Metadata is defined as, simply put, data (information) about data. In the world of websites, metadata is used in the form of meta tags which describe a webpage’s content. Meta tags, for example, can specify a page’s title and description. Metadata is housed within a webpage’s HTML and is not displayed to the user, but is referenced by search engines, browsers and other web services. Search engines reference the metadata to display information about the webpage on their organic search results pages.
Since metadata is “invisible” to the average user, there can be confusion around regulatory requirements for it within branded pharmaceutical promotional websites — especially when it comes to search engines. In June 2014, the FDA released draft guidance for advertising and promotional labeling, including paid search (sponsored links), but that draft guidance did not address metadata or organic search activities. Two years later, metadata designed to aid organic search still has not been addressed in any explicit FDA guidance.
For marketers who are unsure about how to treat metadata, it is safest to look at it as falling under the classification of the website on which it resides. For instance, metadata for a brand.com site should be construed as direct-to-consumer labeling. This precedent was set in a 2010 FDA warning letter related to social sharing metadata1.
While site owners do not always have control over how organic search results are displayed, they do have control over what is placed within the site’s metadata. This POV discusses best practices for how to craft webpage metadata in a compliant format given the constraints of the medium and absence of explicit FDA guidance.
WHAT IS METADATA?
Since 1995, the term metadata has been used to describe standardized, structured data used to support the discovery, organization and archiving of information, such as a webpage. It is coded into every page within a website. Several types are used to inform search engine crawlers, particularly the title and description tags. These key identifiers are used by search engines to understand individual webpages and their relation to other pages on a site. The title and description tags are the two most common meta tags to appear in organic search results.
As stated above, the purpose of organic metadata is to accurately describe the content within a webpage to improve indexing. Unfortunately, search engines view meta tags merely as suggestions, and there is much less control over how search engines use organic metadata compared to how social platforms use sharing metadata, such as the Open Graph protocol.
Unlike social sharing platforms that simply append Open Graph meta tags, search engines routinely ignore and/or alter suggested meta tags, and in their place, they will serve any snippet of content from the webpage deemed relevant. In fact, some researchers have found that search engines alter or completely change site titles 60% of the time.
Fortunately, the FDA pays attention to what pharmaceutical companies do and do not have control over when it comes to digital content on the Web. For our clients, Intouch Solutions recommends making every effort to follow best practices to ensure metadata is compliant to the extent which the site owner has control.
FDA COMPLIANCE AND FAIR BALANCE IN ORGANIC METADATA
When thinking about organic metadata and fair balance, it’s important to remember that organic metadata is not meant to be standalone promotional material. It is written as part of a webpage; meant to describe the contents of that webpage; and should be taken in the context of the larger entity, which includes full prescribing information and fair balance2.
Depending on the content on your webpages, there are two types of metadata written for branded pharmaceutical sites: product promotion and reminder communication. To better understand the FDA regulations that apply, Intouch has created general metadata standards, as well as guidelines for both product promotion and reminder-style metadata.
ORGANIC METADATA STANDARDS
In harmony with inbound marketing and organic search best practices, Intouch has established the following standards for webpage metadata3:
- Keyword strategy — Keyword research is conducted prior to content generation to understand the needs and language of the target audience(s). Keywords are then mapped to pages and included in each of the following elements to provide context and relevance.
- Title tags — Title tags should accurately represent the content of a page. They are restricted to a width of 512 pixels, or approximately 58 characters or less, in the search results pages.
- URLs — URLs are simply the file path browsers follow to access a file on a server. End users think of URLs like an address; it is how they find the resource they are looking for. Concision is crucial for URLs, and they should define the page in 100 characters or less.
- Description tags — Description tags should accurately describe the content of a page in 156 characters or less.
- Image alt-tags — These tags accurately summarize the content of an image in 90 characters or less and be used in compliance with the ADA and Section 508 of the Rehabilitation Act of 1973.
ORGANIC METADATA GUIDELINES FOR REMINDER COMMUNICATION
When developing organic metadata for webpages, it’s important to note that a great deal of the content on a brand’s website can be appropriately and meaningfully described via reminder communications4, which have only two requirements: inclusion of the brand name and the generic name5.
ORGANIC METADATA GUIDELINES FOR PRODUCT PROMOTION
When developing organic metadata for product information pages, a modified version of the FDA’s guidance on character-constrained communications should be applied. For organic metadata, the relevant modifications are that all elements of visible organic metadata should be considered holistically. If including a product’s benefits, the organic metadata must include all of the following:
- Brand name
- Generic name and/or active ingredients (scientific abbreviations are acceptable)
- Non-misleading indication statement
- A statement of the most serious risk(s) and/or contraindication(s) be stated at a minimum6 if mentioning benefits
- A link to the full risk information7
While the FDA has yet to provide specific guidelines surrounding the use of metadata in organic search activities, prudent pharma marketers must consider metadata language in the wider context of known restrictions and best practices. We believe this approach will help clarify and direct medical and regulatory decisions for pharma brands engaged in organic search optimization.
We encourage you to review these guidelines with your agency, your partners, and your medical and regulatory colleagues to determine if this approach is best for your brand.
1In a letter to Novartis, information shared from the TASIGNA® consumer website to Facebook was found to be in violation for risk omission, indication broadening, superiority claims, and failure to submit advertising and promotional labeling.
2In the 2014 draft guidance, the FDA states that a firm should consider how to fulfill other regulatory requirements for advertising or promotional labeling. For example, firms will provide access by either a direct hyperlink to comprehensive risk materials or a landing page that includes risk information.
3These standards are based on use in desktop devices; mobile devices may shorten these standards.
4Because black box drugs are explicitly prohibited from participating in reminder communications, the FDA has recently clarified that they are permitted to engage in a closely related form of communication called reminder-like communication. Black box drugs using reminder-like communication must include the following four elements: brand name, generic name, “Please see…” statement directing recipients to the product information (PI) or brief summary, and a link to the PI on the landing page.
5Because the title tag, URL and meta description tag should be viewed as a single unit, it’s not necessary for the established name to appear in the title tag with the brand name. You can meet FDA regulations by using the established name in either the title tag or the meta description tag.
62014 Draft Guidance, Section V, line 304: “The content of risk information presented within each individual character-space-limited communication should, at a minimum, include the most serious risks associated with the product.
7In organic search results, title tags are hyperlinks and fulfill the requirement for a link to the full risk information.