# Federal Trade Commission - Protecting America's Consumers

- FTC and DOJ Update Guidance That Reinforces Parties’ Preservation Obligations for Collaboration Tools and Ephemeral Messaging The Federal Trade Commission and Justice Department today announced that both agencies are updating language in their standard preservation letters and specifications for all second requests, voluntary access letters, and compulsory legal process, including grand jury subpoenas, to address the increased use of collaboration tools and ephemeral messaging platforms in the modern workplace. These updates reinforce longstanding obligations requiring companies to preserve materials during the pendency of government investigations and litigation.“Companies and individuals have a legal responsibility to preserve documents when involved in government investigations or litigation in order to promote efficient and effective enforcement that protects the American public. Today’s update reinforces that this preservation responsibility applies to new methods of collaboration and information sharing tools, even including tools that allow for messages to disappear via ephemeral messaging capabilities,” said FTC Bureau of Competition Director Henry Liu.“These updates to our legal process will ensure that neither opposing counsel nor their clients can feign ignorance when their clients or companies choose to conduct business through ephemeral messages,” said Manish Kumar, Deputy Assistant Attorney General of the Justice Department’s Antitrust Division. “The Antitrust Division and the Federal Trade Commission expect that opposing counsel will preserve and produce any and all responsive documents, including data from ephemeral messaging applications designed to hide evidence. Failure to produce such documents may result in obstruction of justice charges.”Companies continue to adopt new technologies to do their work, and in recent years there has been an increase in use of collaboration tools and ephemeral messaging applications, such as Slack, Microsoft Teams, and Signal. Some of these technologies allow, or even automatically enable, immediate and irretrievable destruction of communications and documents. Documents created through use of these technologies have long been covered by FTC and DOJ document requests. However, companies have not always properly retained these types of documents during government investigations and litigation.When companies fail to preserve documents covered by an FTC investigation or enforcement action, the Commission has successfully moved for civil spoliation sanctions and may refer cases to criminal prosecutors through the Bureau of Competition’s Criminal Liaison Unit in appropriate circumstances.Today’s announcement underscores the continued cooperation between the Antitrust Division and FTC’s Bureau of Competition on criminal enforcement of antitrust laws and related issues that arise in antitrust actions.
- FTC Sues to Block Novant Health’s Acquisition of Two Hospitals from Community Health Systems The Federal Trade Commission today sued to block Novant Health, Inc.’s $320 million acquisition of two North Carolina hospitals from Community Health Systems, Inc. (“CHS”).The Commission issued an administrative complaint and authorized a lawsuit in federal court to block the proposed acquisition, alleging that Novant Health’s proposed deal to acquire Lake Norman Regional Medical Center and Davis Regional Medical Center from CHS threatens to raise prices and reduce incentives to invest in quality and innovative care that would benefit patients.“Hospital consolidations often lead to worse outcomes for nurses and doctors, result in higher prices, and can have life and death consequences for patients,” said Henry Liu, Director of the FTC’s Bureau of Competition. “There is overwhelming evidence that Novant’s deal with Community Health Systems will be detrimental to patients in the Eastern Lake Norman Area, including leading to higher out-of-pocket costs for critical health care services.”Currently, Novant operates Huntersville Medical Center and serves more patients than any other hospital in the Eastern Lake Norman Area. Novant is one of the largest hospital systems in the southeastern United States including in North Carolina. It is also one of the most expensive hospital systems in North Carolina, according to the FTC’s administrative complaint.Under the proposed deal, Novant would acquire Lake Norman Regional Medical Center, which sits 11 miles away from Novant’s Huntersville Medical Center. Additionally, Novant would acquire other related assets from CHS including Davis Regional Medical Center (a behavioral health hospital), a physician group of 24 physicians employed by Lake Norman Regional Medical Center, a majority interest in an endoscopy center in Mooresville, and an entity holding a North Carolina certificate of need to build an ambulatory surgery center in Mooresville.As the FTC alleges, the proposed deal with CHS would allow Novant to control nearly 65% of the market for inpatient general acute care services (“GAC”) in the Eastern Lake Norman Area of North Carolina, which primarily includes Iredell County and northern Mecklenburg County. Inpatient GAC services include a broad range of essential medical, surgical, and diagnostic services that require an overnight hospital stay.With fewer alternatives for inpatient GAC services, Novant would be able to demand higher rates for its services. The FTC alleges the proposed acquisition would likely increase annual health care costs by several million dollars. These higher costs would then be passed on to patients. The deal would also reduce Novant’s incentive to compete to attract patients by improving its facilities, service offerings, and quality of care.The Commission vote to issue the administrative complaint and authorize staff to seek a temporary restraining order and seek a preliminary injunction was 3-0. The federal court complaint and request for preliminary relief will be filed in the U.S. District Court for the Western District of North Carolina to halt the transaction pending an administrative proceeding.   NOTE: The Commission issues an administrative complaint when it has “reason to believe” that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. The issuance of the administrative complaint marks the beginning of a proceeding in which the allegations will be tried in a formal hearing before an administrative law judge.
- FTC Launches Inquiry into Generative AI Investments and Partnerships The Federal Trade Commission announced today that it issued orders to five companies requiring them to provide information regarding recent investments and partnerships involving generative AI companies and major cloud service providers.The agency’s 6(b) inquiry will scrutinize corporate partnerships and investments with AI providers to build a better internal understanding of these relationships and their impact on the competitive landscape.  The compulsory orders were sent to Alphabet, Inc., Amazon.com, Inc., Anthropic PBC, Microsoft Corp., and OpenAI, Inc.“History shows that new technologies can create new markets and healthy competition. As companies race to develop and monetize AI, we must guard against tactics that foreclose this opportunity, “said FTC Chair Lina M. Khan. “Our study will shed light on whether investments and partnerships pursued by dominant companies risk distorting innovation and undermining fair competition."The FTC issued its orders under Section 6(b) of the FTC Act, which authorizes the Commission to conduct studies that allow enforcers to gain a deeper understanding of market trends and business practices. Findings stemming from such orders can help inform future Commission actions.Companies are deploying a range of strategies in developing and using AI, including pursuing partnerships and direct investments with AI developers to get access to key technologies and inputs needed for AI development. The orders issued today were sent to companies involved in three separate multi-billion-dollar investments: Microsoft and OpenAI, Amazon and Anthropic, and Google and Anthropic. The FTC’s inquiry will help the agency deepen enforcers understanding of the investments and partnerships formed between generative AI developers and cloud service providers.The FTC is seeking information specifically related to:Information regarding a specific investment or partnership, including agreements and the strategic rationale of an investment/partnership.The practical implications of a specific partnership or investment, including decisions around new product releases, governance or oversight rights, and the topic of regular meetings.Analysis of the transactions’ competitive impact, including information related to market share, competition, competitors, markets, potential for sales growth, or expansion into product or geographic markets.Competition for AI inputs and resources, including the competitive dynamics regarding key products and services needed for generative AI.  Information provided to any other government entity, including foreign government entities, in connection with any investigation, request for information, or other inquiry related to these topics.The companies will have 45 days from the date they receive the order to respond.The Commission voted 3-0 to issue the Section 6(b) orders and conduct the study of AI investments and partnerships.
