May 20, 2013 – Although relationships between the pharmaceutical industry and physicians have come under greater scrutiny as the implementation date of the Sunshine Act final rule draws nearer, a recent article in The Atlantic states that critics of these relationships “have it backwards.” Indeed, the author asserts that advancing medical progress “requires, ideally, close communication between industry and outside experts,” and that “we should strive to cultivate, not demonize, these sorts of interactions.”
To read the full article, which provides a common-sense look at the “right” relationships between industry and physicians, go to: http://www.theatlantic.com/health/archive/2013/05/getting-to-the-right-relationship-between-doctors-and-drug-companies/275605/
May 16, 2013 – The Centers for Medicare & Medicaid Services (CMS) is likely “to find itself the target of a First Amendment lawsuit by affected parties” if it does not consider medical textbooks to be “educational materials that directly benefit patients” which are excluded from a reporting requirement under the final rules implementing the Physician Payment Sunshine Act, according to a May 15 letter to CMS from the Washington Legal Foundation (WLF).
In its letter (CMS Textbook Policy), WLF asks CMS to delay application of reporting requirements to medical textbooks until it has had an opportunity to examine the First Amendment implications of including these items as “transfers of value” from manufacturers to doctors.
Coalition for Healthcare Communication (CHC) Executive Director John Kamp remarked that the WLF letter “is strong, balanced, nuanced and likely to be effective. Indeed, if WLF convinces CMS to reverse itself on textbooks, the same reasoning applies to journal supplements, reprints and Website publications that are distributed with company support.”
Specifically, WLF contends the following in its letter:
- The distribution of medical textbooks is speech protected by the First Amendment;
- Although CMS is not banning speech, it is substantially burdening speech (and such burdens are subject to First Amendment constraints);
- The Sunshine final rule’s disclosure requirement imposes a substantial burden on the right to speak by distributing medical textbooks;
- Application of the Sunshine Act to medical textbooks does not serve any substantial government interests; and
- CMS can avoid First Amendment difficulties by construing the Act as inapplicable to medical textbooks.
“Applying the reporting requirements to medical textbooks would constitute a serious infringement on the First Amendment rights of pharmaceutical companies to disseminate medical texts and the First Amendment rights of doctors to receive such information,” WLF Chief Counsel Richard A. Samp wrote in the letter to CMS Acting Administrator Marilyn Tavenner.
“The U.S. Supreme Court has repeatedly held that disclosure requirements of this sort [imposed by the final rule] are subject to ‘exacting scrutiny’ and can pass muster under the First Amendment only if shown to serve important government interests that outweigh the burdens they impose on speakers,” the letter states.
The WLF also states that the burden of reporting and doctors’ concerns about being included on a list of those receiving payments from drug companies will cause doctors to decline offers of medical textbooks and cause companies to cease disseminating them. Because medical textbooks communicate truthful information that helps doctors treat patients, the WLF asserts that they are fully protected by the First Amendment, as demonstrated by multiple U.S. Supreme Court decisions. “By all accounts, medical textbooks supplied by drug companies to doctors ‘directly benefit patients’ – doctors regularly use information gleaned from the textbooks in their treatment of patients,” according to the WLF.
As further evidence that medical textbooks constitute protected speech under the First Amendment, the WLF states that its 1998 lawsuit against the Food and Drug Administration (FDA) resulted in the FDA being subject to a permanent injunction limiting FDA authority to suppress manufacturer dissemination of medical textbooks discussing off-label uses of their FDA-approved products.
“There is little evidence that Congress intended to single out textbook dissemination and other expressive activities for special disapprobation, but the effect of the Act (as interpreted by CMS) is to burden this expressive activity to such an extent that much of the activity will cease,” the WLF letter states. Samp concludes the letter by stating that “in light of the grave constitutional issues raised by CMS’s rule, courts will not defer to CMS’s reading of the Act … even if they deem it a plausible reading,” and advises CMS to reconsider and allow these educational materials to be excluded from reporting requirements.
“Exempting these as educational items not only makes sense under the Sunshine Act, it makes great public policy sense,” CHC’s Kamp said. “Informing doctors about the latest science and practice guidelines drives improved patient care. Everyone can salute that result.”
