Life Science Compliance Update

October 06, 2014

FDA Reopens Comment Period For Social Media Guidance; PhRMA and Washington Legal Foundation Weigh In

Social Media pics

FDA is reopening the comment period for its two controversial draft social media guidances. The decision comes in response to requests for additional time to allow interested parties to submit comments.

As stated in the Federal Register, starting on September 29, 2014, the public will have an additional thirty (30) days to provide comments on the following guidance documents: (1) Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (available here); and (2) Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (available here).

We wrote an extensive analysis on both guidance documents: the character space limit guidance, and the third-party misinformation guidance.

If you are interested in commenting on these guidance documents, submit electronic comments here for the Internet/Social Media Platforms with Character Space Limitations guidance document or here for the Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices guidance document.

Thus far, feedback from industry and user groups has been critical, especially comments from the Washington Legal Foundation and Pharmaceutical Research and Manufacturers of America (PhRMA).

In its comment, the Washington Legal Foundation urged the agency to rescind the draft character limit guidance, arguing it imposes severe restrictions on the right of drug and medical device manufacturers to use Twitter and other social media. The Foundation argues that FDA’s speech restrictions violate the manufacturers’ First Amendment rights and that less restrictive methods could be used to reach the FDA’s goals as opposed to total speech ban.

They wrote: “the gist of the draft guidance is that manufacturers should rarely, if ever, attempt to use Internet/social media platforms with character space limitations because those limitations do not provide manufacturers with sufficient space to include all the risk and benefit information that FDA asserts is a necessary part of any such communications.

“The de facto prohibition on use of such Internet/social media platforms is inconsistent with FDA's statutory mandate and raises serious First Amendment concerns regarding the rights of manufacturers to speak truthfully on important healthcare issues.”

Additionally, the Pharmaceutical Research and Manufacturers of America criticized FDA for its inconsistency:

"PhRMA and its member companies would like to highlight that FDA’s Draft Guidance is inconsistent with the agency’s own responsible communications about medicines using Internet and social media platforms with character space limitations. Specifically, FDA now uses character-limited platforms to announce information about drugs and does it in a responsible, truthful way, including providing safety overviews after Twitter links. Yet FDA proposes to restrict manufacturers from using the same social media tools that FDA uses. FDA’s own actions – including the use of links to present risk information and general descriptions of the benefits of drugs – provide reasonable standards for appropriate use of these media ... it cannot be truthful and non-misleading for FDA to use character-space-limited platforms in one way, but misleading for biopharmaceutical companies to do the same."

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As we noted in our coverage of the guidances when they came out, FDA's document on correcting third party misinformation provided some specific answers to important industry interactions within social media. However, the "Twitter guidance" added little to the discussion. In most cases, 140-characters is an impossibly small amount of space to cover what FDA requires for many drugs.  We will be interested in following FDA’s response to feedback in the coming months. 

June 18, 2014

FDA Social Media Guidance: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.

The Food and Drug Administration (FDA) released two new guidances for drug and device companies looking to communicate online through social media. The issuance of guidance on social media is mandated by the Food and Drug Administration Safety and Innovation Act (FDASIA), Section 1121. FDASIA required FDA to issue social media guidance by July 2014.

In the second of FDA's new guidances, entitled "Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices," FDA provides recommendations to companies that choose to correct third-party information related to their products. FDA uses many helpful examples to answer previously unclear aspects about what companies should do if they encounter false statements about their products from third parties around the internet. We also have an analysis of FDA's other social media guidance on how to provide proper benefit/risk disclosures within character limitations here.

Background

Social media has made it easier for third parties to post information about drugs and devices in real-time, and to a potentially large audience. Information created by third parties, which FDA terms "user-generated content" (UGC), can appear either on a companies' comment section or interactive social media site or on an entirely separate platform that is "not under the control or influence of" that company. Twitter, Facebook, LinkedIn, live podcasts, and blog comment sections allow for real-time and continuous communications and interactions.

