Thursday, November 17, 2005

AstraZeneca's Risky Proposition

AstraZeneca stunned attendees at the recent FDA hearings -- at least those "in the know" -- with an announcement that it submitted written testimony proposing "a mandatory requirement for pharmaceutical companies to submit all [emphasis added] direct-to-consumer (DTC) advertising to the U.S. Food and Drug Administration's (FDA) Division of Drug Marketing and Communication (DDMAC) for review prior to its use. (See "AstraZeneca Proposes Mandatory FDA Review Of All Pharmaceutical Direct-To-Consumer Advertising.")
"The PhRMA guidelines are a solid first step, but the proposals we're making today make clear that AstraZeneca views the PhRMA principles as a floor, not a ceiling," said Tony Zook, Senior Vice President, Commercial Operations, and President and CEO designate, AstraZeneca Pharmaceuticals LP. "If our collective goal is to ensure that accurate and responsible information is communicated to patients and health care providers, then manufacturers, patients, physicians and policymakers ought to welcome such a review process."
AstraZeneca's proposal includes several tradeoffs and loopholes. For example, any pre-approved ad would be exempt from a subsequent finding by the FDA that the advertisement is misleading or inaccurate.

Also, AstraZeneca would support legislation that would require a mandatory review of DTC advertisements by the FDA, but
only [emphasis added] where DDMAC has the necessary resources to conduct its review within a specific timeframe. That's a Catch-22 noted by several Pharma Marketing Roundtable members who unanimously agreed that the announcement was a red herring -- AstraZeneca knows full-well that the FDA doesn't have the resources to pre-approve all DTC ads, including print as well as TV ads.

Smart Move or Dumbass?

James Gardner, a Pharma Marketing Roundtable member, had this to say in his recent post to
The Health Care Blog: "Knowing that the FDA is woefully understaffed for this type of effort, it's a "can't lose" offer on Astra Zeneca's part! However, it'’ll play well in the popular press so my sense is that it was a smart move on their part."

But, this "smart move" may backfire. "AstraZeneca put forth a pretty risky proposition," says Harry Sweeney, Pharma Marketing Roundtable member and CEO/Chief Creative Officer at Dorland Global Health Communications. "If the agency says it doesn't have the resources, then you'll have Congressman Henry Waxman jumping up and down on the Hill promising to get additional resources for the FDA. You just don't know what will happen."


What we're witnessing here is a classic blunder by the pharmaceutical industry. Each company is trying to outdo the other in going beyond the voluntary guidelines for DTC set forth by PhRMA. The 2006 and 2008 political candidates are watching closely the cards that the industry is revealing. They now know how far to go in crafting new legislation to reign in DTC and/or to give the FDA more power. In the end, the industry's voluntary guidelines, plus the extras being piled on by AstraZeneca and other pharma companies, may become mandatory through legislation.


I know there are some industry leaders out there who are saying to themselves about now: "This is the slippery slope down which PhRMA's voluntary guidelines have led us." If they are slipping, they have no one else to blame but themselves.

3 comments:

  1. Connie9:52 AM

    So almost a year later, what happened with this? Was it indeed a risky move? What has been the fall out?

    ReplyDelete
  2. Well, for one thing, Senators Kennedy and Enzi have introduced a bill to revamp the FDA.

    "What the bill will require is better planning before approval of how drugmakers and the FDA are going to identify and manage risks after approval," an aide said.

    A government expert who has seen an outline of the proposal said it would require drug companies to include a risk-management plan with their drug approval submission.

    The proposal would also penalize companies that do not follow the risk plan and would require them to disclose results from major clinical trials, according to a New York Times report.

    Money for this reform might also come from additional fees paid to the agency by pharmaceutical companies.

    ReplyDelete
  3. Catherine6:06 PM

    Who was the moron at Astra-Zeneca that thought that putting Arimidex in a package that old ladies with arthritis in their hands can't open? Do they want to kill us? Just shoot me and save all of us time.

    ReplyDelete