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New Hampshire Amends Patient Privacy Law Following IMS v. Sorrell Decision

May 11, 2012 — In the wake of the June 2011 U.S. Supreme Court decision in IMS v. Sorrell, which ... read more

CMS: Sunshine Act Data Collection Will Be Delayed Until 2013

May 7, 2012 — The Centers for Medicare & Medicaid Services (CMS) stated on the CMS blog that following its ... read more

Guest Column: Heavy Meddle by Peter Pitts

May 7, 2012 — The American Recovery and Reinvestment Act (aka, “the stimulus package”) provided AHRQ with $29.5 million for ... read more

Proposed OTC Drug Distribution Would Expand Patient Access to “Rx” Drugs

April 30, 2012 – Comments are due May 7 on an FDA-proposed paradigm that would allow the agency to approve ... read more

PDUFA V Bills Moving Forward Without Specific Marketing Provisions

April 23, 2012 — The House and Senate both issued draft legislation last week to reauthorize the Prescription Drug User ... read more

CHC and TAC Comments Object to “Dual Modality” Risk Communication in DTC TV Ads

April 16, 2012 – The Coalition for Healthcare Communication (CHC) and The Advertising Coalition (TAC) recently told the FDA’s Office ... read more

ACRE Study Finds Medical Journal Discussion of Academic/Industry Relationships Unbalanced

April 12, 2012 – The Association of Clinical Researchers and Educators (ACRE) announced yesterday the publication of a study in ... read more

FDA Draft Guidance on DTC TV Ads Raises Important Questions

By John Kamp April 9, 2012 – The only thing really clear about the new guidance on pre-review of the ... read more

FTC to Industry: Adopt Consumer Privacy Best Practices Now

March 28, 2012 – Industry members needing another reason to join the fray of companies participating in the Digital Advertising ... read more

Call for Industry Comments: Proposed FDA Study on “Corrective” DTC TV Advertising

March 26, 2012 – Note to Industry Leaders The Coalition for Healthcare Communication needs your input on a study FDA ... read more

New Video Highlights Advances in CME Conflicts of Interest Policies

March 19, 2012 – A new video produced by CME Peer Review – “Conflict of Interest: The Bottom Line” – ... read more

FDA Draft Guidance on DTC TV Ads Identifies Campaigns Subject to 45-day Pre-Review Process

March 13, 2012 – Draft guidance released today by the FDA – “Guidance for Industry Direct-to-Consumer Television Advertisements” – calls ... read more

DAA’s Self-regulatory Ad Program to Protect Consumers Online Is Praised by White House, DOC and FTC

 Feb. 23, 2012 – At a White House meeting held today to unveil the blueprint for the Obama Administration’s “Consumer ... read more

Coalition Calls for Substantial Revisions to Sunshine Act Proposed Rules

Feb. 16, 2012 – Further notice and comment are necessary for the implementation of Section 6002 of the Affordable Care ... read more

Digital Health Coalition Issues Guiding Principles and Best Practices to Help Lead Way on Robust Use of Social Media by Medicine Companies

Feb. 7, 2012 – Responding to patient and professional calls for more industry participation in the Internet and social media, ... read more

Digital Advertising Alliance Launches Consumer Education Campaign

Jan. 27, 2012 – The Digital Advertising Alliance (DAA) last week launched its “Your AdChoices” public education campaign to inform ... read more

MMM: CME Video Addresses Conflict of Interest

Jan. 26, 2012 – Avoiding conflict of interest in continuing medical education (CME) may seem like a daunting task, but ... read more

Does Novo Nordisk’s Victoza + Paula Deen = Recipe for Success?

Jan. 20, 2012 – Common sense should tell people that some of celebrity chef Paula Deen’s infamously unhealthy dishes – ... read more

Sunshine or Rain?

By Jack E. Angel, Education Foundation Executive Director, Coalition for Healthcare Communication Jan. 17, 2012 – The Affordable Care Act ... read more

MMM Features Kamp’s Call for Industry Leadership on Off-label, Online Communications

 Jan. 6, 2012 — This article, written by Coalition for Healthcare Communication Executive Director John Kamp, was featured in the ... read more

FDA Issues Draft Guidance on Unsolicited Off-label Info Requests, Addresses both Professional and Internet Media

Jan. 2, 2012 – In the waning days of 2011, the FDA released a significant draft guidance on company responses to ... read more

FDA Approval Report Contains Good News for Patients and Industry

  By John Kamp, Executive Director, Coalition for Healthcare Communication – Nov. 7, 2011 – Until the research labs and ... read more

RPM Report: Pandora’s Box Officially Open as New Legal Challenges to FDA’s Off-label Restrictions Emerge

Oct. 24, 2011 – After the U.S. Supreme Court struck down speaker- and content-based restrictions in Sorrell v. IMS Health, ... read more

