Word Cloud with Influence related tags

In an age of explosive growth for social media and declining TV viewership numbers, companies are partnering with so-called “influencers” to help the companies grow their brands. Popular users of Instagram, Vine, YouTube and other social media sites have gained celebrity status, generating millions of views, impressions and “likes” with every upload.

Capitalizing on the shift from traditional media to online platforms, advertisers have begun to engage influencers in marketing campaigns. In a May 2015 study, 84% of marketers said they expect to launch at least one influencer marketing campaign in the next 12 months. Of those who had already done so, 81% said influencer engagement was effective. In a separate study, 22% of marketers rated influencer marketing as the fastest-growing online customer-acquisition method.

So what is an influencer, anyway? By its broadest definition, an influencer is any person who has influence over the ideas and behaviors of others. When it comes to social media, an influencer could be someone with millions of followers or a user with just a few loyal subscribers. One thing that all influencers seem to have in common is that their audiences trust them. As such, influencers can be powerful advocates, lending credibility, increasing engagement and ultimately driving consumer actions.

Influencer marketing can be an effective tool, but it’s important to do right. As recent Federal Trade Commission (FTC) and Food and Drug Administration (FDA) investigations demonstrate, online advertising is an area of relatively active enforcement, and influencer marketing presents a number of potential legal issues. The following tips can help companies lead successful influencer marketing campaigns while lessening the risk of liability.

Disclosure Is Key

In September, the FTC settled a case with Machinima, a company that paid popular video bloggers to promote Microsoft’s Xbox One system through YouTube. Despite the hefty sums paid out to the gamers (one of whom pocketed $30,000), Machinima did not require them to make any disclosures. The FTC alleged that the failure to disclose the relationship between Machinima and the gamers was deceptive, in violation of Section 5 of the FTC Act. In its Endorsement Guides, the FTC has taken the position that a failure to disclose unexpected material connections between companies and the individuals who endorse them is deceptive.

This case raises two important questions: (1) when is a disclosure required and (2) what constitutes adequate disclosure? Continue Reading Influencer Marketing: Tips for a Successful (and Legal) Advertising Campaign

From our sister blog, MoFo Tech:

Two FDA Guidelines Help Life Sciences Companies Solve Social Media Conundrums

Social media presents new challenges for life sciences companies. Companies that post about their products on space-constrained social media platforms such as Twitter or Facebook don’t have the luxury of a full page or a long voiceover listing risks or side effects. And it’s unclear how to respond to misleading information about products posted online by third parties. In June, the Food and Drug Administration produced two much-anticipated draft documents that provide some guidance in each case.

The “Twitter Guidance”

“Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices” (found at http://1.usa.gov/1kGYdgK) specifies that a brand should, within the post:

  • Include the brand and established name, dosage form, and ingredient information
  • Accompany benefit with risk information
  • Provide a link to a page devoted “exclusively” to risk information.

If both benefit and risk information can’t be included in the limited space, the company should consider using a different platform, the FDA advises. “The Twitter Guidance provides a fictional example to show that it’s not impossible to produce an acceptable tweet. But it is very difficult,” says Erin M. Bosman, chair of the Product Liability Practice Group at Morrison & Foerster. Companies that go the Twitter route may want to focus on products with only a few risks or
risks that are easy to understand, she says.

Correcting third-party Misinformation

This guidance, called “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices,” can be found at http://1.usa.gov/1kHcfii.

“Companies can breathe a sigh of relief with this guidance because it says companies are not obliged to correct third-party information,” Bosman says. “This reduces the need to monitor and mine massive quantities of Internet data about their products.”

The FDA suggests guidelines for voluntary correction of third-party misinformation, such as posting the correction in the same area or forum where the misinformation is found, when possible. Bosman suggests that companies should have “a standard policy about the type of information to correct. For example, misinformation that presents serious health risks should be a higher priority than correcting more innocuous misinformation.” She also recommends formulating a standard response for correcting common misinformation in order to ensure accuracy and consistency.

The latest issue of our Socially Aware newsletter is now available here.

