Background
Now that the elections are over, the pharmaceutical industry is left to ponder what the new Congress has in store for it. There has already been a lot of speculation in the general press and trade media as well as a few shots fired across the bow by Congress.

It's not just democrats itching to get at Pharma. For example, the Senate Committee on Health, Education, Labor, and Pensions (HELP) chaired by Sen. Michael B. Enzi (R-Wyoming), met in full session on November 16, 2006 ("Hearing on Building a 21st Century FDA: Proposals to Improve Drug Safety and Innovation;" access audio and testimony from this hearing here) and Senator Charles Grassley (R-Iowa) has put a hold on the nomination of Dr. Andrew C. von Eschenbach for commissioner of the FDA.

The following is a synopsis of the issues and changes experts have predicted that the drug industry will be subjected to in the next legislative session:

Drug Price Related

• Medicare reform -- allow government to directly negotiate prices with pharmaceutical companies
• Allow drug importation from Canada
• Patent Reform -- set limits on whether big pharmaceutical firms can make deals with generic drug makers

Marketing Related

• Enact a mandatory 6-month, one- or two-year moratorium on ads for new drugs
• Require FDA pre-clearance of all DTC ads
• Wipe out or limiting tax deductions for advertising expense
• Require a "black triangle" in ads and labels for new drugs
• Set standards for risk presentation that make broadcast ads infeasible

FDA/Drug Approval/Safety Related

• Hold up of Prescription Drug User Fee Act (PDUFA) reauthorization
• Make FDA more powerful -- eg, create office of drug safety within FDA, give the FDA the power to fine companies to force them to do safety studies or change the labels of drugs (Grassley-Dodd and Enzi-Kennedy bills)

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Additional Resources

• Compilation of Articles
  
• Pharma Marketing Blog Post: What's in Store from Congress?