Coalition Commentary On Current Issues Drug Industry and Ad Industry Advocates Sound the Alarm Over Congress's Threats to Tax Drug Advertising The Advertising Coalition and the AAAA D.C. office report that elimination of the tax deduction for marketing costs for drug and related businesses is still among the revenue options to pay for health care reform (HCR). Read more... AMA Rejects Ethics Proposal to Limit Industry Collaboration Today the American Medical Association House of Delegates rejected sweeping ethical guidelines against industry collaboration. The guidelines would have suppressed many education and marketing relationships with practicing doctors and medical researchers. Read more... AMA CME Speakers Urge Revisions To Proposed CEJA Report To view an excellent account of the June 14th AMA proceedings from Tom Sullivan...click here. For more background information, see the Coalition page here. To discuss, visit the Coalition's LinkedIn Group. Feedback Inspires Revision of CEJA Report for June 14th Consideration For more information and details, see Review of Feedback Recommending Revisions to June 14 CEJA Report. AMA's CEJA Report Better, But Still Falls Short; Coalition Encourages Discussion and Comments Read, understand, comment... FDA Announces New "Draft Guidance" On Risk Information in Drug and Device Ads; CHC Solicits Your Participation in Formal Comments. Read more... Coalition Education Committee Applauds ACCME's Open Rulemaking Process; Recommends Refinements in Proposals View Coalition Comments filed with ACCME on May 20, 2009 Industry Responds to IOM Report on Conflict of Interest Read Coalition analysis of the report, plus responses by expert Tom Sullivan and others. Click here... Coalition/CMPI Report Shows That Doctors & Patients Benefit Greatly from Commercially Supported CME View report... ACCME Board Releases Its Response to Solicited Comments ACCME's Executive Summary of its March 2009 Board of Directors Meeting released on April 10th has several significant policy changes with major implications for the CME industry. The most significant is that ACCME "will not be taking any actions to end the commercial support of accredited continuing medical education." Read more... Medscape Enters the CME Debate Read overview of positions, view the roundtable discussion, express your own opinion. Click here. Education Committee Presents CME Outlook for 2009 View presentation by Brad Bednarz at AMM's November meeting. PPT PDF Coalition Offers Summary of Comments Submitted to ACCME View introductory cover letter View summary document Coalition and CMPI Host Education/Conflict-of-Interest Panel in DC Overview and Presentations Coalition and Others Respond To Radical ACCME Proposals Affecting Promotional and Certified Education View all comments here... Coalition Supports New California Law Providing Patients With Drug Info Along With Prescriptions View letter to CA Assemblyman DeLaTorre Coalition Education Committee Urges Industry to Reject Pfizer CME Decision to Eliminate Direct Funding of Independent Providers Data demonstrate that independent commercial providers lead CME industry in education innovation and regulatory compliance to help improve patient care. View Coalition statement. Two Views on Censorship of Prescription Data Coalition View   NLARx View Coalition Executive Director John Kamp Recommends Rejection of AMA Ethics Proposal To End Industry Support for Certified CME View statement. Learn more about this important issue. Read Statement to Be Presented to AMA House of Delegates on Sunday, June 15th, by Dr. William Matory, Director of Education for the National Medical Association and member of the National Task Force on CME Provider/Industry Collaboration. John Kamp, the Coalition's Executive Director and a member of the Task Force, will be present to provide support during the Q&A session. Coalition and AMM Support FDA Clarification of Reprint Guidance To Empower Doctors With Timely Data, Information From Peer-Reviewed Medical Journals View joint statement to FDA. Coalition Presents Statement to IOM Committee on Conflict of Interest March 13, 2008. View Statement. Coalition CME Committe Refutes Anti-CME-Sponsorship Article In response to an article by Ray Moynihan in the February 23rd issue of the British Medical Journal, three members of the Coalition's CME Commitee, Brad Bednarz, Marty Cearnal and Mark Schaffer, defended Industry-Supported CME and its value to prescribers and their patients. View online. View PDF. Presentation: Hot Topics from Inside the Beltway By John Kamp, Coalition Executive Director NAAMECC and Coalition Respond to Macy Foundation Chairman's Conference Summary Major objections to the summary are explained. Coalition and NAAMECC Meet with ACCME on New Policy and Guidelines Read report by John Kamp and NAAMECC's President, Michael Lemon. Read post-meeting letter from ACCME Chief Executive, Murray Kopelow. Coalition and NAAMECC Urge ACCME Board to Modify Definition of "Commercial Interest" Memo sent to ACCME in November explains imbalance and flaws of new criteria. View memo in PDF format. Amicus Brief Filed by Coalition to Support Ruling against NH Prescription Restraint Law. In August, the State of New Hampshire appealed the U.S. District Court ruling that found the law unconstitutional. View Coalition's Amicus Brief View NACDS Amicus Brief View eHi, NAHIT and SureScripts Amicus Brief Coalition Urges DC Council to Reject Unconstitutional Safe Rx Act of 2007 Read the Coalition's letter to the DC Council Coalition Thanks Supporters As Congress Rejects Proposed DTC Regs Read the Coalition's open-letter ad in the September issue of DTC Perspectives Coalition Responds to New ACCME "Commercial Interest" Policy Read the Coalition's position on ACCME's revised policy statement. Stark Bill Denying Tax Deduction for DTC Most Probably Is Unconstitutional. Find Out Why. Prescription Drug User Fee Act (PDUFA). This act and acronym refer to the FDA funding bill that must be "reathorized" i.e., passed, every five years before the FDA can spend government funds. The PDUFA portion refers to the authorization for the FDA to charge user fees to drug companies that ask for drug approvals. Much of the funding for FDA comes from general tax revenues, but beginning in the early 90s the Congress authorized these fees to reduce the general public's cost of funding the agency. Now this bill, which must pass before the FDA can spend government funds, has become a vehicle for the passage of special amendments that direct the agency to do specified things or fund special projects. This year it will be the vehicle for amendments related to drug safety and, possibly, advertising and other drug marketing limits. View John Kamp's Presentation --> More Coalition commentary...

