FTC Requires Bristol-Myers Squibb Company and Celgene Corporation to Divest Psoriasis Drug Otezla as a Condition of Acquisition

Pharmaceutical and biologic manufacturers Bristol-Myers Squibb Company, or BMS, and Celgene Corporation have agreed to divest Celgene’s Otezla, the most popular oral treatment in the United States for moderate-to-severe psoriasis, for $13.4 billion. This divestiture would settle Federal Trade Commission charges that BMS’s proposed $74 billion acquisition of Celgene would violate federal antitrust law. The proposed divestiture is the largest that the FTC or the U.S. Department of Justice has ever required in a merger enforcement matter.

“The Commission has ordered BMS to divest Otezla to preserve BMS’s incentive to continue developing its own oral product for treating moderate-to-severe psoriasis,” said Chairman Joseph J. Simons. “The antitrust laws protect not only competition today, but competition in the future, especially when it comes to the development of new treatments for chronic conditions.”

The FTC alleges that, as proposed, BMS’s acquisition of Celgene would harm consumers in the U.S. market for treatments taken orally for moderate-to-severe psoriasis. BMS has a pipeline product under development that is considered the most advanced oral treatment for moderate-to-severe psoriasis. According to the complaint, BMS’s pipeline product will likely be the next entrant into the market and would compete directly with Otezla.

Psoriasis is a chronic skin disease caused by an overactive immune system. The disease causes skin cells to multiply faster than normal and leads to a build-up of cells on the skin surface, forming bumpy red patches that are covered with white scales, known as plaques.  Several older oral generic drugs are approved by the FDA to treat psoriasis that does not respond to topical medication and light therapy, but most doctors now prescribe treatments that have better efficacy or safety, or less onerous side effects, according to the complaint. While many injectable and infused products are approved to treat moderate-to-severe psoriasis, some patients object to them or find them inconvenient.

The complaint alleges that the acquisition would substantially lessen competition and tend to create a monopoly by eliminating future competition between BMS and Celgene in developing, manufacturing and selling oral products to treat moderate-to-severe psoriasis in the United States. New competitors in this market would face lengthy delays for both drug development and FDA approval. As a result, entry into this market would not be timely, likely, or sufficient to deter the anticompetitive effects of the acquisition.

Under the terms of the proposed consent order, the parties will divest Celgene’s worldwide Otezla business—including its regulatory approvals, intellectual property, contracts, and inventory—to Amgen, Inc. no later than 10 days after consummating the proposed acquisition. Amgen, a California-based pharmaceutical and biologic company, has the expertise, U.S. sales infrastructure, and resources to restore the competition that otherwise would have been lost due to the proposed acquisition.

If the Commission determines that Amgen is not an acceptable acquirer, or that the manner of the divestitures is not acceptable, the proposed order requires the parties to unwind the sale of Celgene’s worldwide Otezla business to Amgen, and then divest that business to a Commission-approved acquirer within six months of the date the order.

Further details about the consent agreement are set forth in the analysis to aid public comment for this matter. The proposed order allows the Commission to appoint a monitor to ensure that the parties comply with all their obligations under the consent agreement and that the Commission stays informed about the status of the divestiture. Also under the order, the Commission may appoint a trustee in the event that Bristol-Myers Squibb and Celgene fail to divest the products as required.

The Commission vote to issue the complaint and accept the proposed consent order for public comment was 3-2, with Commissioners Noah Joshua Phillips and Christine S. Wilson issuing separate statements, and Commissioners Rohit Chopra and Rebecca Kelly Slaughter issuing dissenting statements.  The FTC will publish the consent agreement package in the Federal Register shortly. Instructions for filing comments appear in the published notice. Comments must be received 30 days after publication in the Federal Register. Once processed, comments will be posted on Regulations.gov.

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. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of up to $42,530.

The Federal Trade Commission works to promote competition, and protect and educate consumers. You can learn more about how competition benefits consumers or file an antitrust complaint. Like the FTC on Facebook, follow us on Twitter, read our blogs, and subscribe to press releases for the latest FTC news and resources.

