Thursday, June 14, 2007

Politicians Scrutinize Pharmaceutical Advertising

Advertising of pharmaceutical drugs to the public is a peculiar U.S. phenomenon, which has allowed great expansion of the pharmaceutical business by pushing demand. Hedonistically I've always enjoyed the windfall that the Ad business has enjoyed as well over the past decade however I have wondered about downside of going to our own doctor and announcing our own prescription.

Apparently I’m not alone in this thought process and the Energy and Commerce Committee's Subcommittee on Health is looking over a multi-pronged bill concerning health in the US. Some of the items being considered are an amendment to the Federal Food, Drug and Cosmetic Act "to improve drug safety." Advertising Policy is one of the primary concerns. Here are some of the proposed changes: an ad may need government approval: "the risk evaluation and mitigation strategy for a drug may require that the applicant submit...advertisement of the drug for pre-clearance." The appropriate authorities would have 45 days for review. Second, if there have been any "significant adverse events" or other risk associated with the drug, this must be part of an advertisement, and "advertisements lacking such disclosure would be false or misleading." Finally, the bill states that "the risk evaluation and mitigation strategy for a drug may require that for a fixed period after initial approval, not to exceed three years, the applicant not issue or cause to be issued direct-to-consumer advertisements..."

I’m all for putting a few controls into place however this sounds like bureaucratic BS at it’s finest. One thing we know for sure is nothing will change fast. There are far to many companies involved with very large vested interests.


  1. Here is an except from a letter sent out today on this topic by the AAF.

    AAF Members

    Jeffry Perlman, Executive Vice President – Government Affairs
    Re: House Committee Rejects DTC Advertising Restrictions

    Last night, the House Energy and Commerce Committee Health Subcommittee accepted an amendment to the Drug Safety Act that repeals the restrictions on commercial speech contained in the original bill and gives the FDA authority to assess monetary penalties for advertising found to be false or misleading. This amendment essentially tracks the Roberts-Harkin amendment that was supported by the industry and passed the Senate last month.

    The advertising provisions in the original bill included authority for the FDA to impose a three-year moratorium on prescription drug advertising, required preapproval of both individual DTC ads and comprehensive marketing plans and added additional and unwieldy mandatory warning language to ads and packaging.

    Reps. Edolphus Towns, D-N.Y., and Steve Buyer, R-Ind., sponsored the amendment repealing the restrictions. After much debate, the subcommittee approved the amendment by a vote of 23–9. Ralph
    The next steps are a vote in the House Energy and Commerce Committee, before a vote in the full House of Representatives and conference reconciliation with the Senate version of the bill. It is possible that opponents may try to revisit advertising restrictions. We will inform you of any new developments concerning the legislation.

  2. Thanks for the update David. I was reading the news in the trades last evening just about the time you posted the updated news. If your interested in more hot advertising news involving politics, read todays posting (06/21/07) "The Fair Elections Now Act" - Political Pickpockets