Subscribe   RSS Contact Us

PhRMA Authors Call for FDA to Establish Off-label Communication Safe Harbor

April 27, 2015 – Because “sharing more information rather than less” about the off-label uses of approved drugs “is critical ... read more

FDA Draft Guidance Describes Framework for Electronic Submission of Promotional Materials

April 22, 2015 – Healthcare marketers soon will have to submit promotional labeling and advertising materials to the FDA electronically, ... read more

Changing of the Guard at PhRMA

April 20, 2015 – The Pharmaceutical Research and Manufacturers of America (PhRMA) last week announced changes to its board – ... read more

Coalition to Sponsor Medical Marketing Pitch Webinar

April 6, 2015 – The Coalition for Healthcare Communication is sponsoring a Webinar May 6 that will highlight both basic ... read more

2014 DTC Ad Spending on the Rise

March 25, 2015 – The amount of money that drug companies spent on direct-to-consumer advertising rose from $3.8 billion in ... read more

What Does OPDP’s Enforcement Lull Mean?

March 12, 2015 – The FDA’s Office of Prescription Drug Promotion (OPDP) has issued fewer enforcement letters in recent years, ... read more

Who Says You Can’t Fight City Hall?

Commentary from Jack Angel, Coalition for Healthcare Communication Education Foundation Executive Director March 9, 2015 – I am not sure ... read more

DAA Expands Ad Privacy Controls to Mobile Marketplace

Feb. 26, 2015 – To “bolster both consumer trust and marketplace growth,” the Digital Advertising Alliance (DAA) yesterday launched two ... read more

Leveraging Technology and Other Highlights from DIA Marketing Meeting

Feb. 23, 2015 – Dale Cooke, owner of PhillyCooke Consulting, who spoke Feb. 18 at the Drug Information Association’s Marketing ... read more

FDA Budget Increase Relies on Higher User Fees

Feb. 16, 2015 – Although President Obama’s proposed budget for fiscal year 2016 includes increases for both the FDA and ... 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Feb. 9, 2015 – In a revised draft guidance document released Feb. 6, the FDA is updating a 2004 version ...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

FDA Commissioner Hamburg to Leave FDA

Feb. 5, 2015 – After serving the FDA for six years, Commissioner of Food and Drugs Margaret Hamburg, M.D., will ... read more

21st Century Cures Discussion Draft Includes Textbook/Reprint Language, Communication Fixes

Jan. 29, 2015 – A 393-page discussion draft of legislation designed to accelerate the 21st Century Cures initiative – released ... read more

Transparency Proponents Slam Company-Provider Communication

Jan. 26, 2015 – Although biomedical companies can legally communicate and share information with physicians under the Physician Payments Sunshine ... read more

FDA Moves Forward with Major Statement Study, Responds to Coalition’s Comments

Jan. 14, 2015 – The FDA is taking the next step toward examining whether shorter, simpler risk disclosures in direct-to-consumer ... read more

Coalition: Issues to Watch in 2015

Jan. 13, 2015 — As 2015 gets fully underway, there are several issues that healthcare marketers should be following, according ... read more

Kamp to WSJ’s Pharmalot: CMS Move on CME “One of Biggest Flip Flops” Ever

Dec. 18, 2014 – This week’s release by the Centers for Medicare & Medicaid Services (CMS) of subregulatory guidance on ... read more

MM&M Tax Reform Prognosis: Stay Tuned

Dec. 4, 2014 — The looming threat of eliminating the marketing tax deduction as part of overall tax reform may ... 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.