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FDA Plans to Study Effect of DTC Ads on Adolescents

July 24, 2014 – A better understanding of how adolescents weigh risks and benefits in direct-to-consumer (DTC) ads is needed ... read more

Bruce Grant Urges Pharma Communicators to Recognize Their Role in Health Advances

July 23, 2014 – Although the pharmaceuticals industry has come under fire in recent years, it is important to remember ... read more

FDA Social Media Draft Guidances Answer Some Questions, Raise Others

July 21, 2014 – Although the FDA has attempted to provide some clarity on its position regarding certain social media ... read more

Kamp to Washington Post: Companies Should Be Able to Speak Truthfully About Drugs

July 14, 2014 – Drug companies should be allowed to share truthful information about the off-label uses of their drugs, ... read more

CMS Proposes Eliminating CME Sunshine Act Exemption

July 7, 2014 – About 240 pages into the 600-page physician fee schedule proposed rule, which is due to be ... read more

FDA Device Document Revises Mobile Medical Apps Guidance

July 1, 2014 – The FDA’s recently issued draft guidance on medical device data systems (MDDS) not only lessens the ... read more

New FDA Social Media Guidances Address Space-limited Media, Correcting Online Misinformation

June 23, 2014 – Although the two social media draft guidance documents the FDA’s Office of Prescription Drug Promotion (OPDP) ... read more

AMA House of Delegates: Revise Sunshine Act Rules on Textbook/Reprints and TOV Amount

June 12, 2014 – The American Medical Association’s (AMA’s) House of Delegates is attempting to bring some common sense to ... read more

As Sunshine Act Phase One Implemenation Ends, Compliance Concerns Grow

June 9, 2014 – In a recent Pharmalot blog post on The Wall Street Journal site, Ed Silverman writes that ... read more

House Committee Seeks Patient Input on Availability of Treatments

June 3, 2014 – The House Energy and Commerce Committee is seeking public comments from patients, providers and other stakeholders ... read more

FDA To Study Viewers’ Responses to DTC Ad Risk Information

May 29, 2014 – The FDA announced May 28 in the Federal Register that it plans to conduct an eye ... read more

FTC Calls for Data Broker Legislation To Protect Consumers

May 29, 2014 – The Federal Trade Commission (FTC) released a report May 27 in which it asks Congress to ... read more

OPDP Enforcement Letters Address Omission of Risk Information

May 23, 2014 – The FDA’s Office of Prescription Drug Promotion (OPDP) has issued just three Untitled Letters to date ... read more

New Yorker Article Weighs Sales Rep Free Speech Arguments in Off-label Context

May 22, 2014 – Both sides of the argument over whether sales representatives’ speech about off-label drug uses are protected ... read more

WLF: FDA’s Revised Reprint Draft Guidance Violates Injunction and First Amendment

May 19, 2014 – In May 15 comments to the FDA regarding its draft guidance on reprint practices for articles ... read more

FTC Cites Privacy Concerns Related to Mobile Health Apps

May 9, 2014 – Mobile health and fitness applications are on the Federal Trade Commission’s privacy-protection radar following a study ... read more

CHC Comment to FDA: Less Is More in DTC TV Ads

May 2, 2014 – The Coalition for Healthcare Communication believes that “shorter, simpler disclosures are most likely to lead to ... read more

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 ... read more

CHC Press Release: Comment on Social Media Draft Guidance

April 9, 2014 — The Coalition for Healthcare Communication issued the following press release today regarding the CHC Social Media ... read more

Some States Impose Reporting Requirements That Add to Sunshine Burden

April 7, 2014 – Although the Physician Payment Sunshine Act preempts state laws that require reporting of similar information required ... read more

Kamp to WSJ: FDA Could Do a Better Job of Defending Off-label Limits

March 31, 2014 – The FDA’s recent draft guidance on disseminating reprints, textbooks and clinical practice guidelines (CPGs) discussing off-label ... read more

OPDP Issues First Untitled Letter for Branded Facebook Page

March 14, 2014 – The FDA’s Office of Prescription Drug Promotion (OPDP) on Feb. 24 issued its first enforcement letter ... read more

Cuts in Speaker Payments Should Be Placed in Proper Context

March 10, 2014 – The need for industry to educate the public on why company interaction with physicians is both ... read more

FDA Issues Updated Draft Guidance on Distributing Scientific and Medical Info on Unapproved New Uses

March 3, 2014 – The FDA announced today the availability of a new draft guidance (2014-04560) on distributing scientific and ... read more

New Tax Reform Legislation Includes Limit on Ad Tax Deductions

Feb. 27, 2014 – As expected, tax reform legislation introduced yesterday by Senate Ways and Means Committee Chairman Dave Camp ... read more

FDA Is Considering Shorter List of Risks in DTC TV Ad Major Statement

Feb. 17, 2014 – In recognition that the stream of risks currently disclosed on direct-to-consumer (DTC) television ads may be ... read more

OPDP Enforcement Letters Target Common Issues in Last Half of 2013

Feb. 4, 2014 — Many of the 14 enforcement letters issued by the FDA’s Office of Prescription Drug Promotion (OPDP) ... read more

Caronia Decision One Year Later: Off-label Change May Be Slow, But It’s Brewing

Jan. 27, 2014 – Although FDA officials have treated the U.S. Court of Appeals for the Second Circuit decision in ... read more

Coalition Seeks Input on FDA Online Promotion Guidance

Jan. 23, 2014 – The Coalition for Healthcare Communication would like to receive feedback from its members regarding the FDA ... read more

FDA Draft Guidance Addresses Postmarket Submission of Online Promotional Material

Jan. 14, 2014 – The determining factor regarding whether a firm submits online prescription drug promotional material to the agency ... read more

Kamp on Off-label Discussion at the CMS/FDA Summit

Jan. 3, 2014 – From Coalition for Healthcare Communication Executive Director John Kamp: Several weeks ago I was privileged to ... read more

Coalition Calls on Senators to Reject Tax on Advertising

Dec. 16, 2013 – Today the Coalition for Healthcare Communication sent a letter to U.S. Senators and Members of the ... read more

House Members Speak Out Against Inclusion of Textbooks, Reprints in Sunshine Act Reporting

Nov. 26, 2013 – On Nov. 22, 23 members of the U.S. House of Representatives sent a letter to the ... read more

OPDP Sends Warning Letter Based on Statements Made on Fast Money TV Show

Nov. 11, 2013 – The FDA Office of Prescription Drug Promotion’s (OPDP’s) recent enforcement actions – four Untitled Letters and ... read more

Physician Organizations, Medical Societies Implore HHS to Reverse Policy on Reprints and Textbooks

Oct. 28, 2013 – On Monday, 33 physician organizations and 41 national and state medical societies sent a letter to ... read more

MIWG Asks FDA to Clarify Position Regarding Manufacturer Dissemination of New Use Information

Sept. 16, 2013 – The Medical Information Working Group (MIWG), a coalition of medical product manufacturers seeking to improve the ... 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.”