Pfizer Inc. and Mylan N.V.; Analysis of Agreement Containing Consent Orders To Aid Public Comment, 71895-71900 [2020-25021]

Agencies

• FEDERAL TRADE COMMISSION

[Federal Register Volume 85, Number 219 (Thursday, November 12, 2020)]
[Notices]
[Pages 71895-71900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25021]


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FEDERAL TRADE COMMISSION

[File No. 191-0182]


Pfizer Inc. and Mylan N.V.; Analysis of Agreement Containing 
Consent Orders To Aid Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed consent agreement; request for comment.

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SUMMARY: The consent agreement in this matter settles alleged 
violations of federal law prohibiting unfair methods of competition. 
The attached Analysis to Aid Public Comment describes both the 
allegations in the complaint and the terms of the consent order--
embodied

[[Page 71896]]

in the consent agreement--that would settle these allegations.

DATES: Comments must be received on or before December 14, 2020.

ADDRESSES: Interested parties may file comments online or on paper, by 
following the instructions in the Request for Comment part of the 
SUPPLEMENTARY INFORMATION section below. Write: ``Pfizer Inc. and Mylan 
N.V.; File No. 191 0182'' on your comment, and file your comment online 
at https://www.regulations.gov by following the instructions on the 
web-based form. If you prefer to file your comment on paper, please 
mail your comment to the following address: Federal Trade Commission, 
Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 
(Annex D), Washington, DC 20580; or deliver your comment to the 
following address: Federal Trade Commission, Office of the Secretary, 
Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex 
D), Washington, DC 20024.

FOR FURTHER INFORMATION CONTACT: Jasmine Rosner (202-326-3558), Bureau 
of Competition, Federal Trade Commission, 600 Pennsylvania Avenue NW, 
Washington, DC 20580.

SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal 
Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, 
notice is hereby given that the above-captioned consent agreement 
containing a consent order to cease and desist, having been filed with 
and accepted, subject to final approval, by the Commission, has been 
placed on the public record for a period of thirty (30) days. The 
following Analysis of Agreement Containing Consent Orders to Aid Public 
Comment describes the terms of the consent agreement and the 
allegations in the complaint. An electronic copy of the full text of 
the consent agreement package can be obtained from the FTC website at 
this web address: https://www.ftc.gov/news-events/commission-actions.
    You can file a comment online or on paper. For the Commission to 
consider your comment, we must receive it on or before December 14, 
2020. Write ``Pfizer Inc. and Mylan N.V.; File No. 191 0182'' on your 
comment. Your comment--including your name and your state--will be 
placed on the public record of this proceeding, including, to the 
extent practicable, on the https://www.regulations.gov website.
    Due to the public health emergency in response to the COVID-19 
outbreak and the agency's heightened security screening, postal mail 
addressed to the Commission will be subject to delay. We strongly 
encourage you to submit your comments online through the https://www.regulations.gov website.
    If you prefer to file your comment on paper, write ``Pfizer Inc. 
and Mylan N.V.; File No. 191 0182'' on your comment and on the 
envelope, and mail your comment to the following address: Federal Trade 
Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite 
CC-5610 (Annex D), Washington, DC 20580; or deliver your comment to the 
following address: Federal Trade Commission, Office of the Secretary, 
Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex 
D), Washington, DC 20024. If possible, submit your paper comment by 
courier or overnight service.
    Because your comment will be placed on the publicly accessible 
website at https://www.regulations.gov, you are solely responsible for 
making sure that your comment does not include any sensitive or 
confidential information. In particular, your comment should not 
include sensitive personal information, such as your or anyone else's 
Social Security number; date of birth; driver's license number or other 
state identification number, or foreign country equivalent; passport 
number; financial account number; or credit or debit card number. You 
are also solely responsible for making sure your comment does not 
include sensitive health information, such as medical records or other 
individually identifiable health information. In addition, your comment 
should not include any ``trade secret or any commercial or financial 
information which . . . is privileged or confidential''--as provided by 
Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 
16 CFR 4.10(a)(2)--including in particular competitively sensitive 
information such as costs, sales statistics, inventories, formulas, 
patterns, devices, manufacturing processes, or customer names.
    Comments containing material for which confidential treatment is 
requested must be filed in paper form, must be clearly labeled 
``Confidential,'' and must comply with FTC Rule 4.9(c). In particular, 
the written request for confidential treatment that accompanies the 
comment must include the factual and legal basis for the request, and 
must identify the specific portions of the comment to be withheld from 
the public record. See FTC Rule 4.9(c). Your comment will be kept 
confidential only if the General Counsel grants your request in 
accordance with the law and the public interest. Once your comment has 
been posted on https://www.regulations.gov--as legally required by FTC 
Rule 4.9(b)--we cannot redact or remove your comment from that website, 
unless you submit a confidentiality request that meets the requirements 
for such treatment under FTC Rule 4.9(c), and the General Counsel 
grants that request.
    Visit the FTC website at https://www.ftc.gov to read this Notice and 
the news release describing this matter. The FTC Act and other laws 
that the Commission administers permit the collection of public 
comments to consider and use in this proceeding, as appropriate. The 
Commission will consider all timely and responsive public comments that 
it receives on or before December 14, 2020. For information on the 
Commission's privacy policy, including routine uses permitted by the 
Privacy Act, see https://www.ftc.gov/site-information/privacy-policy.

