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John Kamp Jan 2010


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AMM January Meeting presentation by John Kamp, Executive Director, Coalition for Healthcare Communication: "The Current Regulatory and Political Landscape of Pharmaceutical Marketing & Education"

Published in: Health & Medicine, Business
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John Kamp Jan 2010

  1. 1. Drug Information and Communication in the Obama Era John Kamp Executive Director Coalition for Healthcare Communication AMM, January 21, 2010
  2. 2. What Next ? <ul><li>MA election changes the dynamic, especially for Blue Dogs, Moderate D’s </li></ul><ul><li>Two clear possibilities </li></ul><ul><ul><li>House Passes Senate version, sends to WH </li></ul></ul><ul><ul><li>Scaled down version, but what to save, what to discard </li></ul></ul><ul><li>Expect WH, Senate Leader, Speaker summit meeting very soon; President cannot deliver State of the Union without a plan </li></ul>
  3. 3. So, what about big Four Communication Issues ? <ul><li>Tax on Medical Marketing </li></ul><ul><ul><li>Maybe back on the table </li></ul></ul><ul><li>Transparency </li></ul><ul><ul><li>Maybe stays, one of the few items with bi-partisan support </li></ul></ul><ul><ul><li>States active anyway </li></ul></ul><ul><li>Marketing use of prescription data </li></ul><ul><li>Expanded Brief Summary </li></ul>
  4. 4. A few Kamp Rules of Washington <ul><li>Never wake a snake to kill it </li></ul><ul><ul><li>Watch, listen very carefully </li></ul></ul><ul><li>Dig the well before the drought </li></ul><ul><ul><li>Keep you pens and email lists very handy </li></ul></ul><ul><li>No good or bad idea dies, it just waits for another day </li></ul><ul><li>Keep your friends very close, enemies even closer.. </li></ul>
  5. 5. It’s not (just) Medical Communication <ul><li>Public Perception of Pharma/Biotech/Device Industries </li></ul><ul><ul><li>Approval ratings near lawyers, car dealers & former President Bush; just above insurers </li></ul></ul><ul><li>Fears about safety; Congress, FDA, consumers, prescribers, press </li></ul><ul><li>Cost of Drugs </li></ul><ul><li>Politics of Health Care Reform </li></ul>
  6. 6. Challenges Abound <ul><li>Industry funding of organized medicine challenged by Congress, ACCME, Macy, IOM, Med Pac </li></ul><ul><li>“ Transparency” bills in states & Congress require additional disclosures of all relationships with prescribers </li></ul><ul><li>Whistleblower & HHS-IG/State lawsuits, CIAs & DPAs </li></ul><ul><li>Detailing, sampling & promotional education limited by medical schools, managed care, some practice groups </li></ul><ul><li>State limits on commercial use of prescriber data in New Hampshire, Vermont & Maine </li></ul><ul><li>“ Counter-detailing” in PA, VT, DC </li></ul><ul><li>Plaintiff Class Action Suits </li></ul>
  7. 7. Hill Priorities Beyond HCR: Past is Prologue <ul><li>Unfinished business from 2007-8 </li></ul><ul><ul><li>National Registry of gifts and payments; Grassley/Kohl/DeFazio/Stark </li></ul></ul><ul><ul><li>Limits consumer ads; Kennedy/Waxman/Stupak </li></ul></ul><ul><ul><li>Safety “reviews” of ALL new drugs & marketing plans; Kennedy, Dingell, Waxman </li></ul></ul><ul><ul><li>Tax penalty for all marketing; Rahm Emanuel </li></ul></ul>
  8. 8. Likely FDA Agenda <ul><li>FDAAA of 2007 still sets priorities for 2008-10 </li></ul><ul><ul><li>Dozen rules and reports mandated </li></ul></ul><ul><ul><li>Critical Path--modernizing the clinical trial </li></ul></ul><ul><ul><li>Advisory Committee recruiting/conflict issues </li></ul></ul><ul><ul><li>REMS </li></ul></ul><ul><ul><li>New databases for AERs, safety, etc. </li></ul></ul><ul><ul><li>Customs, foreign inspections for food & drugs </li></ul></ul><ul><ul><li>Bio-similar pathway </li></ul></ul><ul><ul><li>Integrating new personnel </li></ul></ul><ul><ul><li>Plus new Tobacco jurisdiction, Center in FDA </li></ul></ul><ul><li>Congress may: </li></ul><ul><ul><li>create a new Federal Food Safety Admin </li></ul></ul>
  9. 9. FDA Communications Agenda <ul><li>Enforcement </li></ul><ul><li>DTC Reviews & Penalties </li></ul><ul><li>Risk “draft guidance” </li></ul><ul><li>Communication Advisory Committee </li></ul><ul><li>Off-label enforcement </li></ul><ul><li>REMS Program review </li></ul><ul><li>Internet/Social Media Hearings </li></ul>
  10. 10. Broad Safety Provisions FDA Amendments Act of 2007 <ul><li>Active surveillance system </li></ul><ul><ul><li>Public/private partnerships </li></ul></ul><ul><li>REMS </li></ul><ul><ul><li>Communication programs </li></ul></ul><ul><ul><li>Restricted use </li></ul></ul><ul><li>Labeling powers </li></ul><ul><li>New power to require studies, reports, and clinical trials </li></ul>
