May 14, 2013 — The FDA’s Office of Prescription Drug Promotion (OPDP) will be holding an Enforcement Webinar May 16, from 11:30 a.m. to 12 p.m. (ET), to give stakeholders an opportunity to directly communicate with OPDP staff about clarifications or questions concerning recent enforcement letters issued by OPDP. This particular webinar will cover the six Untitled Letters issued by OPDP from November 2012 through March 2013.
These focused Webinars “support OPDP’s mission to protect the public health by assuring that prescription drug information is truthful, balanced, and accurately communicated,” according to OPDP. Viewers can begin submitting questions 30 minutes prior to the Webinar start time.
Meeting details are listed below:
To join the meeting:
Conference Number(s): 877-231-0558
Participant Code: 9291
April 4, 2013 – A new White Paper, “FDA Communications Oversight in a Digital Era,” issued April 2 by Eye on FDA/Fleishman-Hillard, is based on analysis of a database of FDA/Office of Prescription Drug Promotion (OPDP) enforcement letters, and takes a close look at how, in the absence of FDA guidance on digital communications and social media, the agency enforces alleged violations in these media.
“Lacking any sort of formal guidance from the agency, the only peek into FDA’s point of view is to examine enforcement patterns,” according to Mark Senak, Eye on FDA author and Senior Vice President & Partner, Fleishman-Hillard. For the period of 2008-2012, Senak set out to determine how violations by digital communications properties compared to violations by traditional (non-digital) communications vehicles.
“Given the lack of guidance by the FDA, an examination of regulatory action letters over the period of time during which social media became prominent could provide oversight into (1) whether digital communications led to a change in regulatory actions and (2) potential agency points of view derived from action letters involving social media,” the White Paper states.
Of the 173 letters sent by OPDP during this time period, 26 percent involved the issuance of a Warning Letter and 74 percent were Notices of Violation. Of the 45 Warning Letters issued, only 12 cited digital communications vehicles, the report states, and only a single enforcement letter has been issued regarding a social media platform. In that letter, it was the nature of the social media mechanism that brought about the violation, the author notes.
“As more and more people utilize digital and social media to get healthcare information, getting information about the regulatory parameters in which industry can operate is extremely important,” said John Kamp, Executive Director of the Coalition for Healthcare Communication. “There are still more questions than answers, but this paper sheds some important light onto the patterns of enforcement of digital over non-digital communications.”
For full results and analysis, go to: http://www.eyeonfda.com/eye_on_fda/2013/04/some-digital-and-social-media-guidance-fda-regulation-of-pharma-communications-in-a-digital-era-a-white-paper.html
Jan. 3, 2013 – In the FDA’s view, researchers and policymakers “currently lack empirical literature regarding the various influences” of corrective direct-to-consumer (DTC) advertising on prescription drug consumers. To forward the development of this literature, the FDA’s plans to conduct an experimental study on this issue are moving forward.
In a Dec. 26, 2012, Federal Register notice, the agency reiterates its corrective DTC advertising study design overview, sets forth the information collection requirements for the study, and responds to comments received on the initial study proposal published on Feb. 29, 2012.
“I’m optimistic that the FDA, like the FTC, clearly understands that ‘corrective advertising’ is an extraordinary remedy to be applied only to violations that are extraordinary,” said John Kamp, Executive Director, Coalition for Healthcare Communication.
The study, which will
be administered over the Internet, will include 6,650 interviews of randomly assigned participants. Phase 1 of the study will vary exposure to advertising messages about asthma to examine how a combination of original and corrective DTC ads affects message recall, message comprehension, perceived drug efficacy, perceived drug risk and intentions to ask about or use the drug. Phase 2 will examine the similarity of the corrective ad’s theme and visual elements to those of the original ad for weight-loss products, as well as the exposure delay (time) between viewing the original ad and the corrective ad.
In response to a comment suggesting that the study not examine similarity and time delay but instead
evaluate “a truly informative, nondistracting, clear and conspicuous corrective ad” and “an unclear and inconspicuous corrective ad,” the FDA stated that although it appreciated the suggestion to include clarity as a variable in the study, it selected similarity and time delay as its independent variables to “provide information on the effectiveness of FDA guidance on this issue.”
Two comments also expressed concerns that the time delay conditions as proposed were not realistic and stated that a six-month time delay would be more realistic. The agency agreed that a six-month exposure delay “more closely approximates real-world exposure to original and corrective messaging” and has changed the study accordingly by embedding the stimuli in a “clutter reel” to approximate real-world experience and by adding a six-month delay condition.
