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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Sept. 8, 2015 – To incorporate animal prescription drugs into its revised draft guidance on Brief Summary and Adequate Directions ...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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FDA Willing to “Re-examine” Off-label Policies in Light of First Amendment Rulings

April 28, 2014 – The FDA is not taking lightly industry’s concerns that its existing off-label policies are not in line with the most recent First Amendment case law, according to FDA senior officials who spoke recently at the Food and Drug Law Institute’s Annual Meeting held in Washington, D.C.

On April 23, Leslie Kux, FDA’s assistant commissioner for policy and director of the Office of the Commissioner’s Office of Policy, cited some of the off-label promotion policies that the FDA is reconsidering in response to industry’s concerns. These include policies pertaining to unsolicited requests for information, scientific exchange, communication with formulary committees and payers, healthcare economic information and third-party clinical practice guidelines.

“Clearly FDA has officially moved from the denial phase into a more realistic and productive mode in response to the reality that the First Amendment applies to its rules and policies,” said Coalition for Healthcare Communication Executive Director John Kamp. “The CHC and others are anxious to dialogue with the agency on how best to reform the rules for the benefit of patients,” he said.

Kux indicated that the agency has “taken a number of steps to start down this road,” such as opening a docket on scientific exchange (and developing draft guidance document on the matter “relatively soon”), working on the final unsolicited requests draft guidance and drafting a guidance on healthcare economic information.

“We are looking more broadly, so I do want to assure everybody that we are taking the First Amendment concerns that we’ve heard very seriously,” Kux told the FDLI meeting attendees. She noted that the agency is accepting comments on the draft reprint guidance until May 2. “We’d be very glad to have everyone’s comments on that, too,” she said.

The agency’s collective actions in light of First Amendment issues raised by industry in comments and in a citizen petition filed by the Medical Information Working Group in September 2013 – which requested that the agency review the recent developments in First and Fifth Amendment case law, as well as ongoing changes in the delivery of medical services (see – indicate that the agency is not turning a blind eye to First Amendment concerns.

Indeed, Center for Drug Evaluation and Research Director Janet Woodcock said at the FDLI meeting that the agency is aware of recent court decisions in U.S. v. Caronia and IMS v. Sorrell, and of their influence on FDA positions and policies.