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Heather Bresch (née Manchin; born June 27, 1969[2]) is an American business executive. In 2012, she was named as the chief executive officer (CEO) of Netherlands-based pharmaceutical company Mylan, becoming the first woman to run a Fortune 500 pharmaceutical company.[3] Bresch retired in 2020, upon the closing of Mylan’s combination with Upjohn. Bresch has been a central figure in two controversies: a 2007 accusation of inflating her resume with an unearned MBA degree, and as the CEO of Mylan during the 2016 controversy over pricing of the company's EpiPen products. In 2015, she was listed as #22 in Fortune magazine's “Most Powerful Women” list.[4]

Key Information

Bresch is the daughter of former West Virginia Governor and former U.S. Senator Joe Manchin.

Early life

[edit]

Born Heather Renée Manchin, in Morgantown, West Virginia, Bresch grew up in Fairmont and Farmington, West Virginia, in a Roman Catholic family of partial Italian and Czech descent.[5] She is the daughter of Gayle Conelly Manchin and Joe Manchin, who was a prominent politician throughout her childhood and was the senior United States senator from West Virginia until January 3, 2025.[6]

Bresch attended Fairmont Senior High School in Fairmont, West Virginia,[7] and graduated from West Virginia University (WVU) in 1991 with a bachelor's degree in political science and international relations.[8] She also landed her first job in 1991, working as a clerk for Mylan.[9]

MBA controversy

[edit]
Main article: West Virginia University M.B.A. controversy

In 2007, The Pittsburgh Post-Gazette reported that Bresch had claimed to have an MBA degree from West Virginia University, but the university disputed that.[10] The university subsequently awarded her an EMBA despite her having completed only 26 of the required 48 credits. Her father was governor of the state of West Virginia at the time.[11]

In the ensuing controversy, the university announced in April 2008 that it would rescind Bresch's degree. Michael Garrison, WVU president at the time, was reported to be "a family friend and former business associate of Bresch" and a former consultant and lobbyist for Mylan.[10][12] After a faculty vote of no confidence, Garrison and several university officials subsequently resigned.[11][13]

Career

[edit]

Early work

[edit]

In 1992, Bresch started working as a clerk in a factory owned by Mylan, a generic drug company, and rose through the company to become the chief executive officer in 2012.[14] At a WVU basketball game in 1992, Bresch's father, politician Joe Manchin, mentioned his daughter's job search to Mylan CEO Milan Puskar, and the company soon after offered her a position in the quality control department of a factory in Morgantown, before eventually promoting her to the executive level.

Government relations and advocacy

[edit]

From 2002 to 2005, Bresch served as Mylan's director of government relations.[15] She contributed to the development of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, which created Medicare Part D, a prescription-drug benefit.[16]

In 2006, Bresch testified before the U.S. Senate Special Committee on Aging to lobby for changes to the law that would prevent pharmaceutical companies from raising challenges to the introduction of generic competitors by filing citizen's petitions with the FDA, and that would prevent pharma companies from undercutting the profits of generic drug companies by making deals for authorized generics to be introduced.[17]

When Mylan expanded internationally, Bresch noticed that Mylan's U.S.-based pharmaceutical manufacturing plant had full-time staff from the Food and Drug Administration (FDA) devoted to it, whereas facilities abroad had not been inspected by the FDA for more than a decade.[18]

Bresch persuaded fellow American generic drug manufacturers to support the Generic Drug User Fee Act of 2012, which now forces generic drug manufacturers to fund increased FDA inspections of offshore manufacturing plants.[18][19][20] While the law has achieved its goal of equalizing the regulatory burden of American generic drug manufacturers, this change increased the price of some generic drugs since foreign manufacturers were forced to invest in greater quality control measures.[21][22]

Mylan executive

[edit]

Bresch has served in several executive roles at Mylan, such as senior vice president of corporate strategic development,[23] Head of North American Operations,[24] chief operating officer, and chief integration officer.[19][25]

Bresch led the integration of Matrix Laboratories Limited and Merck KGaA's generics and specialty pharmaceutical businesses with Mylan's operations.[19] She was chair of the Generic Pharmaceutical Association (GPhA) for two terms.[26] Bresch was appointed president of Mylan in 2009[19] and joined Mylan's board of directors in March 2011.[27]

Bresch's appointment as chief executive officer (CEO) was announced in 2011, and she officially took the position in January 2012.[19] Bresch was the first female CEO of a large pharmaceutical business.[28] At the time, she was one of 18 female CEOs of a Fortune 500 company.[29] After seeing how few female candidates were available for positions that require a background in science and math, she became more interested in promoting math and science education among young girls.[30]

Bresch was recognized in Esquire's 2011 "Patriots of the Year" list for her work pushing for the Food and Drug Administration Safety and Innovation Act (FDASIA).[31] She was named one of Fortune magazine's "50 Most Powerful Women In Business" in 2014.