- Statement on Second Circuit Order Upholding “Pharma Bro” Martin Shkreli’s Lifetime Ban Today, the United States Court of Appeals for the Second Circuit affirmed a district court ruling which ordered “Pharma Bro” Martin Shkreli to face a lifetime ban from participating in the pharmaceutical industry and found Shkreli liable for $64.6 million in disgorgement for his role in orchestrating an illegal anticompetitive scheme.Bureau of Competition Director Henry Liu issued the following statement on the Second Circuit’s order:“The Second Circuit’s decision is a win for consumers seeking affordable, lifesaving medication and clearly demonstrates that corporate executives will be held personally liable for anticompetitive actions that they help orchestrate. I want to congratulate FTC staff for their hard work on this case and I want to thank our state attorneys general partners for their dedication to this important matter.”In January 2022, the U.S. District Court for the Southern District of New York held that Shkreli organized an illegal anticompetitive scheme to perpetuate a monopoly for the life-saving drug Daraprim, the gold-standard treatment for a rare, potentially fatal parasitic infection known as toxoplasmosis. The Court imposed a lifetime ban against Shkreli participating in the pharmaceutical industry and found Shkreli liable for $64.6 million in disgorgement. The FTC and state enforcers initiated the case in January 2020 against Shkreli, another individual executive, and the companies they founded, Vyera Pharmaceuticals, LLC, and Phoenixus AG. The U.S. District Court found that the defendants’ anticompetitive scheme prevented generic competition and allowed them to protect their Daraprim price increase from $17.50 per tablet to $750 per tablet.
- Federal Trade Commission and Justice Department Hold Trilateral Meeting with Competition Enforcers from Mexico and Canada Today, the Federal Trade Commission participated in a trilateral meeting with enforcers from Mexico’s Federal Economic Competition Commission, Canada’s Competition Bureau, and the Justice Department’s Antitrust Division. Discussions were held among FTC Chair Lina Khan, Assistant Attorney General Jonathan Kanter of the Department of Justice’s Antitrust Division, Canadian Commissioner of Competition Matthew Boswell, and President Andrea Marván Saltiel of the Mexican Federal Economic Competition Commission.The meeting, which took place in Mexico City, included discussions on competition in the technology and platform sectors, the impact of competition on labor markets, as well as discussions on new enforcement tools and approaches to competition law.“This annual trilateral with our enforcement partners lets us share expertise and learning, strengthening our work to promote fair competition and protect the American public from anticompetitive and monopolistic tactics,” said FTC Chair Lina M. Khan.“The competition law agencies of Canada, Mexico, and the United States share the common goal to preserve and protect fair and lawful competition.” said Assistant Attorney General Jonathan Kanter of the Justice Department’s Antitrust Division. “I am grateful for the opportunity to meet with our fellow enforcers and discuss opportunities to promote competition and enhance enforcement in North America.”                  Image                                                  Canadian Commissioner of Competition Matthew Boswell, President Andrea Marván Saltiel of the Mexican Federal Economic Competition Commission, FTC Chair Lina Khan, and Assistant Attorney General Jonathan Kanter of the Department of Justice’s Antitrust Division            The meetings grew out of a 1995 cooperation agreement between the United States and Canada, the 1999 agreement between the United States and Mexico and the 2001 agreement between Canada and Mexico. The agreements commit the agencies to coordinate and cooperate with each other to ensure consistent and effective antitrust enforcement.
- FTC Announces 2024 Update of Size of Transaction Thresholds for Premerger Notification Filings The Federal Trade Commission has approved revised jurisdictional thresholds and a revised filing fee schedule under the Hart‐Scott‐Rodino (HSR) Antitrust Improvements Act of 1976. Section 7A(a)(2) of the Act requires the Commission to revise the jurisdictional thresholds annually, based on the change in gross national product. The FTC is also required to revise the related HSR filing fee schedule annually based on changes in the gross national product and in the consumer price index under Division GG of the 2023 Consolidated Appropriations Act.For 2024, the size-of-transaction threshold for reporting proposed mergers and acquisitions under Section 7A of the Clayton Act will adjust from $111.4 million to $119.5 million.The revised jurisdictional thresholds and filing fee schedule will apply to all transactions that close on or after the effective date of the notice, which is 30 days after its publication in the Federal Register.The vote approving the Federal Register Annual Notice of Revision announcing the new HSR jurisdictional thresholds and filing fee schedule was 3-0.
- FTC Announces 2024 Jurisdictional Threshold Updates for Interlocking Directorates The Federal Trade Commission has approved revised jurisdictional thresholds for Section 8 of the Clayton Act, which prohibits interlocking directorates. For 2024, thresholds under Section 8 of the Act that trigger prohibitions on certain interlocking memberships on corporate boards of directors are $48,559,000 for Section 8(a)(l) and $4,855,900 for Section 8(a)(2)(A). The thresholds for Section 8 of the Clayton Act become effective upon their publication in the Federal Register. A complete listing of current thresholds can be found on the FTC’s website, and will be updated closer to the time they become effective.The vote approving the Federal Register notice announcing the threshold revisions was 3-0.
- FTC Publishes Inflation-Adjusted Civil Penalty Amounts for 2024 The Federal Trade Commission has adjusted the maximum civil penalty dollar amounts for violations of 16 provisions of law the FTC enforces, as required by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. The Act directs agencies to implement annual inflation adjustments based on a prescribed formula. The new maximum civil penalty amounts became effective once they were published in the Federal Register on January 10.The maximum civil penalty amount has increased from $50,120 to $51,744 for violations of Sections 5(l), 5(m)(1)(A), and 5(m)(1)(B) of the FTC Act, Section 7A(g)(l) of the Clayton Act, and Section 525(b) of the Energy Policy and Conservation Act. It has increased from $659 to $680 for violations of Section 10 of the FTC Act.The maximum civil penalty amount has increased from $1,426,319 to $1,472,546 for violations of Section 814(a) of the Energy Independence and Security Act of 2007. The maximum civil penalty amounts for other law violations within the agency’s jurisdiction are listed in the Federal Register notice. The Commission vote to publish the Federal Register notice amending Commission Rule 1.98 was 3-0
- FTC to Host Virtual Summit on Artificial Intelligence The Federal Trade Commission’s Office of Technology is hosting a virtual tech summit on January 25, 2024 that will bring together a diverse group of stakeholders to discuss key developments in the rapidly evolving field of artificial intelligence (AI), looking across the layers of technology related to AI. The summit will bring together representatives from academia, industry, civil society organizations, and government to discuss the state of technology, emerging market trends, and real-world impacts of AI. The discussions will also explore how to cultivate a marketplace that allows both consumers and businesses, including startups and small businesses, to thrive. FTC Chair Lina M. Khan and Commissioners Rebecca Kelly Slaughter and Alvaro Bedoya will provide remarks at the summit. The event will also feature three panel discussions. These include discussions on the hardware and other key infrastructure that will be needed for AI development; issues related to the data and models used in AI; and AI-powered consumer applications. The summit will begin at noon and take place online. The tentative agenda is available on the event website. Information on how to participate will also be posted to the event page soon.
