1. Stresses on Drug Marketing in 2007 & beyond John Kamp Executive Director Coalition for Healthcare Communication AMM, 11/8/07

2. Macro View Public Perception of Pharma Public Perception of Pharma Approval Ratings below lawyers, car dealers & President Bush Approval Ratings below lawyers, car dealers & President Bush Off Bottom, or “Dead Cat Bounce” ? Off Bottom, or “Dead Cat Bounce” ? Congressional Action, consumer & prescriber caution on Safety Issues Congressional Action, consumer & prescriber caution on Safety Issues FDA’s near “freeze” on New Drug Approvals FDA’s near “freeze” on New Drug Approvals

3. Marketing Tactics Under Siege Marketing, esp. DTC, attacked by Voters, Doctors, Policy Makers & the Press Marketing, esp. DTC, attacked by Voters, Doctors, Policy Makers & the Press Detailing, sampling & promotional education limited by medical schools, managed care and individual prescribers Detailing, sampling & promotional education limited by medical schools, managed care and individual prescribers Company funded CME pressured by Congress, ACCME Company funded CME pressured by Congress, ACCME Marketing use of prescriber data banned in New Hampshire, Vermont & Maine Marketing use of prescriber data banned in New Hampshire, Vermont & Maine “False Claims” punished by HHS-IG, Whistleblowers “False Claims” punished by HHS-IG, Whistleblowers “Gifts to Physicians” registries growing in states, proposed in Senate and House “Gifts to Physicians” registries growing in states, proposed in Senate and House “Failure to Warn” class actions suits follow safety concerns “Failure to Warn” class actions suits follow safety concerns

4. What didn’t happen Drug Marketing on Capitol Hill in 2007 Safety Limits on all marketing Safety Limits on all marketing Symbol on all new drugs Symbol on all new drugs REMS “review” of every drug campaign REMS “review” of every drug campaign Tax penalty for all marketing Tax penalty for all marketing DTC Ban, new warnings DTC Ban, new warnings 3 year moratorium on new drug ads 3 year moratorium on new drug ads Pre-clearance of every ad10 second flash of 1-800 Adverse Events line Pre-clearance of every ad10 second flash of 1-800 Adverse Events line 10 second flash of 1-800 Adverse Events line 10 second flash of 1-800 Adverse Events line But, script for Hill and White House in 2008? But, script for Hill and White House in 2008?

5. What Did Happen Significant new FDA power to review all marketing under REMS program Significant new FDA power to review all marketing under REMS program Thirty Six new FDA staff to review of DTC Thirty Six new FDA staff to review of DTC Congressional “cover” for more aggressive DDMAC enforcement action Congressional “cover” for more aggressive DDMAC enforcement action New DTC Advisory Committee New DTC Advisory Committee

6. Broader Safety Provisions FDA Amendments Act of 2007 Active surveillance system Active surveillance system Public private partnerships Public private partnerships REMS REMS Communication programs Communication programs Restricted distribution, use Restricted distribution, use New Labeling power New Labeling power New studies or clinical trials orders New studies or clinical trials orders

7. REMS (the new “Risk Maps”) Secretary may require a REMS, if necessary, to ensure that the benefits outweigh the risks Secretary may require a REMS, if necessary, to ensure that the benefits outweigh the risks Secretary may require a REMS if, Secretary may require a REMS if, based on a signal of serious risk, based on a signal of serious risk, a REMS is necessary to: a REMS is necessary to: Assess signal Assess signal Mitigate risk Mitigate risk Perhaps the most significant change in decades Perhaps the most significant change in decades

8. New DTC Review System Payment for Review of television ads Payment for Review of television ads Except Required Submissions Except Required Submissions Raise $6.25 M/ up to 150 ads Raise $6.25 M/ up to 150 ads Workload and cost of living adjusted Workload and cost of living adjusted Payment: due Oct 1 of submission FY Payment: due Oct 1 of submission FY Late (Nov 1) fee 150% Late (Nov 1) fee 150% Operating reserve fee, 1 st FY you pay Operating reserve fee, 1 st FY you pay Non transferable, carry over max 1 Non transferable, carry over max 1 Cap $83 K in 08; 150% increase per FY Cap $83 K in 08; 150% increase per FY