Also in 2014, Bresch and Mylan announced a $5.3 billion acquisition of Abbott Laboratories[32] as part of a corporate tax inversion plan to re-organize the company in the Netherlands and move its domicile to a country with lower taxes.[33] Bresch said the decision was necessary to "maintain competitiveness against pharmaceutical manufacturers that had already executed similar inversion strategies."[31] The company completed the complex tax inversion in February 2015.[34] The inversion—which formally resulted in the creation of a new company, Mylan N.V., with 78% of its shares held by former Mylan Inc. shareholders and 22% of its shared held by Abbott Labs shareholders—was expected to immediately drop Mylan's U.S. corporate tax rate to 21% (from 24%) in the first year "and into the high teens over the next three to five years."[34] The New York Times said that it was somewhat "disconcerting" for a company that benefits from large government contracts to renounce their citizenship for tax benefits.[31] Proxy filings show that from 2007 to 2015, Bresch's compensation rose from $2,453,456 to $18,931,068, a 671% increase in pay.[35][36]

EpiPen pricing and retirement

[edit]

In 2016, Mylan's pricing of the EpiPen, used to treat anaphylaxis (severe allergic reactions), was severely criticized. Mylan had secured the rights to the nearly 50-year-old EpiPen as part of the Merck KGaA deal in 2007.[35] At that time annual sales were around $200 million.[37] Bresch launched an advertising campaign to increase awareness of "EpiPen" as a treatment for anaphylaxis; the company also successfully lobbied the FDA to broaden the label to include risk of anaphylaxis and in parallel, successfully lobbied Congress to generate legislation making EpiPens available in schools and other public places. The company hired the same lobbyists that Medtronic had used for its defibrillator legislation.[37][38] From 2007 to 2016, Mylan increased the price of EpiPens by 461 percent, from about $100 for a package of two pens to about $600.[36] By the first half of 2015, Mylan had an 85% market share of such devices in the U.S.,[37] and in that year sales reached around $1.5 billion and accounted for 40% of Mylan's profit.[39] The price increase was met with widespread criticism of Bresch and Mylan.[35][40][41][42] Bresch explained at the 2016 Forbes Healthcare Summit that Mylan's price increases were justified by the many improvements she claimed the company had made to the product.[43] Amid this backlash, Bresch led Mylan to introduce a generic version of the device which sells for half the price of the brand-name device.[44][45] The generic version in 2016 remained more expensive than the original brand version of EpiPen prior to Mylan's purchase of the rights, even when accounting for inflation.[46]

In July 2019, Bresch announced that she would retire in 2020 after Mylan merged with Upjohn.[14] The merger was completed in November 2020 and Bresch stepped down.[47] The new company was named Viatris.[47] According to the Pittsburgh Business Journal, when she left Mylan, she was the second most highly paid executive in the area of Pittsburgh, and received a "golden parachute" estimated at $30.8 million.[48]

In 2021, a case was ongoing to determine whether Mylan had attempted to monopolize the EpiPen market, with both Mylan N.V. and Bresch being sued on racketeering claims and anti-trust claims. The lawsuit, which consolidated several consumer cases, was moved to federal court in Kansas City in 2017. In February 2020, the lawsuit moved ahead as a nationwide class action. On June 24, 2021, a federal judge tossed the racketeering claims and some of the antitrust claims, also dropping RICO claims against Bresch. The case went on trial on September 7, 2021.[49] On September 7, 2021, Ryan Grim of The Intercept reported that during an ongoing racketeering case involving Mylan and Bresch,[50] "newly released court documents show [Bresch] discussing a deal with Pfizer to eliminate a chief competitor to EpiPen, clearing the way for major price hikes."[51] The 2010 and 2011 email discussions, unsealed by the judge, showed Bresch's assistant discussing divesting from Adrenaclick after the closure of the Pfizer/King deal. They "also show Bresch approving a scheme to force customers, captured by the company’s monopoly, to purchase two EpiPens at once, regardless of medical need."[50][needs update]

Honors and awards

[edit]

Bresch was ranked #31 in Fortune magazine's 2014 "50 Most Powerful Women" list.[16][28][52] That same year, she won the EY Global Impact of the Year Award.[53] Bresch was the 2017 Albert Schweitzer Leadership Award honoree at an awards gala hosted by the Hugh O'Brian Youth Leadership Foundation.[54]

Bresch served as chair of the Generic Pharmaceutical Association’s board of directors in 2016, 2005, and 2004, and as vice chair in 2003 and 2006.[55]