Analysis of Consent Orders To Aid Public Comment

    The Federal Trade Commission (``Commission''has accepted, subject 
to final approval, an Agreement Containing Consent Orders (``Consent 
Agreement'') from Pfizer Inc., Upjohn Inc., Viatris Inc., Mylan N.V., 
and Utah Acquisition Sub Inc., that is designed to remedy the 
anticompetitive effects resulting from the proposed combination of 
Upjohn and Mylan. Under the terms of the Consent Agreement, the parties 
are required to divest Upjohn's generic drug rights and assets related 
to six products to Prasco, LLC. The Consent Agreement also requires the 
parties to divest Mylan's rights and assets related to eplerenone 
tablets to Prasco. Further, the Consent Agreement requires prior 
Commission approval before Upjohn, Mylan, or Viatris may gain an 
interest in or exercise control over any third party's rights to (1) 
levothyroxine sodium tablets, (2) sucralfate tablets, and (3) 
varenicline tartrate tablets.
    The Consent Agreement has been placed on the public record for 
thirty days for receipt of comments from interested persons. Comments 
received during this period will become part of the public record. 
After thirty days, the Commission will again evaluate the Consent 
Agreement, along with the comments received, to make a final decision 
as to whether it should withdraw the Consent Agreement, modify it, or 
make final the proposed Decision and Order (``Order'').
    Pursuant to agreements dated July 29, 2019, Pfizer proposes to spin 
off its Upjohn business, which includes legacy Pfizer branded products 
and the authorized generic business,

[[Page 71897]]

Greenstone, LLC. Upjohn will combine with Mylan to form a new entity, 
Viatris (``Proposed Combination''). The Commission alleges in its 
Complaint that the Proposed Combination, if consummated, would violate 
Section 7 of the Clayton Act, 15 U.S.C. 18, as amended, and Section 5 
of the Federal Trade Commission Act, 15 U.S.C. 45, as amended, by 
lessening current competition in the following seven U.S. markets: (1) 
Amlodipine besylate/atorvastatin calcium tablets, (2) eplerenone 
tablets, (3) gatifloxacin ophthalmic solution, (4) medroxyprogesterone 
acetate injectable solution, (5) phenytoin chewable tablets, (6) 
prazosin hydrochloride (``HCl'') capsules, and (7) spironolactone 
hydrochlorothiazide (``HCTZ'') tablets. The Commission also alleges 
that the Proposed Combination would violate the aforementioned statutes 
by lessening future competition in the markets for: (1) Levothyroxine 
sodium tablets, (2) sucralfate tablets, and (3) varenicline tartrate 
tablets. The Consent Agreement will remedy the alleged violations by 
preserving the competition that otherwise would be eliminated by the 
Proposed Combination.

