Letter to the Editor
Critically reviewing impact of regulatory actions, not just FDA's
Article first published online: 3 JAN 2014
Copyright © 2013 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 23, Issue 1, page 105, January 2014
How to Cite
Mol, P. G. M. (2014), Critically reviewing impact of regulatory actions, not just FDA's. Pharmacoepidem. Drug Safe., 23: 105. doi: 10.1002/pds.3509
- Issue published online: 3 JAN 2014
- Article first published online: 3 JAN 2014
- Manuscript Accepted: 30 JUL 2013
- Manuscript Received: 17 JUL 2013
To the Editor
I read with great interest the paper ‘A critical review of methods to evaluate the impact of FDA regulatory actions’ by Briesacher et al. Their message that rigorous evaluation of impact of FDA regulatory actions has been limited and that ‘new’ study designs are available and may be used in future evaluations is fully supported. However, what comes as a bit of a surprise is the lack of attention that is paid to the rest of the world efforts to study impact of regulatory actions. In the European context, with the new pharmacovigilance legislation that came into effect last year, evaluation of the impact of regulatory actions has become mandatory.[2, 3] In anticipation of that legislation, we, for example, have performed extensive work to study the impact of regulatory action to provide a point of reference.[4-6] In our systematic review of the impact of safety-related regulatory action, half of the 50 papers included were non-US studies. As Briesacher et al., we found that also world-wide, few drugs or drug groups had been studied; 33 papers looked at three different drug safety issues only. Also we observed that study designs were not always very robust. Moreover, this finding may affect our knowledge base on impact of regulatory action considering that the 23 papers in our review that used weaker before/after study designs showed more often intended effects than the studies with more robust interrupted time series designs. None of the included studies were able to correct for confounding factors such as media attention, which indeed may have affected the impact of the warnings as suggested by Briesacher et al. However, as only the impact of regulatory actions for a few drugs has been studied, the media may not be a factor in all regulatory actions. The press may not have covered many of these regulatory actions, as the drug safety issues may have been less appealing not only for academics to study but also for lay media to cover.
Finally, I agree that rigorous designs should be used to study impact of regulatory actions to optimize their effect. However, in agreement with others, I would like to stress also that goals need to be set of what should be achieved by the regulatory action. Consideration should be given to what endpoints should be used to measure intended and possibly unintended effects. Academics, regulators and industry around the world may find a platform at the ISPE Special Interest Group, Benefit Risk Assessment, Communication and Evaluation to discuss (BRACE), exchange and learn from each other's findings.
CONFLICT OF INTEREST
The author is also an employee of the Dutch Medicines Evaluation Board. The views presented in this article are his personal views and do not necessarily reflect those of the regulatory agency.
- 2The European Parliament and the European Council. REGULATION (EU) No 1235/2010 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, 2010. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0001:0016:EN:PDF
- 3The European Parliament and the European Council. DIRECTIVE 2010/84/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, 2010. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF
- 4Impact of safety-related regulatory action on clinical practice: a systematic review. Drug Saf 2012; 35(5): 373–385., , , et al.
- 5A decade of safety-related regulatory action in the Netherlands: a retrospective analysis of direct healthcare professional communications from 1999 to 2009. Drug Saf 2010; 33(6): 463–474., , , , , .