However, FDA states, “UGC might not always be accurate and may be dangerous or harmful to the public health. In such a case, “it may benefit the public health for firms to correct misinformation about their products,” including, for example, “situations in which a firm is aware of misinformation that may be dangerous or harmful to the public health.”

Previously, companies have struggled with the best way to approach this type of online misinformation. FDA’s Guidance provides clarity: “If a firm voluntarily corrects misinformation in a truthful and non-misleading manner and as described in this draft guidance, FDA does not intend to object if the corrective information voluntarily provided by the firm does not satisfy otherwise applicable regulatory requirements regarding labeling or advertising, if any.”

A fundamental question for firms to ask is whether the draft guidance applies to them in a given situation. FDA states that the draft guidance applies when:

  1. A firm is not responsible for a product-related communication that appears on (1) the firm's own forum, (2) an independent third-party website, or (3) through social media, and
  2. The firm chooses to correct misinformation about its own product contained in that communication.

Preliminary Issues: Should a firm follow this guidance?

The draft guidance DOES NOT apply: when a firm is responsible for the product communication that contains misinformation. A firm is responsible for communications that are “owned, controlled, created, or influenced, or affirmatively adopted or endorsed, by, or on behalf of, the firm.” A firm is thus responsible for online communication made by its employees or any agents acting on behalf of the firm to promote the firm’s product. These communications must comply with any applicable regulatory requirements.

Additionally, if a firm writes, collaborates on, or exerts control or influence on product-specific content provided by a third party, to the extent that responsibility for the development of the content is imputable to the firm, the recommendations set forth in this guidance do not apply.

FDA notes that if a firm hosts a discussion group on its own website, monitors the discussion for content that does not speak positively about its product, then removes or edits postings that portray its product in a negative light, and adds positive postings about the product, this firm is exerting control over the UGC and is responsible for the resulting content. Thus, the firm’s actions would not fall under the scope of this guidance.

The guidance DOES APPLY: for UGC about firms products when the UGC is truly independent of the firm (not produced by, or on behalf of, or prompted by the firm), regardless of whether the firm owns or operates the platform on which the communication appears. If the firm owns or operates the platform or created or initiated the forum on which such UGC appears, the firm should include an overarching clear and conspicuous statement that the firm did not create or control the UGC.

Example: A firm becomes aware of a blogger who is posting inaccurate information about the firm’s product. The blogger does not have any relationship with the firm, and the firm is not responsible for the content of the blog. The firm may decide to attempt to correct the misinformation, but it is not obligated to.

Example: A firm hosts a discussion forum about its product’s FDA-approved use on its corporate website and does not participate in the discussion, but monitors the forum for profanity/obscenity. The forum includes an overarching clear and conspicuous statement that the firm did not create the content of the forum. The firm is not responsible for posts by independent third parties and can, if it chooses, correct misinformation according to this guidance.

FDA Recommendations for Correcting Misinformation

Once a firm decides to voluntarily correct misinformation about its own product that is created or disseminated by an independent third party, they can move on to FDA's recommendations. A firm may choose to (1) provide appropriate truthful and non-misleading corrective information or, alternatively, (2) it may provide a reputable source from which to obtain the correct information, such as the firm's contact information.

To be considered "appropriate corrective information," a firm's communication should:

  • Be relevant and responsive to the misinformation;
  • Be limited and tailored to the misinformation;
  • Be non-promotional in nature, tone, and presentation;
  • Be accurate;
  • Be consistent with the FDA-required labeling for the product;
  • Be supported by sufficient evidence, including substantial evidence, when appropriate, for prescription drugs;
  • Either be posted in conjunction with the misinformation in the same area or forum (if posted directly to the forum by the firm), or should reference the misinformation and be intended to be posted in conjunction with the misinformation (if provided to the forum operator or author); and
  • Disclose that the person providing the corrective information is affiliated with the firm that manufactures, packs, or distributes the product.