I. The Products and Structure of the Markets

    In human pharmaceutical markets, price generally decreases as the 
number of generic competitors increases. Prices continue to decrease 
incrementally with the entry of the second, third, fourth, and even 
fifth generic competitor. And in markets prone to supply shortages, 
additional entry after the fifth generic competitor continues to affect 
price and ensures more stable supply. Accordingly, the reduction in the 
number of suppliers within each relevant market has a direct and 
substantial effect on pricing.
    The Proposed Combination would reduce current competition in the 
markets for seven products where Greenstone distributes the authorized 
generic version of the branded drug:
     Amlodipine besylate/atorvastatin calcium tablets combine a 
calcium channel blocker to treat hypertension with a lipid-lowering 
agent to treat high cholesterol. Only four companies sell generic 
amlodipine besylate/atorvastatin calcium tablets: Greenstone, Mylan, 
Dr. Reddy's Laboratories Ltd., and Apotex Inc.
     Eplerenone is a diuretic that is prescribed as an 
adjunctive therapy when treating hypertension or congestive heart 
failure after a heart attack. Significant sellers of eplerenone include 
Greenstone, Mylan, Breckenridge Pharmaceutical, Inc., and Accord 
Healthcare Inc.
     Gatifloxacin ophthalmic solution is an eye drop that 
treats bacterial conjunctivitis caused by susceptible strains of 
certain bacteria. The market for gatifloxacin has faced historical 
supply disruptions. Five companies supply this product today: 
Greenstone, Mylan, Sandoz International GmbH, Akorn, Inc., and Lupin 
Ltd.
     Medroxyprogesterone acetate is an injectable solution used 
to treat certain types of dysfunctional uterine bleeding. Injectable 
products, such as medroxyprogesterone acetate, have recently 
experienced shortages and supply disruptions. Greenstone, Mylan, 
Amphastar Pharmaceuticals, Inc., Teva Pharmaceutical Industries Ltd., 
and Sun Pharmaceutical Industries Ltd. currently supply 
medroxyprogesterone acetate.
     Phenytoin chewable tablets are an anti-epileptic drug that 
slows down impulses in the brain that cause seizures. Only three 
suppliers provide phenytoin chewable tablets today: Greenstone, Mylan, 
and Taro Pharmaceutical Industries Ltd.
     Prazosin HCl capsules are an alpha-adrenergic blocker that 
treats hypertension by relaxing the veins and arteries so that blood 
can more easily pass. The market for prazosin HCl capsules is supplied 
by four companies: Greenstone, Mylan, Teva, and Novitium Pharma LLC.
     Spironolactone HCTZ tablets are a diuretic used to treat 
hypertension. Only three suppliers provide spironolactone HCTZ tablets: 
Greenstone, Mylan, and Sun.
    The Proposed Combination also would reduce future competition in 
the following generic markets:
     Levothyroxine sodium tablets are offered in a host of 
strengths and are prescribed to treat hypothyroidism or as an adjunct 
therapy for patients undergoing treatment for thyroid cancer. Suppliers 
for levothyroxine sodium tablets vary by strength. Should Upjohn or 
Greenstone launch an authorized generic of Pfizer's levothyroxine 
sodium branded product (Levoxyl[supreg]), the Proposed Combination 
likely would reduce the number of independent suppliers from three to 
two in some strengths.
     Sucralfate tablets are used to treat and prevent ulcers in 
the small intestines. Three companies sold sucralfate tablets 
historically: Greenstone, Mylan, and Teva. Mylan recently discontinued 
sales of sucralfate. The Proposed Combination likely alters Mylan's 
incentives to relaunch sucralfate tablets and would reduce the number 
of firms capable of selling sucralfate tablets from three to two.
     Varenicline tartrate tablets are a smoking cessation aid 
offered under Pfizer's brand Chantix[supreg]. Currently, only branded 
Chantix[supreg] is available in the market. Mylan is one of a limited 
number of companies likely to share the Hatch-Waxman 180-day 
exclusivity period when the generic market forms. Should Upjohn or 
Greenstone launch an authorized generic of Pfizer's Chantix[supreg], 
the Proposed Combination would significantly reduce the number of 
independent generic suppliers.

II. Entry

    Entry into the markets at issue would not be timely, likely, or 
sufficient in magnitude, character, and scope to deter or counteract 
the anticompetitive effects of the Proposed Combination. The 
combination of drug development times and regulatory requirements, 
including approval by the FDA, is costly and time-consuming.

