The Merger Control Review: USA


In the United States, mergers and acquisitions are reviewed by the Department of Justice (DOJ) or the Federal Trade Commission (FTC). These agencies are also responsible for imposing and enforcing appropriate remedies to maintain a competitive market. Parties seeking to merge must receive approval from the relevant agency with jurisdiction over the industry. The DOJ and FTC divide review by subject matter, based on each agency's previous experience and expertise. Mergers between pharmaceutical companies are reviewed by the FTC, which has developed principles and patterns for evaluating the effects of transactions involving prescription drugs. The FTC division known as Mergers I is responsible for examining transactions in healthcare-related industries, including pharmaceuticals.2 The FTC also has a separate Health Care Division, which investigates business practices of health professionals, pharmaceutical companies, institutional providers and insurers, in addition to reviewing transactions involving healthcare products and services.3 Pharmaceuticals are also regulated by the US Food and Drug Administration (FDA), and the FTC's review accounts for the complexity of this highly regulated industry.

This chapter contains three main sections. Section II provides an overview of the FTC's general review process, including the steps merging firms generally must follow and a brief discussion of the FTC's view of the relevant geographic and product markets. Section III discusses merger remedies in the pharmaceutical sector, and what parties can expect from an FTC consent decree. Section IV discusses recent developments in US merger review in the pharmaceutical sector, including potential changes to FTC policy towards certain divestiture remedies.

Year in review

The agencies entered into a number of enforcement actions during 2019.9 The FTC uniquely possesses the ability to seek a preliminary injunction to block completion of a proposed merger in federal district court and to challenge both proposed and completed mergers in its own administrative proceeding. In addition, the FTC can enter into a binding consent decree with the transaction parties without judicial intervention. In contrast, the DOJ must bring its challenges (and file any consents) in federal district court, with a judge ultimately deciding the case. The duration of the administrative process is sufficiently long that rarely will a pending transaction survive the appeals process. For instance, the FTC's administrative challenge of a completed acquisition by Polypore International, Inc that commenced in September 2008 resulted in a March 2010 ruling by the administrative law judge that the acquisition violated the law. The transaction parties appealed the ruling to the full Commission, which held oral argument on 28 July 2010 and unanimously affirmed the decision on 8 November 2010 (over two years after the challenge commenced); the Eleventh Circuit affirmed the Commission's decision almost two years later (i.e., over four years after it challenged the merger). The US Supreme Court denied certiorari in 2013. Similarly, in the challenge of the September 2017, Otto Bock/Freedom Innovations transaction, the FTC brought its administrative challenge in December 2017, the administrative law judge ruled in May 2019 that the transaction violated the law, and the full Commission unanimously affirmed the decision on 30 December 2019. Otto Bock petitioned the DC Circuit to review the Commission's decision.

During FY 2019, the FTC continued to be active with its litigated challenges. The FTC brought two preliminary injunction actions; the parties abandoned one transaction pretrial,10 and the FTC lost the other action on 3 February 2020.11 The administrative law judge held in favour of the FTC in another merger, which then resulted in a divestiture settlement.12 In addition, the Eighth Circuit affirmed the FTC's win in a clinics merger challenge.13 During the first eight months of FY 2020, the FTC brought an additional seven challenges in administrative or district court: the parties abandoned their deals in three cases14 and the remaining four cases are pending trial.15

The FTC entered into 11 consents involving proposed mergers in FY 2019. In addition, the FTC reports that during 2019, parties abandoned eight transactions due to antitrust concerns. During the first eight months of FY 2020, the FTC entered into eight consents involving proposed mergers and the parties abandoned two transactions due to antitrust concerns.

At the beginning of FY 2019, the DOJ's appeal of AT&T's acquisition of Time Warner was pending in the DC Circuit. On 26 February 2019, the DC Circuit affirmed the district court's decision.16 The DOJ brought three cases in FY 2019: the parties abandoned one prior to trial,17 the DOJ won one in arbitration on 9 March 2020,18 and the DOJ lost one in district court on 7 April 2020.19 The DOJ brought no new cases during the first eight months of FY 2020.

The DOJ also entered into seven consents involving proposed transactions in FY 2019; in addition, transaction parties abandoned one transaction because of antitrust concerns raised by the DOJ. In the first eight months of FY 2020, the DOJ entered into eight consents involving proposed transactions.

The merger control regime

Parties may approach the agencies prior to the filing of an HSR Act notification (or, in transactions that are not notifiable but that may raise antitrust concerns, in lieu of filing under the HSR Act), and the agencies can extend confidentiality to any substantive discussions by officially commencing an investigation. In contrast with many other jurisdictions, such consultations are not common prior to the public announcement of a transaction.

An acquisition that is subject to an HSR Act notification may not be completed until the requisite HSR Act notification has been filed with the agencies and the applicable waiting period has expired or has been terminated early. In most transactions, the acquired and the acquiring parties must file separate HSR Act notifications, and the waiting period will not commence until both parties make their filings. In tender offers, the waiting period commences with the filing of the HSR Act notification by the acquirer.