- Statement on FTC Win Securing Temporary Block of IQVIA’s Acquisition of Propel Media The U.S. District Court for the Southern District of New York granted on December 29, 2023, the Federal Trade Commission’s request for a preliminary injunction to prevent IQVIA Holdings Inc. (IQVIA) from acquiring Propel Media, Inc. pending the Commission’s administrative proceeding seeking to permanently block the proposed deal.In response, Bureau of Competition Director Henry Liu issued the following statement:“To close out 2023, the FTC secured another significant victory that temporarily blocks an anticompetitive merger that would raise health care prices for consumers. The federal court’s order in IQVIA is also a win for the FTC as it continues to challenge anticompetitive deals involving health care and emerging technology platforms. We are pleased with the federal court’s decision and look forward to continuing to fight to permanently enjoin this anticompetitive deal via the Commission’s administrative proceedings.Congratulations to the Mergers I Division on this important initial victory and thank you to all the staff who worked on this case.”  On July 17, 2023, the FTC sued to block IQVIA’s acquisition of Propel Media alleging in an administrative complaint that the proposed acquisition would give IQVIA a market-leading position in programmatic advertising targeted to doctors and other health care professionals. The Commission also authorized FTC staff to seek a temporary restraining order and preliminary injunction in federal district court to prevent IQVIA from consummating its acquisition of Propel Media, pending the agency’s administrative proceeding.After a nearly two-week evidentiary hearing and closing arguments in late November and December 2023, U.S. District Court Judge Edgardo Ramos issued an order granting the FTC’s motion for preliminary injunction on December 29, 2023. The administrative trial is scheduled to begin on January 18, 2024.The IQVIA federal court order is the fourth merger victory for the FTC in less than a month as the Commission seeks lower health care costs by preventing anticompetitive deals. In December 2023, the FTC also secured victories in its challenges against Illumina’s acquisition of Grail, John Muir’s takeover of San Ramon Regional Medical Center from Tenet Healthcare, and Sanofi’s acquisition of Maze Therapeutics’ Pompe disease drug. The IQVIA order also comes several weeks after the FTC’s successful challenge of several drug products as improperly or inaccurately listed in the Food and Drug Administration’s Orange Book.
- FTC, DOJ Issue Fiscal Year 2022 Hart-Scott-Rodino Notification Report The Federal Trade Commission, together with the Justice Department’s Antitrust Division, released their annual report detailing fiscal year 2022 data on the HSR Premerger Notification Program, which alerts the agencies to transactions that may substantially lessen competition in violation of federal law.The agencies’ 45th Annual Hart-Scott-Rodino Report notes that in fiscal year 2022, 3,152 transactions were reported under the HSR Act, which is the second-highest number of reported transactions over the past 10 years. Of the 3,152 transactions reported, 47 transactions or 1.6% of all HSR reportable transactions were subject to a second request issued by the agencies. The number of second requests issued by the agencies in fiscal year 2022 is consistent with the average number of second requests issued across the last decade.The FTC and DOJ together filed 50 merger enforcement actions in fiscal year 2022, representing the highest level of enforcement activity in over 20 years. The Commission brought 24 merger enforcement challenges in fiscal year 2022; 11 in which it issued final consent orders after a public comment period; seven in which the transaction was abandoned or restructured as a result of antitrust concerns raised during the investigation; and six in which the Commission initiated administrative or federal court litigation. These enforcement actions preserved competition in numerous sectors of the economy, including consumer goods and services, pharmaceuticals, healthcare, high tech and industrial goods, and energy.The report includes statistical tables profiling HSR filings and investigations during fiscal year 2022. Appendices provide a summary of transactions for the past 10 years, as well as the number of transactions reported and the number of transactions by industry group. Enacted by Congress in 1976, the Hart-Scott-Rodino Act gives the federal government the opportunity to investigate and challenge mergers that are likely to harm consumers before injury occurs.The Commission vote to issue the report was 3-0. FTC Chair Lina M. Khan was joined by Commissioners Rebecca Kelly Slaughter and Alvaro M. Bedoya in a statement.
- Federal Trade Commission and Justice Department Release 2023 Merger Guidelines Today, the Federal Trade Commission and the Justice Department jointly issued the 2023 Merger Guidelines, which describe factors and frameworks the agencies utilize when reviewing mergers and acquisitions. The 2023 Merger Guidelines are the culmination of a nearly two-year process of public engagement and reflect modern market realities, advances in economics and law, and the lived experiences of a diverse array of market participants.“Fair, open, competitive markets have been essential to America’s dynamic, thriving economy, and policing unlawful mergers is our front line of defense against harmful corporate consolidation,” said FTC Chair Lina M. Khan. “The 2023 Merger Guidelines reflect the new realities of how firms do business in the modern economy and ensure fidelity to statutory text and precedent. I am grateful for the thousands of comments submitted by American workers, consumers, entrepreneurs, farmers, business owners, and other members of the public. This input directly informed the guidelines and allowed us to pursue this work with a deeper understanding of the real-life stakes of merger enforcement.”“These finalized Guidelines provide transparency into how the Justice Department is protecting the American people from the ways in which unlawful, anticompetitive practices manifest themselves in our modern economy,” said Attorney General Merrick B. Garland. “Since releasing the Draft Merger Guidelines earlier this summer, we have engaged with stakeholders across the country, and the Guidelines are stronger as a result. The Justice Department will continue to vigorously enforce the laws that safeguard competition and protect all Americans.”“The Guidelines we release today are faithful to the law and reflect how competition plays out in our modern markets. Ensuring that our merger enforcement protects that competition is our North Star. Competitive markets and economic opportunity for all Americans go hand in hand,” said Assistant Attorney General Jonathan Kanter of the Antitrust Division. “We were grateful to hear from authors, nurses, farmers, and other concerned citizens from across the country as we worked to put together the 2023 Merger Guidelines. Their comments were invaluable — and our merger enforcement will be better as a result.”The 2023 Merger Guidelines released today modify the draft Merger Guidelines released on July 19, 2023, to address comments from the public, including extensive engagement from attorneys, economists, academics, enforcers, and other policymakers at the agencies’ three Merger Guidelines Workshops.  They emphasize the dynamic and complex nature of competition ranging from price competition to competition for the terms and conditions of employment, to platform competition. This approach enables the agencies to assess the commercial realities of the United States’ modern economy when making enforcement decisions and ensures that merger enforcement protects competition in all its forms.The agencies protect competition through enforcement of the antitrust laws and other federal competition statutes. Since 1968, the agencies have issued merger guidelines to enhance transparency and promote awareness of how the agencies undertake merger analysis before deciding whether or not to challenge an acquisition.  Over the years, the agencies have worked collaboratively to update the merger guidelines periodically to reflect changes in the law and market realities, including in 1982, 1984, 1992, 1997, 2010, and 2020. The robust process to develop the 2023 Merger Guidelines began in January 2022. The agencies announced an initiative to evaluate possible revisions to the 2010 Horizontal Merger Guidelines and the 2020 Vertical Merger Guidelines and published a Request for Information on Merger Enforcement, which sought public comment on modernizing merger enforcement. The agencies received more than 5,000 comments. Commenters highlighted excessive market consolidation across industries and overwhelmingly urged the agencies to strengthen their approach to merger enforcement. At the agencies’ four listening sessions, business owners, workers, and other advocates similarly highlighted the potential for mergers and acquisitions to undermine open, vibrant, and competitive markets, in industries ranging from food and agriculture to health care. Informed by this feedback, agency experience and expertise, as well as developments in the market, law, and economics, the agencies drafted and jointly released a proposed version of the 2023 Merger Guidelines for public comment in July 2023 and received more than 30,000 comments reflecting the views of consumers, workers, academics, interest organizations, attorneys, enforcers, and many others across various sectors of the American economy. The agencies also held three Merger Guidelines Workshops to discuss the draft Merger Guidelines. This engagement informed an in-depth revision process culminating in today’s release of the 2023 Merger Guidelines.Like the prior horizontal and vertical merger guidelines they replace, the 2023 Merger Guidelines are not themselves legally binding, but provide transparency into the Agencies’ decision-making process.The 2023 Merger Guidelines do not predetermine enforcement action by the agencies. Although the Merger Guidelines identify the factors and frameworks the agencies consider when investigating mergers, the agencies’ enforcement decisions will necessarily depend on the facts in any case and will continue to require prosecutorial discretion and judgment.The Commission vote to approve the 2023 Merger Guidelines was 3-0.