(1) Appropriate Corrective Information

Because risk and other information about the product are not necessarily part of corrective information, the FDA-required labeling should be included or provided in a readily accessible format. As two examples, a firm may provide a link that goes directly to the FDA-required labeling or may provide a link that opens a new window to a portable document format (PDF) file. The information should not be provided by including a link to a promotional website even if the information is available on the promotional website. FDA states that if the address where viewers are directed to obtain the respective FDA-required labeling is promotional in content or tone, FDA would not consider the corrective information to fall within the scope of this draft guidance.

Example: A firm discovers a chat room where participants are discussing the firm's product for one of its approved indications—diabetes. The firm finds misinformation posted by an independent third party about the diabetes indication that the firm would like to correct according to this draft guidance. Although the product has multiple approved indications, the firm should limit its corrective information to the relevant diabetes indication being discussed.

Example: An independent third party writes an online post stating that one reason he likes taking a prescription drug (or using a device) is that it has no food restrictions, which is inconsistent with information from the required labeling regarding the need to avoid taking the drug with fatty foods (or to avoid using the device in a certain way). The firm decides to correct the misinformation according to this draft guidance. The firm's representative identifies herself as being affiliated with the firm and posts the corrective information from the required labeling. She also includes a direct link to the FDA-required labeling.

(2) Correcting a Clearly Defined Portion of a Forum

FDA understands social media forums contain vast amounts of information and notes that it would be unreasonable for a firm to have to correct all misinformation about a product. They clear up an important question firms have had: “[i]f a firm corrects one or more occurrences of misinformation, it is not expected to correct each piece of misinformation in an entire forum.” However, “a firm should clearly identify the misinformation it is correcting, define the portion of the forum it is correcting, and should correct all the misinformation that appears in that clearly defined portion.”

A firm should describe the location or the nature of the misinformation that was corrected and should provide a date the correction is made to ensure that parties reading the information do not assume the firm has responded to the entire forum.

Example: A firm decides to correct misinformation posted by an independent third party on one page of an interactive website. The misinformation consists of three consecutive sentences about the firm’s product. The firm should correct all three sentences. It should provide a statement that the firm is responding only to the specified information on that one page and provide the date the change was made. The firm is not expected to correct misinformation that appears on other webpages of the website.

Example: A firm decides to correct misinformation posted by an independent third party who has commented on a blog that allows comments. The firm should correct each piece of misinformation in the particular comment to which it is responding. The firm should provide a statement that it is responding only to one particular comment along with the date the correction is provided. The firm is not expected to correct misinformation that appears in other comments.

FDA states that a firm must correct all misinformation in the clearly defined portion of the forum it identifies. FDA provides a situation where the company in a sense “promotes” its product by deleting only negative false statement. Even if the firm corrects the misinformation in the limited posts it chose, the firm’s actions are not in accord with this guidance because it has intentionally selected only negative information about its product to correct while readily accessible and visible positive misinformation was not corrected.

(3) Approaches to Correcting Misinformation

FDA does not prescribe the exact method for which a company must correct misinformation. They note that firms may provide corrective information to the independent author for the author to incorporate, they may request the author remove the misinformation, or they may consult with the site administrator. FDA understands that third parties may not always cooperate with corrections: “FDA will not hold a firm accountable for an independent third party’s subsequent actions or lack thereof.”

(4) Communications That Fall Outside the Scope of this Guidance

FDA does not expect the firm to continue to monitor the website or communication that previously included UGC containing misinformation. However, when a communication by or on behalf of the firm to the UGC author, site administrator, or the forum goes beyond the correction of misinformation, the communication falls outside the scope of this draft guidance. 

FDA concludes its guidance by noting that it does not expect firms to submit corrections to the Agency when correcting misinformation pursuant to this draft guidance. However, FDA recommends that firms keep records to assist in responding to questions that may come from the Agency. The records should include, for example, the content of the misinformation, where it appeared, the date it appeared or was located, the corrective information that was provided, and the date the corrective information was provided.