The initial waiting period is 30 days (or 15 days, in the case of a cash tender offer or bankruptcy filing). If the period expires on a weekend or holiday, then it will be extended until the following business day. At the parties' request, the waiting period can be terminated earlier by the agencies. Technically, the waiting period may not be extended other than by the issuance of a request for additional information and documentary material (second request). In practice, however, the acquiring party may withdraw and refile its HSR notification (recommencing the waiting period), agree not to complete the transaction to grant the antitrust enforcement agency additional time, or agree with the enforcement agency out of court that compliance with the HSR Act will not occur until a further submission is made.

The FTC and the DOJ have concurrent jurisdiction over HSR Act notifications. A clearance process exists between the agencies whereby one of the agencies can get 'cleared' to investigate the transaction. Once an agency is cleared, it can contact the parties (and third parties) for information relating to the transaction. The agencies have adopted policies to facilitate the investigation of transactions during the initial waiting period, aimed at decreasing the number of transactions in which second requests are issued and developing more precise second requests. The ability to engage in meaningful review of a transaction during this initial waiting period, however, depends on the transaction parties' willingness to provide certain documents and information quickly and voluntarily.

If, prior to the expiry of the initial waiting period, the reviewing agency issues a second request (typically on the last business day of the waiting period), then the clock stops until the transaction parties comply with the second request. Unless terminated earlier or otherwise agreed to by the parties, the second waiting period ends on the 30th day (or, in the case of a cash tender offer or bankruptcy, the 10th day) following substantial compliance with the second request. Again, if the waiting period expires on a weekend or holiday, it is extended to the following business day. In tender offers, the waiting period is determined according to when the acquiring party substantially complies with the second request. It is not unusual for the parties to agree to extend the waiting period in exchange for a dialogue with the agency regarding the concerns presented, particularly if the parties are willing to resolve any remaining concerns with a consent decree.

In merger investigations, the agencies typically seek information from third parties (competitors, customers, suppliers, etc.) that is relevant to the review of the transaction. The information may be requested or required. Both agencies can also seek interviews or depositions. Generally, the information provided by the merger parties and third parties is not subject to public disclosure. State attorneys general can also review mergers – a process has been in place for about a decade that facilitates their participation in HSR review. With the consent of the merger parties, the agencies will discuss the information received by them and coordinate their investigations with the state enforcers. Ultimately, if the transaction is challenged, the state attorneys general often, but not always, join with the agency as plaintiffs. In some transactions, the state attorneys general will seek additional relief. State attorneys general will sometimes also require transaction parties to pay 'attorneys' fees' for their review of the transaction as part of the settlement. In addition, the US antitrust authorities regularly consult with their foreign counterparts during a merger investigation. Such coordination and dialogue require consent from the transaction parties. The US authorities recently signed a cooperation agreement with China to facilitate such cooperation.

A high percentage of the transactions for which an agency issues a second request will result in some type of enforcement action (i.e., court challenge, consent decree or restructuring). The agencies have a strong preference for structural relief, and require either upfront buyers or short (i.e., 60 to 90 days) divestiture periods. The DOJ will sometimes forgo the need for a consent decree if the merger parties eliminate the potential anticompetitive problems through a voluntary restructuring of the transaction or a sale of assets (a 'fix-it-first' solution). The DOJ also uses 'pocket consent decrees' (decrees that are entered into by the parties and the DOJ but not filed with the court unless either the agency decides that it needs relief or the parties fail to implement the remedy or obtain a regulatory order). These pocket consent decrees can also be used to permit a transaction to proceed before the agency completes its investigation; for instance, in a hostile tender offer situation where the target is uncooperative and seeks to use the HSR review as a means of delay or process denial. Both the FTC and the DOJ permit the transaction to close once they provisionally accept the consent decree and publish it for public comment. The FTC approves the final consent decree after the public comment period expires and the staff sends its recommendation to the Commission; the DOJ files the proposed judgment with a federal district court and seeks approval and entry of the judgment by the judge following the public comment period provided under the Tunney Act.20

If the parties and the reviewing agency are unable to reach an agreement that resolves the agency's concerns, then the agency can seek a preliminary injunction from a federal district court to block the transaction's completion. The DOJ can also challenge a completed merger in federal district court. The FTC, regardless of whether it seeks a preliminary injunction, can also challenge a proposed or consummated merger in its own administrative court.

The agencies can challenge a transaction at any time post-consummation. There is no statute of limitations barring the challenge or suspensory effect from the expiry of the HSR Act waiting periods. State attorneys general can bring challenges as well, on their own behalf or as parens patriae of their citizens. Private parties can bring challenges, although, in most jurisdictions, the standing requirements may be difficult to meet.

Other strategic considerations

Although providing the state attorneys general with an active role in the HSR Act review may complicate the process and potentially delay the resolution of the review at the agency, it is generally advisable that transaction parties consent to such a request. Most states have compulsory process authority and, absent the protocol, can issue subpoenas for information, documents and even testimony. States can also bring challenges. Having the states work with the agency eliminates confusion, an additional burden of compliance with requests and potentially diverging outcomes. Although the T-Mobile/Sprint transaction provided an example of where some states may diverge with a federal antitrust agency, in a number of recent FTC challenges, state attorneys general joined with the FTC in the matter.

