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 26, 2012 – Note to Industry Leaders
The Coalition for Healthcare Communication needs your input on a study FDA is planning to conduct regarding corrective DTC television advertising. In the recent past, FDA has used this enforcement tool only sparingly, most notably as part of a Warning Letter involving contraceptives. Our primary concern is that FDA may be fielding this study to support more extensive use of this extraordinary remedy.
FDA has asked for comments on the following corrective advertising study issues:
- Whether the study is necessary
- Whether the cost estimates are accurate
- Ways to enhance the study
- Ways to reduce the cost
To inform the Coalition comment to FDA, we would like to hear from you on the impact of corrective ads, especially on whether or not corrective ads achieve the intended goals of the FDA and whether or not they may be counterproductive. We would like to include data supporting our comments and recommendations wherever possible.
Corrective advertising was born in the 1970s as a hypothetical remedy for deceptive advertising. The Federal Trade Commission requires it only in extraordinary cases because it is controversial and is subject to limits under the First Amendment. At FDA, corrective advertising has been used in both professional and consumer advertising, but there exist very limited public data on its impact.
FDA’s Stated Objective
To examine how variations in corrective advertising may impact consumer understanding.
FDA proposes to use an Internet panel asking questions online. There would be two phases:
- Phase 1 – Examination of the impact of exposure to combinations of the original and corrective ad.
- Phase 2 – Examination of how the similarity of the original and the corrective ads and the time between their use impact the ability to correct misinformation.
FDA says that there will be no capital or operating and maintenance costs associated with this collection of information.
What You Can Do
If you want more details on the plan, go to the Federal Register/Vol. 77, No. 40 published Feb. 29, 2012. You may wish to pass this message along to those in your organization who focus on market research, requesting comments and suggestions.
Agencies and publishers may choose to comment individually, as well as to support the Coalition comment.
For our part, we are seeking data and information from communication professionals on just how FDA’s use of corrective advertising action might impact consumer perception and behavior. The FDA would be especially interested in data that demonstrate the limits and possible unintended consequences of requiring corrective advertising in its enforcement actions.
Comments must be filed with FDA by April 29, 2012. We would like your views and suggestions by April 6th so we can consolidate and prepare our final comments. Interested members should contact Jack Angel at firstname.lastname@example.org or 203-661-3314.
In addition, you will soon receive a similar request to support Coalition comments on the recently released draft guidance on pre-review of DTC advertising. That comment is due May 15.
Jack Angel & John Kamp
Coalition for Healthcare Communication
March 19, 2012 – A new video produced by CME Peer Review – “Conflict of Interest: The Bottom Line” – features Coalition for Healthcare Communication Executive Director John Kamp and other continuing medical education (CME) experts who are moving ahead with strategies to minimize CME conflicts of interest.
Highlights of the video are discussed in a March 19 article in Policy and Medicine, where Kamp is quoted. In the article, Kamp states that CME stakeholders “have gotten the message” on conflict of interest disclosures and that “CME is the solution to many problems in our health care system because CME can help improve the delivery of efficient and effective health care to patients.” Read the full article and access the video by clicking on this link: http://www.policymed.com/2012/03/continuing-medical-education-and-conflict-of-interest-the-bottom-line.html.
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.
March 5, 2012 – In a case that highlights First Amendment limits to FDA regulation of marketing, the U.S. District Court for the District of Columbia granted a motion for summary judgment Feb. 29 in favor of five tobacco companies who called unconstitutional an FDA rule requiring that new, mandatory graphic images be added to specific textual warnings included on cigarette packaging.
“The Court concludes that these mandatory graphic images violate the First Amendment by unconstitutionally compelling speech,” U.S. District Judge Richard J. Leon wrote in the court’s opinion (Civil Case No. 11-1482 (RJL)).
“If courts refuse to allow this sort of regulation of tobacco products, which cannot be used safely, it’s fair to assume that many other FDA regulations governing speech are at risk. The court’s decision reminds us that the bar for restricting speech is high,” said John Kamp, Executive Director, Coalition for Healthcare Communication.
“While the tobacco regulations were unprecedented, if the FDA can’t get tobacco restrictions past the courts, how can it possibly continue to restrict medicine companies from telling the truth about the off-label uses of their products?” Kamp continued.
The tobacco companies successfully argued that the congressionally mandated graphic warnings unconstitutionally compel speech, “and that such speech does not fit within the ‘commercial speech’ exception” allowing certain types of government-mandated, informational disclosures. In legal terms, the court decided that these mandated warnings had to be analyzed under the “strict scrutiny” test of First Amendment law and that the rules failed that standard.
Stating that the FDA rule’s graphic-image requirements are not the type of purely factual disclosures that are reviewable under a less-stringent standard, the court found that the FDA failed to satisfy the burden of demonstrating that its rule is narrowly tailored to achieve a compelling government interest and, thus, violated the First Amendment.
“While the line between the constitutionally permissible dissemination of factual information and the impermissible expropriation of a company’s advertising space for Government advocacy can be frustratingly blurry, here the line seems quite clear,” the opinion states.
In light of the court’s decision, “it’s fair to ask how the increasingly intrusive ‘fair balance’ disclosures would fare under the ‘compelled speech’ theory applied in this case,” Kamp said. “Even more importantly, it’s time for the industry to ask whether the compelled disclosures do more harm than good to the public health.”