Subscribe   RSS Contact Us

Purple Strategies’ Haynes to Keynote at CHC Member Meeting in D.C.

Sept. 29, 2016 — Bruce Haynes, founding partner and president of Purple Strategies, will give the keynote address at the ... read more

OPDP’s Second Enforcement Letter in Two Weeks Targets Investigational Drug

Sept. 15, 2016 – Although the FDA’s Office of Prescription Drug Promotion (OPDP) has only issued four enforcement letters this ... read more

OPDP Sends Enforcement Letter for Promotion of Investigational Drug

Sept. 8, 2016 — The FDA’s Office of Prescription Drug Promotion (OPDP) takes issue with a conference panel for an ... read more

FDA to Hold Post-election Hearing on Off-label Communication

Sept. 1, 2016 – In the wake of the agency’s recent settlement with Amarin and other rulings that support the ... read more

FDA May Still Issue Four Advertising Guidances in 2016

Aug. 11, 2016 — The FDA announced Aug. 10 that it plans to issue four, much-awaited advertising-related guidance documents before ... read more

Study Shows ACA Increases Use of Rx Drugs, Decreases Out-of-pocket Spending

Aug. 19, 2016 – The Affordable Care Act (ACA) has resulted in increases in the use of prescription drugs and ... 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

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

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

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

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

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

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 http://www.cohealthcom.org/?p=1813) – 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.