In this issue of Socially Aware, our Burton Award-winning guide to the law and business of social media, we examine the use of the Computer Fraud and Abuse Act to combat web scraping; we explore the launch of Google Glass in the UK and the issues it raises; we analyze the FDA’s latest attempt to provide direction for drug and device manufacturers concerning how and when they may use social media; we report on a recent case concerning whether service providers can avail themselves of certain DMCA safe harbors; we highlight the increasingly important role of social media services in proxy contests; we take a look at how the Supreme Court’s Aereo decision might impact other areas of technology; and we discuss the ongoing controversy regarding website accessibility under the ADA and California’s Unruh Act.

All this—plus a collection of thought-provoking statistics about social media and the World Cup…

Read our newsletter.

 

Last week the Food and Drug Administration (FDA) promulgated two much-anticipated draft guidance documents on using social media to present information about prescription drugs and medical devices. The draft guidance documents, which were originally promised by the FDA in 2010, represent the FDA’s latest attempt to provide direction for drug and device manufacturers concerning how and when they may use social media.

BACKGROUND

Drug and device labeling and promotion are highly regulated activities, subject to onerous approval requirements enforced by the FDA under the Federal Food, Drug, and Cosmetic Act (the “Act”). Under the Act, “labeling” includes “all labels and other written, printed, or graphic matter” that “accompany” a drug or device. 21 U.S.C. § 321(m); 21 C.F.R. § 1.3(a). This definition has been broadly interpreted by the courts to include materials that supplement or explain a drug or device, even when there is no physical attachment to the drug. See Kordel v. United States, 335 U.S. 345, 350 (1948).

Rapidly growing Internet-based technologies have made it quicker and easier for both manufacturers and independent third parties to disseminate information about drugs and devices. This has led to a host of issues including (1) what drug companies can say online about their drugs without violating the “misbranding” regulations; and (2) what drug companies can do with what third parties have said online about their drugs. The guidance documents attempt to answer both of these questions.

The Twitter Guidance: “Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices”

The FDA’s position concerning manufacturers presenting “benefit information” for regulated drugs on electronic platforms with character space limitations is laid out in the Twitter Guidance. This Guidance instructs companies on the steps to take to avoid inadvertently “misbranding” a drug by providing information about a drug’s benefits without disclosing accompanying risks. With that in mind, the Twitter Guidance provides the following direction for drug companies seeking to use space-limited social media platforms:

  • Include the brand and established name, dosage form, and ingredient information;
  • Ensure that any benefit information provided is accurate;
  • Accompany benefit information with risk information;
  • Provide direct access to a more complete discussion of the risks associated with the drug or device. Notably, the Twitter Guidance says the link should lead to a page devoted “exclusively” to risk information; and
  • If both benefit and risk information cannot be communicated within the space limit, consider using a different platform.

To prove that it is not impossible to provide the required information within Twitter’s 140 character limit (just very difficult), the Twitter Guidance provides the following – entirely fictional – example of an acceptable tweet:

Notably, this example from the FDA might not prove helpful in reality, especially considering that many drugs would be required to list more than one risk.

The main take-away from the Twitter Guidance is nothing new: to avoid enforcement, provide “truthful, accurate, non-misleading, and balanced product promotion.” If a company cannot achieve this delicate balance within Twitter’s space limitations, it should “reconsider using that platform for the intended promotional message.”

Continue Reading Drugs and the Internet: FDA Distributes New Draft Guidance Regarding Social Media Platforms and Prescription Drugs

In late May 2013, the U.S. Food and Drug Administration (FDA) sent an enforcement letter to a mobile medical app developer for failing to obtain a 510(k) clearance before marketing the app, which the FDA said appears to be a “device” under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FDCA). The mobile app—the uChek Urine Analyzer developed by Biosense Technologies Private Limited and available through the iTunes App store—allows a user to read urine dipsticks using a camera phone to screen for diabetes and urinary tract infections. The FDA’s letter signals the type of oversight the FDA intends to exercise over mobile medical app developers, although the agency has not released final guidance in this murky area.

FDA Previously Indicated Light Regulation of Medical Mobile Apps

In March, Congress urged the FDA to clarify the regulation of mobile medical apps in three days of hearings before the House Energy and Commerce Committee. The FDA generally relieved concerns raised by the mobile communications industry, which had feared heavy regulation of mobile phones and tablets as medical devices. Christy Foreman, the Director of the Office of Device Evaluation in the Center for Devices and Radiological Health (CDRH) at the FDA, testified before the committee that the FDA intends to limit regulation to a small subset of apps, in accordance with the FDA’s July 2011 draft guidance on mobile medical apps.

