The New DTCA Landscape

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The New DTCA Landscape

• A Rose by Any Other Name,
• or Lipstick on a Pig?

www.prescriptionaccess.org
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Direct-to-Consumer Advertising

• 4.7 - 5 Billion to consumers in 2006
• ROI 150-420
• Only US NZ permit it
• But what gets advertised?
• Newest, most expensive, and copycats
• Not necessarily whats better, safer, or
  appropriate

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Whats wrong with DTCAOveremphasizes drug therapy

• Ask your Doctor
• If Diet and
• Exercise are
• Right for you

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Whats wrong with DTCAOverpromotes brand-name
drugs

• Ask your Doctor if hydrochlorothiazide
• Is right for you

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Whats wrong with DTCAHarms Dr-Patient
Relationship

• Wastes scarce time in visit
• Undermines doctor-patient trust
• Affects prescribing

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What drugs need promoting?

• To rely on the drug companies for unbiased
  evaluations of their products makes about as much
  sense as relying on beer companies to teach us
  about alcoholismThe fact is that marketing is
  meant to sell drugs, and the less important the
  drug, the more marketing it takes to sell it.
  Important new drugs do not need much promotion.
  Me-too drugs do.
• Marcia Angell, MD, New England Journal of
  Medicine

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Vioxx DTCAs poster child

• Over 20 million people took it
• Was it useful?
• 1-2 of patients, less gastric risk
• No better than ibuprofen
• Expensive!
• 80,000-120,000 cardiac events, 32,000-48,000
  deaths (Graham)
• Millions of unnecessary Rxs
• Billions in unnecessary spending
• Prediction of public backlash and increased
  regulation of DTCA

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Post-Vioxx predictions

• DTCA spending will decrease
• DTCA will become more sober educational
• Consumers will become skeptical
• Congress will regulate DTCA
• FDA enforcement will increase
• Industry will self-regulate
• DTCA will shift away from TV

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DTCA spend will decrease
Vioxx withdrawal Sept 30, 2004
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DTCA still working
Top 3 Products by Sales, 2006
Drug Sales Rank 2006 Sales DTCA spend rank 2006 DTCA spend
Lipitor 1 8.6 billion 9 138.2 million
Nexium 2 4.3 billion 4 176.7 million
Advair 3 3.9 billion 7 145.6 million
Sources IMS Health, Top 10 Products by U.S.
Sales, and DTC Perspectives, June/July 2007
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DTCA dwarfed by promotions to physicians
(Detailing, Journal ads Samples)
Source A Decade of Direct-to-Consumer
Advertising of Prescription Drugs, Donohue,Julie
M. Cevasco,Marisa Rosenthal,Meredith B., N Engl
J Med, 2007, 357, 7, 673-681
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DTCA will become moresober educational

• Brief surge of doctors in white coats appearing
  in ads
• Now a mixed bag of educational ads and
  over-the-top ads

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What were they thinking?
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Disease Awareness ads will increase
Tamiflu/Happy Feet tie-in

• Not particularly effective 1.3 day reduction
• Cost 85.00
• Adverse events delirium, hallucinations,
  abnormal behavior

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Consumers will becomemore skeptical

• Level of trust with drug industry (Harris Poll,
  4/07)
• Trust 27 vs. Distrust 42
• TNS Healthcare Poll of consumers, 6/07
• 60 Ads are misleading and/or contain
  exaggerated claims.
• Almost half Broadcast ads do not contain enough
  information about risks and side effects
• 43 Ads are unclear and lead patients to request
  inappropriate drugs.

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Congress will regulate DTCA

• PDUFA
• Fines for deceptive ads (Senate max 150k,
  House max 250k)
• Fees for pre-broadcast review
• No moratorium on DTCA
• No change in standards
• No guarantee of increased enforcement

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FDA Enforcement will increase
OCC approval requirement, 1/31/02
Vioxx withdrawal, 9/30/04
3
1
2006
2007 so far
Source GAO, Improvements Needed in FDAs
Oversight of Direct-to-Consumer Advertising
(My additions for 2006 2007)
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Who got FDAs coveted solitary 2007 letter?

• Rozerem would like to remind you that its back
  to school season.
• Rozerem is not approved for children
• Reminder ads violate PhRMA guidelines

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FDA asks Takeda to close the barn door after the
horse is gone

• When do kids go back to school? September
• When was FDA letter issued? March
• What did the letter ask Takeda to do?
• DDMAC requests that Takeda immediately cease the
  dissemination of violative promotional materials
  for Rozerem such as those described above.
• StopOr Ill Shout Stop again!

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Industry will self-regulate

• PhRMA Guiding Principles on Direct to Consumer
  Advertisements
• Vague unenforceable
• Office of Accountability report no details!
• Fox Guarding The Henhouse Award
• Violations aplenty

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DTCA will shift away from TV
Magazines
TV
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Whats happened since Vioxx?

• DTCA spending continues to go up
• Ads not really more sober educational
• Consumers somewhat more skeptical, but DTCA still
  works
• Congress has done little to regulate
• FDA enforcement has continued to go down
• Industry self-regulation is a joke
• DTCA continues to rely on TV, most ineffective
  medium for full information

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Whats needed

• Increase enforcement
• Advisory Review fees would help, but only if will
  is there
• End requirement of FDA Chief Counsel review of
  letters
• Reduce delays in letters
• Impose fines permitted by PDUFA
• Require pre-dissemination broadcast
• Prohibit reminder ads
• Regulate disease awareness ads that connect to
  product ads
• Prohibit coupons
• Return to pre-1997 requirements full brief
  summary

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• Learn more about PAL
• www.prescriptionaccess.org/blog
• www.bitterpillawards.org
• www.askpharmie.org