The FDA concludes the notice by stating that the study was designed “to address a gap in the literature – there is scant work on the specific efficacy of televised corrective ads intended to address claims made regarding prescription drugs – rather than to simply extend and replicate past literature.”
Written comments on this notice will be accepted by the agency via fax until Jan. 25. See the Dec. 26 notice for details.
Jan. 6, 2011 – As the pharmaceutical industry begins 2012, the FDA’s Office of Prescription Drug Promotion (OPDP) recommends that companies focus their efforts on many of the common problem areas faced by their competitors in the last quarter of 2011, according to OPDP Regulatory Counsel Julie Chronis.
When asked by the Coalition for Healthcare Communication what advice OPDP might have for industry in the new year, Chronis, speaking at a Dec. 19, 2011, OPDP Webinar on Q4 enforcement actions, said: “I’ve got two words for you: Voluntary Compliance.”
“We are not off on a witch hunt, but are looking for companies to do the right thing,” she said, while suggesting that companies should both “look at our enforcement actions, guidance and regulations, which are “resources companies can use to assist them in their voluntary compliance,” and submit materials for advisory comments.
The OPDP issued eight Untitled Letters and no Warning Letters during this time period. The Untitled Letters cited a variety of alleged violations, as follows:
- Omitting or minimizing risk information
- Making unsubstantiated claims, including unsubstantiated superiority claims
- Overstating the efficacy of the products
- Omitting material facts
- Failing to communicate the indication in an adequate manner
- Promoting unapproved uses
- Inappropriate reminder labeling
- Presenting misleading claims
- Inadequate presentation of the established name
Although there were no particular trends noted in these enforcement actions, OPDP Regulatory Counsel Bryant Godfrey stated that OPDP “consistently sees the same types of violations, including omission of risk information, failure to communicate the indication, overstatement of efficacy and omission of material fact. These are some of the violations we see time and time again.”
Indeed, a number of questions posed to the speakers centered on when and how to provide risk information. An Oct. 25, 2011, Untitled Letter to Lantheus Medical Imaging for its TECHNELITE product states that an exhibit panel “makes several efficacy claims for Technelite, but omits material risk information for the drug” and in so doing, “misleadingly suggests that Technelite is safer that has been demonstrated by substantial evidence or substantial clinical experience.”
One Webinar participant asked why it was necessary to include all of the risk information mentioned in the enforcement action when the exhibit panel had so few claims. “The type of risk information is going to be very specific to that drug and the drugs in that class,” explained Chronis. “We are always going to want to see the most serious risks, along with the most commonly occurring risks. So, we refer you to the draft guidance that’s available on our Web site to give you more information on which risks we are going to want to see,” she said.
Another participant inquired why the firm including the phrase, “Please see a representative in this booth for full Prescribing Information,” was not a sufficient way of providing safety and risk information.
“There are a variety of reasons,” Chronis stated. “One, it’s entirely possible that the sales rep would leave the booth and not be available to talk to the people who stop by. Also, there are people who walk by and do not have the time or opportunity to speak to that rep,” she continued. “We would like to see risk information more accessible than just being available through one person in one specific place.”
When asked about the general success of the Bad Ad program in leading to enforcement actions, Voyard said that “doctors really seem to understand what we consider a violation and give us some very pointed complaints and accounts of what they’ve seen. In my view, I think it’s been working.” Chronis remarked that OPDP will continue to promote the Bad Ad program in 2012, and will begin holding CME events “to further educate health care professionals about the program and the work we do.”
The Webinar’s moderator, Sangeeta Vaswani-Chatterjee, OPDP regulatory counsel team leader, indicated that the agency has received positive feedback on the quarterly enforcement Webinars and plans to continue holding them in the future.
Jan. 2, 2012 – In the waning days of 2011, the FDA released a significant draft guidance on company responses to unsolicited requests for off-label information by healthcare professionals and consumers. Although the FDA explicitly recognized the value of company-provided information, the draft guidance adhered to its traditional policy stance strickly limiting such answers to the individual making the request and precluding public dissemination.
In effect, the FDA banned all public responses to off-label questions in traditional and Internet-based media where the company has any control of content.
“The FDA guidance is clear and authoritative, so will enable more and better communication with professionals and patients. Indeed, it may clear the way for many companies to more confidently provide data to doctors and patients. It’s required New Year reading for agencies, publishers and media intent on helping companies provide better access to life-saving data. ” said John Kamp, Executive Director of the Coalition for Healthcare Communication.
