Policy Updates and Enforcement Developments from FDA’s Medical Products Centers: Tips on Social Media

A recent conference hosted by the Food and Drug Law Institute looked at the evolving role of technology, particularly in the realm of advertising and promotion in the life sciences industry.   Speakers identified advertising and promotion of medical products online and especially through social media as a hot topic. 

During the session on “Policy Updates and Enforcement Developments from FDA’s Medical Product Centers,” Wayne Pines, President, Regulatory Services and Healthcare, APCO Worldwide, introduced panelists using FDLI’s the LINK.  FDLI’s online Food and Drug Regulatory Directory features profiles of FDA leadership, including, as Pines demonstrated, the designation of the recently elevated Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER), formerly the Division of Drug Marketing, Advertising, and Communications (DDMAC).  

Panelists included Thomas W. Abrams, Director, Office of Prescription Drug Promotion (CDER); Lisa L. Stockbridge, Branch Chief, Advertising and Promotional Labeling Branch (APLB), Division of Case Management, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research (CBER); Toni M. Stifano, Consumer Safety Officer, Office of Compliance, Center for Devices and Radiological Health (CDRH); and Dorothy R. McAdams, Team Leader, Post-Approval Review Team, Division of Surveillance, Office of Surveillance and Compliance, Center for Veterinary Medicine (CVM). 

The panelists discussed how the “increasing number of promotional materials and advertising platforms has increased the difficulty of the agency’s job in reviewing promotional material.” Abrams recognized that “because of constantly evolving technology and changing platforms, FDA guidance on social media will focus on issues and principles, not platforms, in an effort to remain as useful and relevant as possible.” 

FDA has now delayed issuing guidance on the use of social media for over a year, despite numerous announcements that guidance would come out in early 2011.  Nevertheless, Abrams “acknowledged the agency’s efforts to involve industry and others through public meetings and submissions of comments to the open docket in developing guidance for social media advertising and promotion issues.” 

Stifano highlighted how CDRH is working with evolving technology and cited how her group has worked directly with eBay to prevent the sale of certain unapproved and recalled devices, as well as prescription devices without a prescription, through that website.  She emphasized however, that unlike CDER and CBER, CDRH does not receive copies of advertisements or final labeling for products reviewed under the 510(k) clearance process. 

She also stated that medical device mobile applications are “a growing area of concern.” As reflected in a guidance document released for comment in July 2011, FDA may limit its oversight on this issue to a subset of applications that are defined as medical devices and either used as an accessory to a regulated device or that transform a mobile platform into a regulated device. 

All of the speakers emphasized the importance of triage in the review process and a risk-based enforcement approach, as well as the critical role companies play in voluntary compliance efforts.  Abrams stated that “The overall trend is improving in the quality of promotional materials,” although he noted that given the vast amount of promotional materials, it is hard to quantify improvement, especially because areas remain “concerning.” 

Stockbridge explained that many of the products at CBER are for rare conditions and limited populations. She also identified the unique public health aspect at stake in vaccine promotion.  McAdams noted that even in CVM, the primary concern in regulating promotional materials for veterinary medicines is always human health. She also explained that her post-approval review team duties include more than promotional review and extend to anything in the post-approval life of a product, such as post approval research and clinical reports. 

Stockbridge highlighted a hot compliance issue that resulted in several untitled letters: the importance of separating committee or professional organization recommendations regarding general public health practice from specific product information based on adequate and well-controlled studies. She asserted that the failure to separate recommendations from product information in this way may be determined to be misleading. 

“Despite the unique challenges faced by each of the Centers’ advertising and promotion oversight staff, the similarity of common violations in each of the product areas demonstrate that ultimately the importance of high quality promotion that is not misleading is critical regardless of what product is being marketed.” 

Although Abrams noted the Agency’s “active and vigorous enforcement program” and “extensive monitoring” of promotional materials, he encouraged dialogue between FDA and industry and the importance of understanding the rationale of the law in complying with regulations. 

RECOMMENDATIONS FOR SOCIAL MEDIA 

In light of the continued uncertainty surrounding the use of social media by pharmaceutical (pharma), biotechnology (biotech) and medical device (device) companies respond, another recent FDLI article offered a handful of web and social media suggestions and practices that can ease the review work we do. 

The article first noted that staff and employees need to be trained to become familiar with social media, mobile sites and apps, to get a better understanding of how the digital environments work to know what is possible, what is not and what questions to ask. 

Promotion Norms and Expectations 

Universal norms for promotional activity in the United States require consideration of the categories of help seeking and disease awareness, promotional labeling and advertising, and within that, reminder advertising. If working on content in the social media and mobile environments: 

1. As with all promotional activity, keep it on label or consistent with labeling if branded.
2. Have an adverse events reporting strategy developed and implemented for social media and mobile implementations. Involve the right parties from pharmacovigilance in the development of the strategy.
3. Ensure all employees and agents of the company are aware of and fully trained on all social media-related company policies (review processes, requirements and standards for branded and unbranded social media activity, interaction with company sponsored or company created sites, identify who are the authorized users if any, how sites are to be monitored and maintained).
4. Provide access to the current full prescribing information with branded content if not a reminder ad, or if the product labeling carries a boxed warning. 