IRS: Eligible employees can use tax-free dollars for medical expenses

IR-2019-184, November 15, 2019

WASHINGTON — With health care open season now under way at many workplaces, the Internal Revenue Service today reminded workers they may be eligible to use tax-free dollars to pay medical expenses not covered by other health plans.

Eligible employees of companies that offer a health flexible spending arrangement (FSA) need to act before their medical plan year begins to take advantage of an FSA during 2020. Self-employed individuals are not eligible.

An employee who chooses to participate can contribute up to $2,750 through payroll deductions during the 2020 plan year. Amounts contributed are not subject to federal income tax, Social Security tax or Medicare tax. If the plan allows, the employer may also contribute to an employee’s FSA.

Throughout the year, employees can use FSA funds for qualified medical expenses not covered by their health plan. These can include co-pays, deductibles and a variety of medical products. Also covered are services ranging from dental and vision care to eyeglasses and hearing aids. Interested employees should check with their employer for details on eligible expenses and claim procedures.

Under the FSA use-or-lose provision, participating employees normally must incur eligible expenses by the end of the plan year or forfeit any unspent amounts. However, employers can, if they choose to, offer an option for participating employees to have more time to use FSA money.

  • Under the carryover option, an employee can carry over up to $500 of unused funds to the following plan year. For example, an employee with unspent funds at the end of 2019 would still have those funds available to use in 2020.
  • Under the grace period option, an employee has until two and a half months after the end of the plan year to incur eligible expenses. For example, March 15, 2020, for a plan year ending on Dec. 31, 2019.
  • Employers can offer either option (not both) or no option.

Employers are not required to offer FSAs. Interested employees should check with their employer to see if they offer an FSA. More information about FSAs can be found at IRS.gov in Publication 969, Health Savings Accounts and Other Tax-Favored Health Plans.

 

Readout on the International Association of Insurance Supervisors Annual Meeting

A U.S. Treasury Spokesperson issued the following readout at the conclusion of the Insurance Capital Standard (ICS) negotiations with the International Association of Insurance Supervisors (IAIS):

WASHINGTON – The U.S. Treasury’s Federal Insurance Office registered its official objection to the IAIS’s advancement of version 2.0 of the ICS into a five-year monitoring period. 

U.S. Treasury’s Federal Insurance Office, the Federal Reserve Board, and the National Association of Insurance Commissioners and the U.S. states – together known as Team USA – worked together closely during negotiations at the IAIS; however, U.S. Treasury ultimately was not able to support the IAIS proposal on version 2.0 of the ICS. 

U.S. insurers should not face pressure to participate in a reference ICS that is not expected to apply in the United States and does not fit our markets. The current form of the ICS could also risk limiting U.S. consumers’ access to important long-term saving products.

U.S. Treasury will continue to work collaboratively as part of Team USA in our engagement with the IAIS during the ICS monitoring period. Throughout, U.S. Treasury will continue to honor its core principle of protecting U.S. interests.

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Updated FFIEC IT Examination Handbook – Business Continuity Management Booklet

FIL-71-2019
November 14, 2019

Updated FFIEC IT Examination Handbook – Business Continuity Management Booklet

Printable Format:

FIL-71-2019 – PDF (PDF Help)

Summary:

The Federal Financial Institutions Examination Council (FFIEC) issued the Business Continuity Management (BCM) booklet, which is part of the FFIEC Information Technology Examination Handbook. The booklet replaces the Business Continuity Planning booklet issued in February 2015.

Statement of Applicability to Institutions under $1 Billion in Total Assets: This Financial Institution Letter (FIL) applies to all FDIC-supervised financial institutions.

