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.”
Dec. 12, 2012 – An ongoing push to eliminate the tax deduction for prescription drug advertising may actually move forward for a number of reasons, according to Jim Davidson, Executive Director, The Advertising Coalition, who spoke at a recent Medivo BTP
“Leadership Series” meeting held at The New York Times.
“Jim Davidson’s update on Capitol Hill’s approach to medical marketing policy helps underscore the importance of vigilance and good representation in Washington,” said Coalition for Healthcare Communication John Kamp. “If the medical marketing tax issue raises its ugly head again, Coalition members will be called upon to do their part in educating Members of Congress about the importance of medical marketing to patients and the U.S. economy,” he said.
The full Beyond the Pill article covering Davidson’s presentation is listed below:
Tax Reform Efforts Put DTC Advertising ‘Deduction’ at Risk
By Mark Tosh · December 11, 2012
It seems like an old story, or now one that comes up about every year at budget time: some legislators on Capitol Hill want to eliminate the tax deduction permitted for prescription drug advertising.
This time around, direct-to-consumer (DTC) advertising finds itself as a chip in the ongoing discussions about tax reform.
This was one of the messages that Washington policy expert Jim Davidson delivered during his presentation at a recent Medivo BTP “Leadership Series” breakfast at The New York Times. Marketing and policy executives from several NYC-area companies attended the breakfast, along with executives of The New York Times and advertising agencies with New York-area offices.
“For the first time, advertising is really seriously at risk in the tax code because people see a huge pot of gold,” Davidson said. “Why is it at risk? Because you can easily alter the deduction as a business expense and make a lot of money. And it is not a rate increase, which meets the Republican objective.”
In addition, in the current negotiations on tax reform, Davidson said the discussion about eliminating the cost of advertising as a business expense has been extended to include “all advertising” and not just ads for prescription drugs.
The idea of taking away the tax deduction allowed to companies for advertising expense, specifically as it relates to DTC, has been around for several years. Indeed, there are some estimates that this move would raise about $37 billion over a 10-year period for the federal government.
“Even in Washington today, that’s a lot of money,” Davidson noted. “So it’s a very serious risk and it’s one that will continue to dog us.” He noted that the concept of wiping out the tax deduction for pharmaceutical advertising — and this would include both consumer and professional ads — has come up in every two-year session of Congress for the past decade. Nonetheless, he noted that advocates for pharmaceutical marketing are taking the threat “seriously.”
Nov. 30, 2012 – The Massachusetts Public Health Council has approved final amendments to its 2008 Pharmaceutical and Device Manufacturer Code of Conduct, which now allows industry to provide “modest meals” to healthcare professionals for non-continuing medical education, according to an article posted today in Policy and Medicine.
Emergency regulations to amend the
state’s gift ban were passed in late September and the Council held a public hearing in October, at which John Kamp, Executive Director of the Coalition for Healthcare Communication, testified.
Kamp stated on behalf of the Coalition that the “singular goal” of his comments “is to dispel the myth promulgated by some that company-supported education is pure selling and is unfettered by regulation or full company responsibility for the truth, veracity or ‘fair balance’ of the content of the presentations. Nothing could be farther from the truth.”
He also noted that company-sponsored educational events are fully regulated by the federal Food and Drug Administration, state consumer protection statutes, state codes (including the Massachusetts code), federal “false claims” and other statutes, the threat of possible plaintiff “failure to warn” law suits, and the self-regulatory guidelines of the three leading industry trade associations. In other words, according to Kamp’s testimony, “the laws of the federal and state governments … and the internal policies of companies are stringent and work to ensure that
these programs are both educational and in accordance with good care.”
On Nov. 21, the Council approved the final amendments, which take effect Dec. 7.
