$4 BILLION DTC DRUG AD FIGHT FINDS A HUMAN FACE
Widowed Ad Exec Suing Pfizer Testifies at Charged FDA Debate
HEARINGS ON $4 BILLION DTC INDUSTRY BEGIN
Pfizer Talks of Changes, Consumers Union Urges Reform
200 MED SCHOOL PROFESSORS CONDEMN DTC ADVERTISING
Commercial Alert Organizes Effort to Back Upcoming FDA Testiomny
DRUG GIANTS SHIFT DTC ADVERTISING STRATEGIES
Tighter Government Controls Anticipated
FDA TO HOLD NEW DTC ADVERTISING HEARINGS
First Regulations Expected; Celebrity Endorsers May be Banned
PFIZER ANNOUNCES NEW DTC AD POLICY
Branded Campaigns to Focus on Diseases Without Product Mention
PHARMACEUTICAL INDUSTRY ISSUES DTC AD GUIDELINES
Softball Approach Rejects Calls for Restrictions or Moratorium
SENATE MAJORITY LEADER ENDORSES TWO-YEAR DTC AD BAN
Voluntary Moratorium Would Apply to New Drugs on Market
BRISTOL-MYERS SQUIBB ANNOUNCES NEW DTC POLICY
Will Cease Ads During First Year of a New Drug's Release
FDA ORDERS ELI LILLY TO PULL DTC DRUG COMMERCIAL
Cites Strattera TV Ad as False or Misleading
FDA ORDERS PFIZER'S BEXTRA WITHDRAWN
Cites 'Unfavorable' Risk vs. Benefits
FDA ORDERS ASTRAZENECA CRESTOR ADS PULLED
Cites 'Misleading Claims' in 'Clearly the Best' Ad Series
FDA ASKED PFIZER TO HALT CELEBREX ADS
No Indication How Long Suspension Will Last
PFIZER TO PULL CELEBREX CONSUMER ADVERTISING
But Says It Does Not Intend to Withdraw Drug From Market
MERCK PULLS $2.5 BILLION DRUG VIOXX OFF MARKET
$78 Million Advertising Account Is With DDB, FCB
That’s the conclusion of three legal experts at a media briefing and Webcast by the Washington Legal Foundation this week called “Regulating Drug Promotion: Assessing a Tumultuous 2005 and Prospects for the New Year.”
“There was so little common ground” at the FDA’s November public hearings with the drug industry “that I suspect nothing will happen,” said Richard Samp, the foundation's chief counsel. The other two participants were David J. Bloch, a partner in the Washington law firm Reed Smith, and Adonis Hoffman, senior VP-counsel for the American Association of Advertising Agencies.
Mr. Samp said there are major stumbling blocks to a proposed code of conduct drawn up by the drug industry’s trade group, the Pharmaceutical Research and Manufacturers of America. Part of the code requires pharmaceutical companies to submit DTC ads to the FDA, which he said is fraught with problems.
“I don’t think pre-clearance is ever going to work, because the FDA is never going to say that ‘Once we have seen the ad and not objected, we waive our right to object’” in the future, he said.
Mr. Samp said the pre-clearance guideline is dubious, because neither the FDA nor the pharmaceutical companies will come to an agreement on this issue unless drug makers are given assurances against a form of double jeopardy. That is, if the FDA approves marketing for a drug in the pre-submittal process, it cannot come back later and hand out a warning letter for a product that it has already approved.
“That’s the only grounds on which any pharmaceutical company would ever agree to any pre-clearance, that they would get some sort of ‘safe harbor’ if they did so,” Mr. Samp said. “And no amount of resources at DDMAC [the FDA’s Division of Drug Marketing, Advertising and Communication] is ever going to put FDA in a position of agreeing to this kind of safe harbor.”
'Another ball in the air'
Mr. Bloch said pharmaceutical companies need to be wary of issues such as potential liability under the False Claims Act and suggestions of a one- or two-year moratorium on advertising after a product hits the market. “None of this has gone terribly far,” he said, “but it’s another ball in the air to watch as things progress.”