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Upcoming & Past Roundtable Discussions

110th Congress: What’s in Store for Pharma?

Date: Tuesday, 28 November 2006
Time: 1:00 PM Eastern Time
By special invitation only.

The first 30 minutes or so of call will be podcast live! via the Pharma Marketing Talk Channel.

This Roundtable discussion will be devoted to likely new legislation from the newly-elected 110th Congress.

Resources relevant to this discussion.

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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Compilation of Articles

Pharma Marketing Blog Post: What’s in Store from Congress?