To view the full Policy and Medicine article, go to: http://www.policymed.com/2012/11/massachusetts-pharmaceutical-and-device-manufacture-code-of-conduct-final-2012-revisions.html
June 15, 2012 – The Coalition for Healthcare Communication joined other major marketing trade groups asking the Senate Committee on Appropriations to “delete” a directive from the Financial Services
and General Government Subcommittee which would mandate that the Federal Communications Commission (FCC) and the Federal Trade Commission (FTC) issue consumer best practices for protecting personal information over wireless networks, among other privacy action steps.
“Hats off to the leading industry lobbyists who discovered this ‘stealth’ piece of legislative language and enabled industry to interpose a timely objection,” said Coalition Executive Director John Kamp. The letter was signed by several organizations in addition to the Coalition, including the American Association of Advertising Agencies, the Direct Marketing Association, the Association of National Advertisers and the Interactive Advertising Bureau.
In a June 14 letter to Appropriations Chairman Daniel Inouye (D-Hawaii) and Appropriations Vice Chairman Thad Cochran (R-Miss.), the groups state that this directive, which was passed for inclusion in the FY 2013 general appropriations bill by the Subcommittee “without input from the committees with jurisdiction over the FTC and FCC, … is unnecessary and could have significant and negative impacts on the affected industries and American commerce generally.”
“At least two Senators have already noted the industry letter in subsequent debates and we are optimistic the language will be omitted,” Kamp noted. “Although we recognize that privacy is a critical issue for both
consumers and industry, such regulation must be carefully drafted to enable a vigorous Internet marketplace and to enable citizens to protect legitimate privacy interests,” he said.
Specifically, the signatories to the letter assert that the Subcommittee is trying to enact legislation through the “back door” of an appropriations bill, that the committees of jurisdiction have not held hearings or approved legislation in this area, and that any new legislation regarding the complex issue of consumer privacy should be fully deliberated by Congress. Allowing the provision to be included would not give industry and consumer stakeholders any opportunity to provide their views, the letter states.
The groups also argue that consumer privacy already is protected by existing consumer protection laws and industry self-regulation, and that federal initiatives – from both the White House and the FTC – have proposed other methods for addressing mobile privacy.
Further, “the White House and the FTC have specifically recognized the merits of industry self-regulation for addressing consumer privacy concerns in rapidly evolving markets and technologies,” the letter states. Such self-regulation efforts to protect consumers’ privacy online include the Digital Advertising Alliance’s Self-regulatory Program for Online Behavioral Advertising and its “Your Ad Choices” public education advertising campaign. For more information, see http://www.cohealthcom.org/2012/03/28/ftc-to-industry-adopt-consumer-privacy-best-practices-now/
“Self-regulation can address privacy concerns without interfering with innovation, which benefits consumers by delivering paychecks, savings, and exciting products and services,” according to the letter. “In contrast, new regulatory restrictions could stop innovation, slow economic growth, reduce benefits for consumers, and result in job losses.”
As such, the groups ask that the directive be removed from the legislation and that “no funds appropriated in the bill … be used by the FCC or FTC to draft new privacy guidelines that have no statutory foundation and could harm American companies and consumers.”
April 23, 2012 — The House and Senate both issued draft legislation last week to reauthorize the Prescription Drug User Fee Act and with mark-ups imminent, Congress appears to be on track for passing the PDUFA V legislation by mid-year.
“The news from Capitol Hill on PDUFA V reauthorization of the FDA is great,” said Coalition for Healthcare Communication Executive Director John Kamp. “Even in the face of federal deficits, members of Congress understand that FDA must have the people and resources necessary to carry on its business, including approving drugs. Indeed, the discussions are months ahead of previous such debates, enabling possible passage well before the election recess and avoiding distracting layoff contingency plans by agency heads.”
In addition to provisions for user fees for drugs and devices, the discussion drafts from the House and the Senate address fees relating to generic drugs and biosimilar biological products as well as protection for the drug supply chain.
The draft Senate bill, “The Food and Drug Administration Safety and Innovation Act,” includes a provision creating a new review channel for breakthrough treatments and includes the Generating Antibiotic Incentives Now (GAIN) Act, which would extend the market exclusivity period for drugs treating antibiotic-resistant pathogens by five years.
