As Storm Clouds Gather....

There is little doubt that the pharmaceutical and biotechnology industries are in for a tough time in the coming months through the election cycle and beyond.  The breadth and depth of investigations and inquiries coming from Capitol Hill, by members of both parties, certainly signal significant reform.  In the meantime, as a prelude to that reform, lawmakers will be looking for any means at hand to haul expose failures and shortcomings.

Polls released today in the Washington Post make it appear that the Democrats are poised to make hefty gains in the Congress this fall.  Eight out of ten American say we are on the wrong track.  And for eight years, Democrats have felt a drift in regulatory enforcement across the board, and many with FDA in particular.   And whichever of the remaining three candidates win the presidential election, all three favor Medicare Part D reform to allow the government to negotiate prices and the importation of drugs. 

The process of reform will bring added scrutiny in the coming months and industry reputation, as well as individual company reputations, will be tested.  My brilliant colleague Mary Curtin has put together some excellent points in this regard and I've added a few of my own:

• Ask the really hard questions now that run the entire range of topics up for reform discussion - from DTC to the timely conduct of Phase IV trials;
• Once you've anticipated the hard questions and line up your spokespeople and internal protocols on a range of subjects now.  Don't wait.
• Conduct an internal assessment of vulnerabilities and issues;
• Monitor the blogosphere.  You can monitor blogs, you can even monitor twitter and YouTube.  New media offer the first glimpse into where public opinion is going on a whole range of topics.  Don't confine your assessment of trends to mainstream media anymore.
• Assess your attributes, such as plans for good, sound studies that benefit the public interest, particularly around pharmaco-economic data.  If you don't have any planned, consider it.
• Consider partnerships that again demonstrate the role of  the company in areas of public interest.
• Don't assume people understand the depth or breadth of your company's philanthropy. 

These are all sound bits of advice for near-term strategic communications and business planning given the way the current environment is developing.  Go to it.