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AMA Calls for DTC Advertising Ban

Nov. 17, 2015 — The American Medical Association (AMA) announced today that it would support an advertising ban on direct-to-consumer ... read more

Rocky Political Road Ahead for Pharma Industry

Nov. 16, 2015 – From tax inversions to the proposal to reduce ad tax deductions for marketing to being named ... read more

PhRMA Puts Drug Costs in Perspective as Pricing Scrutiny Increases

Nov. 9, 2015 – Congress, federal agencies and the media continue to turn up the heat on their examination of ... read more

Kaiser Poll: DTC Ads Have High Profile, But Mixed Reviews

Oct. 30, 2015 – The drug industry may have additional work to do to improve the public’s perception of its ... read more

CHC DC Meeting: Prescription Drugs Are Cost Savers, Not Cost Drivers

Oct. 26, 2015 – There is no question that prescription drugs have a cost to patients and payers, but that ... read more

FDA Study of DTC Ads Reaches Critical Mass

Oct. 20, 2015 – The FDA’s announcement last week that it was accepting comments on two new studies of direct-to-consumer ... read more

Senate Bill Would Loop Nurse Practitioners and PAs into Sunshine Reporting

Oct. 12, 2015 – A bill introduced in the Senate last week by Sen. Charles Grassley (R-Iowa) and Sen. Richard ... read more

Which Standard of Truth Will Be Used To Evaluate Non-misleading Ad Claims?

Oct. 5, 2015 – Following numerous First Amendment court cases about promotional speech decided in favor of pharmaceutical companies, it ... read more

Prescription Drug Marketing Targeted by Hillary Clinton

Sept. 24, 2015 – Presidential hopeful Hillary Clinton just announced that she would “demand a stop to excessive profiteering and ... read more

CMPI: Value of Prescription Drugs Is Underestimated

Sept. 21, 2015 – Despite widespread reports about the soaring prices of prescription drugs and calls by the federal government ... read more

Pacira Files Complaint Calling FDA Marketing Restrictions Unconstitutional

Sept. 10, 2015 – On the heels of last month’s ruling in Amarin v. FDA, which held that the FDA ... read more

Comment Period for Brief Summary Revised Guidance Extended to Oct. 5 Under Second Revision

Sept. 8, 2015 – To incorporate animal prescription drugs into its revised draft guidance on Brief Summary and Adequate Directions ... read more

Pitts Calls Higher Drug Approval Rate a Sign of Regulatory Progress

Aug. 24, 2015 – Although some may call the FDA to task for approving more new drugs than they have ... 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

Kamp on Presidential Politics: They Matter to Medical Marketers

Aug. 17, 2015 – In an Aug. 11 column posted on the PharmaLive website, Coalition for Healthcare Communication Executive Director ... read more

Amarin Federal Court Decision: FDA Off-Label Marketing Rules Violate the First Amendment By John Kamp

Aug. 10, 2015 – Late last week the U.S. District Court for the Southern District of New York granted Amarin ... read more

FDA Will Study How Market Claims, Efficacy Info Affect Consumers in DTC Drug Print Ads

July 29, 2015 – The FDA’s Office of Prescription Drug Promotion (OPDP) recently announced that it plans to conduct a ... read more

Congressional Briefing: Medical Information Communication Is Important Patient Issue

July 28, 2015 – Physicians and their patients need access to truthful and non-misleading data about available treatments, including off-label ... read more

CME Update: CMS Revises Guidance and Industry Ups Spending

July 20, 2015 – Two recent developments in the continuing medical education (CME) arena – a revision to CME guidance ... read more

Kamp: 21st Century Cures Act and Amarin Case Developments Are Signs of Progress

July 13, 2015 –Two events last week – the House approval of the 21st Century Cures legislation and arguments in ... read more

House Approves 21st Century Cures Act, Bill Now Heads to the Senate

July 10, 2015 — The House of Representatives today passed H.R. 6, also known as the 21st Century Cures Act, ... read more

21st Century Cures Legislation Garners House Majority Support

July 1, 2015 – The 21st Century Cures Act, which was unanimously approved by the House Energy and Commerce Committee ... read more

Google SEM Changes Affect Drug Black Box Reminder-like, Redirecting Ads

June 29, 2015 – Two changes to search engine marketing (SEM) recently announced by Google could soon alter how pharmaceutical ... read more

Physicians Say CHC-backed H.R. 293 Would Remedy “Burdensome” Sunshine Act Reporting

June 15, 2015 – More than 100 physician organizations have written to Rep. Michael Burgess (R-TX) to express their strong ... 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

Revised Guidance on Use of Brief Summary in Print DTC Ads: Full PI Is Not Needed or “Recommended”

Feb. 9, 2015 – In a revised draft guidance document released Feb. 6, the FDA is updating a 2004 version ... 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.”