Similarly, many transactions meeting the jurisdictional thresholds of the HSR Act will also require notification in a number of other jurisdictions.21 The trend is for the FTC and the DOJ to cooperate with other jurisdictions in reviewing cross-border mergers. In that regard, the US agencies have entered into several bilateral and multilateral cooperation agreements. The agencies have cooperated extensively with Canada, Mexico and the European Commission on several mergers, and this cooperation is likely to continue. Transaction parties should consider agreeing to such cooperation for the same reasons as with the states: to avoid confusion, the burden of compliance with requests and potential diverging outcomes. Such coordination is particularly crucial when remedies are likely to be required that affect assets or businesses in more than one jurisdiction. Even with such cooperation, however, geographic and analytical differences can exist among reviewing jurisdictions. It is more likely that divergence will occur between the established competition authorities (e.g., the United States' and the European Commission's) and the newer competition authorities (e.g., India's and China's).

Outlook and conclusions

The simultaneous district court and administrative court litigation strategy being used by the FTC raises the question of whether there should be different standards for the FTC and the DOJ in reviewing merger cases. Section 13(b) of the FTC Act authorises the FTC in a 'proper case' to seek permanent injunctive relief against entities that have violated or threatened to violate any of the laws it administers.22 The statute provides that an injunction may be granted only 'upon a proper showing that, weighing the equities and considering the Commission's likelihood of ultimate success, such action would be in the public interest'.23 In contrast, under traditional equitable standards, a plaintiff must show a likelihood of success on the merits. The circuit courts have not reached an agreement on what the FTC's burden of proof should be. Reference to a public interest criterion has resulted in some circuits relaxing the standard imposed on the FTC from the traditional equitable standards applicable to the DOJ and other plaintiffs in an injunctive proceeding. There is a bill pending in Congress that would conform the process and standard applied to the two agencies. There are also pending in Congress bills that would potentially radically reform the burdens of proof and standards applied in merger reviews; it is by no means clear that these bills will pass in Congress.

US antitrust enforcement continues unabated as at the time of writing. Despite the covid-19 pandemic, US antitrust agencies have continued to actively investigate and take enforcement actions – through consents and legal challenges – both proposed and consummated transactions. The matters include vertical mergers, minority interests and acquisitions of nascent or potential competitors. It is very likely that the agencies will be faced with many distress transactions in which flailing firm, failing firm and changed competitive dynamics will be raised. In addition, both in Congress and at the federal antitrust agencies, there is increased reflection on the adequacy and usage of the antitrust laws and enforcement to address broader industry and societal policy objectives. Antitrust has already been part of the political debate in the 2020 presidential elections, and will likely remain of interest post-election.


1 Michael S Wise is of counsel and Noah B Pinegar and Mary H Walser are associates at Paul Hastings LLP.

2 FTC, FTC's Bureau of Competition Launches Task Force to Monitor Technology Markets, 26 February 2019, available at

3 Steven Overly and Margaret Harding McGill, 'FTC went to Silicon Valley to solicit antitrust complaints', Politico (7 June 2019), available at

4 Bruce Hoffman, Director, Bureau of Competition, Antitrust in the Digital Economy: A Snapshot of FTC Issues, Remarks at GCR Live Antitrust in the Digital Economy (May 2019), available at

5 FTC, FTC to Examine Past Acquisitions by Large Technology Companies, available at

6 Federal Trade Commission, FTC to Examine Past Acquisitions by Large Technology Companies, available at

7 Diane Bartz and Nandita Bose, 'FTC demands data on small buys by Google, Amazon, Apple, Facebook, Microsoft', Reuters (11 February 2020), available at; see also John D McKinnon and Deepa Seetharaman, 'FTC Expands Antitrust Investigation Into Big Tech', Wall Street Journal (11 February 2020), available at

8 FTC, FTC to Examine Past Acquisitions by Large Technology Companies, available at

9 House Committee on the Judiciary, House Antitrust Subcommittee Issues Document Requests as Part of Digital Markets Investigation, available at

10 id.

11 DOJ, Justice Department Reviewing the Practices of Market-Leading Online Platforms, available at

12 Brent Kendall and Sadie Gurman, 'Justice Department's Antitrust Chief removes himself from Google probe', Wall Street Journal (4 February 2020), available at

13 Tim Hanrahan and Brent Kendall, 'Barr sees Big-Tech Probe Wrapping Up by Next Year', Wall Street Journal (10 December 2019), available at

14 5 U.S.C. § 572(b)(4).

15 138 S. Ct. 2274 (2018).

16 Case No. 1:19-cv-01548 (D. Del. 7 Apr. 2020).

17 Dissenting Statement of Commissioner Rohit Chopra, In the Matter of Bristol-Myers Squibb/Celgene, Comm'n File No. 1910061 (FTC 15 November 2019).

18 Press Release, Klobuchar Leads Letter Warning That Pharmaceutical Mergers May Threaten Drug Competition, Increase Prices and Reduce Patient Access to Essential Medications (17 September 2019).

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