Morrison Foerster’s Class Dismissed blog provides insights, recommendations, and timely reports on the latest defense news, developments, and trends in the most current class actions lawsuits and product liability issues that affect consumer-facing companies. Through Class Dismissed, attorneys from our nationally recognized Consumer Class Action and Products Liability practices offer a real-time assessment of the developments in matters that are shaping the industry. This blog examines the full spectrum of consumer-related class action and product liability lawsuits ranging from false advertising, privacy, consumer product safety, ADA, food misbranding, TCPA, environment, retail, and government actions as well as nationwide and multidistrict litigation class actions.<h2>ABOUT MORRISON FOERSTER</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

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Julie Park protects her clients’ products no matter what kind of product issue they face—whether it is planning for new product development, recalling an existing product, or defending clients against product liability or consumer class actions. Drawing on her deep technical and legal expertise, Julie counsels clients on consumer product safety regulation and pharmaceutical and medical device preemption while also managing complex and multijurisdictional litigation both in state and federal court.

Julie Y. Park

<div class="videoWrapper"><iframe frameborder="0" class="sticky-video" allowfullscreen="1" title="Meet Penny Preovolos, Litigation Partner" src="https://www.youtube-nocookie.com/embed/hv7hYn-Bl7c?rel=0&showinfo=0;vq=hd1080" title="iframe"></iframe></div>Penelope has served as lead counsel in major consumer class actions and antitrust cases for more than 35 years, successfully representing high-profile defendants in antitrust, consumer fraud, and product defect matters. Her clients span a range of industries, including consumer electronics, technology, retail, publishing, food and beverage, cosmetics, and household products. According to Chambers USA, Penelope has a “great reputation for antitrust and product liability work” and is a “superb all-around antitrust lawyer.”Penelope was named the 2019 Antitrust Lawyer of the Year by the Antitrust, UCL, and Privacy Section of the California Lawyers Association. She was co-chair of MoFo’s antitrust practice for 14 years. She has served as chair of the Antitrust and Trade Regulation Section of the State Bar of California and as a member of the Ninth Circuit Advisory Committee on Local Rules and Operations. She is an editor of and frequent contributor to Morrison & Foerster’s <a href="https://classdismissed.mofo.com/">Class Dismissed blog</a>, as well as a frequent speaker about class action and antitrust issues.More About PenelopePenelope clerked for the Honorable Charles M. Merrill, United States Court of Appeals for the Ninth Circuit. She graduated cum laude from Harvard Law School, where she was executive editor of the Harvard Civil Rights – Civil Liberties Law Review. Penelope was a member of Phi Beta Kappa at the University of California, Berkeley. She was awarded the University Medal, the highest undergraduate honor at the university, as well as the English Departmental Citation (awarded to the outstanding graduate in that department).

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Senior Counsel

Penelope has served as lead counsel in major consumer class actions and antitrust cases for more than 35 years, successfully representing high-profile defendants in antitrust, consumer fraud, and product defect matters. Her clients span a range of industries, including consumer electronics, technology, retail, publishing, food and beverage, cosmetics, and household products.

Penelope A. Preovolos

Claudia focuses her practice on the defense of consumer class actions and on complex commercial litigation, including unfair business competition, false advertising, product liability, and privacy matters. She is currently representing numerous consumer goods manufacturers and retailers in false advertising and mislabeling class action lawsuits. Claudia also regularly counsels clients in the food, cosmetics, retail, and technology industries. She represents companies in false advertising disputes before the National Advertising Division (NAD) of the Council of Better Business Bureaus, Inc.<h5>More about Claudia</h5>Claudia is active in MoFo’s pro bono efforts, and recently traveled to El Paso, Texas, to work with families separated and detained at the border. She is also supervising a pro bono collaboration with Equal Rights Advocates, a nonprofit fighting for gender justice in work places and schools across the country. The initiative will help students who have been victims of sexual assault, attempted assault, or harassment find support and seek justice. Claudia is also a board member of Bay Area Legal Aid and a former board member of Equal Rights Advocates. Claudia is an editor and frequent contributor to MoFo’s <a href="https://classdismissed.mofo.com/">Class Dismissed</a> blog, which provides reports about the latest defense news, developments, and trends in class action lawsuits and product liability issues that affect consumer-facing companies. Her perspectives are also respected in the larger legal community: Claudia has published articles about class action and false advertising issues, and is a co-author of Chapter 7 — “Unfair Competition in California Business Litigation 2016” — of The Recorder. She also regularly speaks at conferences on class action and advertising trends. Claudia is currently serving as a Lawyer Representative for the Northern District of California. She received her J.D. degree in 2004 from Berkeley Law (Boalt Hall School of Law), where she was an associate editor of the Berkeley Technology Law Journal.