“It’s a small step forward that enables companies to more aggressively inform doctors and patients, but much still needs to be done. The draft guidance simply does not go far enough to foster optimum information dissemination or to address the significant First Amendment issues highlighted by last year’s Supreme Court decision in IMS v. Sorrell,” Kamp said.
“The challenge for industry in 2012 will be to use this guidance aggressively and responsibly while working with the FDA to support much larger steps forward to advance the public health,” he continued. “The Coalition is coordinating with industry partners to respond to this draft guidance and other comments to encourage FDA to enable improved improved information dissemination to healthcare professionals and the public.”
Draft Guidance Basics
The FDA’s Draft Guidance, “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices,” was issued Dec. 27, 2011. The draft begins by describing FDA’s legal framework for restrictioning off-label speech, but quicly acknowledges that “these off-label uses or treatment regimens may be important therapeutic options and may even constitute a medically recognized standard of care.”
In light of the growth of the Internet as a significant source of information for patients and healthcare professionals, the FDA’s draft guidance was developed for firms “wishing to respond to unsolicited requests for off-label information, including both requests made directly and privately to firms and requests made in public forums, including through emerging electronic media.”
In the draft guidance, the FDA describes the difference between unsolicited and solicited requests for information and breaks down its recommendations into two sections – one for non-public unsolicited requests and one for public unsolicited requests.
Unsolicited Non-public Requests
In the non-public request section, the agency makes seven recommendations about responding to unsolicited requests:
(1) The response should be provided only to the individual making the request “as a private, one-on-one communication.”
(2) Response information should “be tailored to answer only the specific question(s) asked.” The agency states that if the request is broad, it is the company’s responsibility to “appropriately narrow the question.”
(3) Response information should “be truthful, non-misleading, accurate, and balanced.”
(4) Response information should “be scientific in nature” and not be “promotional in tone or presentation” or be distributed along with any promotional material or information.
(5) Response information should be generated “by medical or scientific personnel independent from sales or marketing departments.” The agency further recommends that sales and marketing personnel have “no input on the content of responses to unsolicited questions or requests for off-label information.”
(6) Response information should be accompanied by a copy of FDA-required labeling, a prominent statement notifying the response recipient that that FDA has not approved or cleared the product for the off-label use(s), a prominent statement disclosing the approved or cleared indications for the product, a prominent statement providing all safety information and any boxed warnings, and a complete list of references for all of the information disseminated in the response.
(7) Firms are directed to maintain records regarding the nature of the information requests (e.g., name, address and affiliation of requestor), the information provided to the requestor and any follow-up inquiries or questions from the requestor.
Unsolicited Public Requests
Responding to unsolicited public requests for off-label information calls for a different approach, according to the agency, which has concerns that “firms may post detailed public online responses to questions about off-label uses of their products in such a way that they are communicating unapproved or uncleared use information … to individuals who have not requested such information.” Additionally, the FDA has concerns “about the enduring nature of detailed public online responses to off-label questions because specific drug or device information may become outdated.”
Accordingly the agency recommends that firms respond only when the request pertains specifically to its own named product, that the response be limited to providing the firm’s contact information and not include any off-label information, that representatives who provide public responses clearly disclose their involvement with a particular firm, and that public responses not be promotional in nature or tone.
Firms also are advised in the draft guidance to include a mechanism for providing current FDA-required labeling, to not include any promotional material or links to any other information, such as product Web sites, product promotional Web sites, firm Web sites or third-party Web sites, and that the Web address where viewers are directed to obtain product labeling information itself not be promotional (e.g., www.bestcancercure.com).
The agency states that if a company follows the recommendations in the draft guidance for responding to unsolicited requests, “FDA does not intend to use such responses as evidence of the firm’s intent that the product be used for an unapproved or uncleared use.” The FDA further states that alternative approaches outside of these recommendations “would not constitute a per se violation of the law, but could potentially be introduced as evidence of a new intended use.”
Comments and suggestion on the draft guidance should be submitted within 90 days of the guidance issue date.
Dec. 14, 2011 — The FDA’s Office of Prescription Drug Promotion (OPDP) will be presenting a Webinar next week to review the enforcement actions it took during this quarter. The Enforcement Webinar – the third the agency has hosted this year – will be held on Dec. 19, 2011, from 2:30 p.m. to 3:00 p.m. (ET). Viewers can begin submitting questions 30 minutes prior to the Webinar start time.
