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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Sept. 8, 2015 – To incorporate animal prescription drugs into its revised draft guidance on Brief Summary and Adequate Directions ...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 States Keywords Do Not Have To Be Reported on Form 2253s

Sept. 3, 2013 – An FDA official’s statement during a recent enforcement Webinar that online keywords do not have to be submitted to the agency on FDA Form 2253s confirms – in the absence of explicit guidance from the FDA regarding Internet issues – what most in industry already had inferred from enforcement actions taken by the agency over the years, according to Dale Cooke, Vice President/Group Director, Digitas Health.

At an enforcement update Webinar held July 29, Office of Prescription Drug Promotion Regulatory Counsel Julie Chronis was asked whether firms were required to submit keywords used for Internet promotion on 2253s, to which she replied, “Keywords do not have to be submitted on 2253s.”

Although this may seem like a minor comment, Chronis’ response validates industry’s assumptions, Cooke said. “We’ve long told clients that they do not have to submit their keywords on a 2253, and the [Chronis comment] confirmed that advice. But there are definitely considerations about ensuring compliance that go beyond the 2253 submission.”

Marketers reasoned that FDA’s silence on the issue of keywords – for example, the absence of any mention of keywords in 14 letters issued in March 2009 to address alleged search engine marketing violations – demonstrated “that sponsors were not required to submit the keywords,” Cooke told the Coalition. “That was also consistent with offline practices because the function of keywords is analogous to a media buy for an offline print ad. The keywords selected determine where the ad can show up, but they aren’t themselves part of the ad.”

However, industry could not be certain that this was the FDA’s official stance. “The silence by the FDA could have merely been an oversight or a matter of FDA not having a settled position,” Cooke noted. “Actually hearing the FDA articulate this position – even in an informal, non-binding setting such as a Webinar – provides confirmation that our reasoning was correct.”

Bill Evans, Chief Digital Officer, Team Chemistry at WPP, and Managing Editor, Dose of Digital, views Chronis’ statement as “basically a signal that FDA can’t or doesn’t feel the need to preapprove keywords. It’s a herculean task, given that a typical brand may have 400-700 keywords. FDA has been fairly consistent in its guidance and warnings on keywords, so a pre-review is both cumbersome and unnecessary. For marketers, this eases up schedules, but increases the responsibility to keep a brand’s message and metadata on track.”

Indeed, legal experts have suggested that the FDA still may cite companies for the use of sponsored links, search terms and metatags. This includes keywords “that broaden indications or inherently promote off-label uses,” said Wayne Pines of APCO Worldwide. “For example, if my drug for asthma pops up first in a search for foot fungus, the FDA clearly would object to that,” he said.

“The rules of the road are fairly clear and, when followed, simple to abide by,” Evans stated. “Make no claims about a product that can’t be supported with balance: something that’s almost impossible to do in a metadata/keyword environment. Make any kind of claim about a brand without a balance statement and you will get a Warning Letter. Nothing about this has changed,” he asserted.

Cooke disclosed that Digitas Health has established best practices for metadata and keywords. “We advise clients to ensure that all of their message targeting is on label, [which] means both limiting the keywords targeted to the approved indication as well as developing a list of negative keywords for the most commonly searched off-label indications,” he explained. “We advise clients to take steps proactively to prevent their messages from appearing in response to off-label searches by using a robust negative keyword strategy.”

Behind the Digitas Health strategy is a process that is based on an understanding of relevant FDA considerations and of Google search behavior by the targeted users, be they healthcare providers, patients or caretakers, Cooke continued. For example, “we tell all of our clients that they need to take not just their text ads but also their keywords through the medical-legal-regulatory promotional review process.”

He also provided some basic rules that will help companies avoid FDA enforcement action in this area:

  • Stay on label;
  • Use reminder advertising when appropriate;
  • Make sure you mention the generic name with any mention of the brand (even in a URL);
  • Submit any promotional messaging under 2253; and
  • Do not communicate indication and product name in any message without corresponding risk information to provide balance.

Evans reiterated that claims can only be made in a balanced setting. “Do otherwise at your peril,” he said. “Since people mainly search online with very specific types of phrases, this should be an easy one to comply with. I always scratch my head when I read about Warning Letters being issued for this type of thing, as it seems like a … mistake that is easily avoided and with no clear benefit for coloring outside the lines.”

Pines noted that the FDA official’s response regarding online keywords is a clarification and not a change of FDA policy. He also suggested that now that this question has been raised with the agency, “the real issue is whether the agency’s position is going to change when it puts out its social media guidance. This is the type of question that the FDA should be looking at, and I wouldn’t be surprised if they address it.”