Personal life

[edit]

Bresch is married to Jones Day lawyer Jeffrey J. Bresch. She was previously married to West Virginia businessman Douglas Kirby. She lives with her husband and four children in Sewickley Heights, Pennsylvania.[5][1][56]

References

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[edit]
Revisions and contributorsEdit on WikipediaRead on Wikipedia

Heather Bresch

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from Grokipedia
Heather Bresch (née Manchin; born June 27, 1969) is an American pharmaceutical executive who served as of N.V., a major generics and specialty drug manufacturer, from January 2012 until the company's 2020 merger with Pfizer's division. The daughter of U.S. Senator , she began her career at in 1989 as an intern and ascended through roles including , contributing to the firm's growth from a $100 million regional player to a global entity with enhanced focus on affordable medications. Bresch's tenure, however, was marked by significant controversies, including a 2007 West Virginia University MBA awarded despite insufficient credits—prompting the university president's resignation and an independent panel's finding that administrators retroactively adjusted requirements due to her family's political influence—and congressional investigations into Mylan's over 400% list price increase for the EpiPen auto-injector from 2009 to 2016, during which she received compensation totaling more than $113 million.

Early Life and Education

Family Background and Upbringing

Heather Bresch was born Heather Renée Manchin on June 27, 1969, in , the eldest child of Joseph Manchin III, a businessman and future politician, and , an educator. Her parents married in 1967 and raised three children in the state. Bresch grew up primarily in Fairmont and Farmington, small towns in , within a Roman Catholic household that emphasized family closeness and a strong . She attended Fairmont Senior High School, reflecting her roots in the region's working-class communities tied to and manufacturing economies. Her father, who had graduated from Farmington High School and worked in family enterprises before entering as West Virginia's in 2001, provided early exposure to business and governance dynamics. Gayle Manchin, a alumna with degrees in language arts and reading, taught in Marion County public schools and later served on the faculty at , instilling values of and public involvement in the family. This environment, marked by her father's rising political profile—culminating in his governorship from 2005 to 2010—shaped Bresch's formative years amid West Virginia's economic challenges and community-oriented lifestyle.

Undergraduate Studies

Heather Bresch earned a degree in international studies from in 1991. Her undergraduate coursework also encompassed , reflecting an early focus on international affairs and . Unlike her later graduate pursuits, Bresch's faced no reported disputes regarding completion or conferral, as confirmed by university records and her professional biographies. During this period, she balanced studies with initial work experience, including a position at her family's carpet store, which preceded her entry into the pharmaceutical sector.

MBA Pursuit and Credential Controversy

Bresch enrolled in University's Executive program as part of its second cohort in the fall of 1996 while working at Pharmaceuticals. She discontinued coursework in the spring of 1998, at which point university records indicated she had completed only 26 of the 48 required credits, leaving 22 credits unfinished, with no evidence of subsequent completion or substitution based on work experience approved by her program adviser. In October 2007, amid her promotion to at —which included a company listing an MBA from WVU among her credentials—the retroactively updated her transcript to reflect degree conferral in December 1998. This involved adding grades for six classes and resolving two incompletes via a letter from business school Dean R. Stephen Sears, following an inquiry by The ; WVU initially denied the degree's existence before reversing course and attributing the discrepancy to a records transfer error from nearly half her coursework and an unpaid $50 fee. A subsequent independent panel, appointed by WVU's provost and senate, investigated and released a 95-page report on April 23, 2008, concluding that Bresch had not earned the MBA, as the retroactive changes lacked any academic foundation and were executed hastily under perceived external pressure. The panel deemed the process "seriously flawed," noting that high-ranking officials, including Provost E. Lang and Dean , overrode standard procedures during an , 2007, meeting to facilitate the award. In response, Bresch's record was reverted to its pre-2007 state, effectively revoking the degree, and she has not held a valid MBA from WVU since. The prompted resignations: Lang and stepped down from administrative roles shortly after the report, while university President Mike resigned effective September 1, 2008, amid faculty demands and a broader revealing up to 80 potentially suspect degrees in the same program over the prior decade. Critics attributed the irregularities to from Bresch's political connections, including her father, then-Governor , and Mylan's ties to major WVU donor , though the panel focused on procedural lapses rather than explicit corruption. No further pursuit or completion of the MBA by Bresch has been documented.