9. Pre-review of TV Ads Pre-review of Advertisements (45 day) Pre-review of Advertisements (45 day) Information in brief summary relating to a serious risk or a safe use protocol Information in brief summary relating to a serious risk or a safe use protocol Specific Disclosures Specific Disclosures Serious Risk or Safety Protocol Serious Risk or Safety Protocol Fair Balance, False or Misleading, within label indications Fair Balance, False or Misleading, within label indications

10. New FDA DTC Rule Required Rule-Making on “Major Statement”  New requirement that the “major statement” in radio and TV ads must be presented in a “clear, conspicuous, and neutral manner”  FDA must promulgate regulations establishing standards for determining the meaning of “clear, conspicuous and neutral”  Open Question: Are these regulations subject to the Part 15 Public Hearing procedures?  If so (and perhaps even if not), any rule-making may be much broader than specifically required and also quite onerous and contentious

11. New Civil Money Penalties (CMPs)  Hill Compromise to avoid DTC Ban  Applies to DTC ads that are “false or misleading”  $250K for first violation in 3 year period/$500K for subsequent violations  FDA may face heavy pressure to make frequent use of new CMP authority  Major Question: Will CPM authority broaden to all marketing?

12. Risks and Opportunities of DTC Reviews Unclear if voluntary program will sustain new DDMAC program, reviewers Unclear if voluntary program will sustain new DDMAC program, reviewers Participants will get more timely, predictable reviews Participants will get more timely, predictable reviews When is pre-review advisable: When is pre-review advisable: Expensive production; long-running, visible ads Expensive production; long-running, visible ads Ads nearing “edge of envelope” Ads nearing “edge of envelope” Where required by consent decree/accelerated review Where required by consent decree/accelerated review Competitive therapeutic classes where complaints likely Competitive therapeutic classes where complaints likely Insufficient company ad review process; poor compliance history Insufficient company ad review process; poor compliance history

13. What Next ? Congressional Report– FDA must report to Congress within 2-years concerning DTC communication with elderly, children, racial and ethnic minorities Congressional Report– FDA must report to Congress within 2-years concerning DTC communication with elderly, children, racial and ethnic minorities FDA must conduct study by March 2008 to evaluate whether Adverse Events # required in print ads as be in broadcast ads. FDA must conduct study by March 2008 to evaluate whether Adverse Events # required in print ads as be in broadcast ads. FDA Advisory Committees on Risk Communication & DTC will advise, recommend, raise issues FDA Advisory Committees on Risk Communication & DTC will advise, recommend, raise issues New Congress, White House, HHS-FDA leaders New Congress, White House, HHS-FDA leaders Candidate Edwards proposes DTC ban Candidate Edwards proposes DTC ban

14. Certified CME Grants Under Attack ACCME increasing oversight ACCME increasing oversight 2004 Standards for Commercial Support 2004 Standards for Commercial Support August 2007 “Commercial Interest” policy August 2007 “Commercial Interest” policy Congressional Oversight Congressional Oversight 2007 Senate Finance Committee Report 2007 Senate Finance Committee Report Senate (Grassley & Kohl), House (Waxman) proposals for “national registry of payments and gifts to physicians” Senate (Grassley & Kohl), House (Waxman) proposals for “national registry of payments and gifts to physicians”

15. Continuing Medical Education Two types of prescriber education Two types of prescriber education “Promotional detailing, education programs “Promotional detailing, education programs Must stay within labeling Must stay within labeling Closer review by FDA & under HHS-IG “CIAs” Closer review by FDA & under HHS-IG “CIAs” Independent, Certified CME for mandated CE Independent, Certified CME for mandated CE Company grants allowed by 1997 FDA Guidelines Company grants allowed by 1997 FDA Guidelines Accredited by ACCME, AAFP, others Accredited by ACCME, AAFP, others