Highlights:

  • The BCM booklet describes principles and practices for managing business continuity. The booklet also helps examiners determine whether management adequately addresses risks related to the availability of critical financial products and services.
  • The booklet also contains updated procedures to help examiners evaluate the adequacy of an entity’s business continuity management program.
  • The change from business continuity planning to business continuity management reflects the expanded role information technology (IT) plays in supporting business operations and meeting customer expectations.
  • The booklet focuses on assessing an entity’s resilience through an enterprise risk management (ERM) perspective that considers technology, business operations, communication strategies, training, testing, maintenance, and improvement — issues critical to business continuity. The degree of maturity, integration and documentation between the BCM and ERM processes should be assessed commensurate with the entity’s size, complexity, and risk profile.
  • The incorporation of industry principles and frameworks provides examiners with a durable means to assess business continuity management. The changes do not impose new requirements on examined entities.

FTC Criminal Liaison Unit Presents Award to USPIS Team Leader Lisa D. Mayberry

The Federal Trade Commission’s Criminal Liaison Unit honored Lisa D. Mayberry, a Team Leader in the U.S. Postal Inspection Service’s Los Angeles Division, with its 2019 Consumer Shield Award. The Criminal Liaison Unit (CLU) presents the award every two years to recognize a criminal investigator who exemplifies the spirit of cooperation that the CLU seeks to promote.

“American consumers have benefitted immeasurably from the excellent law enforcement partnership between the FTC and the U.S. Postal Inspection Service,” said FTC Associate Director James Kohm. “Lisa’s invaluable service is a great example of that partnership and illustrates why it is so important.”

Ms. Mayberry has provided critical assistance to FTC attorneys on a range of cases combatting fraud over many years, including enforcement actions against those who have deceptively marketed mortgage relief, student loan debt relief, discount clubs, real estate investments, and health products. Her work has helped the FTC identify the people behind these schemes, locate the telemarketing boiler rooms where they operated, and secure evidence at fraudulent business locations. Ms. Mayberry’s support has helped the FTC bring actions halting schemes that defrauded thousands of consumers out of millions of dollars. Her assistance has been a great benefit to American consumers.

The FTC often coordinates with criminal law enforcement to ensure the successful prosecution of fraudsters who prey on American consumers. Since its inception in 2003, the FTC’s CLU has contributed to the successful criminal prosecution of more than a thousand fraudulent telemarketers, phantom debt and mortgage relief scammers, immigration fraudsters, and others who prey on American consumers.

The Federal Trade Commission works to promote competition, and protect and educate consumers. You can learn more about consumer topics and file a consumer complaint online or by calling 1-877-FTC-HELP (382-4357). Like the FTC on Facebook, follow us on Twitter, read our blogs, and subscribe to press releases for the latest FTC news and resources.

FTC Submits Comment in Favor of Massachusetts House Bill 1869, which would Expand Scope of Practice for Podiatrists

The Federal Trade Commission staff has submitted a comment to Massachusetts State Representative Paul Donato in support of a bill before the Massachusetts legislature, which would allow podiatrists to treat not just the foot, but also the lower leg.

The FTC staff’s letter to Rep. Donato on House Bill 1869/Senate Bill 1329 states that “allowing health care professionals to provide additional services that are within the scope of their training should yield procompetitive benefits for Massachusetts’s health care consumers, which may include lower costs, shorter wait times for appointments, and increased access to lower leg health care across the state.”

The letter urges lawmakers to avoid restrictions on podiatrists that are not narrowly tailored to address well-founded patient safety concerns. It also notes that the aging population and increase in chronic conditions such as diabetes and obesity in the United States is likely to lead to increased demand for medical and surgical foot and ankle care.

The Commission vote approving the comment of the staffs of the FTC’s Office of Policy Planning, Bureau of Competition, and Bureau of Economics to State Representative Paul Donato in support of HB1869/SB1329 was 5-0. (The staff contact is Sarah D. Mackey, Office of Policy Planning, 202-326-3254.)

The Federal Trade Commission works to promote competition, and protect and educate consumers. You can learn more about how competition benefits consumers or file an antitrust complaint. Like the FTC on Facebook, follow us on Twitter, read our blogs, and subscribe to press releases for the latest FTC news and resources.