These Webinars are offered under a pilot program “in which OPDP will give our stakeholders a chance to directly communicate with the Agency on clarifications or questions about the Warning Letters and Untitled Letters issued by OPDP in a given quarter.” The Dec. 19 Webinar will cover Warning Letters and Untitled Letters issued from September 2011 to December 2011.
The Webinars are part of a pilot program that is intended to “support OPDP’s mission to protect the public health by assuring prescription drug information is truthful, balanced, and accurately communicated.”
Meeting details provided by the agency are listed below:
To join the meeting:
Conference Number(s): 301-796-2700
Participant Code: 252580
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Test your connection: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm
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Nov. 22, 2011 – Stating that “a robust dialogue” between pharmaceutical companies and the public “would be seriously chilled” if the U.S. Court of Appeals for the Ninth Circuit upholds the 2009 criminal conviction of former InterMune CEO W. Scott Harkonen for allegedly making false statements about Actimmune in a press release, the Pharmaceutical Research and Manufacturers of America (PhRMA) recently filed an amicus or “friend of the court” brief in support of Harkonen’s appeal.
“The Coalition welcomes PhRMA’s participation in this case,” said Coalition for Healthcare Communication Executive Director John Kamp. “The PhRMA brief demonstrates widespread industry support for forcing federal and state law enforcers to recognize the value of industry communication in managing patient health and the power of the recent Supreme Court decision in Sorrell v. IMS Health to defend against these cases.”
The PhRMA brief asserts: “This case concerns an unprecedented prosecution of a pharmaceutical executive for expressing in a press release his scientific opinion about the development of a drug to treat disease. An affirmance of the decision … would threaten core First Amendment principles by establishing that scientific debate over how to interpret data can constitute a crime.”
PhRMA’s brief calls out the following points:
- The press release in question was not a misstatement of objectively verifiable fact, a trigger for criminal liability;
- The trial court unconstitutionally permitted the jury to find that the press release was false “not because no reasonable scientist could have reached the conclusion drawn, but because some scientists, mainly those of the [Food and Drug Administration (FDA)], disagreed with that conclusion”;
- The trial court’s approach violated the First Amendment because a person “may not be convicted for fraud based upon speech about scientific matters unless the level of scientific consensus is such that no reasonable expert could find the defendant’s statement to be true.”
The amicus brief reiterates the Supreme Court decision in Sorrell, which “confirmed that pharmaceutical manufacturers’ communications with doctors about the safety and efficacy of drugs fall within the First Amendment ambit.” PhRMA then states that “the courts should be particularly leery of a government’s attempt to criminalize speech concerning ‘the effectiveness of [a] particular method of treatment of disease.’”
“Sponsor companies have the best information available on the safe and effective use of their drugs,” according to the Coalition’s Kamp. “Systematically eliminating their participation in discussions with healthcare professionals harms patients. It’s time for government to rationalize these rules in court.”
In addition to the Harkonen appeal, other cases that the Sorrell decision may impact in the near future include:
- U.S. v. Caronia appeal: Alfred Caronia claims that FDA’s limitations on speech regarding off-label uses violated the First Amendment. The U.S. Court of Appeals for the Second Circuit requested additional information following the Supreme Court’s Sorrell decision.
- Par Pharmaceutical Inc. v. FDA: Par seeks to preserve its First Amendment right to provide truthful information to physicians and other healthcare providers about off-label uses. The case, filed with the U.S. Court of Appeals for the District of Columbia Circuit, calls into question the FDA’s authority to censor truthful speech by drug sponsors.
- An appeal by three former Purdue Pharma executives who pled guilty to misbranding charges regarding off-label marketing, is slated to be heard Dec. 6 by the U.S. Court of Appeals for the District of Columbia Circuit. The former Purdue executives are appealing their exclusion from federal health care programs.
“There is no doubt that Sorrell empowered companies and industry advocacy groups to question the government’s authority when it attempts to chip away at the protections afforded speech by the First Amendment,” Kamp said. “We applaud PhRMA for getting involved.”
Oct. 11, 2011 – The FDA is seeking to provide more complete compliance and enforcement data to the public and regulated industry, according to a document issued last week by the agency’s Transparency Task Force.
The document, “Draft Proposals for Public Comment to Increase Transparency by Promoting Greater Access to the Agency’s Compliance and Enforcement Data” includes recommendations “focused on making FDA’s compliance and enforcement data more accessible and user-friendly, and they are part of our ongoing efforts to increase the transparency of FDA’s operations and decision-making,” the agency stated in a press release.