Basic Elements 

In a reviewer’s preparation and work on branded content, one basic element includes balancing claims with appropriate risk information, including an indication statement with efficacy claims, and it should also be presented with any safety disclosure or signal.  Any material facts and limitations of use should be used with the indication presentation. 

Following the hierarchy of safety is recommended, particularly if the product includes a boxed warning. If there is not a boxed warning associated with the product, along with the claims it is wise to use the warnings, precautions and most common adverse events or choose risk information most relevant to the efficacy information presented. 

Navigation, Links and Where Things Go 

Thinking about the particular environments of site content, the team needs to know and understand the navigation and links – how things it together, how to move around, the viewing order, the content and how it is displayed.  A diagram called a wireframe is the perfect tool and is recommended to be part of the reviewer’s package for any website, mobile site or app review. 

It shows a visual structure, function and content description of the pages, and how the navigation and links low.  There can be an assortment of sharing widgets displayed or a “share” button included on a page. his can send the content of the page some place else for posting.  This option illustrates why each view should contain a balanced representation to ensure the proper messages are communicated together, when working with branded content.

When reviewing mobile content it is well advised and practical to have the home page display certain buttons (such as “Indications,” “Prescribing Information” and “Important Safety Information”) that remain consistent and available throughout the mobile presentation as a user navigates through the different branded content options. 

When a user finds a page useful and decides to share it, the same appearance and use of consistent buttons as part of each page allows access to the “Important Safety Information” and “Prescribing Information” if it is branded content that is shared.   

An option or button to the home page is also a good idea, by use of a “Home” button or use of a back link, depending where navigating from.  Other buttons that are commonly utilized are “Log In,” “Favorites” or “Bookmark,” and other options, which allow customization. he capability to search should be a standard function. 

Important Additional  Information 

It is important to note that a link to safety information is likely not going to suffice given lessons from enforcement letters, advisory information provided to companies, and the 2009 draft Guidance for Industry Presenting Risk Information in Prescription Drug and Medical Device Promotion.  The guidance specifies that “to be comparably prominent to benefit information, risk information should generally appear in the same parts of the piece as the benefits.” 

If following this thinking, and keeping in mind the likely display dimensions, an approach that is more consistent with the guidance is presentation of the safety information on the vertical display, which may utilize scrolling in order to view the complete information. 

It is recommended that risk information be visible when the content opens.  The treatment of safety information should be comparable to the treatment of benefit information, including how it is conveyed.  Evaluate the presentation by thinking about the net impression given by all of the elements of the presentation.  

The use of headers and signaling is also part of the Risk Communication Draft Guidance and given the smaller footprint and displays likely in the social and mobile realms, the continuation of safety information from page to page may be a common occurrence that should be managed with signals such as “continued,” “more” and “select.” 

Often there are clinical study pages presented, and there too, safety is a necessary part of the presentation to ensure balance. Mobile sites are useable by many different devices and are not designed as a mobile app for use on a speciic device. 

The opening display should include a verification of who your viewer is by offering categories from which they self-identify—a U.S. Healthcare Professional or a U.S. Patient or Caregiver are two of the common options when the mobile site is not for a general audience.

Site content should always be appropriate for the target audience. Once in the site content area, use caution to keep the selectable options or subject titles as short labels. It is very important that they don’t contain claims that aren’t balanced—read and edit those descriptions to be more generalized. Use terms such as BRAND (generic) Data, or labeling sections such as “Clinical Trials.” And yes, include the established name following the proprietary name. he established name is required if naming the drug, but the proprietary name is not. 

When Users Become Advocates 

Social bookmarking and sharing widgets are the small symbols we see virtually anyplace we venture online.  Some of the most popular sharing sites include Facebook, Twitter, MySpace, StumbleUpon, Google, Favorites, Digg, Delicious and Messenger. 

“Stay Connected,” “Share,” “Email his” and “Embed his Video” are some options, along with many others, to place content from one place someplace else. 

When the “share” button is selected, a display of the widgets for bookmarking or sharing is provided for the user to select from and there is also an option for email.  This can send the content of the page someplace else for posting—could be via those just mentioned or any of the 300+ social networks and bookmarking websites. 

Content is passed from the original site and posted on a social sharing site. If a user posts branded promotional content as is, the content reflects what was reviewed and approved on the original site. Be aware that a user can edit contents and post it on a social sharing site.  The current thinking is that if the company does not create, control, maintain or participate in this content on the social sharing site or someone’s social media page, there is a separation between what is company sponsored and what is not. 

The key is what is within control of the drug company. Be careful with what company employees and agents do. It is may be best to draw the line at where content has been reviewed and approved, and either cannot be edited or is screened before posting live. 

A major concern is always the content of comments added to company sponsored or supported sites.  There are many differences from site to site, but here are some quick bits of information:

YouTube allows disabling the commenting feature, so a company can post a video without allowing comments.