16. NEW RULES FROM ACCME Broad definition of “commercial interest” Broad definition of “commercial interest” New “fire wall” requirements New “fire wall” requirements Asserts jurisdiction on “joint sponsor” MECCs Asserts jurisdiction on “joint sponsor” MECCs Double Standard for MECCs and favored providers Double Standard for MECCs and favored providers

17. Coalition/NAAMECC Response to ACCME Coalition letter challenges impossible deadlines on compliance Coalition letter challenges impossible deadlines on compliance Joint Sponsor MECCs deadline now August 2009 Joint Sponsor MECCs deadline now August 2009 Coalition/NAAMECC request meeting to develop clear guidance Coalition/NAAMECC request meeting to develop clear guidance Coalition to challenge definitions, double standard Coalition to challenge definitions, double standard

18. Public/Industry Education “Certified CME is Different” “Certified CME is Different” Development of consistent language, clearer messaging Development of consistent language, clearer messaging Reaching out to broader community Reaching out to broader community SACME, Alliance for CME, AMA Task Force SACME, Alliance for CME, AMA Task Force Speaking Out at Industry Conferences Speaking Out at Industry Conferences DIA, FDLI, Med Ed Forum, etc. DIA, FDLI, Med Ed Forum, etc.

19. Congressional Education on CME Issues Coordinating with Industry Groups, including PhRMA, AMA, AdvaMed Coordinating with Industry Groups, including PhRMA, AMA, AdvaMed Reaching out to Hill leaders Reaching out to Hill leaders Concern about “Gift to Physician” Registries Concern about “Gift to Physician” Registries Tom Sullivan, CEO of Rockpointe, coordinating effort Tom Sullivan, CEO of Rockpointe, coordinating effort

20. Prescriber Data New Hampshire bans “commercial use” in July 2006 New Hampshire bans “commercial use” in July 2006 Federal trial court invalidates under First Amendment Spring 2006 – appeals pending Federal trial court invalidates under First Amendment Spring 2006 – appeals pending Maine & Vermont pass similar legislation several weeks later Maine & Vermont pass similar legislation several weeks later Congressmen Waxman & Pallone propose federal ban Congressmen Waxman & Pallone propose federal ban

21. Federal & State Prosecutions False Claims act False Claims act Focus on “off-label” information that leads to prescribing, thus “false” reimbursement by Medicare, Medicaid, etc. Focus on “off-label” information that leads to prescribing, thus “false” reimbursement by Medicare, Medicaid, etc. New interpretation of FDA labeling rules New interpretation of FDA labeling rules Anti-kickback Act Anti-kickback Act Punishes bribes and gifts to physicians Punishes bribes and gifts to physicians Over $4.5 Billion in Settlements since 2000 Over $4.5 Billion in Settlements since 2000

22. Failure to Warn New private action, negligence tort cases in wake of safety publicity New private action, negligence tort cases in wake of safety publicity High profile actions against Wyeth (phen- phen), Merck (Vioxx) -- GSK ? (Avandia) High profile actions against Wyeth (phen- phen), Merck (Vioxx) -- GSK ? (Avandia) Class actions may be limited, e.g., Merck Class actions may be limited, e.g., Merck But, new theories every day, e.g., failure to inform But, new theories every day, e.g., failure to inform

23. Kamp Crystal Ball Clouded at best, maybe shattered Clouded at best, maybe shattered Some hope Some hope Part D lessens citizen, political pressure Part D lessens citizen, political pressure PhRMA guidelines on DTC, gifts to physicians PhRMA guidelines on DTC, gifts to physicians Legal, political defense by PhRMA, others Legal, political defense by PhRMA, others Some despair Some despair Right to free healthcare, drugs Right to free healthcare, drugs Political value in criticizing drug marketing Political value in criticizing drug marketing Sicko media Sicko media

24. For More Information John Kamp John Kamp Coalition for Healthcare Communication Coalition for Healthcare Communication www:cohealthcom.org www:cohealthcom.org 212-850-0708 212-850-0708 202-719-7216 202-719-7216 jkamp@cohealthcom.org jkamp@cohealthcom.org