The draft House bill also incorporates the GAIN Act and adds a six-month extension for any therapies approved with a companion diagnostic. Both the Senate and House drafts include provisions that would require the FDA to track drug shortages.
Further, the House legislation includes language that would permanently authorize two laws that provide incentives for conducting clinical trials for pediatric therapies: the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. Separate legislation covering this issue was introduced in the Senate and most likely will be integrated with PDUFA V during mark-up.
Interestingly, what is not included in the bills so far is any specific drug marketing language, despite consumer and other groups pressing for this during the FDA phase of the legislation process. During a Feb. 1 House Energy and Commerce Committee Subcommittee on Health hearing to discuss PDUFA V issues, medical marketing was raised in only one exchange, between Rep. Jan Schakowsky (D-Ill.) and Commissioner of Food and Drugs Margaret Hamburg, M.D.
In that exchange, Schakowsky inquired about the agency’s resources to monitor direct-to-consumer (DTC) advertising. Hamburg stated that although advertising was considered in previous PDUFA negotiations, “it is not a part of PDUFA V.”
Efforts by the Pharmaceutical Care Management Association (PCMA) to suppress the use of branded drugs and eliminate advertising tax deductions and by
consumer groups to add marketing rules to PDUFA V – including expanded capacity for DTC monitoring – to date have not yielded results in the legislation.
“But the devil is in the details,” Kamp said, “and last-ditch efforts to revive these issues could emerge during the mark-ups. We must continue to track the progress of the legislation carefully and be prepared to explain the value of drug marketing to U.S. patients.”
March 28, 2012 – Industry members needing another reason to join the fray of companies participating in the Digital Advertising Alliance’s (DAA’s) voluntary consumer privacy protection program got a big one this week: The Federal Trade Commission’s (FTC’s) final report on protecting consumer privacy. In the report, the FTC recommends that companies begin adopting its best practices to protect consumers online; the Commission also asks Congress to consider enacting legislation covering general privacy, data security and breach notification, and data brokers.
“If companies adopt our final recommendations for best practices – and many of them already have – they will be able to innovate and deliver creative new services that consumers can enjoy without sacrificing their privacy,” said FTC Chairman Jon Leibowitz. Indeed, the FTC, the U.S. Department of Commerce and the White House praised the DAA and its members Feb. 23 for their efforts – including DAA’s Self-regulatory Program for Online Behavioral Advertising and its “Your Ad Choices” public education advertising campaign – to protect consumers’ privacy online.
The final FTC privacy report, issued March 26, expands on a report issued by the agency in December 2010 by asking companies handling consumer data to implement specific recommendations for protecting privacy, as follows:
- Privacy by Design – Companies should build in consumers’ privacy protections at every stage in developing their products. These include reasonable security for consumer data, limited collection and retention of such data, and reasonable procedures to promote data accuracy.
- Simplified Choice for Businesses and Consumers – Companies should give consumers the option to decide what information is shared about them, and with whom. This should include a Do-Not-Track mechanism that would provide a simple, easy way for consumers to control the tracking of their online activities.
- Greater Transparency – Companies should disclose details about their collection and use of consumers’ information, and provide consumers access to the data collected about them.
Leibowitz indicated that although many companies are on board with these recommendations, it may be necessary for Congress to step in. “We are confident that consumers will have an easy to use and effective Do Not Track option by the end of the year because companies are moving forward expeditiously to make it happen and because lawmakers will want to enact legislation if they don’t,” Leibowitz said.
To that end, the FTC “urges individual companies and self-regulatory bodies to accelerate the adoption of the principles contained in the privacy framework, to the extent that they have not already
done so,” according to an FTC press release.
The FTC will be active in five key areas over the next year, the report states: (1) Do Not Track; (2) mobile services; (3) data brokers; (4) large platform providers; and (5) enforceable self-regulatory codes.
