In an effort to clarify some advertising grey areas-testimonials, paid spokespeople, etc.-PhRMA last week updated its 

 for consumer advertising of prescription drugs. 

The voluntary principles have been updated as follows:
  • Actors playing physicians must be identified as such. If real doctors are used in the ad, the material must recognize that they are being paid to appear in the ad.
  • Celebrity spokespeople must actually believe in, use, or have used the product they are endorsing, and companies must verify that the celebrity’s statements are true.
  • Television and print ads must include or refer a patient to FDA’s MedWatch phone number to make it easier for consumers to report adverse reactions.
  • It’s recommended that pharma companies allow a period of time to educate healthcare professionals about new drugs or expanded indications prior to the launch of a new consumer ad campaign.
  • Drug ads featuring adult content (i.e., erectile dysfunction ads) should steer clear of youth-oriented television shows and publications.
  • Risk information must be given as much airtime and print space as benefit content, without any distractions.

The new guidelines, which echo many of the changes the Federal Trade Commission made to its guidance earlier this month, will go into effect March 2.

“Whether [these guidelines] make any material difference remains to be seen,” said Peter Rost, former vp of marketing at Pfizer. “But it’s good that PhRMA is clarifying a lot of the specifics that have been in the guidelines since they were issued in 2006. I think that the principles and the goals remain the same, which is to ensure that DTC advertising is done responsibly.”

Pharmaceutical companies are not mandated to follow these guidelines, but most do so. From a policy standpoint, the PhRMA decree does not change any of FDA’s regulations, but the new guidelines could spur further, voluntary regulation. The original guidelines encouraged pharma manufacturers to submit DTC ads to FDA in advance of publication or broadcast. 

“Pharmaceutical research companies for years have voluntarily exceeded regulatory requirements for direct-to-consumer advertising of prescription medicines,” stated PhRMA President and CEO Billy Tauzin in a release. “Our guiding principles help ensure that DTC advertising appropriately and accurately conveys important information about medical conditions, medicines, and other treatment options.”

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Consumer pharma marketers are going to have to be a little more careful when using celebrity spokespeople or actors playing physicians. PhRMA has updated its rules and the consensus is clear - if you are paying for promotion, it must be noted in the ad.

PhRMA Enhances DTC Guidelines

The Massachusetts Public Health Council, last week, publicly announced its 

 to drastically limit what pharmaceutical and medical device firms can and cannot do in terms of marketing to physicians.

If the new rules are approved, pharma companies 

 be able to:
  • Hand out free tickets to any entertainment or sporting event
  • Disperse gifts, including pens, mugs, and calendars
  • Feed spouses or guests of physicians; meals must be heavily restricted and can’t be offered outside the doctor’s work environment 

“Our goal in drafting these regulations was to uphold the intent of the law passed ... last August; namely, to curb any inappropriate influence of industry sales and marketing activities on the independent clinical judgment of health care providers in the Commonwealth,” stated Massachusetts Department of Public Health Commissioner John Auerbach in a release.

 The Massachusetts’s Department of Public Health was required to create these proposed regulations in response to legislation passed in August calling for healthcare reform. “The goal of the regulations is to try to improve the quality of healthcare in [Massachusetts] while trying to control cost,” said John Jacob, spokesperson for the Mass Department of Public Health. “We are trying to drive out as many hidden costs from the health services field as we can.” 

 that the state is trying to curb any kind of financial incentive that could persuade healthcare providers to prescribe particular drugs or healthcare devices unnecessarily or instead of a cheaper alternative.  

While at least six other states have enacted similar regulations, Massachusetts’s officials are touting their code of conduct as one of the strictest in the nation. The state Web site lists a litany of regulatory firsts including initiatives that require disclosure of all drug samples and medical equipment under review, pubic record of all disclosure data, and the fact that Massachusetts is the only state to require pharma compliance under a marketing code of conduct. 

Public hearings are scheduled for January 9 and 12. 

Forget putting a cap on how much a gift to doctors should cost, the state of Massachusetts is considering outlawing everything from pens to meals - and don't even think about handing out free tickets to next week's Red Sox game.

Pharmaceutical Executive-12-17-2008

PhRMA Enhances DTC Guidelines

Mass. Eyeballing Major Promotional Changes for Pharma