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Claudia focuses her practice on the defense of consumer class actions and on complex commercial litigation, including unfair business competition, false advertising, product liability, and privacy matters. She is currently representing numerous consumer goods manufacturers and retailers in false advertising and mislabeling class actions.

Claudia M. Vetesi

Alexandra Barlow is a partner in the Litigation Department of Morrison Foerster’s San Diego office.Alexandra litigates product liability matters involving medical devices, pharmaceuticals, consumer products, automobiles, and AI. Alexandra's litigation expertise spans the entire case life cycle in both state and federal courts. She handles all phases of discovery, including fact investigation and expert discovery. Alexandra has taken over twenty-five depositions, including experts, plaintiffs, treating physicians, and third-party witnesses. She drafts and argues motions of all types, including motions for summary judgment, motions to quash, and motions for preliminary injunction.Alexandra has significant trial experience. She has first-chaired a one-week jury trial and second-chaired a five‑week jury trial, both involving multiple claims and witnesses. She also has extensive experience in alternative dispute resolution, representing clients at mediations, mandatory settlement conferences, and early neutral evaluations.Alexandra enjoys tracking developments and keeping her clients updated on product liability and personal injury claims, frequently writing or presenting on emerging areas such as autonomous vehicles and smart devices. Alexandra’s experience also extends to professional liability, warranty claims, eminent domain, and construction law.Alexandra earned her J.D. from the University of San Diego School of Law. While in law school, the San Diego Law Review published her comment on the recovery of damages by plaintiffs in a persistent vegetative state, and she also served as a comment editor. She received her B.A. from the University of California, Los Angeles, where she majored in Political Science and minored in Spanish. A San Diego native, she attended a Spanish immersion school through the eighth grade. Alexandra is active in the San Diego community, advising students at a local college. She is also a member of several legal organizations in San Diego, including Lawyer’s Club, the Association of Business Trial Lawyers, and Wallace Inn of Court.

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Alexandra Barlow is a partner in the Litigation Department of Morrison Foerster’s San Diego office. Alexandra litigates product liability matters involving medical devices, pharmaceuticals, consumer products, automobiles, and AI. Alexandra’s litigation expertise spans the entire case life cycle in both state and federal courts. She handles all phases of discovery, including fact investigation and expert discovery. Alexandra has taken over twenty-five depositions, including experts, plaintiffs, treating physicians, and third-party witnesses. She drafts and argues motions of all types, including motions for summary judgment, motions to quash, and motions for preliminary injunction.

Alexandra Barlow is a partner in the Litigation Department of Morrison Foerster’s San Diego office. Alexandra litigates product liability matters involving medical devices, pharmaceuticals, automobiles, AI, and robotics. Alexandra's litigation expertise spans the entire case life cycle in both state and federal courts. She handles all phases of discovery, including fact investigation and expert discovery. Alexandra has taken over twenty-five depositions, including experts, plaintiffs, treating physicians, and third-party witnesses. She drafts and argues motions of all types, including motions for summary judgment, motions to quash, and motions for preliminary injunction.