May 14, 2013 — In a Medical Marketing and Media (MMM) column posted May 1, Coalition for Healthcare Communication Executive Director John Kamp said that “although the FDA has been able to cling for decades to the idea that the approved label constitutes virtually the only truth about an approved product, good common sense and the First Amendment are closing in on the traditional regulatory scheme.” Kamp asserts in MMM that “the regulation of drug communication and marketing is on the brink of changes that will enable patients and doctors to garner valuable information from companies about the safe, effective and economically efficient use of drugs, especially for off-label uses.”
To read the full article, go to: http://www.mmm-online.com/off-label-on-the-table/article/290961/
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:
FOR WEB:
To join the meeting:
https://collaboration.fda.gov/ddmac34
FOR AUDIO:
Conference Number(s): 877-231-0558
Participant Code: 9291
May 7, 2013 – The Washington Legal Foundation (WLF) will hold a Webinar on May 14 discussing the implications of the Physician Payment Sunshine Act regulations for U.S. healthcare. Expert speakers James C. Stansel and Meenakshi Datta, both partners at Sidley Austin LLP, will examine the recently issued final rules and assess how “applicable manufacturers” can successfully pursue compliance; how the rules interrelate with similar requirements at the state level; and whether increased reporting will impact drug and medical device research and development. The WLF Webinar, entitled “Physician Payments in the ‘Sunshine’: Implications of CMS Regulations for Businesses and the Future of American Health Care,” will be held 12:30 p.m. – 1:30 p.m. Click HERE to register to view the Webinar.
May 6, 2013 — With Sunshine Act reporting slated to begin in less than three months, it is sobering to note that many physicians and investigators still are unaware of the regulation, a majority are not in favor of making information about physician-industry financial relationships available to the public, and a small percentage would consider not engaging in clinical trials to avoid a perception that they are too involved with one sponsor.
A recent study conducted by Industry Standard Research (ISR), “Sunshine Act: Pharma Impact – Changes in U.S. Physician Behavior,” found that physicians are worried that the Sunshine Act will have a negative effect on their practice. ISR surveyed physicians and other stakeholders affected by the Sunshine Act. Of 103 physician respondents, 74 percent said they were not in favor of sharing these data; 18 percent of the 100 investigators surveyed said they would stop participating in some clinical trials if they started to do “too many” trials for one sponsor, as reported in a recent article in Policy and Medicine (http://www.policymed.com/2013/05/physician-payment-sunshine-act-principal-investigators-and-primary-care-physicians-largely-unaware-of-regulation-1.html).
“If physicians are concerned that interacting with the pharmaceuticals industry has a negative connotation, there could be a chilling effect on those relationships, which are vital to the public health,” said Coalition for Healthcare Communication Executive Director John Kamp. “The Sunshine Act is supposed to lend transparency to these relationships, not undermine them.”
Although the report states that “few physicians believe the rule will have an impact on how they treat patients,” 38 percent of physicians and surveyed say that they are not at all familiar with the Sunshine Act and 23 percent of principal investigators surveyed state that they have never heard of the Sunshine Act.
As part of the study, ISR researchers evaluated physicians’ frequency of use and the value they place on specific communications channels, as well as which channels might be less likely to be used following Sunshine Act implementation. “While the channel expected to be impacted most significantly is ‘group/practice-level detail sessions’ where doctors and their staff typically receives free lunches, we did see a 12-percent drop in the level of interaction expected across all ‘in-person’ activities,” said Andrew Schafer, ISR president.
Indeed, the report states that the Sunshine Act “will have a dramatic impact on the ability of pharma sales representatives to frequently detail physicians, both one-on-one and in a group setting.” The report adds that although 47 percent of physicians indicated that they participate in a group detail on a weekly basis currently, only 30 percent said they plan to continue this practice after the Sunshine Act requirements kick in.
Interestingly, 71 percent of physician respondents stated that they expect pharmaceutical companies to inform them of the value of a service or benefit prior to it being offered to them. However, even though physicians are worried about the potential negative publicity surrounding their interaction with pharma companies, they “mention that they use pharma sales representatives as a key source of information for new medicines and treatments.” One physician quoted in the report said the Sunshine Act rules “will reduce availability to new information about existing and new products.”
“These findings support the fact that industry needs to do all it can to ensure that context regarding the industry-physician relationship is provided and included in press reports about the data that ultimately will be made public,” Kamp said. “The Coalition raised this issue in comments to the Centers for Medicare & Medicaid Services, and we cannot stress enough that getting this point across will make a huge difference in the public’s perception of this information. We have to make clear that these relationships are crucial to keeping physicians informed and to ensuring that patients receive the most effective treatments for their conditions.”