“To the extent that strong privacy codes are developed, the Commission will view adherence to such codes favorably in connection with its law enforcement work,” the report states. However, the FTC states that it “will also continue to enforce the FTC Act to take action against companies that engage in unfair or deceptive practices, including the failure to abide by self-regulatory programs they join.”
March 13, 2012 – Draft guidance released today by the FDA – “Guidance for Industry Direct-to-Consumer Television Advertisements” – calls for drug sponsors to submit nearly all direct-to-consumer (DTC) television ads for review 45 days prior to dissemination and specifies the documentations needed for all new advertising claims.
The draft guidance describes the full array of DTC TV ads the FDA intends to make subject to a pre-dissemination ad review provision mandated by the Food and Drug Administration Amendments Act of 2007. It also explains how the FDA will notify drug sponsors that an ad is subject to the program and sets out procedures sponsors need to follow in order to be in compliance with the provision.
“Maybe it’s a good thing that the longtime ‘voluntary’ pre-review system is now official, but there is no good news here for patients who want speedy access to information about new medicines,” explained John Kamp, Executive Director of the Coalition for Healthcare Communication. “This law and draft guidance in effect create a ‘45-day shot clock’ that blocks information to doctors and patients about new drugs. Moreover, there is no ‘overtime’ added to the patent period to make up for these delays,” he said.
In fact, Kamp points out that these draft procedures appear to impose a new set of mandates on drug sponsors, including the submission of background information and documentation that substantiate the claims in submitted TV ads, including annotated references that are cross-referenced to the ad’s storyboard.
Agencies and clients are urged to review this guidance carefully and submit comments directly or through the Coalition by the May 14 deadline.
Long List of Ads Subject to Requirements
According to the draft guidance, sponsors must submit TV ads for pre-dissemination review if they fit in the following categories:
- Category 1: The initial TV ad for any prescription drug or the initial TV ad for a new or expanded approved indication for any prescription drug;
- Category 2: All TV ads for prescription drugs subject to a Risk Evaluation and Mitigation Strategy (REMS) with elements to assure safe use (see section 505-1(f) of the FD&C Act);
- Category 3: All TV ads for Schedule II controlled substances;
- Category 4: The first TV ad for a prescription drug following a safety labeling update that affects the Boxed Warning, Contraindications, or Warnings & Precautions section of its labeling;
- Category 5: The first TV ad for a prescription drug following the receipt by the sponsor of an enforcement letter (i.e. a Warning or untitled letter) for that product that either cites a TV ad or causes a TV ad to be discontinued because the TV ad contained violations similar to the ones cited in the enforcement letter; or
- Category 6: Any TV ad that is otherwise identified by FDA as subject to the pre-dissemination review provision.
Without specifically saying so, this list includes nearly all types of TV ads that drug companies would run, except for ads that are just remixes of the same basic information, with no new claims or changes.
Further, Category 5 forces sponsors that receive an enforcement letter for a TV ad to continuously submit TV ads – whether or not they include new information – for pre-dissemination review.
The draft guidance states that the FDA will notify drug sponsors of the requirement to submit their ads for review in the following ways: in letters approving future applications or supplements, in a labeling update, in an enforcement letter or “in other correspondence.” Already approved product sponsors falling into Categories 1, 2 or 3 will be informed of the requirement through Federal Register notices, the draft guidance states.
However, the agency also states that the onus is on sponsors to determine whether their ads fall into any of the six categories slated for pre-dissemination review, adding that “dissemination of a television ad without complying with [the provision] is a prohibited act” which can be enjoined and is subject to criminal penalties and potential civil monetary penalties.
