[Live-blogging off-the-cuff, all errors, typos, etc, are my fault]
Geoffrey Levitt, Pfizer, Drug Safety Communication: The Evolving Environment
A drug by itself is just an object. Because of that fact it creates turf, governance. You must have effective processes for communicating accurate info.
Pharmacovigilance is the accuracy part. Spontaneous adverse event reports are flooding to companies. 600,000 of such reports go to Pfizer a year, with 2000 a day on avg. Each has to be classified, reported, and followed-up. If you mess up you get a warning letter. But it has limits: passive, haphazard, poor signal to noise value. Main value is generating safety signals to follow up on. But studies of that kind for follow-up are very expensive and competing with other possible safety studies and new drug development for funding.
For this reason there has been interest in active real-time drug safety monitoring, like Sentinel.
Once you have accurate and up to date info, how do you communicate it to the audiences that need it. It is not static info, dynamic and constantly changing, and often not fully baked. Timing is everything. That leads to governance. Who owns it? Which stakeholders get to drive it. In Wyeth v. Levine, S. Ct says drug sponsor owns the label, and is responsible at all times for content of the label, including safety info. In reality not that simple. Today there is a number of players outside health authority and drug sponsor who have emerged as powerful forces. Academic researchers, drug payers, detailers, and many others. This is not by accident. One reason is emergence of vocal critics who have critiqued the sponsors ability to directly communicate. Claim that this is a form of collusion of which Levitt does not agree.
Vioxx sparked a few important developments. IOM produced one of the most important recommendations that led to FDAAA especially as to post-market surveillance and power over the safety label. Balance of authority shifted from that authority towards FDA. FDA also began to be more proactive about communicating, even before fully confirmed and without participation of sponsor. Also put into place obligations to post clinical trial results on public website, so clinicaltrials.gov is born. In retrospect, that was the opening shot in a full barrage of FDA on clinical trial transparency. In Europe this had led to a drastic new policy of affirmatively publishing clinical study reports full-scale not just trial results.
Critics of the current model want to tear down the gate, and reinterpret data themselves by own standards. That may lead to different results and different conclusions. Will the erosion of the primacy of the sponsor and FDA lead to more truth or more confusion?
W. Nicholson Price II, Petrie-Flom Center, The Role of Innovation Policy in Pharmaceutical Manufacturing
M & M manufacturing is more precise than drug manufacturing. Poor innovation in drugs. 200 to 300 billion dollars a year are spent on drug manufacturing. This is very expensive and inefficient, contrary to the typical story that drug manufacturing is cheap. Drugs are way behind computers and electronics. Uses same processes as decades ago. A 20% reduction in manufacturing costs would lead to a gain annually 50 billion for consumers if paid back directly, or even more if invested in R & D. Connected also to drug shortages.