For details on the ISR survey report, go to: http://isrreports.com/industry-reports/sunshine-act-pharma-impact-changes-in-us-physician-behavior
April 29, 2013 – Although the Digital Advertising Alliance (DAA) has made great strides to protect consumers’ privacy online – which include its industry Self-regulatory Program for Online Behavioral Advertising and its “Your Ad Choices” public education campaign – the Senate Commerce Committee appears to be underwhelmed by companies’ self-regulation efforts and the DAA’s promise to honor “Do Not Track” requests from consumers.
“Consumers are still waiting for these Do Not Track standards. Advertisers are continuing to ignore Do Not Track headers and consumers’ requests for privacy,” said Sen. Jay Rockefeller (D-W. Va.), Chairman of the Senate Commerce Committee, at an April 24 hearing: “A Status Update on the Development of Voluntary Do-Not-Track Standards.”
“I have long expressed skepticism about the ability – or willingness – of companies to regulate themselves on behalf of consumers when it affects their bottom line,” Rockefeller said. “I disclose a generally troubling feeling I have about the nature of corporations around the chance to make money when people don’t know” what information is being collected about them, he continued.
DAA Self-regulatory Program Status
The DAA’s program is designed to provide choice to consumers regarding how they want their privacy protected. “The DAA’s efforts have helped to ensure that consumers will continue to have preferences regarding which ads they wish to see using a one-button mechanism,” said Coalition for Healthcare Communication Executive Director John Kamp. “But clearly, there is still more work to be done and stakeholders have to find common ground to move forward successfully.”
In February 2012, the DAA announced that it would begin work to recognize browser-based choices with a set of tools by which consumers could express their preferences under the DAA principles. Since then, two browser companies, Microsoft and Mozilla, have announced plans to install Do Not Track features that would automatically default to full protection without consumers having to make a choice.
DAA Managing Director Lou Mastria testified before the Senate committee that these features undermine the industry agreement made in February 2012, because they remove consumer choice – a linchpin in the agreement – from the equation.
In March 2012, the Federal Trade Commission (FTC) called on industry to step up self-regulatory practices or live with Congress stepping in. At the recent American Advertising Federation annual advertising day on Capitol Hill, FTC Chairwoman Edith Ramirez stated that the advertising industry should work with the World Wide Web Consortium (W3C) to develop a browser-based solution and praised Microsoft and Mozilla for their efforts, so it appears that support for voluntary programs may be wavering.
Although Harvey Anderson, Mozilla Senior Vice President of Business and Legal Affairs, told the committee that “industry has not moved forward quickly enough,” and that “the efficacy of the Ad Choice program remains questionable,” he did also state that “the work of the DAA should be acknowledged.”
Mastria told the committee that the DAA self-regulatory program protects consumers while also allowing them access to ad-supported content, adding that changes to the current paradigm would harm small publishers while also “chilling innovation.” He said that the DAA “is a solution provider” and the only entity that actually delivers choice for consumers.
“Today, the DAA calls on all stakeholders, including the FTC, W3C, Microsoft and Mozilla to honor the terms of the [February 2012] announcement and remove impediments that are preventing implementation of browser-driven choice for consumers,” Mastria said.
Is Legislation Needed?
Sen. Richard Blumenthal (D-Conn.) asked whether Congress should move forward with legislation in this area, because “when voluntary agreements fail to provide compliance, that’s the classic instance where a law is needed.” Mastria replied that “legislative or technological fiats are not necessarily what the Internet needs. A nimble, self-regulatory approach [like DAA’s] is exactly the kind of thing that fosters consumer trust while protecting privacy.”
He later added that the DAA program delivers “the very mechanisms” that are in Do Not Track legislation (DNT2013) introduced Feb. 28 by Rockefeller and Blumenthal. This legislation would:
- Create a universal legal obligation for all online companies to honor consumer choice when consumers do not want anyone to collect information about their online activities;
- Allow the FTC to pursue enforcement action against any company that does not honor this request by consumers;
- Allow companies, upon consumer requests to not be tracked, to collect only the information that is necessary for the Web site or online service to function and be effective, but then place a legal obligation on the online company to destroy or make anonymous the information after it is no longer needed.
