Welcome to Washington!
Sound the alarm - the ad fight is not over Rep. Henry Waxman • Chairman Henry A. Waxman: A moratorium is a 'top priority' speaking to the Prescription Project in December 2008 • Delivered same message to a media executive Yogi Berra • Waxman staff has echoed the quest for a moratorium Yogi was right - it ain’t over till it’s over!
Brief summary of why we are still alive! 1982 – FDA approves for print advertising to consumers 1996 – FDA approves for broadcast advertising 1999 – FDA survey: 62% say ads improve talks with doctors 2001 – Senate Commerce Committee invites DTC opponents 2002 – GAO links DTC advertising to increased pharmaceutical costs 2002 – Business coalition quietly works to clamp down on DTC ads 2002 – Chairman Thomas warns of possible limits on drug ads 2003 – Rep. Stark proposes tax on prescription drug advertising 2003 – U.S. Senate defeats two amendments to eliminate DTC ads 2003 – Senate Aging Committee chair [Sen. Larry Craig] warns government will restrict ads
Brief summary of why we are still alive! 2003 – FDA holds 2-day public forum on regulating DTC advertising 2004 – Senators Snowe and Wyden offer deduction disallowance 2004 – Finance Committee Chair embraces deduction disallowance penalty 2004 – Three Presidential candidates propose limits on DTC advertising – Gephardt, Dean, Edwards 2005 – Multiple witnesses criticize DTC ads in E&C hearing 2005 – Senate Majority Leader Frist hammers ads in hour long speech 2005 – Sen. Wyden offers ad rebate bill 2005 – Senate Aging Committees holds special DTC ad hearing 2006 – Boston Globe, Atlanta Constitution, Ad Age call for DTC restrictions 2006 – IOM releases report calling for moratorium, content restrictions
Showdown in 2007! • Democrats win majorities in House and Senate Rep. Ed Towns • FDA Reform was a top priority for Chairman Kennedy and Chairman Dingell • Senate and House FDA reform bills included advertising restrictions • Moratoriums, pre-clearance of ad content, Rep. Steve Buyer warning language/labels • Reported on party line vote in HELP – lacked Senate votes • Lost on a 23-9 vote in E&C Health Subcommittee
2008 – Setting the stage for Round II Oversight Subcommittee launches investigations • Lipitor : Dr. Jarvik’s medical credentials Did Dr. Jarvik use a double? • Procrit : Was advertising of treatment for chemo-therapy induced anemia accurate • Vytorin : Effectiveness of drug to treat high cholesterol • Kaiser Research : “ . . . Public views are mixed about how well drug ads present specific information about the drugs they advertise.” • GAO : “FDA officials told us . . . That the agency received substantially more final and draft materials than the DTC Review Group could review.”
What's di fg erent this year? • Rep. Waxman is now Chairman Waxman • Defeated John Dingell for Energy & Commerce Chair • Dingell is the longest serving Member of House – 53 years • Chairman Dingell supported advertising in 2007 despite questions
An "inconvenient truth" – Chairman Waxman " The truth is that we inevitably allow drugs on the market whose risks are not fully known." - Chairman Henry Waxman speaking in favor of moratoriums on new ads
The Health Subcommittee has changed • 23 of 34 Representatives voted with us in 2007 • 7 of the 23 have left the Subcommittee • Subcommittee membership expanded to 39 • Thus we have potential 16 votes out of 39 We have work to do!
Changes in political environment • In 2007, Rep. Waxman was on E&C – today he is Chairman Jonathan Sharfstein FDA Deputy Commissioner • Multiple potential vehicles – begin with healthcare reform • Current Acting Commissioner and future Deputy Commissioner at FDA – Jonathan Sharfstein • Stronger Democratic majorities in the Senate and House • President's Chief of Staff, Rahm Emanuel: Deny deduction for ad costs
The core issues in the advertising debate Chairman Waxman believes ads expose more people to risk Rep. Rosa DeLauro • Waxman has proposed two or three year moratoriums on new drug ads Waxman (and Pallone, Dingell and Stupak) believe FDA oversight is inadequate • Dingell and Kennedy proposed a user-fee for ad oversight - it failed • Appropriations Subcommittee Chair Rosa DeLauro gave FDA $11.25 million • 2 years ago FDA only received $1.2 million
Why can't Congress do what it wants to pharmaceutical advertising? First Amendment: Congress shall make no law . . . abridging the freedom of speech, or of the press . . .
Why can't Congress do what it wants to pharmaceutical advertising? Congress may regulate advertising: • Regulation advances a substantial government interest • Congress can assert public health • Regulation directly advances the asserted government interest • Will less advertising protect patients – or hurt them? • Regulation is not more extensive than necessary • Hardly seems to permit 3-year moratorium on all ads for all new drugs • Regulation must be the last and not the first resort!
Thompson v. Western States Medical Center (2002) • FDA rule banned advertising of compounded drugs • Concern — compounding would become unregulated manufacturing • Supreme Court struck down the regulation • FDA had many other options to restrict compounding • Cannot choose to restrict speech first
What the First Amendment really means Former Supreme Court Justice Sandra Day O'Connor: " Even if the Government . . . fear[s] that advertising compounded drugs would put people who do not need such drugs at risk by causing them to convince their doctors to prescribe the drugs anyway, that fear would fail to justify the restrictions. . . “ Supreme Court Justice Sandra Day O’Connor “ [It] amounts to a fear that people would make bad decisions if given truthful information about compounded drugs."
Justice O’Connor struck down rationale for a moratorium • Some in Congress want to withhold information for fear that more patients will ask for a drug and a yet unidentified risk may appear and harm those patients • Even if Congress imposed an ad moratorium, millions of Americans would still be able to receive the new drug because the moratorium would only be on the speech, not on the ability of doctors to prescribe it.
Moratorium ignores the consumer protection value of advertising The law requires the advertising, even broadcast and cable advertising, to set forth major risks identified in research and trials. For all new medicines, moratorium supporters assume: • High likelihood that a dangerous side effect will emerge • No educational value to warnings in advertising • Only the government can protect you from yourself and from your doctor
Why is Justice O'Connor right? Instead of censoring all advertising information – advertising communicates to everyone about risks associated with a prescription medicine. These advertising messages save lives every day: • Lipitor: Liver conditions • NSAIDs: Increase chance of heart attack or stroke and could lead to death • Boniva: Do not take if – have low blood calcium, cannot sit or stand for 60 minutes, have severe kidney disease
Factors working against us Kathleen Sebelius • Healthcare reform is a natural vehicle Secretary of Health and Human Services. Designee • Public and congressional attitudes remain negative toward pharmaceutical industry • Deduction limit or moratorium could be a lucrative pay-for (if Pay-Go applies) • New HHS Secretary, Health Care Czar or FDA Commissioner could affect outcome
Factors that work in our favor • To those who say the advertising is false or misleading • Congress enacted a new administrative law process • Gave FDA authority to fine false ads $250,000 a day • Congress gave FDA $11.25 million to oversee DTC ads • The economy – a moratorium on ads in one of the largest categories would harm broadcast, cable and print
You made the di fg erence before - you will make the di fg erence again • Advertising industry • Publishing industry • Broadcast and cable industries • Members of Congress need to hear from you
Contact: Jim Davidson 1152 15th Street Northwest, Suite 800 Washington, D.C. 20005 jdavidson@polsinelli.com www.polsinelli.com
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