- Statement Regarding Illumina’s Decision to Divest Grail Illumina, Inc. announced it would divest Grail, Inc. following a U.S. Court of Appeals for the Fifth Circuit decision that supported the Federal Trade Commission’s determination that the acquisition threatened competition in the market for cancer detection tests. Federal Trade Commission Bureau of Competition Director Henry Liu issued the following statement: “This is a major win for the FTC as it works to protect competition in health care.  Illumina’s decision to unwind its acquisition of Grail ensures the market for cancer detection tests remains competitive and delivers a choice of high-quality tests for patients and physicians, ultimately saving lives. The Fifth Circuit’s unanimous ruling in this case recognizes how vertical deals can threaten competition and provides a clear roadmap for future cases. The ruling is also a victory for patients who need affordable, high-quality quality cancer detection tests. I applaud FTC staff for their dedication to this case and effort to ensure this critical health care market remains competitive.” The FTC challenged Illumina’s acquisition of Grail in March 2021 alleging the deal would diminish innovation in the U.S. market for multi-cancer early detection (MCED) tests while increasing prices and decreasing choice and quality of tests. In April 2023, the Commission issued an opinion and order reversing the Administrative Law Judge’s dismissal of the proceeding and requiring Illumina to divest Grail. In June 2023, Illumina petitioned the Fifth Circuit to review the Commission’s order and opinion, and the Fifth Circuit heard arguments in the case in September 2023.  On December 15, 2023, the Fifth Circuit issued an opinion in the case finding that there was substantial evidence supporting the Commission’s ruling that the deal was anticompetitive. The Fifth Circuit vacated the Commission’s order and remanded it for further proceedings based on the standard the Commission applied when reviewing one aspect of Illumina’s rebuttal evidence. On December 17, 2023, Illumina then announced it would divest Grail.
- FTC Staff Report Details Key Takeaways from AI and Creative Fields Panel Discussion In a new report, Federal Trade Commission staff detailed key takeaways from an October 2023 public virtual roundtable that examined how generative artificial intelligence, tools that can generate outputs like text, images, and audio on command, is being used and is affecting professionals in music, filmmaking, software development, and other creative fields.During the virtual event, working creative professionals representing artists, writers, actors, musicians and other creative fields noted that while there are benefits to AI, such as potentially aiding their own work, they also expressed concerns: Collection without Consent: Creative professionals noted how their past work was being collected and used without their consent or awareness to train generative AI models, including by using expansive interpretations of prior contractual agreements.Nondisclosure: Participants also expressed concern that they might not even know that their works are being used because many AI developers do not publicly disclose what works have been included in training data.Competing for work with AI: Participants said that generative AI outputs are starting to appear in the venues where creative professionals compete for work, potentially making it more difficult for consumers and potential publishers to find human-made work.Style mimicry: Some participants expressed concerns about generative AI tools being used to mimic their own unique styles, brands, voices and likenesses, which could allow strangers and former clients to create knockoffs including synthetic voices and images.Fake endorsements: Participants said generative AI has been used to create false depictions of artists selling products that they never endorsed or used by trolls to generate offensive content using their cloned voices.While some companies have begun allowing artists to opt out of having their work used by AI, participants said this option puts the burden on creators to police a rapidly changing marketplace. They also noted that opt-outs would only address future uses and would be difficult to implement given the lack of transparency by AI developers. Instead, participants urged AI developers to adopt an opt-in approach to using artists work, which would give artists control over whether they want their work to be used for generative AI.The staff report noted that, although many of the concerns raised at the event lay beyond the scope of the Commission’s jurisdiction, targeted enforcement under the FTC’s existing authority in AI-related markets can help protect fair competition and prevent unfair or deceptive acts or practices. The report stated that the FTC will continue to closely monitor generative AI industry developments and will remain vigilant and ready to use its law enforcement and policy tools to foster fair competition, protect consumers, and help ensure that the public benefits from this transformative technology.The Commission voted 3-0 to issue the staff report.The lead staffers on the report are Madeleine Varner, Jessica Colnago, and Stephanie Nguyen.
- Statement Regarding the Termination of John Muir’s Takeover of San Ramon Regional Medical Center from Tenet Healthcare The FTC and the State of California moved to dismiss their case challenging John Muir Health’s proposed deal to acquire sole ownership of San Ramon Regional Medical Center, LLC from current majority owner Tenet Healthcare Corporation following an announcement of the deal’s termination. Bureau of Competition Director Henry Liu issued the following statement:“The FTC has scored another major health care win in less than a month, delivering patients in California continued access to quality, affordable health care services. John Muir’s anticompetitive hospital takeover would have driven up health care costs for critical services like heart surgery, spinal surgery, and maternity care. It also threatened to eliminate improvements in care driven by competition, which directly benefit patients. Now that this transaction is terminated, John Muir and Tenet’s San Ramon Regional Medical Center can continue competing head-to-head to offer high-quality care at the best prices for Californians in the I-680 corridor. I want to thank the Office of the California Attorney General for their partnership in this matter. Thank you to the FTC staff, attorneys and economists for their work and dedication to this case.”On November 17, 2023, the FTC sued to block John Muir’s proposed acquisition, issuing an administrative complaint alleging the deal would drive up health care costs and eliminate competition to improve services. The FTC and the California Attorney General also jointly sought a temporary restraining order and preliminary injunction in the U.S. District Court for the Northern District of California to halt the proposed transaction. On December 15, 2023, John Muir announced it would terminate its proposed deal to acquire Tenet’s remaining interest in San Ramon Medical Center. Following this development, the FTC and California moved to dismiss their federal court case and the FTC dismissed its administrative challenge on December 18, 2023.