Alexandra Barlow

Adam J. Hunt is a partner in the Litigation Department of Morrison Foerster’s New York office. His practice focuses on complex litigation, with an emphasis on class action and commercial litigation.Mr. Hunt has extensive experience representing consumer products companies, financial institutions, and technology firms in class action cases and complex commercial disputes before state and federal trial courts, as well as in arbitrations. Clients seek Mr. Hunt’s counsel for his creative, strategic thinking in high-stakes, high-profile matters. He has represented clients facing claims under false advertising, antitrust, and privacy laws throughout the country, securing wins at the pleading stage, summary judgment, and trial, in addition to negotiating favorable settlements, often early in the case. Representative experience includes successfully securing rulings dismissing two putative false advertising class action cases against one of the best-known consumer electronics companies in the world; obtaining a complete win on summary judgment for a major shipping and logistics company in a multimillion-dollar commercial dispute; appearing as counsel at trial for a leading financial institution in a $100 million commercial dispute, winning a bench trial verdict; and prevailing on motions to dismiss false advertising class actions against a leading Greek yogurt company.Mr. Hunt is also an editor of the firm’s <a href="https://classdismissed.mofo.com/" target="_self">Class Dismissed blog</a>, which provides insights, recommendations, and timely reports on the latest defense news, developments, and trends in the most current class action lawsuits that affect consumer-facing companies.Mr. Hunt maintains an active pro bono practice and is the recipient of the New York State Bar Association’s 2017 President’s Pro Bono Service Award for the First Judicial Department, the 2018 Public Service Award from New York University School of Law, and Morrison Foerster’s Kathi Pugh Award for Pro Bono Services.Mr. Hunt received his B.A. with honors from Swarthmore College and his J.D. cum laude from New York University.

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Adam Hunt is a partner in the Litigation Department of Morrison Foerster’s New York office. His practice focuses on complex litigation, with an emphasis on class action and commercial litigation.

Adam Hunt

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Right-to-Repair Laws: The Trend Continues