Pre-dissemination Package Requirements
The pre-dissemination “review package,” to be submitted 45 days prior to
dissemination, must include:
- A cover letter that:
- Provides the following subject line: Pre-Dissemination Review Package for a Proposed TV Ad for [Proprietary Name/Established Name (dosage form) (for drugs), or Trade name/Proper name (for biologics)] Subject to 503B of the FD&C Act Includes the NDA or STN number
- Provides the name of the proposed TV ad
- Lists the contents of the pre-dissemination review package and the number of copies provided of each item contained in the pre-dissemination review package
- Provides a sponsor contact’s name, title, address, phone, fax, and email
- Annotated storyboard of the proposed TV ad to show which references support which claims
- The most current FDA-approved prescribing information (PI) and, if applicable, the FDA-approved patient labeling or Medication Guide with annotations cross-referenced to the storyboard
The guidance also states that a sponsor should include other appropriate documentation, if any of the following apply:
- Annotated references to support product claims not contained in the PI, cross-referenced to the storyboard
- Verification that a person identified in a TV ad as an actual patient or health care practitioner is an actual patient or health care practitioner and not a model or actor; and/or verification that a spokesperson who is represented as a real patient is indeed an actual patient; and/or verification that an official translation of a foreign language TV ad is accurate
- Annotated references to support disease or epidemiology information, cross-referenced to the storyboard
- A video of the TV ad in an acceptable format, if available. FDA cannot provide final comments on the acceptability of a TV ad without viewing a final recorded version in its entirety. FDA understands that some sponsors may wish to receive comments from the Agency before producing a final recorded version of the ad. In such situations, sponsors can submit a pre-dissemination review package without a final recorded version of the ad, but once the final recorded version is produced, it will need to be submitted to the Agency for pre-dissemination review.
“Industry must speak up,” Kamp said. “The FDA must be made aware of the practical impact of these proposals, and we must give them alternatives that are consistent with the statute but that also provide doctors and patients with speedy access to information.” Agencies and publishers interested in participating in the development of the Coalition’s comments are urged to contact Jack Angel; email@example.com.
March 8, 2012 – Fifteen trade associations – including the Coalition for Healthcare Communication – sent a letter to Congressional leaders this week asking them to hold off on pursuing consumer privacy legislation while industry-led self-regulatory program efforts take hold.
Because these efforts are an efficient and effective way to protect consumer privacy interests, the groups are concerned that new legislation “could undermine future efforts for successful voluntary practices,” according to the Industry Letter to Leadership re Privacy Legislation, which was delivered to all members of the House Energy & Commerce Committee and the Senate Commerce and Judiciary Committees.
“Contrary to many press reports, the industry opposes legislation at this time. Instead, Congress should acknowledge that industry self-regulation is working and give the process time to take root,” said Coalition for Healthcare Communication Executive Director John Kamp. “Even though industry needs to do more to fully engage Web stakeholders, early efforts are very promising. Voluntary, collaborative self-regulation is far superior to government regulation.”
The trade association letter stresses that voluntary codes of conduct, unlike government regulation or legislation, “can adapt in a timely manner to shifting technologies, business models, and consumer expectations.”
Indeed, in February, the Digital Advertising Alliance (DAA) and its members were praised by White House, Department of Commerce and Federal Trade Commission officials for their efforts, which include the DAA’s Self-regulatory Program for Online Behavioral Advertising and “Your Ad Choices” public education advertising campaign.
Voluntary programs, the industry groups contend, also can address privacy concerns “without interfering with innovation, which benefits consumers by delivering paychecks, savings, and exciting products and services.” These programs, they conclude, are “the ideal way to balance privacy and innovation.”
Meanwhile, Kamp implores industry members “to get on board with voluntary programs today to help prove industry’s commitment to consumer privacy, because legislation will come in the absence of robust industry participation.”
In addition to the Coalition, associations signing the letter include: American Advertising Federation, American Association of Advertising Agencies, American Business Media, Association of National Advertisers, Consumer Electronics Association, Direct Marketing Association, Financial Services Roundtable, Interactive Advertising Bureau, National Retail Federation, NetChoice, Online Publishers Association, Performance Marketing Association, Toy Industry Association, and U.S. Chamber of Commerce.