Analysis

As noted above, FDA will not object to a companies’ corrections if they are provided in a truthful, non-misleading manner pursuant to FDA’s recommendations. Companies should understand that corrections are voluntary, and can only refer back to on-label information.

FDA notes that corrections must be “consistent with the FDA-required labeling for the product, and be supported by sufficient evidence, including substantial evidence, when appropriate, for prescription drugs.” FDA’s guidance provides some clarity, but the fact that a correction could open the door to liability should give companies pause about whether to interact with users on social media. Furthermore, companies may only correct claims based on the companies’ own product. Compliance teams should have tailored corrective information that avoids comparisons with other products that could be seen as promotional in nature.

On the plus side, this guidance does seem to offer firms answers to many previously unclear aspects of social media communication. By providing companies with necessary flexibility, as well as specific, real world-examples, FDA seems to have taken note of stakeholders’ desire for clarity surrounding social media.

One aspect of the guidance that offers welcomed (and necessary) clarity is that if a firm corrects one or more occurrences of misinformation, it is not expected to correct each piece of misinformation in an entire forum. FDA advises firms to clearly identify the misinformation it is correcting, define the portion of the forum it is correcting, and then correct all the misinformation that appears in that clearly defined portion. This clears up confusion around a companies’ responsibility in a long real-time comment section or continuously updated Twitter feed. Without the guidance, companies may have thought this would require continuous monitoring.

A less clear aspect of the guidance involves FDA’s concern that a company will correct only negative misinformation. Companies must take into consideration that FDA expects them to correct both bad information as well as good information. FDA notes that if a company leaves up all the “beneficial” false comments, they are promoting their product in a sense. However, we don’t know what FDA’s standard will be or in what time frame they will look to in making its determination. For example, if a company deletes two posts about inaccurate negative side effects, how long is the company “on the hook” for waiting to see if a user provides incorrect positive information about the product? The real-time capabilities of social media still present many risks for pharmaceutical and device manufacturers.

Comments:

Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register, so, by September 15, 2014. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

FDA Social Media Guidance: Presenting Risks and Benefits With Social Media’s Character Space Limitations

The Food and Drug Administration (FDA) released two new guidances for drug and device companies looking to communicate online through social media. In the first of its new guidances, entitled "Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices," FDA provides recommendations for the presentation of risk and benefit information for drugs or devices using Internet and social media sources with character space limitations, such as Twitter and the paid search results links on Google and Yahoo. FDA also offers some clarity regarding use of scientific abbreviations and recognized symbols to address the character space constraints.

Thomas Abrams Director, Office of Prescription Drug Promotion (OPDP) noted that the guidance comes two weeks before the July 2014 goal date set by congress for completion of the social media guidelines. Abrams recently released a blog post about the guidances.

Background

FDA tightly regulates pharmaceutical advertising, and currently companies are required to submit to the FDA every promotional document—including printed, television, and website advertisements—at the "time of initial dissemination." Companies must submit promotional activity for a particular drug product on Form FDA-2253. Furthermore, each ad must contain a variety of elements, such as cited evidence for all claims, a "fair balance" of the benefits and risks of the drug, and any Black Box warnings.

With the rapid increase of promotion through real-time social media outlets, pharmaceutical and device companies have wondered how to properly follow the regulations in the digital age. Promotions via tweet or Facebook post, for example, can be uploaded instantly, in large quantities, and, on Twitter at least, in a maximum 140 characters. Many stakeholders worried that the FDA would require companies to submit "interactive promotional material" as if it were a traditional printed advertisement. Should a company have to submit risk information for every tweet or LinkedIn message it sends out?

In light of the confusion surrounding space limitations, FDA's new guidance seeks to offer some black and white recommendations.

FDA Guidance on Character Space Limitations

FDA's Guidance covers the following Internet/social media platforms with character space limitations include online microblog messaging:

  • Messages on Twitter or "tweets," which are currently limited to 140 character spaces per tweet
  • Online paid search (e.g., "sponsored links" on search engines such as Google and Yahoo, which have limited character spaces as well as other platform-imposed considerations).