Among the proposals is a recommendation that the FDA “explore ways to better utilize social media, such as Facebook and Twitter, as well as Agency-sponsored webinars and automatic e-mail notifications,” to better communicate with its constituents (Draft Proposal 7).
The task force also calls for the agency to look for ways to better present its compliance and enforcement data graphically and better utilize mobile Web applications to draw more users to its compliance and enforcement Web pages (Draft Proposal 3). The document states that the agency already has implemented this proposal “by developing a centralized webpage where stakeholders can easily access” press releases regarding the filing and resolution of enforcement actions filed by the Department of Justice on the FDA’s behalf.
The FDA also states it has placed “a number of enforcement-related datasets on the Data.gov website.” Further, the agency has launched a redesigned Web page and a phone app to permit the public to search easily for enforcement information.
Other proposals direct the FDA to focus on more timely data disclosure, develop user interfaces, integrate compliance and enforcement data, determine whether additional data compilations or analysis would “increase transparency or better inform the Agency’s own compliance efforts,” and decide if providing appropriate context for the noncompliance and enforcement data that it discloses might avoid misinterpretation or misuse of those data.
Comments on the draft proposals will be accepted until Dec. 2 via http://www.regulations.gov/#!docketDetail;dct=FR%252BPR%252BN%252BO%252BSR;rpp=10;po=0;D=FDA-2009-N-0247. The FDA Commissioner will determine whether to adopt any of the proposals by Jan. 31, 2012.
Sept. 16, 2011 – Trying to assess industry adherence with FDA advertising and promotion regulations is a tricky endeavor, according to an article posted today in Policy and Medicine. The article, “Study Shows Adherence to FDA Advertising Guidelines Are in the Eye of the Beholder,” states that although there currently is no “systemic assessment of physician-directed advertisements to FDA regulations in the last 20 years” and a study of smaller sample size has limits, the best approach to improving compliance under a modest DDMAC enforcement budget may be “more objective advertisement guidelines requiring transparent presentation of basic safety and efficacy information.”
To read this article, in which Coalition for Healthcare Communication Executive Director John Kamp is quoted, go to: http://www.policymed.com/2011/09/study-shows-adherence-to-fda-advertising-guidelines-are-in-the-eye-of-the-beholder.html
Sept. 6, 2011 – The FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) issued three Warning Letters and nine Untitled Letters in the past four months, according to DDMAC officials speaking at an Enforcement Webinar held Aug. 25. The Webinar was part of a DDMAC pilot program to allow stakeholders to better understand and learn from the enforcement actions the agency issues in a recent quarter.
The promotional materials that were the subject of these enforcement actions included one magnet, one detail aid, one booklet, one flyer, two flashcards, and six Web sites (one of which was a YouTube video). Three of these alleged violations came to DDMAC’s attention through complaints under its “Bad Ad” program.
“These DDMAC programs give drug sponsors and their marketing partners clear guidance on the enforcement priorities of the FDA,” said John Kamp, executive director of the Coalition for Healthcare Communication. “DDMAC is responding to complaints elicited through the Bad Ad program. Marketers must pay attention to Internet promotions and detail aids that could violate FDA policies.”
The DDMAC Webinar detailed several specific violations that drew Untitled and Warning Letters in the last few months:
- Omission/minimization of risk
- Unsubstantiated claims (e.g., unsubstantiated superiority claims)
- Broadening of indication
- Overstatement of efficacy
- Omission of material facts
- Promotion of an investigational drug
- Misleading claims (i.e., those related to dosing, compliance)
- Failure to submit under Form 2253
In a Warning Letter issued for promotion of an investigational drug on the company’s Web site, DDMAC explains that it finds the promotion “concerning from a public health perspective” because it suggests that the drug “is safe and effective when the product has not been approved by the FDA and the promotional claims made have not been demonstrated by substantial evidence or substantial clinical experience.”
DDMAC has said it is holding these “focused Webinars” to “support DDMAC’s mission to protect the public health by assuring prescription drug information is truthful, balanced, and accurately communicated.”
On Sept. 26 and 27, Tom Abrams, head of DDMAC, and representatives of the other marketing enforcement centers at the FDA will be making additional enforcement presentations at the FDLI marketing meeting in Washington, D.C. (link to the FDLI Marketing Conference Agenda). On Tuesday, Sept. 27, Kamp will be moderating a luncheon panel with industry legal experts addressing these issues and the legal ramifications of the IMS Supreme Court decision issued in June.