Sept. 19, 2011 – Center for Drug Evaluation and Research (CDER) Director Janet Woodcock announced in an e-mail to CDER staff that as part of the reorganization of the Office of Medical Policy (OMP) into a Super Office, the former Division of Drug Marketing, Advertising and Communications has been reorganized and elevated into a new Office of Prescription Drug Promotion (OPDP), which divides promotional oversight into two divisions, one for professional promotion and one for direct-to-consumer (DTC) promotion.
“This reorganization will leverage OPDP’s resources and processes to provide for the highly effective oversight of prescription drug promotion,” Woodcock states.
“Maybe this is a good omen,” remarked John Kamp, executive director, Coalition for Healthcare Communication. “It took 18 months to get this reorganization approved. Let’s hope that the Internet and Social Media rules show up soon.”
The new OPDP, still under the direction of Thomas Abrams, consists of an Immediate Office, the Division of Professional Promotion (DPP), and the Division of Direct-to-Consumer Promotion (DDTCP). The new structure “will help prevent misleading promotion about prescription drugs and enhance the quality of communications about prescription drugs and other health information developed by companies,” according to Woodcock.
Leadership of the OPDP also includes:
- Mark Askine, Associate Director, Office of Prescription Drug Promotion
- Marci Kiester, Associate Director of Operations, Office of Prescription Drug Promotion
- Catherine Gray, Acting Director, Division of Professional Promotion
- Robert Dean, Acting Director, Division of DTC Promotion
The Office of Medical Policy also encompasses the Office of Medical Policy Initiatives, led by Rachel Sherman and her Deputy, Kathleen Uhl. Janet Norden is Associate Director for Regulatory Affairs. OMP plays a critical role in directing medical policy programs and strategic initiatives.
Enter CHC Contest for New OPDP Nickname
The Coalition for Healthcare Communication (CHC) will award autographed copies of both volumes of the great coffee table book, Medicine Avenue: The Story of Medical Advertising in America to the best new nickname for the FDA OPDP. Enter today by commenting below. Entries will be judged and announced by the Executive Committee of CHC. More details will be announced soon.
The first volume of Medicine Ave was published in 1990 by the Medical Advertising Hall of Fame. Medicine Ave 2 chronicles the history of the industry from 1990 through the present. In addition to featuring hundreds of examples of the best work since 1990, the publication covers the evolution of the modern agency in terms of creativity, structure, and client relationships, and further details the legal and governmental framework that has shaped the industry, the evolution of the science, the globalization of medical advertising, mergers and acquisitions, the impact of digital communications, the rise of DTC advertising, the impact of technology, and the changing role of medical publishing.
More than a dozen industry experts contributed to the publication, lead by a publications committee composed of legendary agency CEOs Ron Pantello (Lally, McFarland, Pantello), John Kallir (Kallir, Phillips, Ross), and Harry Sweeney (Dorland, Sweeney, Jones) and Euro RSCG creative head Julien Jarreau. The work of dozens of leading healthcare advertising agencies is shown to illustrate the caliber and diversity of the industry’s work.
Be nice, now. Have fun, but be good. ;-)
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.
Aug. 3, 2011 — The FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) announced today that it would hold its second Enforcement Webinar on Thursday, Aug. 25, from 11 AM EST to 11:30 AM EST.
“This is a pilot program in which DDMAC 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 DDMAC in a given quarter,” the DDMAC announcement states. Viewers can begin submitting questions 30 minutes prior to Webinar start time. This particular Webinar will cover Warning Letters and Untitled Letters issued from May 2011 to August 2011.
DDMAC is holding “focused Webinars” that “will support DDMAC’s mission to protect the public health by assuring prescription drug information is truthful, balanced, and accurately communicated.”
Meeting details follow:
To join the meeting:
Conference Number(s): 301-796-2700
Participant Code: 232312
June 14, 2011 — The FDA proclaimed success for the first year of the “Bad Ad” program, through which healthcare professionals are asked to report suspected untruthful or misleading drug promotion to the Division of Drug Marketing, Advertising, and Communications (DDMAC). The program is so successful, says DDMAC leaders, it will be expanded, “based on the overwhelmingly positive feedback and response from the medical community.”
