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So the democrats are in control, what does that mean for you?

 

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Despite the best efforts by pharma, which I covered recently, the Democrats won control of the US House and Senate.

Now, in the aftermath of the midterms, the wooing commences. Lobbying against some key Democrat policies has already begun. Pharmaceutical companies are recruiting Democratic lobbyists, lining up allies in the Bush administration and Congress, renewing ties with patient organizations, and even lobbying for enough republican support to give them a potential veto from the White House.

The attitude, though hopefully exaggerated, expressed by Ken Johnson, a senior vice president at Pharmaceutical Research and Manufacturers of America, as “It’s all hands on deck. It’s like a hurricane warning flag. You don’t know where it will hit. You don’t know who will be affected. But everybody has to be prepared.”

So why so much lobbying? Why so afraid of these big bad Democrats? While many of the issues are well document and old news, I’ll try and present ‘The Stakes.’

The most obvious is the price of prescription drugs, with solutions being an overhaul of Medicare Part D, biogenerics and re-importation of Canadian drugs. Safety and conflicts of interest also weigh heavily on the minds and campaign promises, which could result in greater DTC regulation and increased scrutiny of the FDA.

  • Re-importation. Many democrats made campaign promises to introduce or support legislation to allow re-importation of Canadian drugs. Nothing new there. However, a recent AP post argues that it isn’t a top priority. However, even if they allow re-importation, that doesn’t mean us Canadians will allow access to our drugs, for fear of reprisals.
  • Generics. Briefly, unlike with most pharmaceuticals produced by traditional drug companies, there is no federal regulatory system to approve generic versions of biotech drugs (more on this here). For more on how this may play out, go here.
  • FDA reform. Democrats are seeking new post-approval studies, giving the agency more authority to update drug labels and new funding support for the FDA. There are pros and cons of this for the pharma industry, as explained here. A summary of recommended FDA improvements can be found here.

Some other interesting perspectives on the role of science and the recent elections:

  • A broader look at the exploding politics of biotech can be found here, with a particular look at the role of stem cell research.
  • In a compelling assessment of the election’s implications for technology more broadly, Jason Pontin, editor of Technology Review paints a much rosier picture. He argues, among other things, that historically, Republicans have been less inclined to fund research whose only end is discovery. A Democratic Congress will be friendlier towards technology ventures, will fund discovery-based research like stem cell research, while creating more, new technologies, but will at the same time be much more ready to regulate emerging technologies.

So what does it all mean? An end to the status-quo? Bad news for big pharma might also bring good news for researchers and early stage companies seeking non-dilutive funding. Wait and see, I guess. Either way, it’s a good time to be a lobbyist.

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  • http://www.pros-and-cons-of-stem-cell-research.com Stem Cell Research

    Sometimes we don’t like to admit it. We think that the FDA, and science initiatives would be party-independant. After all, shouldn’t the FDA support the same drugs either way. Wrong, there’s a lot more politics involved than we would like to think. I’m not saying it’s all bad, but politics are definately involved.

Kevin Downing @ MaRS

Kevin Downing @ MaRS

Kevin currently manages initial client engagements with the MaRS Venture Group. He also administers a federal fund that provides mentorship to start-up companies across Ontario.

 
 
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