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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Sept. 8, 2015 – To incorporate animal prescription drugs into its revised draft guidance on Brief Summary and Adequate Directions ...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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WLF to CMS: Deem Medical Textbooks Educational Materials or Face Potential First Amendment Challenge

May 16, 2013 – The Centers for Medicare & Medicaid Services (CMS) is likely “to find itself the target of a First Amendment lawsuit by affected parties” if it does not consider medical textbooks to be “educational materials that directly benefit patients” which are excluded from a reporting requirement under the final rules implementing the Physician Payment Sunshine Act, according to a May 15 letter to CMS from the Washington Legal Foundation (WLF).

In its letter (CMS Textbook Policy), WLF asks CMS  to delay application of reporting requirements to medical textbooks until it has had an opportunity to examine the First Amendment implications of including these items as “transfers of value” from manufacturers to doctors.

Coalition for Healthcare Communication (CHC) Executive Director John Kamp remarked that the WLF letter “is strong, balanced, nuanced and likely to be effective. Indeed, if WLF convinces CMS to reverse itself on textbooks, the same reasoning applies to journal supplements, reprints and Website publications that are distributed with company support.”

Specifically, WLF contends the following in its letter:

  • The distribution of medical textbooks is speech protected by the First Amendment;
  • Although CMS is not banning speech, it is substantially burdening speech (and such burdens are subject to First Amendment constraints);
  • The Sunshine final rule’s disclosure requirement imposes a substantial burden on the right to speak by distributing medical textbooks;
  • Application of the Sunshine Act to medical textbooks does not serve any substantial government interests; and
  • CMS can avoid First Amendment difficulties by construing the Act as inapplicable to medical textbooks.

“Applying the reporting requirements to medical textbooks would constitute a serious infringement on the First Amendment rights of pharmaceutical companies to disseminate medical texts and the First Amendment rights of doctors to receive such information,” WLF Chief Counsel Richard A. Samp wrote in the letter to CMS Acting Administrator Marilyn Tavenner.

“The U.S. Supreme Court has repeatedly held that disclosure requirements of this sort [imposed by the final rule] are subject to ‘exacting scrutiny’ and can pass muster under the First Amendment only if shown to serve important government interests that outweigh the burdens they impose on speakers,” the letter states.

The WLF also states that the burden of reporting and doctors’ concerns about being included on a list of those receiving payments from drug companies will cause doctors to decline offers of medical textbooks and cause companies to cease disseminating them. Because medical textbooks communicate truthful information that helps doctors treat patients, the WLF asserts that they are fully protected by the First Amendment, as demonstrated by multiple U.S. Supreme Court decisions. “By all accounts, medical textbooks supplied by drug companies to doctors ‘directly benefit patients’ – doctors regularly use information gleaned from the textbooks in their treatment of patients,” according to the WLF.

As further evidence that medical textbooks constitute protected speech under the First Amendment, the WLF states that its 1998 lawsuit against the Food and Drug Administration (FDA) resulted in the FDA being subject to a permanent injunction limiting FDA authority to suppress manufacturer dissemination of medical textbooks discussing off-label uses of their FDA-approved products.

“There is little evidence that Congress intended to single out textbook dissemination and other expressive activities for special disapprobation, but the effect of the Act (as interpreted by CMS) is to burden this expressive activity to such an extent that much of the activity will cease,” the WLF letter states. Samp concludes the letter by stating that “in light of the grave constitutional issues raised by CMS’s rule, courts will not defer to CMS’s reading of the Act … even if they deem it a plausible reading,” and advises CMS to reconsider and allow these educational materials to be excluded from reporting requirements.

“Exempting these as educational items not only makes sense under the Sunshine Act, it makes great public policy sense,” CHC’s Kamp said. “Informing doctors about the latest science and practice guidelines drives improved patient care. Everyone can salute that result.”