Aug. 30, 2011 — A final rule from the National Institutes of Health (NIH) issued last week (76 FR 53256) modifies the existing conflict-of-interest rules established in 1995 in an effort to “enhance the objectivity and integrity of the research process,” according to an in-depth article on the subject published Aug. 25 in Policy and Medicine.
The article, “National Institutes of Health Final Rule on Conflict of Interest Summary,” outlines the rule’s major changes (including a new definition for significant financial interest (SFI)), its evolution, and a summary of key provisions, including SFI, travel and exclusions. The article also spells out the responsibilities of institutions regarding investigator conflicts of interest, management and reporting of conflicts of interest, reporting of financial conflicts of interest, and remedies and enforcement.
Read the Excerpt from Policy and Medicine to learn more about how this important issue impacts our business and feel free to add your comments below.
By John Kamp, Executive Director, Coalition for Healthcare Communication
While the headlines cite implausible rates of non-compliance with FDA marketing regulations, a close reading of the recent PLOS One article, “Adherence of Pharmaceutical Advertisements in Medical Journals to FDA Guidelines and Content for Safe Prescribing,” demonstrates:
1. the stated preference (bias) of the authors for their own brand of marketing regulation and
2. the underlying challenge industry, doctors and patients face under the current FDA regulation of drug ads.
Simply put, no one knows for sure what’s compliant until the FDA says so, most often in a FDA warning letter. This serves no one including doctors, patients, FDA and industry. Regardless of the authors regulatory preferences, they are absolutely correct in this conclusion: “The FDA could better protect public health by creating new more objective advertisement guidelines requiring transparent presentation of basic safety and efficacy information.” Everyone loses under the current standards because the rules prevent good communication and subject the industry to unwarrented criticism from the press, politicians and medical professionals and uneven, unpredictable enforcement from FDA. Better regulations would enable better informed patients and doctors, thus better patient care.
The Coalition filed a Citizen Petition in March of 2006 asking the FDA to create clear, objective standards for professional and consumer advertising. It’s time for widespread industry dialogue on how to improve these rules to better serve the public health.
The PLOS article can be found on the PLOS website: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0023336
The Coalition Citizen Petition:
Aug. 12, 2011 – Investing in regulatory compliance testing to build better promotional campaigns that track with FDA marketing regulations and guidance is a wise business decision for advertising and promotion agencies, according to a recent article in Rx COMPLIANCE REPORT.
Participating in a new online certificate program developed by the Center for Communication Compliance (CCC) – “Internet Promotion and Social Media” – “demonstrates a company’s good-faith commitment to doing everything possible to maximize compliance,” according to Michael Misocky, a former FDA official and CCC Advisory Board member, as quoted in the article, which lists the primary benefits of the program as minimizing client risk and increasing agency efficiency.
Industry veteran Wayne Pines, who chairs the CCC Advisory Board and is among those quoted in the article, states that “Testing is essential to ensure that companies understand the rules the government enforces.”
Commenting on the article, Coalition for Healthcare Communication Executive Director John Kamp (also a CCC Advisory Board member) said that “creative medical marketers cannot initiate programs without a working knowledge of compliance issues.” The CCC program allows agencies to gain first-hand knowledge of the government’s regulatory requirements instead of relying on the client to transfer that knowledge, Kamp explained. “Today, regulatory compliance must be baked in to every medical marketing program.”
Companies that participate in the CCC program receive post-training testing reports that helps the agencies determine where the knowledge gaps may be, whether the gaps are specific to individuals or whether entire departments may need spot training, the Rx COMPLIANCE REPORT article notes.
In a follow-up conversation, CCC President and Founder Ilyssa Levins told the Coalition that the CCC “commends those agencies that are proactively participating in our testing program, including a mix of advertising, promotional medical education, PR, digital and direct-to-patient companies,” Levins said. [View a representative CCC Agency List of participating companies.] “By the end of 2011, we will have in excess of 6,000 professionals enrolled in our programs, with the number increasing every day now that drug companies are mandating participation.”
Enrollment in the program is easy, Levins said, either through the CCC registration page (http://www.communicationcompliance.com/go/Static/registration_social_media) “or a call to me.”
Read the full Rx COMPLIANCE REPORT article, “Promotional agencies invest in regulatory compliance to minimize client risk and increase efficiencies,” which begins on page 12 of RxComplianceReport.
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
Aug. 1, 2011 — The recent Supreme Court decision in Sorrell v. IMS Health Inc. is earning robust commentary in the legal community because it extends greater First Amendment protection for marketing and expands that protection to data mining and use. In addition, many legal scholars openly are questioning whether the FDA can continue its current regulation of “off-label” communication by drug companies as well as whether the government can continue to use privacy as a justification for marketing limits.
The following are summaries and links to recent articles on the decision written by lawyers from Arnold & Porter, Jenner & Block, and Wiley Rein, as well as an article from the National Legislative Association on Prescription Drug Prices (NLARx) that outlines the organization’s disappointment with the decision.
Does Sorrell v. IMS Health Mark the End of Off-Label Promotion Prosecution? In an article appearing in BNA’s Pharmaceutical Law & Industry Report, Arnold & Porter partners Lisa Blatt, Jeffrey Handwerker, John Nassikas and Kirk Ogrosky discuss the impact of the Sorrell decision on “the debate over the constitutional validity of ‘off-label’ promotion prohibitions.” The authors assert in the piece that Sorrell “provides strong support for challenging FDA’s efforts to regulate what the government calls the off-label promotion of drugs for medical uses that are not approved by the FDA.” Indeed, the authors state, “Sorrell builds on prior Supreme Court precedent in establishing a strong foundation to argue that a pharmaceutical company’s truthful, non-misleading information about its products cannot be subjected to content-based and speaker-based restrictions.” Read more by clicking here.