- FTC Approves Final Order Settling Horizon Therapeutics Acquisition Challenge The Federal Trade Commission today finalized a consent order that resolves potential competitive harm stemming from Amgen Inc.’s acquisition of Horizon Therapeutics plc. As part of a nationwide settlement of their challenge to the acquisition, the FTC and attorneys general from six states – California, Illinois, Minnesota, New York, Washington, and Wisconsin – previously dismissed the related federal court preliminary injunction action.In May 2023, the FTC sued to block the deal alleging that the acquisition would enable Amgen to leverage its large portfolio of blockbuster drugs to pressure insurance companies and pharmacy benefit managers into favoring Horizon’s two monopoly products – Tepezza and Krystexxa – or disadvantaging rivals to these two products. The FTC also alleged that the deal would entrench Tepezza’s and Krystexxa’s monopoly positions in the thyroid eye disease and chronic refractory gout markets, respectively, by substituting Amgen, with its broad and powerful portfolio of blockbuster drugs, for Horizon with its smaller portfolio, thus raising entry barriers and dissuading smaller firms from competing aggressively.This case was the FTC’s first litigated challenge to a pharmaceutical merger in more than a decade.Under the final consent order, Amgen is prohibited from bundling an Amgen product with either Tepezza or Krystexxa, Horizon’s medications used to treat thyroid eye disease and chronic refractory gout, respectively. In addition, Amgen may not condition any product rebate or contract term related to an Amgen product on the sale or positioning of either one of these drugs. Amgen also is barred from using any product rebate or contract term to exclude or disadvantage any product that would compete with Tepezza or Krystexxa.Amgen, under the terms of the final consent order, must seek FTC approval if it seeks to acquire any pre-commercial products that have completed FDA clinical trials to treat either thyroid eye disease or chronic refractory gout. Amgen is also required to seek prior FTC approval through 2032 and notify the states if it is seeking Commission approval.The final consent order, among other provisions, also prohibits Amgen from entering into any agreement or understanding to acquire any products or interest in any business engaged in the manufacturing or sale of any products, biosimilars, or therapeutic equivalents that treat either thyroid eye disease or chronic refractory gout, unless it receives prior approval from the Commission.All other requirements in the consent order will be effective for 15 years, including a requirement that Amgen submit annual compliance reports to the FTC and states.Additionally, the Commission approved the appointment of Ms. Jeri Hilleman as the monitor in this case.Following a public comment period, the Commission voted 3-0 to approve the final order and to appoint Ms. Hilleman as monitor.
- Statement Regarding the Termination of Sanofi’s Proposed Acquisition of Maze Therapeutics’ Pompe Disease Drug Following Sanofi’s decision to terminate its proposed acquisition of an exclusive license to Maze Therapeutics Inc.’s developmental drug to treat Pompe disease, the Federal Trade Commission moved to dismiss its case challenging the transaction. Bureau of Competition Acting Deputy Director Nate Soderstrom issued the following statement:“Sanofi’s decision not to pursue this anticompetitive transaction is a big win for patients and an important victory for the FTC. The proposed deal would have allowed Sanofi to maintain its monopoly power by eliminating nascent competition, in turn reducing innovation for lifesaving, essential care. The deal also would have enabled Sanofi to continue charging patients monopoly prices of over $750,000 for an annual course of treatment for its Pompe therapies.Now, with this transaction off the table, Sanofi and Maze can continue to compete on the merits, and both can work to offer patients suffering from this debilitating disease better treatment at affordable prices. This continued incentive to innovate will give patients and their doctors better health care alternatives and ultimately reduce patients’ treatment burden.The FTC will not hesitate to take action in enforcing the antitrust laws to protect patients. I would like to congratulate and thank all of our incredibly talented staff who worked on this matter. This result would not have been possible without the exceptional skill, hard work, and dedication of staff to the FTC’s mission.”On December 11, 2023, the FTC sued to block Sanofi’s acquisition of an exclusive license to Maze’s Phase 2-ready developmental drug—a glycogen synthase 1 inhibitor called MZE001— alleging the deal would eliminate a nascent competitor poised to challenge Sanofi’s monopoly in the Pompe disease therapy market. After the FTC issued an administrative complaint and authorized a lawsuit in federal court, Sanofi announced it would terminate its agreement with Maze. The FTC then moved to dismiss its federal court and administrative challenge on December 13, 2023.
- FTC Seeks to Block Sanofi’s Acquisition of Rare Disease Drug that Threatens Sanofi’s Monopoly The Federal Trade Commission is seeking to block Sanofi’s proposed acquisition of an exclusive license to Maze Therapeutics Inc.’s therapy in development for treatment of Pompe disease.The Commission today issued an administrative complaint and authorized a lawsuit in federal court alleging the deal, valued at up to $755 million, would eliminate a nascent competitor poised to challenge Sanofi’s monopoly in the Pompe disease therapy market.Pompe disease is a debilitating and potentially fatal genetic disorder. Sanofi is a monopoly supplier of Food and Drug Administration (FDA) approved drugs to treat the disease. According to the FTC’s complaint, Maze’s Phase 2-ready developmental drug—a glycogen synthase 1 inhibitor called MZE001—threatens to undermine this monopoly as the first oral medication available for Pompe disease patients.The complaint, which also names Genzyme Corporation, the Sanofi subsidiary seeking to license the drug from Maze, alleges the transaction would protect Sanofi’s monopoly and eliminate competition between Sanofi and Maze to develop new Pompe drugs, denying patients and doctors the benefits of competition, including lower prices and greater innovation.“Sanofi’s acquisition of Maze’s Pompe disease drug threatens to deprive patients of a new, innovative treatment and maintain a status quo of exorbitant pricing for essential life-saving medicines,” said Nate Soderstrom, Acting Deputy Director of the FTC’s Bureau of Competition. “The FTC is challenging Sanofi’s deal with Maze because it’s critical that patients and doctors have access to innovative, affordable treatment options.”As a monopolist, Sanofi charges hundreds of thousands of dollars for an annual course of treatment on its Pompe therapies. Sanofi’s drugs are administered via lengthy, biweekly intravenous infusions, whereas Maze’s MZE001, as an oral tablet taken twice daily, would significantly reduce patients’ treatment burden.According to the FTC’s complaint, Sanofi singled out MZE001 as a significant threat to its lucrative Pompe monopoly shortly after Maze publicly revealed its development plans in 2021. MZE001 threatens to not only capture substantial market share from Sanofi, but also potentially replace Sanofi’s treatments as the standard of care for Pompe disease altogether. The complaint alleges that the proposed acquisition would both extend Sanofi’s monopoly power over Pompe disease treatments and reduce innovation competition to develop new Pompe drugs.In addition to the administrative complaint, the Commission has authorized FTC staff to seek a temporary restraining order and preliminary injunction in federal district court to prevent Sanofi from acquiring MZE001, pending the agency’s administrative proceeding. The Commission’s federal court complaint will be filed in the U.S. District Court for the District of Massachusetts. A public version of the complaint will be made available at a later time.The Commission vote to issue an administrative complaint and authorize staff to seek a temporary restraining order and preliminary injunction in federal district court was 3-0.The Mergers I Division of the FTC’s Bureau of Competition was responsible for this matter.NOTE: The Commission issues an administrative complaint when it has “reason to believe” that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. The issuance of the administrative complaint marks the beginning of a proceeding in which the allegations will be tried in a formal hearing before an administrative law judge.