III. Competitive Effects

    The Proposed Combination would likely cause significant 
anticompetitive harm to consumers in the relevant generic 
pharmaceutical markets by eliminating current and/or future competition 
in concentrated existing generic markets or in future generic markets. 
In generic pharmaceuticals markets, price is heavily influenced by the 
number of participants with sufficient supply. Market participants 
consistently characterize generic drug markets as commodity markets in 
which the number of generic suppliers has a direct impact on pricing. 
Customers and competitors alike have confirmed that the prices of the 
generic pharmaceutical products at issue continue to decrease with new 
entry even after a number of suppliers have entered these generic 
markets.
    The evidence shows anticompetitive effects are likely because the 
Proposed Combination will reduce the number of independent competitors 
in the markets at issue. In each of the current generic drug markets, 
industry participants have indicated that the presence of Greenstone 
and Mylan as independent competitors has allowed them to negotiate 
lower prices and, in some markets, has improved surety of supply.
    In five of the markets where Upjohn and Mylan currently compete 
(amlodipine besylate/atorvastatin calcium tablets, eplerenone tablets, 
phenytoin chewable tablets, prazosin HCl capsules, and spironolactone 
HCTZ tablets), the Proposed Combination likely would reduce competition 
by combining two of only four or fewer

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current suppliers, likely leading to higher prices. In two of the 
markets where Upjohn and Mylan currently compete and where significant 
product shortages have occurred (gatifloxacin ophthalmic solution and 
medroxyprogesterone acetate injectable solution), the Proposed 
Combination would eliminate an independent supplier. Customers have 
indicated that preserving competition between Upjohn and Mylan, 
particularly in markets prone to shortages, is important to maintaining 
adequate supplies and competitive prices.
    In addition, the Proposed Combination likely would delay or forego 
the introduction of beneficial competition, and subsequent price 
decreases, by eliminating future competition in the markets for generic 
levothyroxine sodium tablets, sucralfate tablets, and varenicline 
tartrate tablets.
    Absent the Consent Agreement, the Proposed Combination would 
eliminate significant current and future competition between the 
parties and likely cause U.S. consumers to pay higher prices for the 
aforementioned generic pharmaceutical products.

IV. The Consent Agreement and Order

    The proposed Order effectively remedies the competitive concerns 
raised by the Proposed Combination for the ten generic pharmaceutical 
product areas at issue. Pursuant to the proposed Order, the parties are 
required to divest to Prasco Upjohn's authorized generic rights and 
assets related to six products. The proposed Order also requires the 
parties to divest Mylan's rights and assets related to eplerenone 
tablets to Prasco. The parties must accomplish these divestitures and 
relinquish their rights no later than ten days after the Proposed 
Combination is consummated. The proposed Order further allows the 
Commission to appoint a trustee in the event the parties fail to divest 
the products.
    Further, the proposed Order requires prior Commission approval 
before Upjohn, Mylan, or Viatris may gain an interest in, or exercise 
control over, any third party's rights to the following products: (1) 
Levothyroxine sodium tablets, (2) sucralfate tablets, and (3) 
varenicline tartrate tablets.
    The Commission's goal in evaluating possible purchasers of divested 
assets is to maintain the competitive environment that existed prior to 
the Proposed Combination. Prasco is a capable purchaser with management 
and employees who have experience marketing and distributing generic 
pharmaceutical products. It will be able to replicate the competition 
otherwise lost from the Proposed Combination.
    The proposed Order contains several provisions to help ensure that 
the divestitures are successful. As to the products and rights being 
divested to Prasco, generic drug manufacturing will continue to be 
performed by the same entity as prior to the Proposed Combination, 
reducing the risk of any interruption in supply to Prasco. In some 
instances, Pfizer--which will be an independent entity, separate from 
Viatris after the Proposed Combination--will serve as Prasco's contract 
manufacturer, allowing Prasco to step into the shoes of Upjohn/
Greenstone. Should Prasco decide to move manufacturing to another 
contract manufacturer, the proposed Order requires the parties to 
provide transitional services to assist Prasco or its designated 
contract manufacturer in establishing manufacturing capabilities and 
securing all necessary FDA approvals. These transitional services 
include technical assistance to manufacture the currently marketed 
products in substantially the same manner and quality employed or 
achieved by the parties. To the extent that Pfizer will manufacture 
relevant products on behalf of both Viatris and Prasco, the proposed 
Order requires that supply to Prasco is provided at a pre-determined 
cost and is prioritized over supply to Viatris. For amlodipine 
besylate/atorvastatin calcium tablets, Viatris will provide the active 
pharmaceutical ingredient (``API'') used in Prasco's product. The 
proposed Order requires that Viatris provide Prasco with API at a pre-
determined cost and that it prioritizes Prasco's use of API over its 
own. Moreover, the proposed Order requires a firewall between Viatris's 
API business and its commercial business to prevent the sharing of 
commercially sensitive information. Under the proposed Order, the 
Commission also will appoint two Monitors.
    The purpose of this analysis is to facilitate public comment on the 
Consent Agreement, and it is not intended to constitute an official 
interpretation of the proposed Order or to modify its terms in any way.
    By direction of the Commission, Commissioner Chopra and 
Commissioner Slaughter dissenting.

