Is this a patient blog?
No, its focus is on regulation of the pharma industry and in particular the activities of the US Food and Drug Administration (FDA).
So it’s just another blogger sounding off?
Not at all. Mark Senak, author of the Eye On FDA blog, is senior vice president at Fleishman-Hillard in Washington. He has both a legal and comms background and knows what he’s talking about: his day job involves being a strategist helping pharma and biotech companies prepare products for advisory committee approval.
Where does the UK media interest come in?
Andrew Jack, the London-based pharma correspondent of the Financial Times, recently took the unusual step of appearing in a podcast conversation with Senak. They talked about pharma regulation in view of issues such as the scandal over Merck’s Vioxx, withdrawn from the market three years ago after it was found to increase the risk of a heart attack.
Why is the blog is of interest to UK PROs?
Because, as all pharma PROs will tell you, the industry is global. The FDA and European Agency for the Evaluation of Medicinal Products (EMEA) are often announcing guidance on the same products, so the parallels – and differences –between decisions on indications can be instructive. There are common trends too: in recent years the EMEA has speeded up its decision-making process in line with the FDA’s, for example.
Senak comes from a PR perspective which gives a useful slant to thoughts on, say, direct to consumer comms.
Is he critical of the FDA?
Not exactly – although he does want its ‘food’ and ‘drug’ briefs split between two agencies. While acknowledging its faults, Sedak thinks the FDA does a pretty good job but one of his main beefs is that it needs to present itself more constructively to its stakeholders.
Are there any other relevant blogs by healthcare PROs?
Peter Pitts, senior vice president for health affairs at Manning, Selvage & Lee, is behind a well-regarded blog, www.drugwonks.com. It’s also worth a look on regulatory issues, not least because Pitts worked as associate commissioner of external relations for the FDA itself for two years.
For further information visit www.eyeonfda.com