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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

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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

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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

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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 for the drug industry and its marketing partners. New legislative authority has spured an already energized FDA drug approval staff to focus on novel drugs. The new program,  giving prioity for agents in critical areas,  builds on recent progress and could signal “the beginning of a new era in drug approvals,” said Coalition for Healthcare Communication Executive Director John Kamp. “Such new drugs are great for patients and give industry new reason to energize flagging marketing programs.”

Speaking March 19 at the Drug Information Association’s Medical and Scientific Communications 2013 Annual Forum held in Chandler, Ariz., Kamp told attendees that in addition to the new drug approvals program recently adopted by the FDA’s Center for Drug Evaluation and Research (CDER), the FDA Safety and Innovation Act (FDASIA) provides incentives for breakthough products and  antibiotics. These augment the biosimilar approval pathway created in the Affordable Care Act.

“It is not surprising that drug promotion rates declined in recent years as approvals slowed down,” Kamp said. “But current upward approval trends — including a recent record of 39 approvals in 2112 — combined with the CDER program to speed the approval of breakthrough products, makes it nearly certain that marketing opportunities will increase in 2013. While most of the new products are speciality products, not the blockbusters of the past, they are new products nonetheless and many will grow into substantial markets.”

But the recent numbers published by PLOS tell a different story over the past several years. The study, “Promotion of Prescription Drugs to Consumers and Providers, 2001-2010,” which was released March 4, states that a number of factors appear to have had an impact on drug promotion, which peaked in 2004 at $36.1 billion and sank to $27.7 billion by 2010. Its authors propose that those factors include a slowdown in new drug introductions, changes in the pharmaceutical pipeline, patent expiry for blockbuster drugs, and a greater number of approved biologics.

Spending on direct-to-consumer (DTC) advertising dropped from nearly $6 billion in 2006 to $4.4 billion in 2010, the study states. “During this period, television accounted for a decreasing proportion of all DTCA, declining from 62% in 2001 to 54% by 2010. Print DTCA increased 84% 2001-2006, but then declined 24% by 2010. In 2010, internet promotion accounted for less than 5% of overall consumer promotion,” according to the study summary.

“Manufacturers of branded pharmaceuticals continue to expend considerable sums on promotion to consumers and providers,” the PLOS study concludes. “However, in the context of marketplace changes, firms are decreasing spending but changing little about how expenditures are allocated across types of promotion.”

Kamp asserted that new drug development and approval initiatives will help reverse the decline in approvals that industry has seen in the past several years. For example, with FDASIA codifying accelerated approvals, innovative drugs have a better chance of being approved in a timely manner. Further, “breakthrough therapies” – those that show extraordinary clinical effectiveness – have access to “hyper fast” development, he said. And, the Generating Antibiotic Incentives Now Act (GAIN Act) provides five additional years of patent protection for qualified agents targeting priority infections.

“Add these to priority treatment for rare disease drug applications and for pediatric drugs, and the numbers surely will go up,” Kamp predicted. He also pointed out that during the past two years, FDA new drug approvals have increased from where they stood in 2010. [Editor’s note: The recent study did not tabulate spending data after 2010.]

Kamp described the new approval system – known as “The Program” – as including the following features:

  • Longer review cycles, but faster review times;
  • Better meetings, including outside consultants that will report on system
  • More late-cycle meetings to avoid “surprises” to drug sponsors;
  • Fewer, “less exciting” Advisory Committee meetings; and
  • Fewer late-cycle “complete response letters” and demands for new studies.

How all of the new approval system changes will stack up against some of the current market challenges remains to be seen, but, Kamp told DIA Forum attendees, “the greater number of approvals for new drugs that we saw in 2012 – with even more new drug approvals likely in 2013 – is most definitely an encouraging trend.”