April J. Tabor,
Acting Secretary.

Statement of Commissioner Christine S. Wilson

    Today, the Commission announces that it has voted 3-2 to issue a 
complaint and accept a settlement to remedy the threats to competition 
arising from Mylan's proposed acquisition of Pfizer's off-patent drug 
business.
    The experienced staff of the Federal Trade Commission thoroughly 
investigated all cognizable theories of harm to competition during more 
than a year of review. Their extensive investigation put to rest some 
concerns and produced grounds for other concerns. Staff negotiated 
comprehensive remedies to address the potential anticompetitive effects 
identified during their exhaustive investigation--as they have done in 
many transactions in the pharmaceutical sector, including Bristol-Myers 
Squibb/Celgene and AbbVie/Allergan. Yet, as Commissioners Slaughter and 
Chopra did in those merger reviews, they are again opposing the 
settlement of this enforcement action.
    Prices for pharmaceuticals and biologics deserve the attention of 
the American public and the federal government. As I stated in 
connection with the announcement of the FTC's settlement with Bristol-
Myers and Celgene, within its limited civil authority as a competition 
agency, the Commission vigorously pursues a comprehensive agenda to 
address anticompetitive mergers and unlawful conduct in the 
pharmaceutical industry.\1\ I continue to encourage those government 
entities with the appropriate mandates to fix the many problems in this 
sector that lie beyond our jurisdiction.
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    \1\ Statement of Commissioner Christine S. Wilson, In the Matter 
of Bristol-Myers Squibb Company/Celgene Corporation, File No. 191-
0061, Nov. 15, 2019, available at https://www.ftc.gov/system/files/documents/public_statements/1554278/bms-celgene-wilson-statement.pdf.
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Dissenting Statement of Commissioner Rohit Chopra Joined by 
Commissioner Rebecca Kelly Slaughter

Summary

     The FTC's record when it comes to reviewing pharmaceutical 
mergers suggests that the agency will simply never seek to block a 
merger. Instead, the agency's approach is to strike narrow settlements. 
This encourages market actors to propose even more unlawful mergers.
     Both Pfizer and Mylan have been accused of collusion in 
the generic drug business. We must assess whether this merger will 
enhance their ability to conspire and collude.
     Rajiv Malik, who will be president of the merged entity, 
is currently a defendant charged with antitrust