- FTC Sues 7-Eleven for Anticompetitive Acquisition in Violation of 2018 Consent Order The Federal Trade Commission today sued 7-Eleven, Inc. alleging the convenience store chain violated a 2018 FTC consent order by acquiring a fuel outlet in St. Petersburg, Fla. without providing the Commission prior notice.According to the Commission’s federal complaint, which also names 7-Eleven’s parent company, Seven & i Holdings Co., Ltd., 7-Eleven’s acquisition of the St. Petersburg outlet plainly violated the consent order, was anticompetitive, and likely allowed 7-Eleven to charge higher fuel prices at locations near the St. Petersburg location. The FTC is seeking a civil penalty for a four-year violation period, starting when 7-Eleven acquired the outlet without giving the required notice. 7-Eleven faces a maximum penalty of over $77 million.The consent order stems from 7-Eleven’s $3.3 billion acquisition of more than 1,000 retail fuel outlets with attached convenience stores from Sunoco in 2018. 7-Eleven and its parent company agreed to a consent order to settle FTC charges that its proposed acquisition would harm competition for retail gas and diesel fuel in certain local markets, resulting in consumers paying higher fuel prices. The consent order, among other conditions, prohibited 7-Eleven from acquiring Sunoco fuel outlets in many of these local markets, including in the local market surrounding the St. Petersburg location in the Tampa, Fla. metropolitan area, and required 7-Eleven to provide the FTC with notice before acquiring any interest in specific third-party retail fuel outlets in certain local markets for a period of 10 years. According to the complaint, 7-Eleven’s acquisition of the St. Petersburg outlet was an undisputed violation of the 2018 consent order since this location was specifically listed as an outlet that could not be acquired without first providing prior notice to the FTC. 7-Eleven submitted false compliance reports to the FTC related to this acquisition. The FTC is seeking civil penalties for 7-Eleven’s violation of the Commission’s consent order to protect the public interest and deter 7-Eleven, a serial acquirer of retail fuel outlets across the United States, and others from flouting future consent orders, the FTC’s complaint states.The Commission vote authorizing staff to file a complaint and seek civil penalties was 3-0. The complaint was filed in the U.S. District Court for the District of Columbia.NOTE: The Commission files a complaint when it has “reason to believe” that the named defendants are violating or are about to violate the law, or a Commission order, and it appears to the Commission that a proceeding is in the public interest.
- FTC Issues Annual Report on Ethanol Market Concentration 2023 The Federal Trade Commission has issued its 2023 Report on Ethanol Market Concentration. The Energy Policy Act of 2005 directs the Commission to perform an annual review of market concentration in the ethanol production industry “to determine whether there is sufficient competition among industry participants to avoid price-setting and other anticompetitive behavior.”As in prior years, the 2023 report concludes that “[t]he level of concentration and large number of market participants in the U.S. ethanol production industry continue to suggest that the exercise of market power to set prices, or coordinate on price or output levels, is unlikely on a nationwide basis.”The Commission vote to approve the report was 3-0. The lead staff attorney on this matter for the FTC is Christopher Grengs in the Bureau of Competition.
- FTC Authorizes Compulsory Process for AI-related Products and Services The Federal Trade Commission has approved an omnibus resolution authorizing the use of compulsory process in nonpublic investigations involving products and services that use or claim to be produced using artificial intelligence (AI) or claim to detect its use.The omnibus resolution will streamline FTC staff’s ability to issue civil investigative demands (CIDs), which are a form of compulsory process similar to a subpoena, in investigations relating to AI, while retaining the Commission’s authority to determine when CIDs are issued. The FTC issues CIDs to obtain documents, information and testimony that advance FTC consumer protection and competition investigations. The omnibus resolution will be in effect for 10 years.AI includes, but is not limited to, machine-based systems that can, for a set of defined objectives, make predictions, recommendations, or decisions influencing real or virtual environments. Generative AI can be used to generate synthetic content including images, videos, audio, text, and other digital content that appear to be created by humans. Many companies now offer products and services using AI and generative AI, while others offer products and services that claim to detect content made by generative AI.Although AI, including generative AI, offers many beneficial uses, it can also be used to engage in fraud, deception, infringements on privacy, and other unfair practices, which may violate the FTC Act and other laws. At the same time, AI can raise competition issues in a variety of ways, including if one or just a few companies control the essential inputs or technologies that underpin AI.The Commission voted 3-0 to approve the omnibus resolution authorizing compulsory process in investigations related to the use of AI.The lead FTC staffers on this matter are Nadine Samter and Ben Halpern-Meekin in the FTC’s Northwest Region office.
- FTC Files Amicus Brief Outlining Anticompetitive Harm Caused by Improper Orange Book Listings The Federal Trade Commission filed an amicus brief to address the anticompetitive harm that stems from improperly listed patents in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book.”The Commission’s filing relates to an antitrust case brought by drug manufacturer Mylan Pharmaceuticals Inc. and several other affiliated entities alleging that Sanofi-Aventis U.S. LLC and other affiliated entities have engaged in anticompetitive conduct to monopolize the market for injectable insulin glargine, a drug used to treat diabetes. Mylan alleges Sanofi monopolized the injectable insulin glargine market in part by abusing the FDA’s Orange Book regulatory process. Specifically, Mylan alleges Sanofi delayed and blocked Mylan’s generic drug called Semglee from competing with Sanofi’s branded insulin glargine drug Lantus by improperly listing several drugs in the Orange Book.In its amicus brief filed in Mylan Pharmaceuticals Inc., et al. v. Sanofi-Aventis U.S. LLC, et al., the FTC explains that improper Orange Book listings, such as those alleged in Mylan’s case, can cause significant harm to competition, including delaying consumer access to a lower-priced competing drug that would save patients money while also potentially offering better access and higher quality medications.As detailed in the FTC’s amicus brief, when a brand pharmaceutical company lists a patent in the Orange Book it may lead to a statutory stay that blocks the introduction of competing drug products for up to 30 months, including lower-cost generic alternatives. When this stay is triggered by a patent that is improperly filed and does not meet the statutory listing criteria, the stay may improperly delay consumer access to a competing product that might reduce prices, improve quality and access, or both. Given the high cost of many drugs, even a short delay in competition can have enormous consequences for consumers in accessing cost-effective medications, the FTC stated in the brief.In September, the FTC issued a policy statement which warned that the agency would be scrutinizing the improper submission of patents for listing in the Orange Book. The Commission’s statement warned that improper listings in the Orange Book may harm competition from cheaper generic alternatives and keep brand prices artificially high. In November, the FTC sent letters to 10 drug manufacturers notifying them of more than 100 improperly listed Orange Book patents.The FTC’s amicus brief was filed in the U.S. District Court for the Western District of Pennsylvania. The Commission vote approving the filing of the amicus brief was 3-0. The Commission takes no position on Mylan’s allegations.The Federal Trade Commission works to promote competition, and protect and educate consumers. As part of the FTC’s policy work, the Commission submits amicus briefs in cases involving areas of law relevant to its competition and consumer protection missions to provide information that can help courts to make their decisions in ways that protect consumers or promote competition. You can learn more about how competition benefits consumers or file an antitrust complaint.  For the latest news and resources, follow the FTC on social media, subscribe to press releases and read our blog.