It does not address:

  • Promotion via product websites
  • Webpages on social media networking platforms (e.g., individual product pages on websites such as Facebook, Twitter, YouTube)
  • Online web banners.

Under the Food Drug and Cosmetic (FD&C) Act and FDA's implementing regulations, promotional labeling for drugs and devices and advertisements for prescription drugs and restricted devices misbrand the product if they make representations about the use of a firm's product without disclosing certain information about the product's risk.

In the latest guidance, FDA provides a crash course on misbranding that firms "should consider" when using Internet/social media platforms with character space limitations for product promotion:

  • Any promotional labeling for a drug or device must be truthful and non-misleading;
  • Any promotional labeling that makes claims about a firm's prescription drug or prescription device must include the indicated use of the product and the risks associated with use of the product;
  • Information required to appear on the label must be placed prominently with such conspicuousness and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;
  • Prescription drug advertisements must present a fair balance between information relating to risk and information relating to benefit. In addition, risk information must be presented with a prominence and readability reasonably comparable to claims about drug benefits;
  • Prescription drug advertisements must contain risk information in each part, as necessary, to qualify any representations and/or suggestions made in that part about the drug. The risk information may be concise if supplemented by a prominent reference to the presence and location elsewhere in the advertisement of a more complete discussion;
  • In determining whether a drug or device is misbranded because its labeling or advertising is misleading, it must be considered whether the labeling or advertising fails to reveal facts that are material with respect to possible consequences of the use of the product as represented in the labeling or advertising or under conditions of use that are customary or usual;
  • FDA notes that character limitations may allow sufficient room for "reminder" promotions— labeling or advertising that calls attention to the name of a drug or device but does not include indications, dosage recommendations, or other information, that are exempted by the FD&C.

Thomas Abrams noted in his description of the guidance: "We understand that communicating on electronic Internet sites with character space limitations can be challenging. But, no matter the Internet source used, benefit claims in product promotions should be balanced with risk information. And companies should provide a way for consumers to gain direct access to a more complete discussion of risks associated with their products." This guidance does not stray far from established promotion principles that companies are already very familiar with.

General Factors Considered in the Communication of Benefit Information on Internet/Social Media Platforms with Character Space Limits

  1. Benefit information should be accurate and non-misleading and reveal material facts within each individual character-space-limited communication (e.g., each individual message or tweet).
  2. Benefit information should be accompanied by risk information within each individual character-space-limited communication. Firms must consider whether enough capacity will remain in the character-space-limited communication to adequately convey certain other required information.
  3. If a firm concludes that adequate benefit and risk information, as well as other required information, cannot all be communicated within the same character-space-limited communication, then the firm should reconsider using that platform for the intended promotional message. The FDA uses an example tweet: "NoFocus for mild to moderate memory loss," uses 40/140 characters. This tweet is accurate and non-misleading and includes material facts about the indications and limitations of the drug "NoFocus." FDA states: The firm should consider whether the remaining 100 character spaces are enough to include risk information and certain other required information, as applicable." If not, "the firm should reconsider using Twitter for the intended promotional message for NoFocus."

Factors considered in the Disclosure of Risk Information

FDA notes that the Agency considers two primary factors to determine whether risk information is comparable in scope to benefit information within promotional materials: (1) whether the risk information qualifies any representations made about the product (i.e., content of the risk information compared to content of the benefit information) and (2) whether the risk information is presented with a prominence and readability comparable to the benefit claims about the product.

But FDA did acknowledge that this could be a challenge with character constraints. FDA noted that a "concise disclosure of specific risk information may be presented together with benefit information within the confines of character-space-limited Internet/social media platforms if supplemented by a prominent reference to the presence and location elsewhere of a more complete discussion of the risks associated with the product (or for restricted-device advertising, a "brief statement" of intended use and relevant risk information) and that this is consistent with requirements of the FD&C Act and FDA's implementing regulations."