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misconduct. The Commission's silence about his role is deeply 
problematic.
    Drug prices are out of control, and in too many instances, are out 
of reach for patients who depend on them. Competition from generic 
drugs pushes down high prices. That's why it's critical to combat abuse 
of intellectual property that allows branded drug makers to block 
generic entry. But we should also be deeply concerned that patients 
can't reap the full benefits from generic competition, given the 
alleged collusion in the generic drug industry to drive up prices. Any 
investigation of massive mergers in the generic business must take this 
into account.
    Today, the Federal Trade Commission has voted to settle allegations 
that Mylan's (NASDAQ: MYL) proposed $12 billion acquisition of Pfizer's 
(NYSE: PFE) generic drug business is unlawful.\1\ The combined firm 
would become the largest generic pharmaceutical firm in the world and 
offer approximately 3,000 drug products that treat a broad range of 
diseases and conditions.\2\ The FTC's proposed settlement requires 
divestiture of seven individual products, as well as other provisions.
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    \1\ Pfizer, Press Release, Mylan and Upjohn, a Division of 
Pfizer, to Combine, Creating a New Champion for Global Health 
Uniquely Positioned to Fulfill the World's Need for Medicine (July 
29, 2019, 2:45 a.m.), https://www.pfizer.com/news/pressrelease/pressreleasedetail/mylan_and_upjohn_a_division_of_pfizer_to_combine_creating_a_new_champion_for_global_health_uniquely_positioned to fulfill the worlds need 
for medicine.
    \2\ See Mylan & Upjohn Investor Presentation, A New Champion for 
Global Health at 17 (July 29, 2019), https://www.championforglobalhealth.com/media/championforglobalhealth/pdf/mylanupjohninvestorpresentation072919.pdf; see also Mylan & Upjohn 
Fact Sheet, A New Champion for Global Health (n.d.a.), https://www.championforglobalhealth.com/media/championforglobalhealth/pdf/MylanUpjohnFactsheet072919.pdf.
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    When it comes to pharmaceutical mergers, I am unable to identify a 
single instance in recent history where the agency has filed a 
complaint in federal court seeking to halt a prescription drug company 
merger. This lack of litigation creates the strong impression that the 
FTC simply looks to strike settlement deals involving individual 
product divestitures. Virtually every market participant I have spoken 
to in this industry believes that there is simply no risk of the FTC 
blocking an unlawful pharmaceutical merger outright.
    I respectfully disagree with the status quo approach the Commission 
applied to this pharmaceutical merger. The use here is especially 
concerning, since both firms and two of Mylan's top executives have 
been accused of a wide-ranging price fixing and market allocation 
conspiracy in the generic drug industry.\3\ With an expanded empire of 
generic drug products, these alleged antitrust crimes may be even 
easier to perpetrate by the new entity.\4\
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    \3\ See Compl., Connecticut v. Teva Pharms. USA, Inc., Case No. 
3:19-cv-00710 (D. Conn. filed May 10, 2019) ] 50; In re Generic 
Pharms. Pricing Antitrust Litig. ] 34, Civ. Action No. 17-3768 (E.D. 
Pa. filed June 15, 2018).
    \4\ The Department of Justice also charged Teva with criminally 
conspiring to fix prices, rig bids, and allocate customers for 
generic drugs. Five previous corporate cases were resolved by 
deferred prosecution agreements; Teva and its co-conspirator 
Glenmark are awaiting trial. Four executives have also been charged; 
three have entered guilty pleas, and one is awaiting trial. See 
Press Release, Dep't. of Just., Seventh Generic Drug Manufacturer Is 
Charged In Ongoing Criminal Antitrust Investigation (Aug. 25, 2020), 
https://www.justice.gov/opa/pr/seventh-generic-drug-manufacturer-charged-ongoing-criminal-antitrustinvestigation.
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    In this statement, I focus on how mergers involving companies 
competing across a large number of product lines can exacerbate the 
risk of collusive conspiracies, particularly in industries where 
middlemen may not have an incentive to keep prices low.\5\ I also focus 
on issues we must always confront. For example, the Commission should 
always look to testimony from top executives at companies proposing to 
merge in order to fully understand the range of potential effects on 
competition. The Commission can only make a conclusion about the risk 
of collusion and any impacts on competition when it has a full range of 
data and evidence.
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    \5\ Most generic drugs are sold by their manufacturers to group 
purchasing organizations and large retail purchasers, who negotiate 
pricing contracts for their members that ultimately purchase the 
products. These contracts typically have inflation-based provisions 
that allow for potentially greater compensation when prices are 
higher. See In re Generic Pharms. Pricing Antitrust Litig. ] 74.
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Conditions for Collusion

