nonetheless trying to learn the art of dialogue, enlisting medical liaison officers in place of reps, engaging social media experts to navigate the minefields of Facebook and YouTube, and creating whole new departments to become more conversant in health economics and patient reported outcomes.
On Facebook, where it can seem the entire world is engaged in conversation, pharma companies are seriously outcast. Read More »