IRS updates guidance for deductible business, charitable, medical and moving expenses

IR-2019-183, November 14, 2019

WASHINGTON — The Internal Revenue Service today issued guidance for taxpayers with certain deductible expenses to reflect changes resulting from the Tax Cuts and Jobs Act (TCJA).

Revenue Procedure 2019-46 (PDF), posted today on IRS.gov, updates the rules for using the optional standard mileage rates in computing the deductible costs of operating an automobile for business, charitable, medical or moving expense purposes.

The guidance also provides rules to substantiate the amount of an employee’s ordinary and necessary travel expenses reimbursed by an employer using the optional standard mileage rates. Taxpayers are not required to use a method described in this revenue procedure and may instead substantiate actual allowable expenses provided they maintain adequate records.

The TCJA suspended the miscellaneous itemized deduction for most employees with unreimbursed business expenses, including the costs of operating an automobile for business purposes. However, self-employed individuals and certain employees, such as Armed Forces reservists, qualifying state or local government officials, educators and performing artists, may continue to deduct unreimbursed business expenses during the suspension.

The TCJA also suspended the deduction for moving expenses. However, this suspension does not apply to a member of the Armed Forces on active duty who moves pursuant to a military order and incident to a permanent change of station.

Apple launches three innovative studies today in the new Research app

Cupertino, California — Apple today announced that customers in the US can enroll in three landmark health studies — the Apple Women’s Health Study, the Apple Heart and Movement Study, and the Apple Hearing Study. Conducted in partnership with leading academic and research institutions, these multi-year longitudinal studies are available in the new Research app, which can be downloaded today from the App Store. Now participants can contribute to potentially groundbreaking medical discoveries with iPhone and Apple Watch, and help create the next generation of innovative health products.1

“Today marks an important moment as we embark on research initiatives that may offer incredible learnings in areas long sought after by the medical community,” said Jeff Williams, Apple’s chief operating officer. “Participants on the Research app have the opportunity to make a tremendous impact that could lead to new discoveries and help millions lead healthier lives.”

Now it’s easier than ever to contribute to medical research through a streamlined enrollment process and engaging tasks in a straightforward and secure app. After enrolling in a study, participants using Apple Watch and iPhone can contribute useful data around movement, heart rate and noise levels — captured during everyday activities, from taking a walk to attending a concert. The Research app joins Apple’s lineup of products and services that enable medical discovery on a scale never before attempted, including iPhone, Apple Watch, ResearchKit and HealthKit.

The Apple Women’s Health Study 

There is a great opportunity to better understand menstrual cycles and how they relate to women’s health. The Apple Women’s Health Study is the first long-term study of this scale and scope; it aims to advance the understanding of menstrual cycles and their relationship to various health conditions, including polycystic ovary syndrome (PCOS), infertility, osteoporosis and menopausal transition. Conducted in partnership with Harvard T.H. Chan School of Public Health and the NIH’s National Institute of Environmental Health Sciences (NIEHS), the study will use iPhone and Apple Watch to collect study-specific data like cycle tracking information, and use monthly surveys to understand each participant’s unique menstrual experience. The study seeks to analyze the impact of certain behaviors and habits on a wide breadth of reproductive health topics.

BRP TO PRESENT ITS THIRD QUARTER RESULTS FOR FISCAL YEAR 2020

Valcourt, Quebec, November 13, 2019 – BRP Inc. (TSX:DOO; NASDAQ:DOOO) will hold its third quarter FY2020 financial results conference call on Wednesday, November 27, 2019.

José Boisjoli, President and Chief Executive Officer, and Sébastien Martel, Chief Financial Officer, will present the results of the third quarter of FY2020 and address questions from analysts on a conference call at 9 a.m. (EST).

The press release will be distributed on Canadian and American newswires on Wednesday, November 27 at approximately 6 a.m. (EST).

For investors and analysts:

Telephone:                                                      514-392-0235 or

                                                                        1-800-377-0758 (toll-free in North America)

                                                                        Event code 4313848

                                                                        Click here for international dial-in numbers

Webcast:                                                         Click here to access the webcast

Business media are allowed to join the call but will not be permitted to ask questions. This webcast will also be live on the Internet here and accessible to media and interested participants. An archived recording will be available here two hours after the event for 30 days following the original broadcast.