The FDA proposed a narrowly tailored approach focusing on apps that could threaten patient safety if they do not work as intended. These include apps that either: (1) affect the performance or functionality of a currently regulated medical device or (2) have traditionally been considered medical devices. Consistent with this philosophy, the agency does not intend to regulate mundane apps that help people achieve a healthier lifestyle, such as pedometers or calorie counters. Nor does the agency plan to regulate apps that track medical data but otherwise do not meet the definition of “device” in section 201(h) of the FDCA because they are not intended to diagnose, treat, or cure conditions or diseases.

Specifically, the 2011 draft guidance indicated that the FDA will regulate mobile apps that qualify as medical devices under section 201(h) and that are intended to perform one of two functions: (1) serve as an accessory to a regulated medical device—for example, an app that allows doctors to diagnose patients by viewing medical images on a tablet; or (2) transform a mobile platform into a regulated medical device—for example, an app that allows a patient to measure blood glucose with a smartphone. The FDA’s recent enforcement letter to Biosense falls squarely in line with this proposed regulatory scheme. As the FDA noted in its letter, the uChek app is intended for use with urinalysis dipsticks that have received 510(k) clearance for “direct visual reading.” However, the app allows a mobile phone to analyze the dipsticks and that means “the phone and device as a whole functions as an automated strip reader” that requires new clearance.

FDA Does Not Intend to Regulate Other Mobile Technology

In a prepared statement released on the day of her testimony, Foreman laid out the boundaries of the FDA’s proposed mobile medical app policy. The statement made clear that the FDA does not intend to regulate mobile technology apart from the medical apps themselves. Thus, the FDA will not regulate the sale or general consumer use of smartphones or tablets. Entities that solely distribute mobile medical apps (such as owners and operators of the “iTunes App store” or the “Android market”) will not be considered medical device manufacturers. And mobile platform manufacturers will not be deemed medical device manufacturers simply because their platforms support mobile medical apps regulated by the FDA. Based on these statements, smartphone manufacturers and app distributors can put to rest for now any concerns they might have had about FDA oversight regarding health-related mobile apps.

FDA’s Statements on Mobile App Regulation Ease Uncertainty in Industry

Congress held the recent hearings in response to uncertainty among mobile app developers, which the House Energy and Commerce Committee voiced in a letter to the FDA Commissioner in early March. The letter relayed industry fears of widespread regulation by the FDA and concerns over the lack of final guidance on the regulation of mobile medical apps. At the hearing, the committee also inquired whether the FDA intends for smartphones, tablets, and other devices that display mobile medical apps to be taxed as medical devices under the Patient and Protection and Affordable Care Act (PPACA). Foreman deflected these questions, noting that the IRS, not the FDA, has the authority to impose taxes on medical devices.

Though the mobile medical app market has been growing, Foreman’s testimony showed that the industry is still in its infancy. Foreman stated that the FDA receives fewer than 20 submissions per year for mobile medical apps, which amounts to approximately 0.5% of all medical device applications the agency reviews each year. All mobile medical apps cleared thus far have gone through the 510(k) process, which in 2011 and 2012 took an average of 67 days to complete. The agency has not yet deemed any mobile medical apps to be Class III medical devices.

Further Guidance Expected Later This Year

Mobile medical app developers should look for a final guidance from the FDA on regulation of mobile medical apps later this year. Though Foreman initially projected that the guidance would be published in “the coming months,” when pushed to be more specific she narrowed her projection to the end of the FDA’s fiscal year in September. Technological developments in mobile medical apps have far outpaced the FDA’s sluggish timing in releasing its final guidance. Congress and mobile app developers will be watching closely to see if the FDA’s final guidance brings the clarity and light regulation of mobile medical apps that the agency has proposed. In the meantime, developers whose apps work in tandem with regulated medical devices should pay attention to the FDA’s enforcement letter to Biosense and consider whether FDA clearance is appropriate. We will continue to monitor this topic and provide relevant updates.