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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

Coalition Rising Leaders Conference: Industry Advocacy Will Help Shape Healthcare’s Political Landscape

May 17, 2016 — Healthcare policy improvements are underway in Washington, and industry advocacy makes a difference—that was the recurring message ... read more

The Advertising Coalition Reminds FDA of First Amendment Limits to Advertising Regulation

May 9, 2016 – In an April 29 comment to the FDA on its recent proposal to conduct research on ... read more

Drug Companies Should Be Able to Share Information with Payers

May 2, 2016 – In order to make reasonable coverage decisions about new medicines, payers need access to information from ... read more

Commissioner of Food and Drugs Califf Lists Advertising, Labeling Among Priorities

April 25, 2016 — In a speech at the Alliance for a Stronger FDA’s quarterly meeting April 19, new Commissioner ... read more

FTC to Pharma on Native Advertising: Proceed with Caution

April 18, 2016 – Although native advertising – online content that appears similar to the news, feature articles or other ... read more

American College of Physicians Calls DTC Advertising “Inappropriate”

April 4, 2016 – The hits just keep coming against direct-to-consumer (DTC) drug advertising, with the latest criticisms being made ... read more

Coalition to Host ‘Rising Leaders’ Conference in May

March 28, 2016 – To further educate and integrate the up-and-coming leaders in the healthcare communication industry, the Coalition for ... read more

Comments on FDA’s DTC Advertising Survey Due by April 29

March 21, 2016 – Industry members planning to send comments to the FDA on the “National Direct-to-consumer Advertising Survey” that ... 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

Drug Innovation Success Story: President Carter and Keytruda

March 10, 2016 — The article below, which covers drug pricing concerns in the news and the success of Merck’s ... read more

Sen. Franken Introduces Legislation to End Drug Advertising Tax Breaks

March 4, 2016 – Yesterday Sen. Al Franken (D-Minn.) introduced legislation that would end the tax deduction that drug companies ... read more

Jury Says “Not Guilty” to Off-label Charges in Medical Device Case

March 3, 2016 – As the FDA fails to update or further clarify its policy regarding off-label promotion, the courts ... read more

Best Offense Is a Good Defense When Discussing Drug Pricing

Feb. 29, 2016 – When faced with criticism of drug pricing, industry members need to be able to defend drug ... read more

DeLauro’s House Bill to Restrict DTC Advertising Likely Would Violate First Amendment

Feb. 18, 2016 – A bill introduced in the House last week by Rep. Rosa DeLauro (D-Conn.) — the Responsibility ... read more

CDER’s Woodcock Says FDA Is Meeting GDUFA Challenges at House Pricing Hearing

Feb. 8, 2016 – At last week’s House hearing on drug pricing a bipartisan group of U.S. Congressional members, the ... read more

Industry More Than Ready for FDA Off-label Communications Guidance

Feb. 2, 2016 – The FDA’s recent announcement regarding which new and revised guidance documents it plans to publish in ... read more

OPDP Enforcement Letter Cites Hospira for Omission of Risk in YouTube Video

Jan. 25, 2016 – The Office of Prescription Drug Promotion (OPDP) kicked off 2016 with a Jan. 14 Untitled Letter ... read more

Industry Prepares for DTC Battle

Jan. 12, 2016 – As criticism of prescription drug direct-to-consumer (DTC) advertising continues to be levied by presidential hopefuls and ... read more

Are DTC Ads Being Mischaracterized?

Dec. 28, 2015 – The supposed ill effects of direct-to-consumer (DTC) advertising are being levied without much evidence, according to ... read more

Pacira Prevails in Exparel Settlement with FDA

Dec. 16, 2015 – Pacira Pharmaceuticals Inc. announced yesterday that it had reached a settlement with the FDA of a ... read more

Save the Date: PhRMA’s Lori Reilly to Speak to Coalition on Feb. 16

Dec. 14, 2015 – Lori Reilly, executive vice president, Policy and Research, at the Pharmaceutical Research and Manufacturers of America ... read more

Coalition Arms Industry with Tool Kit to Defend DTC Advertising

Dec. 14, 2015 – With medical marketing being targeted by politicians and the media as one cause of high drug ... read more

NBER: DTC Ads Increase Treatment of the Undertreated and Undiagnosed, Improve Drug Adherence

Dec. 7, 2015 – While direct-to-consumer (DTC) advertising increases the number of drug prescriptions, it also boosts the number of ... read more

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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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 Healthcare Communication (CHC) recommended that the agency address key concerns before moving forward with planned FAQs regarding compliance with and implementation of the Sunshine Act final rules. CHC believes that its suggestions “will advance the goal of transparency while ensuring that the reporting process is as clear, consistent and efficient as possible for CMS, the industry and the public,” the comment states.

“Our member companies, which include publishers of medical news, information, research and scholarly data on the latest medical science intelligence, believe that important issues must be considered and clarified before the agency publishes FAQs on the Sunshine rules,” said Jack Angel, Executive Director, Coalition for Healthcare Communication Foundation. A number of these issues involve educational materials – textbooks, journal reprints, journal supplements and digitally delivered materials – which are prepared by professional publishers and sent to physicians but were not specifically mentioned in the Sunshine rule provisions, he said.

“If confusion or perceived reporting burdens cause reduced publication or restricted distribution of these valuable educational items, physicians will no longer receive crucial information and patient care will suffer,” Angel explained.

In its comments, the CHC discusses each type of educational material individually. Those comments are summarized here:

Textbooks

The CHC asserts that providing textbooks to physicians has been in practice for decades and  supports better care for patients. Additionally, textbooks are intended for professional, not personal use. Accordingly, textbooks should be excluded from the reporting requirement because these materials, like other educational materials, ensure “that clinicians are equipped with the most current medical information,” the CHC comment states. The CHC also asserts that the FDA regulates the distribution of medical education materials, which gives the Department of Health & Human Services “sufficient reason … to exempt them from reporting.”

Reprints

Reprints – copies of published articles from peer-reviewed journals – “reinforce the latest medical developments and facilitate the diffusion of medical innovation in the clinical setting,” according to the CHC. Deeming reprints – which likely cost well under $10 each – subject to Sunshine reporting would cause an untenable reporting burden on both covered entities and physicians, because covered entities would have to collect information on the identity of each physician who received a reprint and track when that physician reached the $10 threshold, and because physicians would have to log in each reprint they received from each covered entity to confirm that this tabulation is accurate.

“Instead, we recommend that [reprints] be treated like the distribution of pens and pencils,” which do not have to be tracked or reported, the comment states. “A contrary determination by CMS creates a real risk that physicians would choose to not receive reprints … a loss for healthcare providers and, ultimately, patients.”

Supplements

The CHC believes that supplements, which are special educational publications that publishers deem acceptable for mailing with the associated medical journal, would be subject to the same complications that reprints face, according to the comment, which also states that, “in the final analysis, any diminution of the availability of these educational materials would affect patient care.”

Digitally Delivered Educational Materials

Tracking this category, which covers educational materials (including reprints and supplements) that are delivered electronically, would be difficult to calculate as well, because neither the publisher nor the sponsor would have the complete or specific knowledge of the recipients. “This obvious reporting complication is a serious question in the administration of this regulation and needs to be addressed before data collection begins,” the CHC advised.

Angel underscored a point made in the CHC comment. “Receiving these materials provides no financial benefit to physicians. Making them reportable would impose great costs on industry, government and physicians, and have a negative effect on patient care,” he said. “We trust that these issues will be addressed by CMS appropriately.”