Subscribe   RSS Contact Us

Pines Floats Six Ideas about FDA for Trump Administration Consideration

Dec. 6, 2016 – When the dust settles post-inauguration, the Trump administration likely will be considering how it might want ... read more

Sunshine Clarifications Stripped from 21st Century Cures Act

Special Report and Commentary from Jack Angel, Coalition for Healthcare Communication Education Foundation Executive Director Nov. 30, 2016 – As ... read more

Kamp: Coalition Will Continue to Fight for Free Flow of Information

Nov. 28, 2016 – Although President-elect Donald Trump was not who the Coalition for Healthcare Communication was preparing for in ... read more

Coalition Meeting: Moving Forward in Washington, D.C.

Nov 18, 2016 – Although many in the medical marketing industry were bracing for a post-election drug pricing battle with ... read more

Kamp: Moving forward after the election

Nov. 11, 2016 – Post-election report from Coalition for Healthcare Communication Executive Director John Kamp: The pollsters and pundits sure ... read more

Speakers at FDA Off-label Hearing Call for Action that Protects Free Speech

Nov. 10, 2016 – As FDA Commissioner Robert Califf described the issues surrounding the communication of off-label uses as “numerous ... read more

Report from the Coalition Executive Director

Nov. 8, 2016 – When the votes are counted, expect many discussions on what will happen next. One thing is ... read more

Kamp to Urge FDA to Provide Clear Guidance on Off-label Communication at November Hearing

Oct. 31, 2016 – In testimony at the upcoming off-label hearing at the FDA, Coalition for Healthcare Communication Executive Director ... read more

Jenkins to Speak at CHC’s D.C. Meeting

Oct. 27, 2016 — Pam Jenkins, president of Powell Tate/Weber Shandwick, will be the keynote speaker at the Nov. 16 ... read more

Coalition Commentary: How Information Flows … or Doesn’t

Commentary from Jack Angel, Coalition for Healthcare Communication Education Foundation Executive Director Oct. 25, 2016 – The Coalition for Healthcare ... read more

Kamp: Pharma Needs to Step up to Stem Opioid Abuse

Oct. 17, 2016 – In a recent guest commentary in PM360, Coalition for Healthcare Communication Executive Director John Kamp praised ... read more

CMS Clarifies Sunshine Act CME Exclusion

Oct. 6, 2016 – The Centers for Medicare & Medicaid Services (CMS) recently clarified in a revised FAQ that manufacturers ... read more

OPDP’s Abrams: Enforcement Still a Priority, Despite Decrease in Letters

Oct. 3, 2016 – Although the FDA’s Office of Prescription Drug Promotion (OPDP) has issued just four enforcement letters in ... read more

OPDP’s Second Enforcement Letter in Two Weeks Targets Investigational Drug

Sept. 15, 2016 – Although the FDA’s Office of Prescription Drug Promotion (OPDP) has only issued four enforcement letters this ... read more

OPDP Sends Enforcement Letter for Promotion of Investigational Drug

Sept. 8, 2016 — The FDA’s Office of Prescription Drug Promotion (OPDP) takes issue with a conference panel for an ... read more

FDA to Hold Post-election Hearing on Off-label Communication

Sept. 1, 2016 – In the wake of the agency’s recent settlement with Amarin and other rulings that support the ... read more

FDA May Still Issue Four Advertising Guidances in 2016

Aug. 11, 2016 — The FDA announced Aug. 10 that it plans to issue four, much-awaited advertising-related guidance documents before ... read more

Study Shows ACA Increases Use of Rx Drugs, Decreases Out-of-pocket Spending

Aug. 19, 2016 – The Affordable Care Act (ACA) has resulted in increases in the use of prescription drugs and ... read more

Gender and Healthcare Communications

By Nick Colucci, Publicis Health CEO July 21, 2016 — I was moved by a recent op-ed in The New ... read more

Medical Associations Support Bill Exempting Journals and Textbooks from Sunshine Reporting

July 15, 2016 – More than 100 medical associations, including the American Medical Association, signed a letter of support for ... read more

Pfizer Gets in Front of Opioid Marketing Issue

July 8, 2016 – As organized medicine, politicians and the public seek to reverse the scourge of opioid addiction, Pfizer ... read more

CEOs to Coalition’s Rising Leaders: Engage in Political Process, Keep Learning

June 17, 2016 – In order to stay ahead of change, further their careers and forward the positive message of ... read more