    When competitors enter into agreements to fix prices, rig bids, and 
divvy up markets, they can face civil and criminal charges. Pfizer and 
Mylan are defendants in several state attorneys general and private 
plaintiff lawsuits alleging market allocation and price fixing in the 
generic drug industry.\6\ They are also under investigation for 
criminal market allocation and price fixing by the Department of 
Justice.\7\ Over thirty additional generic drug companies are 
defendants in the same state attorneys general suits, including well-
known drug firms Sandoz, Actavis, Teva, and Allergan, among others. 
Patients have allegedly paid many billions of dollars in overcharges 
for the generic drugs involved, causing a significant negative impact 
on our national health and economy.\8\
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    \6\ See e.g., Pl. States' Consol. Am. Compl., In re Generic 
Pharms. Pricing Antitrust Litig.; Compl., Connecticut v. Teva 
Pharms.; Compl., Connecticut v. Sandoz, Inc., Civ. Action No. 3:20-
cv-802 (D. Conn. filed June 10, 2020).
    \7\ See Pfizer Inc., Current Report (Form 8-K) (Aug. 6, 2020) at 
175; Mylan N.V., Annual Report (Form 10-K) (Dec. 31, 2019) at 153.
    \8\ Compl., Connecticut v. Teva Pharms. USA, Inc. ] 5.
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    Typically, collusion is easier to pull off when a market has only a 
few big players, since coordination is more difficult with more 
actors.\9\ However, there are many generic drug companies that operate 
in the United States. So why might there be widespread misconduct?
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    \9\ This concept is reflected in the FTC's Horizontal Merger 
Guidelines. U.S. DEP'T OF JUST. & FED. TRADE COMM'N, HORIZONTAL 
MERGER GUIDELINES Sec.  7.2 (Aug. 19, 2010), https://www.justice.gov/sites/default/files/atr/legacy/2010/08/19/hmg-2010.pdf.
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    One potential explanation is that these companies compete with each 
other in multiple different product markets. The enormous profit 
potential for these firms from collusion likely contributes to their 
incentives to engage in mutually beneficial coordination. By trading 
favorable competitive terms in one market for favorable competitive 
terms in another market, it may be easier for competing firms to reach 
mutually beneficial terms of trade and punish each other for any 
deviations.\10\
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    \10\ See Federico Ciliberto & Jonathan W. Williams, Does 
multimarket contact facilitate tacit collusion? Inference on conduct 
parameters in the airline industry, 45 RAND J. OF ECON. 764-791 
(2014) (noting that such multimarket contact facilitates tacit 
collusion in the U.S. airline industry).
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    Pfizer and Mylan allegedly did just that.\11\ In addition to 
colluding within individual generic drug product markets, Pfizer's 
Greenstone division, Mylan, and others are charged with trading 
customers across different drug markets.\12\ They allegedly allowed 
price increases on generic drugs without competing, based on a quid pro 
quo from competitors on different drug products.\13\ Given these 
allegations, it is important that we closely investigate how this 
transaction could increase the ability of the merged entity to engage 
in similar--or even more harmful--collusive conduct. For example, the 
merged entity would become the top supplier of generic drugs by global 
revenues, with an enormous number of

[[Page 71900]]

products and a broad range of competitors with which to engage in quid 
pro quo collusive arrangements.\14\ With more generic drugs in the 
hands of one competitor, it may be easier to form a cartel and punish 
those who don't adhere to its terms. Despite this risk, the 
Commission's analysis is silent with respect to the alleged price 
fixing conduct.\15\
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    \11\ Compl., In re Generic Pharms. Pricing Antitrust Litig. ]] 
103-105 (describing Defendant Malik's willingness to ``play fair'' 
and give up two large customers to Heritage because Heritage had 
previously allowed Mylan to enter another market without 
competition); see also Compl., Connecticut v. Sandoz, Inc. ] 1299.
    \12\ Id.
    \13\ Compl., In re Generic Pharms. Pricing Antitrust Litig. ] 
101; see also Compl., Connecticut v. Teva Pharms ] 12.
    \14\ Beth Snyder Bulik, Mylan and Pfizer roll out tricolor 
branding for their giant generics combo, Viatris, FIERCEPHARMA (July 
9, 2020, 10:06 a.m.), https://www.fiercepharma.com/marketing/mylan-and-pfizer-debuts-new-viatris-generics-merged-brandunveils-tri-color-logo-for.
    \15\ See, e.g., Analysis Of Agreement Containing Consent Orders 
To Aid Public Comment, In the Matter of Pfizer Inc./Mylan N.V., File 
No. 191 0182 (Oct. 29, 2020).
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    The FTC often acts without the benefit of the experience of other 
law enforcement partners.\16\ In all matters, the Commission should 
avoid a go-it-alone approach and collaborate with other agencies to 
help shed light on the mechanisms involved in the allegations. 
Together, we should closely assess whether the likelihood of harm 
increases post-merger.
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    \16\ See Statement of Commissioner Rohit Chopra In the Matter of 
AbbVie, Inc./Allergan plc, File No. 191 0169, 2, 19 (May 5, 2020), 
https://www.ftc.gov/system/files/documents/public_statements/1574583/191_0169_dissenting_statement_of_commissioner_rohit_chopra_in_the_matter_of_abbvie-allergan_redacted.pdf; see also Statement of 
Commissioner Rohit Chopra In the Matter of Social Finance, Inc., 
File No. 162 3917 (Oct. 29, 2018), https://www.ftc.gov/system/files/documents/public_statements/1418711/162_3197_statement_of_commissioner_chopra_on_sofi_10-29-18.pdf.
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Investigating Executives