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On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and discuss alternatives to the much-criticized rule, which would allow generic drug manufacturers to unilaterally update their warning labels. Comments and suggestions related to the rule will now be accepted through April 27, 2015, and the meeting will take place on March 27, 2015.PROPOSED RULEThe FDA proposed the rule in response to the Supreme Court’s opinion in PLIVA v. Mensing. PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011). Mensing held that generic drug manufacturers could not unilaterally change or strengthen their warnings. The end result was that most failure-to-warn claims were preempted as to generic manufacturers, though the corresponding claims against branded manufacturers survived. Justice Thomas memorably noted that the Supreme Court “will not distort the Supremacy Clause in order to create similar pre-emption across a dissimilar statutory scheme. As always, Congress and the FDA retain the authority to change the law and regulations if they so desire.” Id. at 2852.The proposed rule was no doubt a direct response to Justice Thomas’ plea. Under the proposal, holders of abbreviated new drug applications (ANDAs) would be allowed to update product labeling to reflect newly acquired safety information even if the updates differ from the reference listed drug (RLD). ANDA holders would be permitted to distribute a revised label to the market without prior FDA guidance or approval, while concurrently submitting the proposed label changes to the FDA. Additionally, ANDA holders would have an affirmative duty to notify the new drug application (NDA) holder about the supplemental revisions and pass along information forming the basis for the revision.The proposed rule further suggests that, upon receiving notification from an ANDA holder, the NDA holder is “expected” to submit its own revised label to the FDA along with its views as to whether the ANDA holder’s proposed supplement should be approved. The FDA would then evaluate the proposed labels and decide which should be approved. Upon approval, ANDA holders would have only 30 days to update their labels through an electronic process. The proposal then requires “timely distribution” of the product label “accompanied by an updated package insert as soon as feasible thereafter or at the time of next printing of the product labeling for packaging.”RESISTANCE TO PROPOSED RULEAs we’ve previously highlighted, the proposed rule has drawn ire from industry insiders and lawmakers who have voiced concerns over multiple potential issues, including excessive costs, uncertain potential liabilities, and decreased generic drug availability.<a name="_ftnref1" href="#_ftn1">[1]</a> Given the proposal’s potential impact on the entire pharmaceutical industry, it is no surprise that the Generic Pharmaceutical Association (GPhA) has already threatened to sue the FDA if the agency adopts the proposed rule.<a name="_ftnref2" href="#_ftn2">[2]</a>Although the FDA has insisted the proposed rule’s benefit to public health outweighs “concerns related to temporary differences in labeling,” the reopening of the comment period belies the strength of its position.NEW COMMENT PERIODThe FDA’s proposed rule, if adopted in its current form, would have a deleterious and widespread impact on the entire pharmaceutical industry. By reopening the comment period, the FDA has given the industry reason to believe that the rule could change significantly before final publication. This new comment period allows parties to submit guidance to the FDA as it attempts to achieve its goal of improving “communication of important safety information to prescribing health care providers and the public.” The FDA welcomes guidance and is accepting comments until April 27, 2015. We strongly urge affected parties to submit comments at <a href="http://www.regulations.gov">http://www.regulations.gov</a>, identified with Docket No. FDA-2013-N-0500-0081. Those interested in attending the public meeting on March 27, 2015, in Silver Spring, Maryland, may register by emailing <a href="mailto:CBESupplements.PublicMeeting@fda.hhs.gov">CBESupplements.PublicMeeting@fda.hhs.gov</a> by March 20, 2015.About Morrison & Foerster’s Product Liability Group:Morrison & Foerster’s Product Liability Group defends and provides counsel to product manufacturers and suppliers of all types of products. We serve as trial and national coordinating counsel in product liability and toxic tort cases, including class actions, multiparty serial tort litigation, mass tort litigation, and multidistrict litigation proceedings. We bring to every case a wealth of experience, a keen understanding of the multifaceted issues confronted by manufacturers, and the skills and knowledge to communicate scientific and medical defenses to juries.    <a name="_ftn1" href="#_ftnref1">[1]</a> See “Goodbye to Generic Preemption? FDA Publishes Proposed Rule,” Morrison & Foerster Client Alert (Nov. 13, 2013);  “$4 Billion Price Tag for Pleasing Plaintiffs’ Bar? New Study Estimates Costs of FDA’s Proposed Rule on Generic Drug Labeling,” Morrison & Foerster Client Alert (Feb. 26, 2014).<a name="_ftn2" href="#_ftnref2">[2]</a> Alexander Gaffney, Generic Drug Industry Threatens FDA With Lawsuit Over Drug Labeling Proposal, Regulatory Affairs Professionals Society (Oct. 7, 2014).

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Erin Bosman is chair of MoFo’s Class Actions and Mass Torts Practice Group and is a founder and co-head of the Artificial Intelligence Group. Clients value her business strategy, seeking her comprehensive counsel throughout the product life cycle, especially in high-stakes litigation and product recalls.

Erin M. Bosman

Erin Bosman is chair of MoFo’s Class Actions and Mass Torts Practice Group and is a founder and co-head of the Artificial Intelligence Group. Clients value her business strategy, seeking her comprehensive counsel throughout the product life cycle, especially in high-stakes litigation and product recalls.

Erin Bosman

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Julie Park provides analytic and strategic counsel for issues in product life cycle, product liability and defective products, consumer class actions, and more.

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Julie Park | Product Liability Lawyer

FDA Proposed Rule in Flux?

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has

FDA Proposed Rule in Flux?