“Industry needs to strongly advocate for – and deliver on – its promise to implement the levels of online privacy protection that the public is seeking,” Kamp said. “For the DAA’s program to thrive, consensus on how the program will work for all stakeholders is key.”
April 22, 2013 – In April 18 comments to the Centers for Medicare & Medicaid Services (CMS) the Coalition for Healthcare Communication (CHC) recommended that the agency address key concerns before moving forward with planned FAQs regarding compliance with and implementation of the Sunshine Act final rules. CHC believes that its suggestions “will advance the goal of transparency while ensuring that the reporting process is as clear, consistent and efficient as possible for CMS, the industry and the public,” the comment states.
“Our member companies, which include publishers of medical news, information, research and scholarly data on the latest medical science intelligence, believe that important issues must be considered and clarified before the agency publishes FAQs on the Sunshine rules,” said Jack Angel, Executive Director, Coalition for Healthcare Communication Foundation. A number of these issues involve educational materials – textbooks, journal reprints, journal supplements and digitally delivered materials – which are prepared by professional publishers and sent to physicians but were not specifically mentioned in the Sunshine rule provisions, he said.
“If confusion or perceived reporting burdens cause reduced publication or restricted distribution of these valuable educational items, physicians will no longer receive crucial information and patient care will suffer,” Angel explained.
In its comments, the CHC discusses each type of educational material individually. Those comments are summarized here:
Textbooks
The CHC asserts that providing textbooks to physicians has been in practice for decades and supports better care for patients. Additionally, textbooks are intended for professional, not personal use. Accordingly, textbooks should be excluded from the reporting requirement because these materials, like other educational materials, ensure “that clinicians are equipped with the most current medical information,” the CHC comment states. The CHC also asserts that the FDA regulates the distribution of medical education materials, which gives the Department of Health & Human Services “sufficient reason … to exempt them from reporting.”
Reprints
Reprints – copies of published articles from peer-reviewed journals – “reinforce the latest medical developments and facilitate the diffusion of medical innovation in the clinical setting,” according to the CHC. Deeming reprints – which likely cost well under $10 each – subject to Sunshine reporting would cause an untenable reporting burden on both covered entities and physicians, because covered entities would have to collect information on the identity of each physician who received a reprint and track when that physician reached the $10 threshold, and because physicians would have to log in each reprint they received from each covered entity to confirm that this tabulation is accurate.
“Instead, we recommend that [reprints] be treated like the distribution of pens and pencils,” which do not have to be tracked or reported, the comment states. “A contrary determination by CMS creates a real risk that physicians would choose to not receive reprints … a loss for healthcare providers and, ultimately, patients.”
Supplements
The CHC believes that supplements, which are special educational publications that publishers deem acceptable for mailing with the associated medical journal, would be subject to the same complications that reprints face, according to the comment, which also states that, “in the final analysis, any diminution of the availability of these educational materials would affect patient care.”
Digitally Delivered Educational Materials
Tracking this category, which covers educational materials (including reprints and supplements) that are delivered electronically, would be difficult to calculate as well, because neither the publisher nor the sponsor would have the complete or specific knowledge of the recipients. “This obvious reporting complication is a serious question in the administration of this regulation and needs to be addressed before data collection begins,” the CHC advised.
Angel underscored a point made in the CHC comment. “Receiving these materials provides no financial benefit to physicians. Making them reportable would impose great costs on industry, government and physicians, and have a negative effect on patient care,” he said. “We trust that these issues will be addressed by CMS appropriately.”
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
April 4, 2013 — Headlines run by news outlets regarding the status of industry-physician relationships rarely focus on the benefits of those relationships, according to an April 3 article in Policy and Medicine. Instead, “news outlets are continuing their misleading headlines and stories regarding physician-industry collaboration over the last few weeks by relying on the recently updated payment
data posted by ProPublica and its Dollars for Docs campaign,” the article states. It outlines news coverage in five states from news organizations that used the Dollars for Docs database as the basis for their stories.
“Focusing on the negatives and ignoring the positives of industry-physician relationships is both misleading and detrimental to the public health,” said Coalition for Healthcare Communication Executive Director John Kamp. “The public and the press need to be aware that without these important and necessary collaborations, healthcare innovation and patient quality of life would most certainly suffer.”
To read the full story, go to: http://www.policymed.com/2013/04/physician-payment-sunshine-propublica-database-leads-with-disparaging-headlines.html
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