Drug Information and Communication

in the Obama Era

John KampExecutive Director

Coalition for Healthcare CommunicationAMM, January 21, 2010

What Next ?

• MA election changes the dynamic, especially for Blue Dogs, Moderate D’s

• Two clear possibilities– House Passes Senate version, sends to WH– Scaled down version, but what to save, what to

discard

• Expect WH, Senate Leader, Speaker summit meeting very soon; President cannot deliver State of the Union without a plan

So, what about big FourCommunication Issues ?

• Tax on Medical Marketing– Maybe back on the table

• Transparency– Maybe stays, one of the few items with bi-

partisan support– States active anyway

• Marketing use of prescription data

• Expanded Brief Summary

A few Kamp Rules of Washington

• Never wake a snake to kill it– Watch, listen very carefully

• Dig the well before the drought– Keep you pens and email lists very handy

• No good or bad idea dies, it just waits for another day

• Keep your friends very close, enemies even closer..

It’s not (just) Medical Communication

• Public Perception of Pharma/Biotech/Device Industries– Approval ratings near lawyers, car dealers &

former President Bush; just above insurers

• Fears about safety; Congress, FDA, consumers, prescribers, press

• Cost of Drugs

• Politics of Health Care Reform

Challenges Abound• Industry funding of organized medicine challenged

by Congress, ACCME, Macy, IOM, Med Pac• “Transparency” bills in states & Congress require

additional disclosures of all relationships with prescribers

• Whistleblower & HHS-IG/State lawsuits, CIAs & DPAs• Detailing, sampling & promotional education limited

by medical schools, managed care, some practice groups

• State limits on commercial use of prescriber data in New Hampshire, Vermont & Maine

• “Counter-detailing” in PA, VT, DC• Plaintiff Class Action Suits

Hill Priorities Beyond HCR:Past is Prologue

Unfinished business from 2007-8– National Registry of gifts and payments;

Grassley/Kohl/DeFazio/Stark– Limits consumer ads; Kennedy/Waxman/Stupak– Safety “reviews” of ALL new drugs & marketing

plans; Kennedy, Dingell, Waxman– Tax penalty for all marketing; Rahm Emanuel

Likely FDA Agenda• FDAAA of 2007 still sets priorities for 2008-10

– Dozen rules and reports mandated– Critical Path--modernizing the clinical trial– Advisory Committee recruiting/conflict issues– REMS – New databases for AERs, safety, etc.– Customs, foreign inspections for food & drugs– Bio-similar pathway– Integrating new personnel– Plus new Tobacco jurisdiction, Center in FDA

• Congress may:– create a new Federal Food Safety Admin

FDA Communications Agenda

• Enforcement

• DTC Reviews & Penalties

• Risk “draft guidance”

• Communication Advisory Committee

• Off-label enforcement

• REMS Program review

• Internet/Social Media Hearings

Broad Safety Provisions FDA Amendments Act of 2007

• Active surveillance system– Public/private partnerships

• REMS– Communication programs– Restricted use

• Labeling powers• New power to require studies, reports, and

clinical trials

Tax deduction for marketing biopharmaceuticals and devices

• $37 B in tax revenue requires $100 B in expenditures over 10 years– Companies in approx. 37% tax bracket

• $10 Billion per year no longer deductible– Not just DTC – DTC “rack rate spend” = $4.2 B; probably under $3 B– Requires $7 Billion in other expenditures, i.e., must

include all agency type communications & some other marketing costs

Transparency popular & important

• Intended to dampen company-prescriber interaction• Revenue neutral• Target for Class Action lawyers• House version

– Strict liability reporting by companies– “Death Penalty” for Non Compliance– targets association payments, grants, threatens medical

society memberships

New Labeling Requirements

• Jack Reed, Rhode Island

• S-1142: Informed Health Care Decision Making Act

• Would empower FDA to develop new “brief summary” labeling and advertising requirements– Drug benefits and risks box– Comparative effectiveness

Reed Amendment (cont.)

• One year study, then FDA empowered to enact rules

• Legislates “brief summary”– Holy Roman Empire analogy fades

• Further support for FDA Risk Guidance

• Could undermine First Amendment challenges to FDA ad regulations

Prescriber Data Provision

• House Education and Labor Committee includes HR 3200, Section 138

• Federal Version of New Hampshire statute

• Reduced to a study by HHS, but will not go away

• HIO Alliance includes IMS, WK & SDI-Verispan

Meanwhile, States Very Active

• Minnesota first to require registries of payments, gifts to prescribers, now source for NY Times

• New Hampshire, Maine, Vermont, DC & Mass. pass new legislation

• Congress supports state whistleblower statutes• NLARx & Prescription Project have proposals in

nearly ½ the states, energized by Vermont court decision

Federal & State Prosecutions

• False Claims act– Focus on “off-label” information that leads to

prescribing, thus “false” reimbursement by Medicare, Medicaid, etc.

– New interpretation of FDA labeling rules

• Anti-kickback Act– Punishes bribes and gifts to physicians

• Over $4.5 Billion in Settlements since 2000

Public & Private Law Suits

• New private actions, negligence torts in wake of safety publicity

• High profile actions against Wyeth (phen-phen), Merck (Vioxx) -- GSK (Avandia)

• But, class actions may be limited, e.g., Merck• But, new theories every day, e.g., failure to

inform

Kamp Crystal Ball

• Clouded at best, maybe shattered• Some hope

– Excellent leadership choices by Obama– Health reform part of economic crisis

• Some despair– Financial times limit alternatives– Unrealistic expectations re: free healthcare, drugs

• Some certainty– Healthcare top priority of Boomers– Critics of healthcare communications energized– Change, change, change

Communication Policy Issues

• Value of Medical Communications Not Clear to Policy Makers– Patient care connection not explicit– Concerns about cost of marketing– Policy value of marketing outcomes not well measured,

distributed – Doctors and patients must join effort

• Communication professionals must respect economic & political realities & be prepared to adapt to rapid change

• Must BE and be SEEN as part of the solution

For More Information

• John Kamp

• Coalition for Healthcare Communication

• www:cohealthcom.org– 212-850-0708– 202-719-7216– jkamp@cohealthcom.org