Par Pharma Case Asserts That First Amendment Protects Truthful Off-label Speech

Oct. 18, 2011 – A case filed by Par Pharmaceutical, Inc. against the FDA seeks to preserve Par’s First Amendment ... read more

Kamp on the Sunshine Act: Collaboration Key to Patient Care

Dec. 14, 2011 — UPDATE — CMS has published the proposed rules enforcing the Sunshine provisions of the Affordable Care ... read more

Experts Weigh In on Implications of Sorrell Decision

Aug. 1, 2011 — The recent Supreme Court decision in Sorrell v. IMS Health Inc. is earning robust commentary in ... read more

Academic Detailing and Health Plan Communications: Is the Playing Field Level?

By Kenneth P. Berkowitz, Esq. July 21, 2011 — Why does the government fail to apply current regulatory requirements and ... read more

Sorrell v. IMS: What Marketing Professionals Need to Know

By John Kamp, Executive Director, Coalition for Healthcare Communication July 18, 2011 — For those who have not read the ... read more

Kamp Column: Industry Must Embrace Internet and Social Media or Become Irrelevant in Many Health Conversations

By John Kamp, Executive Director, Coalition for Healthcare Communication June 29, 2011 — Yesterday I had the pleasure of moderating ... read more

PhRMA Survey Shows That Physicians Value Industry Communication

March 31, 2011 — At a time when interaction between biopharmaceutical companies and physicians is under increased scrutiny, a recent ... read more

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DDMAC Reorganized into Office of Prescription Drug Promotion

Sept. 19, 2011 – Center for Drug Evaluation and Research (CDER) Director Janet Woodcock announced in an e-mail to CDER staff that as part of the reorganization of the Office of Medical Policy (OMP) into a Super Office, the former Division of Drug Marketing, Advertising and Communications has been reorganized and elevated into a new Office of Prescription Drug Promotion (OPDP), which divides promotional oversight into two divisions, one for professional promotion and one for direct-to-consumer (DTC) promotion.

“This reorganization will leverage OPDP’s resources and processes to provide for the highly effective oversight of prescription drug promotion,” Woodcock states.

“Maybe this is a good omen,” remarked John Kamp, executive director, Coalition for Healthcare Communication. “It took 18 months to get this reorganization approved. Let’s hope that the Internet and Social Media rules show up soon.”

The new OPDP, still under the direction of Thomas Abrams, consists of an Immediate Office, the Division of Professional Promotion (DPP), and the Division of Direct-to-Consumer Promotion (DDTCP). The new structure “will help prevent misleading promotion about prescription drugs and enhance the quality of communications about prescription drugs and other health information developed by companies,” according to Woodcock.

Leadership of the OPDP also includes:

  • Mark Askine, Associate Director, Office of Prescription Drug Promotion
  • Marci Kiester, Associate Director of Operations, Office of Prescription Drug Promotion
  • Catherine Gray, Acting Director, Division of Professional Promotion
  • Robert Dean, Acting Director, Division of DTC Promotion

The Office of Medical Policy also encompasses the Office of Medical Policy Initiatives, led by Rachel Sherman and her Deputy, Kathleen Uhl. Janet Norden is Associate Director for Regulatory Affairs. OMP plays a critical role in directing medical policy programs and strategic initiatives.

Enter CHC Contest for New OPDP Nickname

The Coalition for Healthcare Communication (CHC) will award autographed copies of both volumes of the great coffee table book, Medicine Avenue: The Story of Medical Advertising in America to the best new nickname for the FDA OPDP. Enter today by commenting below. Entries will be judged and announced by the Executive Committee of CHC.  More details will be announced soon.

The first volume of Medicine Ave was published in 1990 by the Medical Advertising Hall of Fame.  Medicine Ave 2  chronicles the history of the industry from 1990 through the present.   In addition to featuring hundreds of examples of the best work since 1990, the publication covers the evolution of the modern agency in terms of creativity, structure, and client relationships, and further details the legal and governmental framework that has shaped the industry, the evolution of the science, the globalization of medical advertising, mergers and acquisitions, the impact of digital communications, the rise of DTC advertising, the impact of technology, and the changing role of medical publishing.

More than a dozen industry experts contributed to the publication, lead by a publications committee composed of legendary agency CEOs Ron Pantello (Lally, McFarland, Pantello), John Kallir (Kallir, Phillips, Ross), and Harry Sweeney (Dorland, Sweeney, Jones) and Euro RSCG creative head Julien Jarreau. The work of dozens of leading healthcare advertising agencies is shown to illustrate the caliber and diversity of the industry’s work.

Be nice, now.  Have fun, but be good.  ;-)

User Comments 1

  1. Oh Please Don’t Promote

    Jim C on Sep 19, 2011 @ 8:55PM