However, some industry lawyers are not so sure. For example, Arnold Friede, who has experience both in the FDA General Counsel’s office and at Pfizer, and who is now in private practice, said this on an industry blog: “I think the news here isn’t so much about what FDA has heard from doctors or about how many letters FDA has sent, but about the in terrorem impact of the Bad Ad program. This program gives companies yet another reason to monitor their promotional behavior,” Friede said. “The FDA is deputizing doctors to become informants. It’s like the old ‘Deputy Dawg’ show, except it’s ‘Deputy Doc.’”
Interestingly, the agency states in the report that the sheer volume of reports is not how it will measure the success of the program. Instead, “FDA’s most important measure of success for this program is the heightened sense of awareness of misleading promotion among HCPs throughout the health care community and the likely useful deterrent this awareness has on drug promoters who might run afoul of regulation absent such messaging.”
Program Expansion Plans
In an annual report released yesterday, entitled “Bad Ad Program: 2010-11 Year End Report,” the FDA states that it “expects to continue and expand its Bad Ad efforts in the coming years.” Expansion activities will include the development of a Web-based continuing education program, a focus on students and early-career health care professionals and the active pursuit of opportunities to collaborate with the nation’s medical, pharmacy and nursing schools to enhance student education, according to the report.
Healthcare marketers also should be aware that DDMAC representatives will continue to attend industry events, including this roster of trade shows:
- American Academy of Physician Assistants
- American Academy of Nurse Practitioners
- American Academy of Family Physicians
- American Academy of Pediatrics
- American College of Gastroenterology
- American Society of Health System Pharmacists
At an FDA Webinar in April, Catherine Gray, DDMAC management advisor, said that although DDMAC is charged with regulating print, broadcast and oral communications made by or on behalf of prescription drug companies, it cannot possibly “be in every discussion with every sales rep,” so it is asking healthcare providers to use the agency’s “Bad Ad” initiative to report any marketing activities that could potentially be in violation of FDA marketing rules.
Year One Results
During its first year, the Bad Ad program yielded 328 reports of questionable marketing. Of those, 188 were sent in by healthcare professionals, 116 were sent in by consumers and 24 were submitted by industry competitors; only 4 percent of reports were submitted anonymously. Five Warning Letters were issued by the FDA as a result of these reports.
Immediate Guidance Slips Again
May 9, 2011 – A recent notice in the Federal Register calling for comments on a series of Food and Drug Administration (FDA) studies to determine the most effective way of presenting risk information online indicates that the FDA is still a long way from developing significant new social media guidance. This status leaves industry in an unsurprising state of limbo after the Division of Drug Marketing, Advertising, and Communications (DDMAC) missed at least two self-imposed deadlines for issuing draft guidance and did not set a new target date for the much-anticipated document.
“The FDA’s choice to start new studies rather than issue guidance is unfortunate,” said John Kamp, executive director of the Coalition for Healthcare Communication. “Healthcare providers, patients and care givers are on the Internet, searching and finding health information. Companies, knowing that much Internet health information is uninformed and biased, must participate even without FDA guidance,” Kamp asserted.
The agency states in an April 28 Federal Register notice that it plans to research the new venues available online for displaying risk and benefit information for prescription drug ads in a fair and balanced way.
According to the FDA, “The interactive nature of the Internet allows for features not possible with traditional media … such as scrolling information, pop up windows, linking to more information, and embedded videos.” The agency is planning a series of studies that test the different methods of risk and benefit information on branded drug sites, the results of which will “inform the development of future guidance.”
Study 1 will examine the visibility of risk information (scrolling versus no scrolling), Study 2 will look at whether special features (e.g., testimonial videos, interactive videos) influence the perception of risks and benefits, and Study 3 will investigate whether links to and citations from external organizations referenced on the home page affect consumer perception and understanding of risks and benefits.
“It was anticipated that the FDA’s draft Internet guidance … would address the key question about the possible use of hyperlinks to provide risk information in a variety of online and social media formats,” according to Arnold I. Friede, Arnold I Friede & Associates. “In its 14 [notices of violation] on the use of hyperlinks in sponsored research results, FDA categorically rejected the possibility that providing information via such links could possibly constitute ‘fair balance.’”
Friede also commented that the FDA’s “categorical rejection” of the use of hyperlinks to provide risk information is “inconsistent with the approach FDA has taken in other analogous contexts.”
Without any guidance in “the near term,” Friede continued, industry has two choices: (1) “refrain from engaging in any behavior that is the subject of the proposed studies,” or (2) “make rational decisions about what is and is not justified, or at least what should be justified, from a legal, policy, and communications standpoint.”