- FTC Sues to Block John Muir Health’s Takeover of San Ramon Regional Medical Center The Federal Trade Commission today sued to block John Muir Health’s proposed $142.5 million deal to acquire sole ownership of San Ramon Regional Medical Center, LLC from current majority owner Tenet Healthcare Corporation, saying the deal will drive up health care costs.The Commission issued an administrative complaint and authorized a lawsuit in federal court alleging the proposed acquisition will eliminate head-to-head competition between John Muir Health (John Muir) and nearby San Ramon Regional Medical Center (San Ramon Medical). John Muir and San Ramon Medical operate in California’s I-680 corridor, which spans Contra Costa and Alameda Counties in the San Francisco Bay Area.The deal would allow John Muir to demand higher rates at its two hospitals as well as San Ramon Medical for inpatient general acute care services (GAC), which are a broad range of essential medical, surgical, and diagnostic services that require an overnight hospital stay. The elimination of competition between John Muir and San Ramon Medical would also reduce incentives for these hospitals to invest in quality improvements.“San Ramon Regional Medical Center has played an important role in ensuring Californians in the I-680 corridor have access to quality, affordable care for critical health care services, such as cardiac surgery and childbirth,” said Henry Liu, Director of the FTC’s Bureau of Competition. “John Muir’s acquisition of San Ramon Medical would increase already high health care costs in the area and threaten to stall quality improvements that help advance care for all patients.”The FTC and the California Attorney General’s office closely cooperated throughout the investigation and will jointly file a complaint in federal district court.John Muir Health, a non-profit corporation headquartered in Walnut Creek, California, operates two hospitals that provide inpatient GAC services along the I-680 corridor. Dallas-based Tenet operates 61 general acute care hospitals and hundreds of outpatient facilities nationally, including numerous facilities in California.Currently, Tenet operates San Ramon Medical and holds a 51% interest in the medical center, while John Muir owns a 49% non-operating interest in San Ramon Medical. Under the terms of the proposed deal, John Muir would acquire Tenet’s remaining interest in San Ramon Medical and would become its sole owner and operator.The complaint alleges that the proposed deal would allow John Muir to control more than 50% of the market for inpatient GAC services sold to commercial insurers and their enrollees in the I-680 corridor, eliminating competition between John Muir and San Ramon Medical to provide better services, high-quality care, and access that benefits patients in this region. Currently, San Ramon Medical is a lower-priced competitor seeking to offer inpatient GAC services in the I-680 corridor to enrollees. John Muir’s hospitals are close competitors to San Ramon Medical in terms of both patient preference and geographic location, according to the complaint. The proposed acquisition would lead to higher insurance premiums, co-pays, deductibles, and other out-of-pocket costs, or reduced benefits for commercial health insurance enrollees, the complaint alleges.In addition to filing an administrative complaint, FTC staff will also ask a federal court to issue a temporary restraining order and preliminary injunction to prevent John Muir from taking control of San Ramon Medical pending the agency’s administrative proceeding.The Commission vote to issue the administrative complaint and authorize staff to seek a temporary restraining order and preliminary injunction was 3-0. The federal court complaint and request for preliminary relief will be filed jointly with the California Attorney General in the U.S. District Court for the Northern District of California to halt the transaction pending an administrative proceeding. A public version of the complaint will be available and linked to this news release as soon as possible.NOTE: The Commission issues an administrative complaint when it has “reason to believe” that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. The issuance of the administrative complaint marks the beginning of a proceeding in which the allegations will be tried in a formal hearing before an administrative law judge.
- FTC Announces Tentative Agenda for November Open Meeting Today, Federal Trade Commission Chair Lina M. Khan announced that an open meeting of the Commission will be held virtually on Thursday, November 16, 2023. The open meeting will commence at 11 a.m. ET and will begin with time for members of the public to address the Commission.The following items will be on the tentative agenda for the November 16 Commission meeting:Voice Cloning Challenge Announcement: FTC staff will announce an exploratory Voice Cloning Challenge to encourage the development of multidisciplinary solutions—from products to procedures—aimed at protecting consumers from artificial intelligence-enabled voice cloning harms, such as fraud and the broader misuse of biometric data and creative content. The challenge complements efforts across the federal government to address and mitigate the risks of AI.Presentation on Public Comments on Business Practices of Cloud Computing Providers: FTC Staff will present findings from and ongoing areas of inquiry following the Commission’s Request for Information and public panel discussion on cloud computing. The presentation will address a number of issues raised in the RFI and panel discussion, including competition, security, and generative AI. At the start of the meeting, Chair Khan will offer brief remarks and will then invite members of the public to share feedback on the Commission’s work generally and bring relevant matters to the Commission’s attention. Members of the public must sign up for an opportunity to address the Commission virtually at the November 16 event.Each commenter will be given two minutes to share their comments. Those who cannot participate during the event may submit written comments or a link to a prerecorded video through a webform. Speaker registration and comment submission will be available through Tuesday, November 14, 2023 at 8 p.m. ET.A link to the event will be available on the day of the open meeting, shortly before it starts via FTC.gov. The event will be recorded, and the webcast and any related comments will be available on the Commission’s website after the meeting. The Commission retains discretion to make public comments available following the event on ftc.gov.
- FTC, DOJ Meet with G7 Enforcement Partners to Discuss Competition in Digital Markets The Federal Trade Commission and Justice Department’s Antitrust Division participated in the G7 Competition Authorities and Policymakers’ Summit today to discuss how members are addressing competition concerns in digital markets, including in emerging technologies such as artificial intelligence (AI).G7 competition authorities and policymakers issued a statement on digital competition at the conclusion of the Summit, which describes a shared commitment to enforce competition laws and develop policies necessary to ensure that principles of fair competition are applied to digital markets.The statement highlights competition concerns arising from emerging technologies and describes the ways in which G7 members are enhancing their ability to better understand and anticipate the challenges to competition when dealing with new technologies such as generative AI. The statement emphasizes that current competition law applies to AI and its uses, and that G7 members are committed to addressing any risks to competition associated with the rise of AI.  “Competition enforcers around the world are committed to ensuring that free, fair, and open competition prevails across our digital markets. At the G7 Summit, global enforcers have the opportunity to discuss key competition issues and to share best practices as we all work to promote competition in emerging technologies and to effectively enforce our competition laws,” said FTC Commissioner Rebecca Kelly Slaughter.  In preparation for the Summit, G7 members contributed to the Compendium of Approaches to Improving Competition in Digital Markets, which describes competition agency efforts in digital markets.The Summit was convened by the G7 Digital and Tech Ministers and hosted in Tokyo by Japan’s Secretariat of Headquarters for Digital Market Competition and the Japan Fair Trade Commission. Delegates from G7 authorities in Canada, France, Germany, Italy, Japan, the UK, the United States, and the European Commission participated in the event.