On January 16, 2015, the Food and Drug Administration (FDA) promulgated a much-anticipated draft guidance<a href="#_ftn1" name="_ftnref1">[1]</a> concerning the classification and regulation of general wellness products.  The draft guidance is the FDA’s latest attempt to provide some regulatory clarity in the wake of the explosion in popularity of wearable wellness devices and general fitness products.  The draft guidance—which slightly loosens the FDA’s hold on general wellness products—comports with the FDA’s current policy of refocusing its resources on high-risk products and away from products that present low risk to the end-user.BackgroundHistorically, the FDA has not regulated devices intended to benefit a user’s overall health and wellness, unless those products made claims about disease prevention, treatment, mitigation, or cure.  In the FDA’s prior guidance of 1995, it stated that it would regulate fitness equipment only if the equipment was “intended to be used for medical purposes[.]”  On the other hand, if the equipment was to be used for “general physical conditioning,” the equipment was outside the FDA’s regulatory scheme.However, even if the equipment was only used for physical conditioning, it could still be subject to rigorous FDA regulation if the promotional materials made any medical claims or associated the device with improved medical outcomes.  Such regulation includes premarket notification requirements, labeling requirements, good manufacturing practices requirements, and Medical Device Reporting (MDR) requirements.  This left many wellness products with the choice of foregoing marketing activities that made reference to improved medical outcomes or facing onerous FDA regulation.The General Wellness Draft GuidanceThe January 2015 draft guidance concerning general wellness products finally clarifies what constitutes a “general wellness product” and allows for certain well-known promotional claims about health to be made by the manufacturers of these products.Under the draft guidance, a general wellness product is defined as one intended for general wellness use that presents a very low risk to users’ safety.  In order to qualify as low risk, the product must not be (i) invasive; (ii) involve an intervention or technology that may pose a risk to users’ safety (such as lasers, radiation exposure, or implants); (iii) raise novel questions of usability; or (iv) raise questions of biocompatibility. The FDA specifically lists exercise equipment, video games, software programs, and other products commonly available in retail stores as examples of devices likely to be included within the above definition of a general wellness product.If a product falls within definition of a general wellness product, it must also have one of two identified uses in order to be covered by the new draft guidance.  The product must have (1) “an intended use that relates to maintaining or encouraging a general state of health or healthy activity,” or (2) “an intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.”The first identified “use” category of general wellness devices are those that make no reference to diseases or conditions, including products relating to weight management, physical fitness, sleep management, and self-esteem.  These types of devices have traditionally been, and continue to be, outside the FDA’s regulatory purview.More interesting is the second category of general wellness intended uses, which the draft guidance explains can be broken down into two subcategories: (i) those intended to be used to promote, track, and/or encourage choices that “as part of a healthy lifestyle, may help reduce the risk of certain chronic diseases or conditions,” and (ii) those intended to be used to track and/or encourage choices that, “as part of a healthy lifestyle, may help living well with certain chronic diseases or conditions.”According to the FDA, manufacturers of devices that fall into these subcategories may now, as part of their promotional materials, make claims that using the product may help reduce the risk of disease, or help someone live better should they suffer from a certain disease or condition.  The following types of claims are permissible under the draft guidance:  “Product X promotes physical activity, which, as part of a healthy lifestyle, may help you reduce the risk of high blood pressure”; or “Product Z tracks activity sleep patterns and promotes healthy sleep habits, which, as part of a healthy lifestyle, may help reduce the risk for developing type 2 diabetes.”  Another example of a permissible claim is the statement that a calorie tracker may promote a healthy weight and/or may help living well with type 2 diabetes, or may assist in healthy living with high blood pressure.  Notably, health-related claims in marketing materials (like the examples provided by the FDA) are only permissible under the draft guidance when it is well known that a healthy lifestyle is associated with the improved health outcome.The FDA has also provided a decision algorithm so manufacturers can determine if their product qualifies as a general wellness product under the draft guidance.Likely Impact of New Draft GuidanceThe shift presented by the draft guidance is significant; if implemented, general wellness device manufacturers would be able to say more about the well-known health benefits of their products without risking FDA regulation.  Indeed, under the draft guidance, manufacturers are permitted to link products to potential health outcomes, implying that the product itself may help mitigate or reduce the risk of certain diseases.  Such statements—though only permitted when it is “well understood and accepted” that a healthy lifestyle is associated with the improved outcome—were impermissible (or at best, questionable) under the FDA’s prior guidance.This change may prove particularly important for the wearable activity tracker market, which has experienced significant growth in the last year.  Under the guidance, promotional materials can now make specific health-related claims; manufacturers are no longer limited to marketing claims such as “helps you stay active” or “gives you feedback about your daily activity.”  Permitting a manufacturer to make specific health-related claims—such as “encourages activity that, as part of a healthy lifestyle, may help reduce high blood pressure”—likely opens up the market for consumer segments that may not have been interested in merely “tracking their daily activity” but are, for example, keenly interested in reducing their blood pressure.Given these likely benefits, manufacturers should consider commenting on the draft guidance to help further shape the final outcome and to ensure that the draft guidance is implemented.  Comments are due by April 20, 2015.The draft guidance is a step in the right direction for the FDA.  The shift away from needlessly regulating low-risk products, and toward allowing manufacturers to use well-known and accepted health benefits in their promotional marketing, is a welcome one.  <a href="#_ftnref1" name="_ftn1">[1]</a> FDA guidance documents do not establish legally enforceable responsibilities, but rather describe the FDA’s current thinking on a topic.