FDA offered four points regarding risk information within character space limits:

  1. Risk information should be presented together with benefit information within each individual character-space-limited communication (e.g., each individual message or tweet).
  2. 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. For a prescription human drug, FDA noted the most serious risks would generally include all risk concepts from a boxed warning, all risks that are known to be fatal or life-threatening, and all contraindications from the approved product labeling (the PI). For devices, FDA notes that risks associated with a particular identifiable use or population should be included.
  3. A mechanism, such as hyperlink, should also be provided to allow direct access to a complete discussion of risk. Twitter allows for shortening of links to fit within the character limits.
  4. The prominence of risk information should be comparable to the benefit information within each individual character-space-limited communication.

    FDA continued its NoFocus example for a full tweet:

    NoFocus for mild to moderate memory loss; may cause seizures in patients with a seizure disorder www.nofocus.com/risk [117/140]

Other Legal Considerations beyond Risk/Benefit

In addition to including both benefit and risk information within a character-space-limited communication, FDA states that there may be other applicable legal requirements to consider:

  • The established name must accompany the trade or brand name in labeling and in prescription drug and restricted-device advertising. Drug regulations specifically require that the established name be in direct conjunction with the proprietary name.
  • The drug regulations also stipulate that advertisements shall prominently display the name of at least one specific dosage form and have the quantitative ingredient information required by the FD&C Act in direct conjunction with such display. If other dosage forms are listed in the advertisement, the quantitative ingredient information for such dosage forms shall appear in direct conjunction and in equal prominence with the most prominent listing of the names of such dosage forms.

However, FDA noted that they do "not intend to object where the following approaches are used":

  • Firms should communicate both the proprietary (trade or brand) name and established name (for drugs, often referred to as the generic name) within the character-space-limited communication. The generic name of the product should be listed directly to the right of, or directly below, the brand name.
  • On the landing page associated with each hyperlink provided in the character-space-limited communication, firms should again communicate both the brand and established names as recommended in the preceding bullet. In addition, for prescription drugs, firms should prominently display at least one dosage form and quantitative ingredient information in direct conjunction with the brand and established names.

In addition, the Agency believes that common abbreviations (including scientific and medical abbreviations), punctuations marks, and other symbols may reasonably be used to help with character space constraints. The following examples illustrate instances where FDA does not intend to object to such usage:

  • Commonly recognized linguistic symbols may be substituted for words. For example, the ampersand symbol (&) may be used in place of the word and.
  • Punctuation marks may be used to help with the presentation of information. For example, dashes may be used to help separate benefit and risk information.
  • A scientific abbreviation may be used to denote a chemical ingredient name (e.g., "HCl" for hydrochloride; "HBr" for hydrobromide).

    FDA offered a Twitter example:

    "NoFocus (rememberine HCl) for mild to moderate memory loss-May cause seizures in patients with a seizure disorder www.nofocus.com/risk [134/140]"

Analysis

While this guidance does provide some clarity regarding FDA's expectations about companies' character limited promotions, the Guidance will prohibit many companies from using social media. Communicating the brand name and scientific name, benefits, risks, and a hyperlink is perhaps unreasonable within 140 characters, despite FDA's examples. This guidance will only be useful if your product has very limited side effects such as drugs that have gone OTC.  If you have serious adverse side effects than you will more than likely have to pass on limited charater social media.  We will be interested to see whether companies are able to navigate FDA's guidance and meaningfully utilize social media to inform patients about their products.

First Amendment Critique:

In our coverage of FDA's reprint guidance, we noted stakeholders were upset that FDA "omit[ted] any reference to the First Amendment." Likewise, in the social media guidance, John Kamp, of the Coalition for Healthcare Communication, noted that "despite assurances by senior FDA officials to address the serious First Amendment challenges raised by recent court decisions, the draft guidances contain no reference to the First Amendment and no careful analysis of any of the proposed restrictions using the factors outlined in the Supreme Court's Central Hudson test for commercial speech restrictions. These omissions could well come back to haunt the FDA if these restrictions are challenged in court."

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