• There is a “Safe Watch” feature that allows channel owners with 10 or more videos to control what videos show up on the watch pages of YouTube.  This was done by Google in response to pharma company concerns about adjacent content.
• It is possible to disable video embedding to limit the use of company videos outside of the company’s more controlled YouTube environments.
• Facebook previously allowed pharma clients to disable viewer commenting on wall posts, photos and videos. On May 17, 2011, Facebook sales representatives sent emails to clients announcing a policy change where Facebook will no longer grant the ability to disable comments, unless the company’s Facebook page is a branded page “solely dedicated to a prescription drug.” Original content can be controlled—there is a distinction. 

Tweeting in Twitter 

Twitter provides a good way to communicate in short messages of 140 characters or less.  A tweet is sent to all of the people who follow the sender, and is also available on the sender’s profile page. If a person re-tweets the message, it then becomes available on their profile page. Twitter is a good way to inform many people quickly about timely events such as a drug approval or the release of new data at a scientific meeting.  Things to think about for a tweet: 

1. Unbranded tweets provide flexibility and allow linking to other branded sites
2. Use of a BRAND (generic) name works for products that do not carry a boxed warning, and can be treated as a reminder ad.
3. For communication about a drug which carries a boxed warning, the tweet should include a URL that navigates directly to display the full prescribing information, and this page can contain other ixed links to the brand website or other related information. Format of the URL to the PI is important. Example: Approval granted by FDA for BRAND (generic)—See Full Prescribing Information and boxed WARNING at www.(put brand here).com
4. Tweets regarding drugs that do not carry a boxed warning may include other URL links directly to the brand site or other information mentioned in the tweet.
5. Use of claims in a tweet is problematic, because the safety information cannot display completely with the 140 character limitation, and linking to safety is not considered a suicient solution.
6. Tweets describing new data for either a marketed product’s investigational use (as of yet unapproved) or for an investigational product should not state any specific investigational uses or potential indications or include any claims of safety or efficacy. Approach it similarly to a reminder ad—BRAND (generic) or generic name only. Beware the name of the medical meeting to ensure the disease or indication is not revealed unintentionally. When not using the product name the tweet may include information such as the company name, data presented at…, study phase. 

Thoughts for ePOCRATeS 

DocAlerts are the messages sent by ePOCRATeS to healthcare professional (HCP) subscribers of the service. Some of these are commercially sponsored by pharma, biotech or device companies.  The DocAlert message is a brief piece of practice relevant information, clinical study results or drug information delivered most often to mobile devices, and contains just enough information for the HCP to determine if they are interested in receiving more in-depth subject content. 

If the HCP selects the option from the DocAlert for more information, a detailed email is sent in response containing what the company sponsor provides as the content and message. 

1. The DocAlert title has a 100 character limitation that is best treated as a reminder ad for products that do not carry a boxed warning. he title is the only information displayed when a subscriber syncs their device and finds new information is available. Multiple titles are sometimes delivered together.
2. For the DocAlert title page, it is best to use an unbranded approach for those drugs with a boxed warning.
3. There is a single tab at the top of the DocAlert. It is a good idea to use this on the DocAlert body as the direct link to the full prescribing information. Because there is a 15 character tab limitation, be eicient in the use of this tab with something like “Prescribinginfo.”
4. The DocAlert body identifies the company sponsor, and typically contains the title, indications, limitations of use and safety information to balance this information in a display area with a maximum 650 characters. When reviewing a branded DocAlert, safety information included ater the company sponsor information will require that the reader scroll down below the viewable 650-character display to view the safety information in its entirety.
5. Remember the use of signals and headings, and in this case, consider signaling the safety information with a header where the complete safety information is presented in the DocAlert body.
6. When a subscriber receives the DocAlert body content, they may choose to “Read More Info,” in which case the full detail is sent by ePOCRATeS on behalf of the company sponsor. 

Email 

1. The email title has a 100 character limitation that again is best treated as a reminder ad for products that do not carry a boxed warning. he title is the only information displayed when a subscriber syncs their device.
2. For the email title page, it is best to use an unbranded approach for those drugs with a boxed warning.
3. The email body is where the bulk of the content is provided. If the content is branded use the standard approaches with prominent links to the safety information and full prescribing information. Included in the body of this branded email should be the indication(s), limitations of use and integrated safety, along with other content and messaging. It is always a good idea to utilize the 2009 draft Guidance Presenting Risk Information in Prescription Drug and Medical Device Promotion to refresh on what to think about. 

Conclusion

Ultimately, the author recommended that companies need to provide their sales, marketing and advertising staff with basic instructions to follow promotional norms and expectations, and how to apply the information of navigation, links and where things go. She also told companies to look for the basic elements, important additional information, and what happens when users become advocates. She asserted that companies should use the details provided for tweeting in Twitter and thoughts for ePOCRATeS to give everyone a stronger understanding of potential approaches, considerations and things to think about.