If a company takes the latter approach, it should be “prepared to defend those decisions if questioned by the FDA,” Friede asserted, adding that “many decisions in business are made in the absence of perfect knowledge.”
The Coalition’s Kamp consistently has stated that agencies and clients should continue their marketing efforts online while following existing FDA policy, especially in light of DDMAC officials’ statements that the FDA will not break new ground with its social media guidance.
“Wrong or right, the FDA has been up front in stating that it has no intention of creating a new Internet and social media policy at this time,” Kamp said. “FDA’s plan to conduct research in this area is just one more indication of that position.”
April 29, 2011 – In a Webinar yesterday, the U.S. Food and Drug Administration’s (FDA’s) Division of Drug Marketing, Advertising, and Communications (DDMAC) reminded medical marketers of its continued actions to enhance surveillance and monitoring of industry marketing by urging physicians and other healthcare professionals to report any potentially misleading marketing activities to DDMAC.
Although the year-old program has resulted in only two Warning Letters to date, the DDMAC clearly wants the industry, doctors and the public to know it intends to aggressively enforce its rules. “I have my doubts about the value of this program,” said John Kamp, executive director of the Coalition for Healthcare Communication, “but FDA is sending a clear signal. We must pay attention.”
Catherine Gray, DDMAC management advisor, explained in the FDA-sponsored Webinar that although DDMAC is charged with regulating print, broadcast and oral communications made by or on behalf of prescription drug companies, it cannot “possibly be in every discussion with every sales rep,” so it is asking healthcare providers to use the agency’s “Bad Ad” initiative to report any marketing activities that could potentially be in violation of FDA marketing rules.
During the Webinar, Gray explained that the Bad Ad outreach program is designed to educate healthcare providers about the role they can play in helping the FDA enforce rules requiring prescription drug advertising and promotion to be truthful and not misleading.
The program “fills gaps” between what DDMAC finds during its normal surveillance activities and allows the agency to gain important intelligence regarding company-driven interaction with healthcare professionals, “including oral statements made in physician offices or at industry-sponsored lunches or dinners,” she said. “The program was created by two former drug reps who are very familiar with what goes on behind closed doors.”
Gray outlined the most common types of drug promotion activities that could be considered misleading:
- Omitting or downplaying the product’s risk factors;
- Overstating effectiveness of the product;
- Making misleading drug comparisons without substantial evidence; and
- Promoting unapproved use(s) of a drug.
She noted that this last violation type represents an area “where individuals can be very helpful” because physicians may be more likely to be apprised of unapproved uses in private settings. She indicated that healthcare professionals who become aware of any of these potential violations should submit – through the Bad Ad program e-mail address (BadAd@fda.gov) – their name (or the complaint can be anonymous), the name of the drug in question, when the activity occurred and what it was, “as well as the drug rep’s name” if one was involved. Gray remarked that competitors also may use this forum to file complaints.
Then, DDMAC will evaluate the allegation and determine whether action – such as an Untitled Letter or a Warning Letter, a criminal investigation, seizure, injunction or consent decree – is warranted. “Even if the agency does not take action after you submit a complaint, the data collected through the program is valuable information for ongoing DDMAC surveillance,” Gray told Webinar attendees. Further, she described several DDMAC enforcement actions that were a direct result of complaints received through the Bad Ad program.
Gray concluded by telling attendees that when physicians tell DDMAC about specific incidents, “we can take steps to stop it.” Healthcare professionals can have a big impact … in stopping misleading promotion,” she said.
April 11, 2011 – While waiting for the Food and Drug Administration’s (FDA’s) Division of Drug Marketing, Advertising, and Communications (DDMAC) to begin issuing social media guidance, it is important for agencies and clients to create compelling sites for professionals and patients that stay within the FDA’s existing policies, according to John Kamp, executive director of the Coalition for Healthcare Communication. “Whenever the FDA starts issuing the guidelines, they will be important, but not dramatically change the landscape,” Kamp said.
Kamp made these observations this week to a group of agency heads, in light of the recent announcement by the FDA that it missed the April 1 deadline for its first draft of social media guidelines. “There is no reason to wait for the guidance. DDMAC head Tom Abrams repeatedly has made it clear that the new guidelines will not include new Internet and social media marketing policy,” said Kamp. “Doctors and patients are using the Internet at increasing rates. If we want to remain relevant, we must participate and do so within the existing rules.”
