Relaxing Rules for Off-Label Prescribing: "Akin to Crying 'Fire!' in a Crowded Theater?"

In the Amarin court case, the court ruled that the company has the right, under the First Amendment, to promote information to health-care professionals about certain uses of the drug Vascepa that aren't covered by the drug's FDA-approved labeling -- as long as the information is true and not misleading (read "Amarin Wins Off-Label Case Against FDA"). This case is likely to influence new guidance from the FDA regarding off-label drug promotion by pharma marketers.

"Might changes in rules for promotion of off-label indications based on free speech arguments lead to a situation akin to crying fire in a crowded theater?," asks authors of Commentary published in the recent issue of JAMA Internal Medicine. The authors of the commentary -- Chester B. Good, M.D., M.P.H., and Walid F. Gellad, M.D., M.P.H., of the Veterans Affairs Pittsburgh Heathcare System -- referred to "compelling evidence" that "off-label prescribing is frequently inappropriate and that prescribing in these circumstances increases the risk for an adverse event substantially."

That evidence was presented in a study published in the same issue of the journal titled "Off-label Prescription Drug Use and Adverse Drug Events" (JAMA Intern Med. Published online November 2, 2015. doi:10.1001/jamainternmed.2015.6058).

What is the "compelling evidence?"

Read more »

Patient Centricity Does Not Apply When the Patient is Dead

Pharma Delays Reporting Serious Drug AEs (i.e., Death) to FDA

FDA Develops a Mobile App for Reporting Drug Shortages. But Wouldn't an App for Adverse Events Better Fit the Agency's Mission?

FDA/CDER launched its first and only mobile app on iTunes: DrugShortages (see logo on left).

The iTunes blurb suggests the public would find this information important:

"Access to drug shortage information is now easier and faster. FDA has developed an app that allows users to quickly identify current drug shortages, resolved shortages, and discontinuations of drug products. This app was developed to accelerate public access to important – and sometimes critical -- information about drug shortages. The application uses a searchable database to provide real-time information to key stakeholders, including health care practitioners and pharmacists."

I'm not sure how useful this app is for the public versus HCPs who definitely would like easy access to such information. According to the blurb, the app "helps health care practitioners make quick decisions about patient treatment."

More importantly, the app "provides information on how to report a shortage or supply issue, and links to other resources from FDA". Of course, the general public would not find this feature of the app very useful.

But an app that would be VERY useful for HCPs and patients is an app that provides easy access to adverse event data and that allows users to report adverse events. This, I believe, would better fulfill FDA's mission: to "protect the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices..."

What would such an app look like? I used the DrugShortages screen to create what I call "DrugAE," a concept for a mobile app that I hope the will FDA launch on iTunes soon. Here's my concept:

Read more »