In deciding what to have as my next blog topic I was torn between the mega-merger news within the Pharma industry or the appointments at the top of the HHS/FDA hierarchy. I couldn’t decide between the two so I am blogging on both.

I have been affected in a peripheral way with the mega-mergers that began this year with the news that Pfizer would be acquiring Wyeth. Although I have never worked for either company as an employee, everyday on my drive to work I go by Wyeth’s headquarters in Collegeville, PA. This was the former home to Rhone Polenc Rohrer and I was living in the area when they merged with the multiplex company that is now known as Aventis. It was sad to see a building empty out and people move away and to see the local economy affected by the moves. But, it was also exciting when Wyeth moved in and expanded the facility and gave a boost to our area.

No one seems to know what this merger will mean for either the employees or the local area. If you look to the areas where Pfizer acquired before, it looks like the immediate effects might be minimal, but that eventually Collegeville could look like Kalamazoo. Enough said . . .

As for the Merck/Schering Plough merger, that too hit close to home. I used to work at Merck back in the 1980’s and early 1990’s and I still have friends there and fond memories of working there. This was where I learned a lot of the regulatory ins and outs I use on a daily basis, even now some 16 years after I left. It is hard to imagine Merck merging with anyone and I suppose the NJ folk will be more affected than the PA people because of the proximity of Schering Plough's HQ to Merck in Whitehouse Station and Rahway. Again, time will tell.

What is the bigger message here I wonder…is it that Drug Development is only for the REALLY REALLY big players? It is expensive and getting more so; it is competitive and getting more so (can you say Biosimilars?); it is scary!

The other shakeup that we have all been waiting for since the November elections is almost a done deal now as well. We will soon have a new HHS Secretary – Kathleen Sebelius - if she can pay her taxes (welcome to our world KS!). And more importantly, at least for me, is that we will have a new FDA Commissioner, Dr. Margaret Hamburg, and Deputy Commissioner, Dr. Joshua Sharfstein.

Again, a lot of speculation as to what the joint appointments mean . . . splitting of Food and Drugs (Highly unlikely – too much stationary printed and too well known an acronym, it would be like Sting getting a last name); balance of interests (Hers – public health and equipping FDA to fight Bioterrorism and pandemics which empower the agency. His – well anyone familiar with his former boss, Senator Grassley’s agenda over the last 10 years would have to conclude it would be to 'dis-empower' the agency or at least distance it from the industry it regulates).

All this speculation has been presented in the media in an interesting fashion that focuses on the closeness of the pharma industry to the FDA and in some respects that is true – there is a lot of communication going on there. But, I wonder if any of these people have ever sat through an FDA/Sponsor meeting, because if they had they might see what I see . . . a lot of good healthy exchanges that mostly have to do with science, medicine and patients!