News and Commentary from the Industry BLOG CORNER Blogs with interesting comments on current issues: Peter Pitts Thomas Sullivan Endrocinologist Groups Strongly Support Industry Collaboration Position paper by the American Association of Clinical Endocrinolgists and the American College of Endocrinology cites contribution to patient care; they do not think physicans' access to third party information should be restricted. Read AACE/ACE position paper. Proposed Legislation Labeling Erectile Dysfunction Commercials Indecent: Why It Should Not Be Enacted Adonis Hoffman spells out "The 10 Cs of ED Advertising" in Ad-Vantage blog. Read more... State of the Industry Healthcare industry expert Tom Sullivan offers a current overview of the policy and legislative picture, complete with links and contact information. Click to view... Appeals Court Severely Undermines Speech Rights The decision by the U.S. Court of Appeals for the First Circuit sustaining a New Hampshire statute regulating the use of prescriber-identifiable information by pharmaceutical sales representatives as a valid regulation of "conduct" misunderstands and misapplies settled First Amendment doctrine. View article. Revised Sunshine Act Deals Pharma Sharp Blow:Eliminates Preemption of State Laws A special issue of Rx Compliance Report looks at the revised Physician Payments Sunshine Act introduced by Senators Charles Grassley and Herb Kohl last week. The final bill essentially eliminates the proposed preemption of state laws, leaving drug and device companies facing a nightmarish scenario. "This could be a disaster, in short order," warns Sidley Austin's Bill Sarraille. View article. MA Governor Signs Bill to Limit Industry/Doctor Collaboration Marketing, Gifts, Education and Research Face New Regulations For more information and links to MA Bill, go to: http://www.policymed.com/ NAMECC Asks for Public Disclosure of Written Comments Submitted in Response to ACCME's Call for Comments on Recently Proposed Policy Changes. NAMECC Also Asks for an Extension of the Comment Period to August 25th. Click Here to Access NAMECC's Letter. Read This White Paper: Merck's Settlement with State AGs involves much more than money. Significant restrictions are included on DTC, CME and use of physician consultants. Glaxo Executive Blasts Massachusetts on Pending Legislation Viehbacher speaks out against Murray bill which would ban gifts to physicians as conflict of interest. View Boston Herald article. PhRMA Primer on Pharmaceutical Marketing: The PhARMA Web site contains a primer on facts about pharmaceutical marketing and promotion that put important issues into perspective. View and download. NAAMECC Spells Out CME Realities to IOC Committee Read NAAMECC Statement of March 13, 2008 Gifts to Physicians: Thomas P. Stossel, Harvard Medical School Professor, argues that restrictions on doctors' and academics' interactions with commercial companies damage research and that no evidence supports that detailing and gifting adversely affect patient care. View article. Peter Pitts Assesses John Edwards' Policy on Drug Information Edwards would deny consumer access to drug advertising. Pitts shows why this is a faulty notion. IMS Health Article Outlines Chronology of New Hampshire Prescription Restraint Law and Opposition to It View article. Coalition Members Defend DTC Advertising As some members of Congress and the media continue to oppose dissemination of prescription drug information to consumers, industry leaders are becoming more vocal in defense of this practice. One of the cornerstones of the opposition is the Kravitz, et al. study published in JAMA in 2005. In his blog on the Dorland Global Communications Web site, Harry A. Sweeney, Chair of the Executive Committee for the Coalition, shows that the study actually proves the need for DTC advertising. Read Mr. Sweeney's blog. Prominent First Amendment Scholar Critiques Kennedy Drug Safety Bill Dean Smolla's letter concludes the bill would not withstand a First Amendment challenge. New PERC Report: The Impact of Provider-Indentifiable Data on Healthcare Quality and Cost by Michael Turner, Ph.D., Joseph Duncan, Ph.D., Robin Varghese, Ph.D., and Patrick Walker, M.A. This study examines the uses of provider-identifiable data within the U.S. healthcare system with particular emphasis on the impact of the commercial use of this data on the market for prescription drugs. Executive Summary (PDF) Full Report (PDF) New NMA Study Shows Increased DTC Advertising Approval among Black Physicians Research published in the March, 2007 Journal of the National Medical Association compares 2006 results to less favorable views in 2001. View entire report View analysis by Target Market News More Industry commentary... INDUSTRY CALENDAR 7/23/09 - Coalition Meeting, NYC