The agency’s statement about the guidelines’ delayed release said that although “policy and guidance development for promotion of FDA-regulated medical products using the Internet and social media tools are among our highest priorities,” it could not give a new target date for the guidelines.
In the interim, industry should follow existing regulations and policies. DDMAC’s Abrams advised pharma companies at a DIA meeting earlier this year that the forthcoming guidelines will address specific social media matters, but in general, “there will be no new regulations or new standards.”
“Look at our recent Warning Letters involving social media, such as Facebook,” Abrams said. “These Warning Letters cite existing rules and do not make new policy.”
Kamp similarly counsels industry to follow current rules and policies until DDMAC issues formal guidance. “Companies already know the 10 Commandments of DDMAC. There likely won’t be any huge surprises when Moses descends from the mount,” he said.
However, this reality may create tough choices for clients, Kamp indicated. For example, many companies only host social media sites about relevant disease states and avoid branded drug sites. “Branded sites are a problem because company-moderated discussions must stay on label. This confuses and sometimes angers site visitors because they don’t understand the FDA constraints,” he said.
DDMAC’s recent statement explained that it is considering both internal and external input as it develops guidelines, including testimony and comments from last year’s Part 15 hearing, and has identified the following issues it believes should be addressed in social media guidelines:
- Responding to unsolicited requests
- Fulfilling regulatory requirements when using tools associated with space limitations
- Fulfilling post-marketing submission requirements
- On-line communications for which manufacturers, packers, or distributors are accountable
- Use of links on the Internet
- Correcting misinformation
The statement also suggested that DDMAC will be developing multiple draft guidance documents to address these topics.
In response to DDMAC’s statement, the Pharmaceutical Research and Manufacturers of America (PhRMA) reiterated that social media outlets are important outreach tools for the industry. “There are incredible potential public health benefits to using electronic media in healthcare, including allowing innovative companies to provide truthful, scientifically accurate FDA-regulated information,” according to PhRMA Assistant General Counsel Jeffrey K. Francer.
Kamp applauded the PhRMA proposal, saying that it would establish a responsible mechanism for providing safety information in space-restricted media. For example, PhRMA proposed allowing the use of a universal symbol alerting patients of Web sites that feature FDA-regulated benefit and risk information. “Internet users understand that Web information can be suspect,” Kamp added. “The PhRMA proposal would point to reliable information vetted by the FDA.”
April 7, 2011 — The FDA’s Division of Drug Information and its Division of Drug Marketing, Advertising, and Communications are presenting a Webinar April 28 to better inform healthcare professionals about the role they can play in helping the FDA ensure that prescription drug advertising is truthful and not misleading. The Webinar is part of a series of a series of educational outreach Webinars developed by FDA pharmacists and targeted to the needs of all healthcare professionals and students.
The April 28 Webinar, held at 12 Noon (ET), is titled, “An Overview of the FDA’s Bad Ad Program.” Catherine Gray, Pharm.D., will present an overview of the FDA’s “Bad Ad” program, specifically focusing on how to identify misleading prescription drug promotion and report this activity to the agency. A recent survey showed that only 30 percent of healthcare professionals were aware of the Bad Ad program.
Feb. 28, 2011 — In yet another indication that industry and agencies should not expect major changes in social media marketing rules, Tom Abrams, the head of FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC), told participants at DIA’s annual marketing meeting in Washington, D.C., on Feb. 22 to “follow the regulations” while waiting for formal FDA guidance.
During an FDA enforcement update session at the DIA workshop, panel moderator Wayne Pines, president, regulatory services and health care, APCO Worldwide, posed a question about what advice Abrams would give companies regarding their Internet and social media activities. Abrams replied that both before and after any industry guidance is issued (likely by April 2011), companies simply should “follow existing regulations and policies.”
Elaborating, Abrams said, “There will be guidance on some specific matters, but there will be no new regulations or new standards. Look at our recent Warning Letters involving social media, such as Facebook. These Warning Letters cite existing rules and do not make new policy.”
“Read this to mean that DDMAC is unlikely to create a major new standard for social media as it did in 1997 when it developed the ‘reasonable accommodation’ policies for broadcast advertising,” said Coalition for Healthcare Communication Director John Kamp. Many participants at the November 2009 FDA Internet and Social Media hearings urged the FDA to recognize that digital marketing was very different from traditional marketing and that the agency needed to adopt significant new policies.
