On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
CEO Media Statements Draw Additional Scrutiny
Dr. Cox stated that Protein Sciences “is able to put three times more protein in there, so it is also a high dose vaccine. More protein means your body will form more antibodies that will help you fight the flu.” FDA found this claim misleading because it implied that the higher antigen content results in greater flu protection, and concluded it was unsubstantiated. According to the agency, it had previously advised the company that the claim was misleading. FDA also noted that the video presented multiple efficacy claims for the drug, such as “helps you fight the flu,” but omitted important safety information.
When FDA issued its first enforcement letter in November 2013 to a company for an executive’s statements to the media, we were cautiously optimistic that it would be a rare occurrence. Now, with a second letter, this seems more like a trend. As a result, we recommend that companies ensure that all media statements and talking points are reviewed by promotional review committees (PRCs) in advance.
Pursuant to the Untitled Letter, the Protein Sciences interview was removed from the company’s website, though it is still available on The Balancing Act’s website here.
The Protein Sciences Untitled Letter is available here.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017