Feb. 23, 2012 – At a White House meeting held today to unveil the blueprint for the Obama Administration’s “Consumer Privacy Bill of Rights,” the Digital Advertising Alliance (DAA) and its members were praised by White House, Department of Commerce and Federal Trade Commission officials for their efforts during the past three years to protect consumers’ privacy online. These efforts include the DAA’s Self-regulatory Program for Online Behavioral Advertising and last month’s “Your Ad Choices” public education advertising campaign.
“While privacy remains one of the most challenging issues in the Internet age, the Coalition for Healthcare Communication, through its work with the American Association of Advertising Agencies, is proud to be part of the solution announced by the White House today to enable consumers to better exercise their privacy and marketing preferences,” said Coalition Executive Director John Kamp. “Much still remains to be done, including urging all Web publishers, agencies and clients to take full advantage of the DAA’s self-regulatory program in order to create a more robust and trustworthy Internet marketplace,” he added.
The DAA also announced today that it will immediately begin work to recognize browser-based choices with a set of tools by which consumers can express their preferences under the DAA principles.
“The Administration, Congress, and the FTC have been pushing the business community for several years to make sure consumers are aware of the information practices occuring online and providing choices to consumers regarding the collection and use of information about them,” said DAA General Counsel Stu Ingis. “The DAA is an embodiment of leading companies responding to this call.”
For more information on this groundbreaking news, see the press release from the 4A’s, released at noon today: http://www.aaaa.org/news/press/Pages/022312_daa_whitehouse.aspx
Feb. 16, 2012 – Further notice and comment are necessary for the implementation of Section 6002 of the Affordable Care Act – known as the “Sunshine Act” – to ensure that the data submitted under the Act are accurate and are placed in the proper context for public understanding, according to the Coalition for Healthcare Communication Sunshine Act Comment submitted to the Department of Health & Human Services (HHS).
“Although the Coalition understands the importance of transparency, there are numerous issues that need to be resolved – and further commented on by all stakeholders – if the rule is to fulfill its intended purpose,” said Coalition Executive Director John Kamp. “To get transparency right, the HHS must do a further notice on accuracy and context,” he asserted.
The Coalition is concerned that the current proposal would have a chilling effect on important collaborations between industry and healthcare providers, lead to unnecessary and significant complexities, increase costs and create public perception issues. These concerns “must be addressed fully before final rules are adopted,” according to the Coalition comment.
“Rubber-stamping the proposal as written would be a huge mistake that, ultimately, would hurt, rather than protect, patients,” Kamp noted, adding that the public perception issues are particularly important.
“It’s time for the press and some politicians to stop treating every reported payment as a newly uncovered scandal,” he said. “The real scandal is the demonization of collaborations between industry, academia and government. Collaboration has enabled the great medical breakthroughs that have added 10 years to the average American life in just a generation.”
In addition to the call for a further notice on accuracy and context, the Coalition’s comments focus on several areas needing additional refinement and review, and make the following recommendations:
- HHS should hone the rules to more accurately reflect the legislative intent and the specific language of the statute, and “narrow its burdens and reach” accordingly. The Coalition cites indirect payments and vital prescriber education as examples of how HHS has expanded its purview under the proposed rule.
- HHS should take a closer look at the costs associated with the proposal, including the significant cost of industry and provider compliance. The Coalition believes that HHS has underestimated the direct compliance costs and largely ignored the indirect “intangible costs of possibly misleading patients, caregivers and professionals regarding the nature and value of these relationships.”
- HHS should clarify explicitly in the final statement of the rule that commercially supported meetings and educational enduring materials are not intended to be covered by the statute and are not subject to any reporting requirement.
Further, because many details of the proposed rule are unknown, the Coalition is concerned that entities involved in the medicines industry will simply avoid many collaborative programs that provide healthcare providers with valuable professional education. Such a result “would harm, not help, patients,” Kamp said. “There is a lot more work to be done.”