  11. 11. Tax deduction for marketing biopharmaceuticals and devices <ul><li>$37 B in tax revenue requires $100 B in expenditures over 10 years </li></ul><ul><ul><li>Companies in approx. 37% tax bracket </li></ul></ul><ul><li>$10 Billion per year no longer deductible </li></ul><ul><ul><li>Not just DTC </li></ul></ul><ul><ul><li>DTC “rack rate spend” = $4.2 B; probably under $3 B </li></ul></ul><ul><ul><li>Requires $7 Billion in other expenditures, i.e., must include all agency type communications & some other marketing costs </li></ul></ul>
  12. 12. Transparency popular & important <ul><li>Intended to dampen company-prescriber interaction </li></ul><ul><li>Revenue neutral </li></ul><ul><li>Target for Class Action lawyers </li></ul><ul><li>House version </li></ul><ul><ul><li>Strict liability reporting by companies </li></ul></ul><ul><ul><li>“ Death Penalty” for Non Compliance </li></ul></ul><ul><ul><li>targets association payments, grants, threatens medical society memberships </li></ul></ul>
  13. 13. New Labeling Requirements <ul><li>Jack Reed, Rhode Island </li></ul><ul><li>S-1142: Informed Health Care Decision Making Act </li></ul><ul><li>Would empower FDA to develop new “brief summary” labeling and advertising requirements </li></ul><ul><ul><li>Drug benefits and risks box </li></ul></ul><ul><ul><li>Comparative effectiveness </li></ul></ul>
  14. 14. Reed Amendment (cont.) <ul><li>One year study, then FDA empowered to enact rules </li></ul><ul><li>Legislates “brief summary” </li></ul><ul><ul><li>Holy Roman Empire analogy fades </li></ul></ul><ul><li>Further support for FDA Risk Guidance </li></ul><ul><li>Could undermine First Amendment challenges to FDA ad regulations </li></ul>
  15. 15. Prescriber Data Provision <ul><li>House Education and Labor Committee includes HR 3200, Section 138 </li></ul><ul><li>Federal Version of New Hampshire statute </li></ul><ul><li>Reduced to a study by HHS, but will not go away </li></ul><ul><li>HIO Alliance includes IMS, WK & SDI-Verispan </li></ul>
  16. 16. Meanwhile, States Very Active <ul><li>Minnesota first to require registries of payments, gifts to prescribers, now source for NY Times </li></ul><ul><li>New Hampshire, Maine, Vermont, DC & Mass. pass new legislation </li></ul><ul><li>Congress supports state whistleblower statutes </li></ul><ul><li>NLARx & Prescription Project have proposals in nearly ½ the states, energized by Vermont court decision </li></ul>
  17. 17. Federal & State Prosecutions <ul><li>False Claims act </li></ul><ul><ul><li>Focus on “off-label” information that leads to prescribing, thus “false” reimbursement by Medicare, Medicaid, etc. </li></ul></ul><ul><ul><li>New interpretation of FDA labeling rules </li></ul></ul><ul><li>Anti-kickback Act </li></ul><ul><ul><li>Punishes bribes and gifts to physicians </li></ul></ul><ul><li>Over $4.5 Billion in Settlements since 2000 </li></ul>
  18. 18. Public & Private Law Suits <ul><li>New private actions, negligence torts in wake of safety publicity </li></ul><ul><li>High profile actions against Wyeth (phen-phen), Merck (Vioxx) -- GSK (Avandia) </li></ul><ul><li>But, class actions may be limited, e.g., Merck </li></ul><ul><li>But, new theories every day, e.g., failure to inform </li></ul>
  19. 19. Kamp Crystal Ball <ul><li>Clouded at best, maybe shattered </li></ul><ul><li>Some hope </li></ul><ul><ul><li>Excellent leadership choices by Obama </li></ul></ul><ul><ul><li>Health reform part of economic crisis </li></ul></ul><ul><li>Some despair </li></ul><ul><ul><li>Financial times limit alternatives </li></ul></ul><ul><ul><li>Unrealistic expectations re: free healthcare, drugs </li></ul></ul><ul><li>Some certainty </li></ul><ul><ul><li>Healthcare top priority of Boomers </li></ul></ul><ul><ul><li>Critics of healthcare communications energized </li></ul></ul><ul><ul><li>Change, change, change </li></ul></ul>
  20. 20. Communication Policy Issues <ul><li>Value of Medical Communications Not Clear to Policy Makers </li></ul><ul><ul><li>Patient care connection not explicit </li></ul></ul><ul><ul><li>Concerns about cost of marketing </li></ul></ul><ul><ul><li>Policy value of marketing outcomes not well measured, distributed </li></ul></ul><ul><ul><li>Doctors and patients must join effort </li></ul></ul><ul><li>Communication professionals must respect economic & political realities & be prepared to adapt to rapid change </li></ul><ul><li>Must BE and be SEEN as part of the solution </li></ul>
  21. 21. For More Information <ul><li>John Kamp </li></ul><ul><li>Coalition for Healthcare Communication </li></ul><ul><li> </li></ul><ul><ul><li>212-850-0708 </li></ul></ul><ul><ul><li>202-719-7216 </li></ul></ul><ul><ul><li>[email_address] </li></ul></ul>