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DTC Study Does Not Claim DTC Ads Cause Doctors to Prescribe Inappropriately

May 23, 2013 – A study of the effect of direct-to-consumer advertising for statin drugs on physician prescribing that recently was ... read more

The Atlantic: Finding the Right Industry-Physician Relationship Advances Medicine

May 20, 2013 – Although relationships between the pharmaceutical industry and physicians have come under greater scrutiny as the implementation ... read more

WLF to CMS: Deem Medical Textbooks Educational Materials or Face Potential First Amendment Challenge

May 16, 2013 – The Centers for Medicare & Medicaid Services (CMS) is likely “to find itself the target of ... read more

Kamp in MMM: Off-label Is on the Table

May 14, 2013 — In a Medical Marketing and Media (MMM) column posted May 1, Coalition for Healthcare Communication Executive ... read more

Many Physicians Are Both Unaware and Wary of Sunshine Act Requirements, Survey Says

May 6, 2013 — With Sunshine Act reporting slated to begin in less than three months, it is sobering to ... read more

Senate Commerce Committee Growing Impatient with Self-regulatory Measures

April 29, 2013 – Although the Digital Advertising Alliance (DAA) has made great strides to protect consumers’ privacy online – ... read more

Coalition: Educational Materials Should Be Excluded from Sunshine Reporting

April 22, 2013 – In April 18 comments to the Centers for Medicare & Medicaid Services (CMS) the Coalition for ... read more

White Paper Examines FDA Enforcement in Digital, Social Media Realm

April 4, 2013 – A new White Paper, “FDA Communications Oversight in a Digital Era,” issued April 2 by Eye ... read more

Policy and Medicine: News Outlets Accentuate the Negative in Describing Industry-Physician Relationships

April 4, 2013 — Headlines run by news outlets regarding the status of industry-physician relationships rarely focus on the benefits ... read more

Kamp Commentary: Supreme Court Decision Could End “Pay for Delay,” Hurt Patent Protection

April 1, 2013 – By John Kamp, Executive Director, Coalition for Healthcare Communication While not directly about communication and marketing, ... read more

Promotion Down, But Prospects Up for New Drugs

March 22, 2013 – Although spending on drug promotion has declined in recent years,  2013 could be a pivotal year ... read more

“Cyberspace Is Not Without Boundaries,” FTC States in Digital Advertising Guidelines

March 19, 2013 – Although the FDA has not yet issued its long-awaited social media guidance for the biopharma industry, ... read more

NDHI Releases Statement Outlining Four Principles for Industry/Provider Collaborations

March 11, 2013 – Healthcare industry collaborations with physicians and researchers have “been at the heart of most of the ... read more

Study Cites Benefits of Pharma’s Promotional Efforts

March 4, 2013 – A recent study released by the National Bureau of Economic Research (NBER) states that although consumer-directed ... read more

CMS Launches "OpenPayments" Site as Part of Sunshine Implementation

Feb. 25, 2013 – The Centers for Medicare & Medicaid (CMS) launched its “OPENPAYMENTS” Website last week, which will be ... read more

Sunshine Act Final Rule: Coalition for Healthcare Communication Summary

On Feb. 1, the Centers for Medicare & Medicaid Services (CMS) issued a final rule implementing the Sunshine Act provisions ... read more

Sunshine Act Final Rule Resets Clock on Annual Reporting of Payments to Physicians

Many Questions Still Unresolved Feb. 4, 2013 – Although the final rule to implement the Sunshine provisions of the Affordable ... read more

Coalition’s Policy Update: Keep Fiscal Challenges, Privacy Regulation on Radar

Jan. 15, 2013 – If 2012 – with its high number of new drug approvals, senior staff stability within the ... read more

OPDP Untitled Letters on PR Materials Surprise Industry

Nov. 27, 2012 – An Oct. 31 enforcement letter from the FDA’s Office of Prescription Drug Promotion (OPDP) to Cornerstone ... 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

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

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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