News and views that affect health care communications arise daily. The Coalition comments on these issues and events, reflecting on their effect on the exchange of information that helps medical professionals and their patients.

DTC Advertising	Drug Safety	Marketing Use of Prescription Data
CME	Fax Ban	General Industry Issues

DTC Advertising

Coalition Testifies at FDA Hearing on PDUFA and DTC Advertising Reviews, February 16, 2007
What Is PDUFA?

Coalition Responds to DTC Study, Editorial
In Annals of Family Medicine, January/February 2007


Coalition Seeks New Prescription Drug Advertising Rules
Citizen Petition to FDA also Proposes New FDA Standing Communication Advisory Committee
Press Release
Full Text of Petition (PDF)

DTC Advertising Hearings:
A Decade of Change
But Little Agreement
Presentations reviewed in detail by John F. Kamp, Coalition Executive Director, and Wayne L. Pines, President of Regulatory Services and Health Care, APCO Worldwide

COALITION TESTIFIES AT
FDA HEARING
ON DTC ADVERTISING
Read transcript of Executive Director John Kamp's November 1 testimony before the FDA. Also view presentations by other Industry experts.
Nov. 2005

NEW PHRMA PRINCIPLES COULD REDEFINE DTC ADVERTISING Article by John Kamp, Coalition Executive Director, in September Issue of FDA Advertising and Promotion Manual
Sep. 2005

COALITION APPLAUDS PHRMA DTC PRINCIPLES;
URGES POLICY MAKERS TO HALT ADDITIONAL REGULATIONS

JAMA REJECTS COALITION LETTER CHALLENGING
DTC STUDY CONCLUSIONS
Read Coalition comments and full text of the letter.
June 2005

DTC Advertising Hearings:
A Decade of Change
But Little Agreement
Presentations reviewed in detail by John F. Kamp, Coalition Executive Director, and Wayne L. Pines, President of Regulatory Services and Health Care, APCO Worldwide

COALITION RESPONSE TO FDA REQUEST FOR DTC COMMENTS
The Coalition makes two points: (1) burdening DTC advertising with too many copy points will defeat its purpose; (2) pharmaceuticals are becoming more like a “studied purchase”, similar to products such as automobiles.
Jan. 2004
(Includes White Paper by Lewis Pringle, Ph.D., former holder of an important marketing chair and retired Executive Vice President of one of the largest multi-national advertising agencies.)

Drug Safety

Legislative Update
Moderates in House Health Subcommittee Adopt Strict Drug Safety Bill But Strike the Most Onerous Marketing Provisions
(Full Energy and Commerce Committee Votes Tomorrow)

FDA Testimony: Use of Medication Guides to Distribute Risk Information to Patients, presented by Coalition Executive Director John Kamp, June 13, 2007 PowerPoint PDF

Coalition and 4As Release Joint Statement on IOM Report on the Future of Drug Safety
Statement expresses cautious encouragement while citing First Amendment concerns.
Read IOM Report Brief
Read entire Report free online.
Sept. 2006

Coalition Seeks New Prescription Drug Advertising Rules
Citizen Petition to FDA also Proposes New FDA Standing Communication Advisory Committee
Press Release
Full Text of Petition (PDF)
March 31, 2006

Coalition Testifies at FDA Hearing on CDER's Current Risk Communication Strategies for Human Drugs
View Coalition Executive Director John Kamp's December 8th presentation.
Dec. 2005

Marketing Use of Prescription Data

New Hampshire Law Banning Commercial Use of Prescription Information Declared Unconstitutional

The Wrong Prescription for New Hampshire?
Op-Ed Article by Coalition Executive Director John Kamp published in the New Hampshire Business Journal
Sept. 2006.

Coalition Supports IMS/Verispan Challenge of New Hampshire Law Banning Use of Prescription Data for Marketing
The Coalition is preparing a "friend of the court" brief highlighting the importance of these data to patient care, research and social policy decision-making, as well as their contribution to the efficiency of medical marketing. For more information on the issue and the IMS/Verispan lawsuit, visit: http://www.imshealth.com/

CME

Coalition CME Committee Responds to Critics of Industry-Supported CME
In an article on PharmaLive.Com, Brad Bednarz, Marty Cearnal and Mark Schaffer say critics ignore value of CME to prescribers and their patients. View PharmaLive article.

Highlights of 2008 Alliance for CME Meeting

Coalition's Message to ACCME: Treat Non-Profits and For-Profits the Same
Response to Proposed Changes in ACCME Standards for Commercial Support, March 23, 2007 (PDF)

CME and the Washington Healthcare Debates: Demystifying the Policies, Politics, and Press Coverage
Debate between John F. Kamp, PhD, JD, and Judith G. Ribble, PhD, January 19, 2007, 32nd Annual Conference of the Alliance for Continuing Medical Education

Coalition Statement:
Commercial Support for Continuing Medical Education
Plays Central Role in Patient Care



Fax Ban

JUNK FAX PROTECTION ACT
PASSES BOTH SENATE & HOUSE



General Industry Issues

Advertising Coalition Seeks Industry Support For
Towns/Buyer Amendment to Drug Safety Bill

Advertising Coalition Alert on US House Proposals to Restrict Drug Marketing

First Round Victory in Protecting DTC Advertising

U.S. Senate Delays Vote on Drug Marketing Limits

U.S. Senate to Vote on Drug Marketing Limits

How FDA and Capitol Hill May Change the Rules of Drug Marketing in 2007
Presentation by John Kamp to Association of Medical Publications (AMP), February 28, 2007 (PDF format for print)

Election 2006
Presentation by Dick O'Brien, American Association of Advertising Agencies, November 8, 2006

Coalition Legal Brief Supports Major Victory for Advertisers in California
Loophole closed for frivolous lawsuits.
July, 2006

COALITION URGES CALIFORNIA LEGISLATORS TO REJECT BAN ON SPONSORED MEDICAL INFORMATION IN DRUG STORES
Read the Coalition's letter opposing California S.B. 401. The letter is in PDF format and may be copied and circulated.

Call for Dialog
DOJ AND HHS-IG MARKETING INVESTIGATIONS MAY ENDANGER PUBLIC HEALTH

COALITION RESPONSE TO NEW ACCME “STANDARDS FOR COMMERCIAL SUPPORT” PROVISIONS
The Coalition applauds the effort but urges some modifications.
July, 2004

COALITION UPDATES COMMENTARY ON ACCME “STANDARDS FOR COMMERCIAL SUPPORT”
Most of what the Coalition forecast has come to pass.

For Research and Profit

JAMA Letter to the Editor

Coalition Response to FDA Comments on First Amendment Issues

FDA Guidance on Unsolicited Requests

FDA Guidance on Industry Supported Scientific and Educational Activities

Response to FDA Rejection of "Off-Label" Information