Another area where Gottlieb might have an impact is in FDA’s willingness to weigh real world data in evaluating medications. Last week, GSK announced favorable results from a real world study of Breo for asthma, echoing an earlier study for COPD (the two studies combined reportedly cost GSK around $100 million, which would probably compare favorably with clinical trials for a big drug). These sorts of studies, though not admissible for the marketing of new medicines, could bolster brands seeking new indications, per the 21st Century Cures Act, or help persuade payers to grant more favorable status. The sped-up approvals system envisioned by the White House could prove costly, and payers will be eyeing approved medications with more scrutiny.
Postmarketing studies like GSK’s may be more in demand going forward, as FDA looks to juice up the rate of new drug approvals, trading some safety for speed in the process. A Yale study found that nearly 1 in 3 drugs approved between 2001 and 2010 saw safety events including boxed warnings, safety alerts and withdrawals.
“Text messaging is inevitable,” writes a physician in JAMA, noting that doctors are communicating with patients through texts despite a lack of clarity on how to do so securely. Interesting look at what instruction HIPAA does and does not offer physicians here.