The agency appears to be relying on current policy when conducting social media enforcement. A recent DDMAC Warning Letter on social media cited a company for generating misleading “shared content” using a Facebook Share “widget.” DDMAC stated in the letter that the company’s content made representations about the product but failed to communicate any risk information associated with use of the drug, implied superiority over other products and inadequately communicated the FDA-approved indication, thereby misbranding the drug. The basis for these alleged violations all were found in existing FDA regulations.
A Preview of Forthcoming Guidance
Abrams gave details on other DDMAC priorities as well, including updated guidance on the brief summary and comparative claims. He also discussed areas the agency is mandated to address under the FDA Amendments Act of 2007: a preview program for certain direct-to-consumer (DTC) television ads and a report to Congress on a possible “drug facts” box (report issued April 2010), and a rule establishing standards for how the “major statement” of risk in consumer-directed prescription drug television and radio ads should be presented in a “clear, conspicuous, and neutral manner.”
The “clear, conspicuous and neutral” proposed rule, issued March 29, 2010, states that a major statement is clear, conspicuous and neutral if:
- Information is presented in language that is readily understandable by consumers;
- Audio information is understandable in terms of the volume, articulation and pacing used;
- Textual information is placed appropriately and is presented against a contracting background for sufficient duration and in a size and style of font that allows the information to be read easily; and
- The advertisement does not include distracting representations (including statements, text, images or sounds or any combination thereof) that detract from the communication of the major statement.
Abrams emphasized a new fifth standard likely would require that major statements in television ads be included in both the audio and the visual parts of the presentation. Abrams said that this standard would be similar to one used for television ads by the Federal Trade Commission and would integrate research showing that a dual-mode presentation enhances consumer comprehension. Abrams had no comment regarding when the final rule on this matter would be issued.
“In his discussion of the DTC rulemaking, Abrams reiterated his commitment to the proposed standards,” Kamp. “In effect, he is indicating that these are the current standards being used by DDMAC and that companies should expect them to become fully integrated into the final guidance when issued.”
Warning Letters on the Rise
Abrams reported at the session that the number of Warning Letters issued by DDMAC in 2010 (52 Warning Letters) increased nearly 26 percent from 2009, and that he expects a similarly high number in 2011. As such, DDMAC encourages companies to voluntarily comply with FDA regulations in this area to avoid regulatory actions, preserve their image, provide good information to the public and prevent interruption of their promotional campaigns, he indicated.
This philosophy will continue as DDMAC is elevated to office status, which is likely to take place later this year. DDMAC is poised to enable an immediate transition to the new Office of Prescription Drug Promotion, which will consist of two divisions, one for healthcare professional promotional materials and one for consumer promotional materials.
Promotional vehicles cited in the 52 Warning Letters issued by DDMAC in 2010 included both traditional and evolving technology venues.
Other Social Media Perspectives
At a later DIA session on industry/agency perspectives on social media, moderated by the Coalition’s Kamp, Peter Pitts, president, Center for Medicine in the Public Interest, noted that promotional venues are irrelevant to compliance. If the content is noncompliant, he said, it is noncompliant regardless of the platform.
Pitts also pointed out that pharmaceutical social media critics may be confusing online advertising with social media and are reluctant to monitor social media sites for fear of discovering adverse events. He called the latter fear a misguided notion, stating that companies should be embracing opportunities to uncover adverse events in any forum.
Further, Pitts remarked that DDMAC should be addressing user-generated content and off-label conversations and should define property owners versus property users in its forthcoming guidance. He also would like to see DDMAC adequately address what the term “sponsored by” both means and implies in the social media context.
Please add your important comments below.
Although 2011 brings political party shifts in Congress and new challenges, the mission of the Coalition for Healthcare Communication (CHC) remains the same: To protect, for society and individual patients, the benefit of the free flow of healthcare information. This year the CHC will be focusing on four major issues: (1) tax treatment of marketing costs; (2) “transparency,” conflict of interest and collaboration; (3) proposals to limit the collection and use of Rx and consumer medical data; and (4) FDA DDMAC’s policies and guidelines (including social media guidelines). The 2011 Focus of the Coalition describes the issues CHC will be tracking in 2011, the political climate in which those issues will be debated and how potential outcomes could change the Rx communication business and affect the public health.