Davidson Sums Up Past and Current State of DTC Ad Restrictions, Ad Tax Deduction

June 7, 2016 – The Advertising Coalition (TAC) Executive Director Jim Davidson gave industry’s next generation a comprehensive overview of ... read more

Congressman Jenkins to Coalition’s Rising Leaders: You Have the Power to Influence Lawmakers

May 24, 2016 – At a recent Coalition for Healthcare Communication Rising Leaders Conference, keynote speaker Rep. Evan Jenkins (R-W. ... read more

NYTimes: Ban on Drug Ads Would Also Eliminate Ad Benefits

March 14, 2016 — The American Medical Association (AMA) as well as Rep. Rosa DeLauro (D-Conn.) and Sen. Al Franken ... read more

CHC and CCC Launching Regulatory Compliance University for Agencies, Publishers

Aug. 19, 2015 – The Coalition for Healthcare Communication (CHC) is partnering with the Center for Communication Compliance (CCC) to ... read more

Author of “Pharmaphobia” Says Conflict-of-interest Regulations Are Slowing Medical Progress

June 8, 2015 – In his new book, “Pharmaphobia: How the Conflict of Interest Myth Undermines American Medical Innovation,” Tom ... read more

Previous Next

House Health Subcommittee PDUFA V Hearing Yields Little Talk of Marketing – For Now

Feb. 2, 2012 – More than four hours of testimony before the House Energy and Commerce Committee’s Subcommittee on Health — and members’ follow-up – nearly exhausted the issues related to the Prescription Drug User Fee Act V (PDUFA V) legislation yesterday, but just one question focused on drug marketing.

“It has taken hard work so far to keep direct-to-consumer [DTC] and other marketing on the back burner in PDUFA V,” said John Kamp, Executive Director of the Coalition for Healthcare Communication. “But I’m still worried. Consumer and other groups pressed FDA at several points last year in the FDA phase. I don’t think they are going to give up now, so we’re watching carefully and remain prepared for a challenge.”

During the Feb. 1 hearing, medical marketing was raised just briefly. “Do you actually have any resources for DTC advertising monitoring to ensure that consumers do have a balanced understanding of the drugs and the risks advertised to them and the accuracy of those?” Rep. Jan Schakowsky (D-Ill.) asked Commissioner of Food and Drugs Margaret Hamburg, M.D. “Where are we with monitoring these DTC drug ads?” she queried.

“We do have a

group that is charged with working on the oversight of DTC advertising and there is a process that involves the screening of the DTC advertisements,” Hamburg said, adding that “we don’t have fees associated with that.” Hamburg explained that although advertising was considered in previous PDUFA negotiations, “it is not part of PDUFA V.”

Hamburg said she gathered “that in the last PDUFA negotiation this had been identified as a possible area of focus, but actually including it was moved away from for a number of reasons that I think may have included the willingness to … include budget authority.”

“Hamburg’s response is right and appropriate,” Kamp said. “May it be the last word. However, we’re not betting the farm,” he added.

Indeed, although the exchange between Schakowsky and Hamburg was the only mention of drug advertising during this comprehensive hearing, it is unlikely to be the last, especially considering Schakowsky’s ending remark: “Given the prevalence of those ads on television, I would think that should be a major focus and I hope we can work together to make that happen,” she concluded.

Recent efforts by other entities to push for drug marketing restrictions or greater regulation of DTC ads as a part of PDUFA V are worth noting. An Aug. 31, 2011, letter from the Pharmaceutical Care Management Association (PCMA) to the Joint Select Committee on Deficit Reduction called suppressing the use of branded drugs and eliminating the tax deduction for DTC advertising “debt-reducing solutions” that it claims, combined with other prescription drug measures, could save the federal government $100 billion over 10 years.

In highlighting the PCMA recommendation to ban the DTC advertising tax deduction, the letter states that “while the First Amendment allows for such advertising, it does not require tax payers to subsidize promoting the most expensive drug treatments.”

Further, a last-minute plea from a coalition of consumer groups to Department of Health & Human Services Secretary Kathleen Sebelius asked that more marketing rules – including expanded capacity for monitoring of DTC advertising – be added to PDUFA V language.

In tandem, these proposals forward the view that further discussion of marketing in the context of PDUFA reauthorization legislation is likely to rear its head again.

“Once groups like PCMA and Consumers Union take a position, they seldom give up easily,” said Kamp. “It would be naïve to think that our fight is over.”