Does the Supreme Court’s Sorrell Decision Threaten Privacy? An article written by Wiley Rein Partner Bruce McDonald in the firm’s Privacy in Focus publication discusses the role privacy plays in the Sorrell case. Although some privacy advocates assert that the Supreme Court’s decision is a blow to privacy, McDonald states that “another reading is simply that invoking privacy arguments as justification for a statute having another purpose can prove to be an unsuccessful legislative or litigation strategy.” He also comments that the Court’s willingness to give considerable weight to First Amendment protections in a commercial context may trouble privacy advocates, but notes that “a conclusion that the majority decision is anti-privacy would appear to be overreaching,” largely because the majority “clearly doubted” that the Vermont statute in question sought to advance privacy. Read more at http://www.wileyrein.com/publications.cfm?sp=articles&id=7222
Supreme Court Observations: Sorrell v. IMS Health Inc. An article appearing in the Washington Legal Foundation’s Legal Pulse publication, written by Paul M. Smith, chair of Jenner & Block LLP’s Appellate and Supreme Court Practice and co-chair of its Media and First Amendment Practice, analyzes the dissenting opinion in the 6-3 decision. “This dissent reflects a remarkable indifference to the core First Amendment principle that government should not use direct or indirect regulation of speech as a means of influencing people not to make perfectly lawful decisions,” Smith writes. Read more at http://wlflegalpulse.com/2011/06/24/supreme-court-observations-sorrell-v-ims-health-inc/
Will Supreme Court Decision in Sorrell v. IMS Tie States’ Hands in Medical Records Privacy Efforts? The National Legislative Association on Prescription Drug Prices (NLARx) calls the Sorrell decision “a huge disappointment to legislators who have sought to protect the confidentiality of private prescription records.” An article on the NLARx Website, written by NLARx Executive Director Sharon Anglin Treat, states that “the expansive decision by the U.S. Supreme Court, which extends new protections to commercial speech, should be a concern to anyone interested in keeping private information private.” Read more at: http://www.reducedrugprices.org/read.asp?news=6207
Aug. 1, 2011 — Listed below are excerpts from the keynote speech on Social Media, presented at EPharma West by Peter Pitts (reprinted with permission):
Social media for regulated industry is a wonderful green field of opportunity. But to maximize the opportunity, we must accommodate the reality of a messier world. Social media, almost by definition, is messy – and the regulatory framework (or lack thereof) is equally so. And it’s not likely to get much better. Get used to it.
Embracing social media means embracing regulatory ambiguity. And that’s a paradigm shift for an industry that has (in a post-Vioxx world) been going in precisely the opposite direction.
Social media (and its game-changing opportunities) demands a move away from the cautious tactics of the Vioxx Populi towards a better understanding of the digital Vox Populi. And that means more than sponsored Google links and branded Facebook pages with the interactivity turned off.
It means mixing it up with real people in real time. And when it comes to FaceBook, it means – turn the interactivity on!
It’s not going to be easy, or risk-free, or inexpensive. And whatever social media “marketing models” companies build will have to be elastic – just like the media environment in which they are designed to operate.
Benjamin Franklin once said: “Every problem is an opportunity in disguise.” While Facebook strategies and approaches have to be reexamined, Mr. Zuckerberg’s medical mandate provides pharmaceutical marketers with an excellent opportunity to finally acknowledge and embrace the full capabilities of two-way social communication writ large.
Facebook’s changes represent an opportunity for regulated industry to learn, understand and embrace the three key tenets of Pharmaceutical Marketing 3.0:
1. The Rise of the “Face of Pharma”
For the past 20 years, the overwhelming majority of pharmaceutical marketing budgets were dedicated to promoting specific products.
Now, due to both a less robust drug development pipeline and an increase in the rates of patent expiry, the next era of pharma marketing will put the company – and its corporate reputation – front and center.
When you think about it (if you allow yourself to think about it), it’s a perfect match for social media where transparency is the most urgent, non-negotiable and magnificent mantra.
Not third-party groups, not KOLs (although these traditional avatars have their place) – but the company speaking on behalf of itself and its products. What a concept!
2. The Role of Social Media in the Era of Post-Patent Medicine
I believe that the blockbuster era of the pharmaceutical industry will be replaced by the Era of Post-Patent Medicine. To compete in an era of generics and biosimilars, Pharma companies will need not only a robust portfolio of lower cost medications, but an army of brand loyalists.
Communications programs, supported by social media must be one tool. Why? Because it’s where the people are.
3. Social Media Can Help Increase Patient Education and Prescription Compliance
You know the numbers. It’s estimated that Pharma loses $30 billion a year in patient non-compliance. True two-way social media has the potential to serve as a new and puissant health education platform by helping to keep patients informed of the dangers of non-compliance by earning their trust through transparent dialogue. And that’s twice as true when it’s mobile-based.
As another conference presenter, Dr. James Fowler, of the University of California at San Diego opined, “Pharma must realize their own network power.”
PS/ I am also pleased to announce that I have joined the board of the Digital Health Coalition – a nonprofit corporation – that seeks to promote responsible innovation via digital marketing and communications in a connected world. Their first initiative is focused on the rapidly evolving space of social media and seeks to promote a world where patients, physicians, and brands can connect, empower, and drive positive health outcomes. Individuals interested in learning more about the Digital Health Coalition are encouraged to visit: http://www.digitalhealthcoalition.orgwww.digitalhealthcoalition.org