- FTC Challenges More Than 100 Patents as Improperly Listed in the FDA’s Orange Book Today, the Federal Trade Commission (FTC) challenged more than 100 patents held by manufacturers of brand-name asthma inhalers, epinephrine autoinjectors, and other drug products as improperly or inaccurately listed in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book.”The Commission has also notified FDA that it disputes the accuracy or relevance of the listed information for these patents, which may require that the manufacturers remove the listing or certify under penalty of perjury that the listings comply with applicable statutory and regulatory requirements.  The FTC sent notice letters to 10 companies, which include: AbbVie, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Impax Laboratories, Kaleo, Mylan Specialty, and subsidiaries of Glaxo-Smith Kline and Teva. The notice letters and the patent listing dispute notifications provided to FDA identify specific patents that FTC contends are improperly listed for specific asthma and other inhaler devices, Restasis multidose bottles, and epinephrine autoinjectors, also commonly known as EpiPens.“Wrongfully listed patents can significantly drive up the prices Americans must pay for medicines and drug products while undermining fair and honest competition,” said FTC Chair Lina M. Khan. “The FTC’s action today identifies over 100 patents that we believe are improperly listed, affecting products ranging from inhalers to EpiPens. We will continue to use all our tools to protect Americans from illegal business tactics that are hiking the cost of drugs and drug products.”When the listing of a drug substance or drug product patent is disputed consistent with the applicable FDA regulations FDA will send the statement of dispute to the New Drug Application (NDA) holder who will then have 30 days to withdraw or amend these listings, or certify under penalty of perjury that the listings comply with applicable statutory and regulatory requirements.Last month, the FTC issued a policy statement that warned that the agency would be scrutinizing the improper submission of patents for listing in the Orange Book. The Commission said improper listings in the Orange Book may harm competition from cheaper generic alternatives and keep brand prices artificially high.The Orange Book is a list of drug products approved by the FDA as safe and effective. When a brand pharmaceutical company lists a patent in the Orange Book, it may lead to a statutory stay that generally blocks the introduction of competing drug products for 30 months, including lower-cost generic alternatives. Listing patents in the Orange Book may negatively affect competitive conditions if listings are improper, as defined by law.“The FDA reminds all NDA holders they are obligated to ensure that patent listings comply with statutory and regulatory requirements and to substantively respond to statements of dispute provided under the FDA’s patent listing dispute process,” said FDA Commissioner Robert M. Califf, M.D. “The FDA will continue its longstanding engagement with FTC to help protect American consumers.”According to the FTC’s policy statement, costs associated with challenging improperly listed patents can disincentivize investments in developing generic drugs, which risks delaying or thwarting competitive generic alternatives. Delays in generic competition, even if brief, can reduce patient access to more affordable alternatives and increase costs across the entire health care system.FDA regulations allow any interested person to dispute the accuracy or relevance of patent information published in the Orange Book. While the FTC is utilizing the FDA’s patent listing dispute process to address patents relating to these products, and potentially others, the letters to the drug companies highlight that the Commission retains the right to take any further action as needed in the public interest, which includes investigating the manufacturers’ conduct as a violation of FTC laws.
- FTC Approves Final Order Resolving Antitrust Concerns Surrounding ICE, Black Knight Deal The Federal Trade Commission today finalized a consent order that resolves antitrust concerns surrounding Intercontinental Exchange, Inc.’s (ICE) acquisition of Black Knight, Inc. The final consent order settles FTC charges, first announced in March 2023, that ICE’s deal with Black Knight, which combines the two top mortgage technology providers, would drive up costs, reduce innovation, and limit lenders’ choices for mortgage origination tools. Under the terms of the final consent order, Black Knight’s Optimal Blue and Empower businesses, which provide critical services in the mortgage origination process, were divested to Constellation Web Solutions Inc. (Constellation), a provider of mortgage-related tools and software, along with certain related products. To ensure the success of these divestitures, ICE and Black Knight were required to maintain the viability of Optimal Blue and Empower until they were successfully divested to Constellation and are required to provide transition assistance to enable Constellation to operate the businesses along the same lines that Black Knight has operated them. Other provisions of the final consent order include a requirement that ICE and Black Knight, for the next 10 years, seek prior FTC approval before either reacquiring any divested asset or acquiring an interest in a loan origination system business. In addition, the companies must provide prior notice to the FTC before acquiring an interest in a product, pricing, and eligibility engine business for that same period. ICE and Black Knight are also prohibited from enforcing any noncompete or non-solicit provision or agreement against any employee who seeks or obtains a position in either Optimal Blue or Empower. Following a public comment period, the Commission voted 3-0 to approve the final order.
- FTC and DOJ to Co-Host November 3 Workshop on the 2023 Draft Merger Guidelines WHAT: 	The Federal Trade Commission and Justice Department are co-hosting a workshop as part of their ongoing efforts to facilitate public dialogue on the 2023 Draft Merger Guidelines. The event will be co-hosted with the University of Chicago Law School, Coase-Sandor Institute for Law and Economics. WHEN: 	Friday, November 3, 2023, 9:00 a.m. ET – 4:00 p.m. CT WHERE:	The workshop will be held in person at the University of Chicago Law School in Chicago and live streamed. To view the live stream, please register. After registering, a link to the live stream will be provided via email. WHO:	The event will feature three panel discussions with FTC and DOJ leaders, state enforcers, academics, and practitioners regarding questions and issues on which public comment will be most useful. A full list of participants can be found on the event page. TWITTER:		Join the discussion on Twitter using the hashtag #DraftMergerGuides 	 
- FTC Takes Total Wine to Federal Court to Enforce Compliance with Antitrust Civil Investigative Demand The Federal Trade Commission today filed a petition seeking a federal court order to force Total Wine to comply with an FTC civil investigative demand (CID), which is a type of administrative subpoena that seeks documents and other information related to an ongoing antitrust investigation. The CID issued to Total Wine is part of an FTC investigation into a different company, Southern Glazer’s Wine & Spirits LLC. The FTC’s petition notes that it has tried to work cooperatively with Total Wine, but the company has failed to comply with the Commission’s CID for more than four months. Total Wine has categorically refused to search any employee-maintained files for documents and information needed to address the FTC’s CID and has failed to assert any valid reason for its refusal to comply. Total Wine’s actions have impeded and delayed the FTC’s investigation, forcing the Commission to seek federal court enforcement. “A civil investigative demand issued by the FTC is not a voluntary request, it is a demand made by the federal government that companies must comply with,” said Henry Liu, Director of the FTC’s Bureau of Competition. “Failing to comply with a CID ultimately hinders the FTC’s ability to protect consumers and businesses from anticompetitive practices. The FTC will not hesitate to use the full force of the law and take companies to court if they fail to comply.” The Commission is requesting that the U.S. District Court for the Eastern District of Virginia order Total Wine to appear before the Court and demonstrate why it should not be required to comply with the CID. Otherwise, the FTC is asking that the Court order Total Wine to produce specified documents and information within 20 days. The Commission issued the CID to Total Wine as part of its investigation into whether Southern Glazer’s, a distributor of wine and spirits products, has engaged in discriminatory practices in its sales to retailers like Total Wine in violation of the Robinson-Patman Act or engaged in other unfair methods of competition in violation of Section 5 of the FTC Act.
- FTC Approves Final Order to Prevent Interlocking Directorate Arrangement, Anticompetitive Information Exchange in EQT, Quantum Energy Deal The Federal Trade Commission finalized a consent order that prevents entanglements and the exchange of confidential, competitively sensitive information to resolve antitrust concerns surrounding a $5.2 billion cash-and-stock deal between private equity firm Quantum Energy Partners and natural gas producer EQT Corporation.Quantum and EQT are direct competitors in the production and sale of natural gas in the Appalachian Basin, the largest natural gas-producing region in the United States. The proposed acquisition would have made Quantum one of EQT’s largest shareholders and given Quantum – an active investor in natural gas production in the region – a seat on EQT’s board of directors, which the FTC alleged would violate the antitrust laws and harm competition in this industry.Under the FTC’s order, Quantum is prohibited from occupying an EQT board seat to prevent the formation of an interlocking directorate, which is an arrangement that occurs when an officer or director of one firm simultaneously serves as an officer or director of a competing firm. The final order also requires Quantum to divest its EQT shares, prevents anticompetitive information exchange, unwinds a separate anticompetitive joint venture between the two entities, and imposes additional restraints to protect competition.The order also imposes other provisions designed to ensure the effectiveness of the consent order, including the appointment of a monitor to track compliance and a requirement that for the duration of the order, Quantum is prohibited from acquiring additional EQT shares absent prior Commission approval. This finalized consent decree resolves the FTC’s first case in 40 years that enforces Section 8 of the Clayton Act, which prohibits interlocking directorates.Following a public comment period, the Commission voted 3-0 to approve the final order.