    In any matter where a company has a history of potential 
wrongdoing, a key method to determine the motivations for a merger and 
to predict how it will affect competition is to seek sworn testimony 
from key executives. This is especially critical to understand how 
sales, pricing, and market forces are working. This evidence is also 
helpful if the agency must prepare a lawsuit.
    While filings submitted by merging parties shed light on many 
aspects of a transaction, they do not always provide a complete picture 
of the deal rationale, pricing models, and boardroom behavior. The 
state allegations of price fixing and market allocation make clear that 
individual executives play a key role in sales and price setting, so it 
is critical that we fully understand this element of the competitive 
process. For example, what is their involvement in developing a pricing 
model? Do they approve deviations from this pricing model? How do they 
decide which new markets to enter? In what contexts do they interact 
with their competitors? There are a long list of questions that are 
absolutely essential in an inquiry like this.
    In this transaction, one of the alleged masterminds of the ongoing 
price fixing and market allocation schemes is Rajiv Malik, Mylan's 
current president, who is a named defendant in one of the state 
lawsuits.\17\ A second Mylan executive, Vice President of Sales James 
Nesta, is also a named defendant in one of the cases.\18\ The merging 
parties have publicly announced that Mr. Malik will retain the top 
executive role in the expanded generic drug empire, if the transaction 
closes.\19\ As president, he will be in charge of the merged entity's 
sales and marketing operations.\20\ He will also serve on the merged 
company's board.\21\
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    \17\ Compl., In re Generic Pharms. Pricing Antitrust Litig. ] 
34.
    \18\ See Compl., Connecticut v. Teva Pharms. USA, Inc. ] 50.
    \19\ See Pfizer Press Release, supra note 1.
    \20\ Compl., In re Generic Pharms. Pricing Antitrust Litig. ] 
34.
    \21\ See Pfizer Press Release, supra note 1.
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    Mr. Malik's role in the alleged price fixing scheme is significant. 
He allegedly conceived and directed many of the schemes.\22\ In one 
example, he is alleged to have agreed to cede market share in one 
market to a specific competitor in exchange for an agreement from that 
competitor to allow Mylan to enter a different market without 
competition.\23\
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    \22\ Compl., In re Generic Pharms. Pricing Antitrust Litig. ] 
10.
    \23\ Id. ] 188.
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    Despite the alarm bells raised by Mr. Malik's planned role in the 
merged firm, the Commission's analysis does not discuss his involvement 
in the ongoing price fixing and market allocation allegations in the 
industry or his plans for the company. In my view, the Commission owes 
the public a clear explanation about Mr. Malik's role. In matters like 
this, it is critical that the Commission rely on a wide range of data 
and evidence, including testimony from key executives.\24\
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    \24\ This is particularly important in industries where the 
Commission cannot rely on evidence and testimony from customers who 
act as middlemen. We know from the allegations in the state 
attorneys general lawsuits that drug wholesalers and large retailers 
allegedly benefit when generic drug prices are higher. These firms 
have contractual provisions allowing for potentially greater 
compensation when prices are higher. Id. ]] 71-75.
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Conclusion

    I am concerned that executives in the pharmaceutical industry 
routinely propose anticompetitive mergers without any fear that their 
transactions will ever be blocked. In my view, the status quo approach 
of seeking settlements through divestitures of individual products is 
myopic and misses some of the fundamental elements of how firms compete 
in this industry. I am also not aware of any instance where the 
Commission publicly relied on the testimony under oath of a 
pharmaceutical executive in approving a pharmaceutical divestiture 
settlement.
    Unless we change our approach, anticompetitive mergers in the 
pharmaceutical industry will continue unabated, and we will all suffer 
for it. I appreciate the diligence of our staff, who work at the 
direction of the Commission. Unfortunately, the directives of the 
Commission are deeply flawed, favoring routine over rigor. For all 
these reasons, I respectfully dissent.

[FR Doc. 2020-25021 Filed 11-10-20; 8:45 am]
BILLING CODE 6750-01-P