Subscribe   RSS Contact Us

OPDP Issues Just Two Enforcement Letters in First Half of 2016

July 22, 2016 – Although 2015 was considered a slow year for enforcement letters issued by the FDA’s Office of ... 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

Medical Associations Support Bill Exempting Journals and Textbooks from Sunshine Reporting

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

Bill Gates Defends U.S. Drug Pricing System

July 1, 2016 – Amidst criticism over the high cost of drugs in this country, billionaire and philanthropist Bill Gates ... 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

Washington Health Policy Focus Is on Drug Innovation, Reform and Pricing, Rawson Says

June 13, 2016 – Before and after the 2016 elections, Washington health policy will remain fixed on improving the path ... 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

Courts’ Support for “Truthful and Non-misleading” Speech Has Not Yet Resulted in FDA Policy Change

May 31, 2016 – Although the U.S. Supreme Court and other courts consistently are deciding cases in favor of First ... 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

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

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

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

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

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 http://www.cohealthcom.org/?p=2016.)

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.