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FDA Plans to Study Effect of DTC Ads on Adolescents

July 24, 2014 – A better understanding of how adolescents weigh risks and benefits in direct-to-consumer (DTC) ads is needed ... read more

Bruce Grant Urges Pharma Communicators to Recognize Their Role in Health Advances

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Kamp to Washington Post: Companies Should Be Able to Speak Truthfully About Drugs

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FDA Device Document Revises Mobile Medical Apps Guidance

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As Sunshine Act Phase One Implemenation Ends, Compliance Concerns Grow

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New Yorker Article Weighs Sales Rep Free Speech Arguments in Off-label Context

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WLF: FDA’s Revised Reprint Draft Guidance Violates Injunction and First Amendment

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FTC Cites Privacy Concerns Related to Mobile Health Apps

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CHC Comment to FDA: Less Is More in DTC TV Ads

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FDA Willing to “Re-examine” Off-label Policies in Light of First Amendment Rulings

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CHC Press Release: Comment on Social Media Draft Guidance

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Kamp to WSJ: FDA Could Do a Better Job of Defending Off-label Limits

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OPDP Issues First Untitled Letter for Branded Facebook Page

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Cuts in Speaker Payments Should Be Placed in Proper Context

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FDA Issues Updated Draft Guidance on Distributing Scientific and Medical Info on Unapproved New Uses

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New Tax Reform Legislation Includes Limit on Ad Tax Deductions

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FDA Is Considering Shorter List of Risks in DTC TV Ad Major Statement

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OPDP Enforcement Letters Target Common Issues in Last Half of 2013

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Caronia Decision One Year Later: Off-label Change May Be Slow, But It’s Brewing

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Coalition Seeks Input on FDA Online Promotion Guidance

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FDA Draft Guidance Addresses Postmarket Submission of Online Promotional Material

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Coalition Calls on Senators to Reject Tax on Advertising

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House Members Speak Out Against Inclusion of Textbooks, Reprints in Sunshine Act Reporting

Nov. 26, 2013 – On Nov. 22, 23 members of the U.S. House of Representatives sent a letter to the ... 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.”