The New DTCA Landscape

Transcription

1 The New DTCA Landscape A Rose by Any Other Name, or Lipstick on a Pig?

2 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 what s better, safer, or appropriate

3 What s wrong with DTCA Overemphasizes drug therapy Ask your Doctor If Diet and Exercise are Right for you

4 What s wrong with DTCA: Overpromotes brand-name drugs Ask your Doctor if hydrochlorothiazide Is right for you

5 What s wrong with DTCA Harms Dr-Patient Relationship Wastes scarce time in visit I saw an ad on TV for Undermines doctorpatient trust Affects prescribing

6 What drugs need promoting? [T]o 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 alcoholism The 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

7 Vioxx: DTCA s 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 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

8 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

9 DTCA spend will decrease Annual DTCA spend in billions Vioxx withdrawal Sept 30,

10 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

11 DTCA dwarfed by promotions to physicians 30 Spending in billions DTCA 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,

12 DTCA will become more sober & educational Brief surge of doctors in white coats appearing in ads Now a mixed bag of educational ads and over-the-top ads

13 What were they thinking?

14 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

15 Consumers will become more 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.

16 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

17 FDA Enforcement will increase OCC approval requirement, 1/31/02 Vioxx withdrawal, 9/30/ so far Source: GAO, Improvements Needed in FDA s Oversight of Direct-to-Consumer Advertising (My additions for 2006 & 2007)

18 Who got FDA s coveted solitary 2007 letter? Rozerem would like to remind you that it s back to school season. Rozerem is not approved for children Reminder ads violate PhRMA guidelines

19 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. Stop Or I ll Shout Stop again!

20 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

21 DTCA will shift away from TV DTCA Spending by Media Type, % 1.00% All TV 3.46% Magazines 26.70% TV 68.30% National Magazines Sunday Supplements Internet Other

22 What s 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

23 What s 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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