Regulating a Healthy Lifestyle? FDA Distributes New Draft Guidance on “General Wellness Products”

On January 16, 2015, the Food and Drug Administration (FDA) promulgated a much-anticipated draft guidance  concerning the classification and regulation of gener

Regulating a Healthy Lifestyle?  FDA Distributes New Draft Guidance on “General Wellness Products”

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.BackgroundDrug 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:<ul><li>Include the brand and established name, dosage form, and ingredient information;</li><li>Ensure that any benefit information provided is accurate;</li><li>Accompany benefit information with risk information;</li><li>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</li><li>If both benefit and risk information cannot be communicated within the space limit, consider using a different platform.</li></ul>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.”The Misinformation Guidance:  “Internet/Social Media Platforms:  Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices”The Misinformation Guidance describes the “FDA’s current thinking” about how manufacturers and distributors “should respond, if they choose to respond, to misinformation” related to FDA-approved products, specifically when the misinformation is disseminated by third parties over the Internet.  Per the Guidance, “misinformation” is “positive or negative incorrect representations or implications” about a company’s drug or device that is created by someone who “is not under the firm’s control or influence.”  Thus, the Guidance does not apply when misinformation is created or disseminated by the firm itself.Companies can, however, breathe a small sigh of relief; the Misinformation Guidance makes it clear that companies have no independent obligation to correct third-party posted misinformation.  This may obviate the need for companies to continuously monitor and mine massive amounts of Internet data related to their products.Nonetheless, the FDA recognizes that it may “benefit the public health” for companies to have the ability to correct misinformation about their products.  With the public health benefit in mind, the Misinformation Guidance sets forth the following guidelines for companies that are seeking to voluntarily correct misinformation:<ul><li>Post the correction in the same area or forum where the misinformation is found. If that is not possible, reference the area where the misinformation can be found;</li><li>Disclose that the person making the correction is a company employee;</li><li>Include the package insert via PDF or link to the approved labeling;</li><li>Limit the correction to the scope of the misinformation;</li><li>Do not use the misinformation as a catalyst for promotional messaging; and</li><li>Record misinformation corrections in case the FDA has questions or concerns.</li></ul>The Misinformation Guidance’s bottom line is that “if a firm voluntarily corrects misinformation in a truthful and non-misleading manner,” then the “FDA does not intend to object if the corrective information . . . does not satisfy otherwise applicable regulatory requirements regarding labeling or advertising[.]”ConclusionAlthough the draft guidance documents provide some clarification on the FDA’s positions, it is not clear that they provide a noticeable benefit to the industry.  The strict requirements related to providing risk information, including linking to a page dedicated exclusively to risks, may sway companies away from using popular social media platforms at all.  Indeed, the guidance documents may have the unintended consequence of limiting, as opposed to expanding, the information available to the public about a given drug.Companies have 90 days from the publication to comment on the draft guidance documents.

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

Last week the Food and Drug Administration (FDA) promulgated two much-anticipated draft guidance documents on using social media to present information about pr

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