About BRP

We are a global leader in the world of powersports vehicles, propulsion systems and boats built on over 75 years of ingenuity and intensive consumer focus. Our portfolio of industry-leading and distinctive products includes Ski-Doo and Lynx snowmobiles, Sea-Doo watercraft, Can-Am on- and off-road vehicles, Alumacraft, Manitou and Telwater boats, Evinrude and Rotax marine propulsion systems as well as Rotax engines for karts, motorcycles and recreational aircraft. We complete our lines of products with a dedicated parts, accessories and clothing to fully enhance the riding experience. With annual sales of CA$5.2 billion from over 120 countries, our global workforce is made up of more than 12,500 driven, resourceful people.

www.brp.com

@BRPnews

Ski-Doo, Lynx, Sea-Doo, Can-Am, Rotax, Evinrude, Alumacraft, Manitou, Telwater and the BRP logo are trademarks of Bombardier Recreational Products Inc. or its affiliates. All other trademarks are the property of their respective owners.

For media enquiries:                                     For investor relations:

Elaine Arsenault                                               Philippe Deschênes

Senior Advisor, Media Relations                      Manager Treasury and Investor Relations

Tel.: 514.732.7092                                            Tel.: 450.532.6462

[email protected]                                             [email protected]

FTC Testifies before House Judiciary Subcommittee On Competition Enforcement and Policy, Including in Technology Markets

In testimony before the House Subcommittee on Antitrust, Commercial and Administrative Law, the Federal Trade Commission described its enforcement and policy work to promote competition in U.S. markets, including high-priority efforts to address technology markets.

Testifying on behalf of the FTC, Chairman Joe Simons highlighted recent Commission enforcement actions to stop anticompetitive mergers and conduct.

With respect to technology markets, the testimony states, the Commission has prioritized efforts to monitor, study, and, where necessary, bring enforcement actions to maintain competition. This year, the FTC’s Bureau of Competition announced the creation of a Technology Enforcement Division to monitor competition and recommend enforcement action when warranted.

“Given the importance of these markets to consumers and to the economy, the Commission is committed to vigorous enforcement of the antitrust laws to promote current and future competition in critical technology markets,” the testimony states.

The testimony recounts the monopolization case that the Commission brought in April 2019 against the health information technology company Surescripts LLC. The FTC’s complaint alleges that Surescripts employed both vertical and horizontal restraints to maintain its dominant position in two electronic prescription markets: routing and eligibility.

Current law provides the Commission with several potential avenues to counter anticompetitive conduct by large technology firms that seek to thwart nascent and potential threats by acquisition or other means, the testimony states. The Commission pays particularly close attention when an industry leader seeks to acquire an up-and-coming competitor that is changing customer expectations and gaining sales. Under certain circumstances, the acquisition of an emerging or nascent competitor may constitute anticompetitive conduct that illegally maintains a monopoly position, the testimony states.

The Commission also has relied on a theory of potential competition to require relief in numerous pharmaceutical markets where one firm had a product on the market while the other merging firm had a product in development that would likely compete in the near future. The testimony notes, however, that future competition cases pose challenges in weighing and assessing evidence, since predictions about entry can often be called into question.

The testimony also notes the FTC’s engagement with international counterparts and organizations, and its robust research and policy function. As part of its commitment to examining the effectiveness of its antitrust enforcement efforts, the Commission has held a series of hearings on competition and consumer protection topics over the last year, the testimony states. Several panels discussed issues relating to technology and the digital economy, including the acquisition of potential or nascent competitors in the digital marketplace.

The Commission voted 5-0 to approve the testimony and include it in the formal record.

The Federal Trade Commission works to promote competition, and protect and educate consumers. You can learn more about how competition benefits consumers or file an antitrust complaint. Like the FTC on Facebook, follow us on Twitter, read our blogs, and subscribe to press releases for the latest FTC news and resources.