Subscribe   RSS Contact Us

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Sept. 8, 2015 – To incorporate animal prescription drugs into its revised draft guidance on Brief Summary and Adequate Directions ...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

Previous Next

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 Centers for Medicare & Medicaid Services (CMS) to voice their disagreement with the Department of Health and Human Services (HHS) decision to include textbooks and scientifically peer-reviewed medical journals as “transfers of value” reportable under the Physician Payment Sunshine Act. The letter demonstrates that there is widespread disagreement with the current HHS policy.

“This letter from 23 prominent House Members – who are leaders of both parties – should help demonstrate to the CMS rulemaking team that it simply erred in including texts and reprints among reportable items under the Sunshine Act,” according to John Kamp, Executive Director, Coalition for Healthcare Communication. “It also confirms the opinion of 33 physician organizations and 41 national and state medical societies that the statute did not include these items and that doing so is not in the best interest of patients.” (For a related story, see

The letter’s co-signers state that “The importance of up-to-date, peer-reviewed scientific medical information as the foundation for good medical care is well documented.” They also assert that Congress outlined 12 specific exclusions from the Sunshine Act reporting requirements, including “educational materials that directly benefit patients or are intended for patient use,” and that CMS’ interpretation that reprints and textbooks do not fall under this category “is inconsistent with the statutory language on its face, congressional intent, and the reality of clinical practice where patients benefit directly from improved physician medical knowledge.”

The letter also states that as currently written, “the reporting requirement presents a clear disincentive for clinicians to accept high-quality, independent educational materials, an outcome that was unintended when the provision was passed into law” and notes that if the final regulations stand, they “could inadvertently prevent” physicians and patients from receiving these materials, and “thereby undermine efforts to improve the quality of care provided to patients.”

“Many thanks go to Congressmen Rob Andrews [D-N.J.] and Dr. Michael Burgess [R-Texas] for leading on this issue,” Kamp said. “We trust that CMS will meet with these Members of Congress to get a more detailed view of the intent of the statute. Meanwhile, ad agency and publisher representatives will continue to meet with government and industry leaders to pursue a quick resolution of the issues.”

In addition to Andrews and Burgess, House members who signed the letter are:

  • Allyson Schwartz (D-Pa.)
  • Richard Neal (D-Mass.)
  • Pat Meehan (R-Pa.)
  • Andy Harris, M.D. (R-Md.)
  • Phil Gingrey, M.D. (R-Ga.)
  • Paul Broun, M.D. (R-Ga.)
  • Tom Price (R-Ga.)
  • Phil Roe, M.D. (R-Tenn.)
  • Michael Turner (R-Ohio)
  • Mike Fitzpatrick (R-Pa.)
  • John Tierney (D-Mass.)
  • Michael Capuano (D-Mass.)
  • Marsha Blackburn (R-Tenn.)
  • Paul Gosar (R-Ariz.)
  • Charles Boustany Jr., M.D. (R-La.)
  • Charles Rangel (D-N.Y.)
  • Dan Benishek, M.D. (R-Mich.)
  • Bill Johnson (R-Ohio)
  • Kathy Castor (D-Fla.)
  • Robert Brady (D-Pa.)
  • Ann Wagner (R-Mo.)

Including Burgess, seven of the co-signers are physicians.

Comments are closed.