Professional Career

Initial Roles at Mylan

Heather Bresch joined Laboratories, a generic pharmaceutical manufacturer headquartered in , in January 1992 as an entry-level . In this role, she performed basic administrative tasks in the basement of the company's manufacturing facility, including typing prescription labels onto medication packaging. This position represented her first full-time employment following her undergraduate degree from . During her early years at , Bresch transitioned through operational and administrative functions, building foundational experience in the company's production and support processes. By the early , she assumed her first significant leadership role as Director of Relations, where she managed efforts and regulatory interactions on behalf of the firm. These initial positions provided her with broad exposure across more than 15 functional areas, including operations, , and communications, which contributed to her rapid internal advancement.

Government Relations and Regulatory Advocacy

From 2002 to 2005, Heather Bresch served as director of government relations at Pharmaceuticals, where she managed the company's lobbying efforts and interactions with U.S. regulatory bodies, including the (FDA). In this position, she focused on advancing policies favorable to manufacturers, such as expedited FDA approvals and reduced barriers to market entry for affordable alternatives to brand-name drugs. Bresch played a pivotal role in the passage of the Generic Drug User Fee Act (GDUFA) of 2012, testifying before on February 9, 2012, to support the legislation, which authorized the FDA to collect user fees from manufacturers to fund additional reviewers and accelerate approval processes. She conducted hundreds of visits to to rally bipartisan support, framing the act as essential for enhancing U.S. competitiveness in global generics markets by addressing backlogs in FDA reviews, which had delayed access to lower-cost medications. The act, signed into on July 9, 2012, as part of the FDA Safety and Innovation Act, enabled the FDA to inspect foreign facilities more rigorously and standardize global quality requirements, aligning with 's emphasis on international manufacturing. In regulatory advocacy, Bresch pushed for FDA recognition of global quality standards to facilitate approvals of generics produced abroad, arguing that uniform international benchmarks would ensure while promoting and affordability. This effort stemmed from Mylan's experiences with multinational supply chains and aimed to level the playing field against competitors reliant on varying national regulations. Bresch also led Mylan's campaign for expanded access to epinephrine auto-injectors, culminating in the School Access to Emergency Epinephrine Act of 2013, which provided grants to states for stocking EpiPens in schools and led to mandates in 48 states. Mylan invested approximately $4 million in from 2012 to 2013 to support this and related access initiatives, directly benefiting its EpiPen product by increasing institutional demand amid limited competition. These activities underscored Mylan's strategy of leveraging government partnerships to broaden markets for its specialty pharmaceuticals while navigating FDA oversight on device approvals and pricing dynamics.

Rise to Senior Executive Positions

Bresch advanced through Mylan's ranks over nearly two decades, gaining experience in over 15 functional areas including operations, , and global expansion. By , she had risen to Head of , overseeing regional sales and operations for the company's largest market. In October 2007, following Mylan's $6.9 billion acquisition of Merck KGaA's generics , Bresch was promoted to (COO), a role that positioned her to manage day-to-day global operations amid the integration of new assets and workforce expansion. As COO, Bresch contributed to Mylan's growth strategy, which included pursuing additional acquisitions and enhancing manufacturing capabilities to support a shift toward international markets. In 2009, she was elevated to President, expanding her oversight to include corporate strategy, , and , while reporting to CEO Robert J. Coury. This promotion reflected her role in navigating complex regulatory environments and driving revenue growth, with Mylan's annual sales surpassing $2 billion by 2010. In October 2011, Mylan announced an expanded management structure, designating Bresch to succeed Coury as CEO effective January 2012, while Coury transitioned to Executive Chairman. Her ascent to these senior positions was attributed to her operational expertise and alignment with 's focus on affordable generics, though critics later questioned the influence of her political connections via her father, U.S. Senator , on her rapid promotions.

CEO Tenure at Mylan (2012–2019)

Heather Bresch was appointed Chief Executive Officer of Mylan N.V. effective January 1, 2012, succeeding Robert J. Coury who transitioned to executive chairman. Under her leadership, the company focused on expanding its portfolio of generic and specialty pharmaceuticals through acquisitions and partnerships, contributing to revenue growth. Mylan's total revenues reached $11.08 billion in 2016, an 18% increase from the prior year, driven by key deals such as the $6.92 billion acquisition of Meda AB completed in August 2016. Subsequent years saw revenues of $11.91 billion in 2017, $11.43 billion in 2018, and $11.50 billion in 2019, reflecting sustained operations amid competitive pressures in the generics market. Bresch's tenure, however, faced intense scrutiny over Mylan's pricing strategy for EpiPen auto-injectors, a critical treatment for . The for a two-pack escalated from approximately $103.50 in 2009 to $608.61 by 2016, prompting congressional hearings and public backlash. In testimony, Bresch accepted full responsibility for the decisions but attributed the hikes to enhancements in , such as improved needle length and environmental sensors, alongside investments in and that precluded immediate generic entry. She also highlighted complexities in the U.S. pricing system, noting that roughly half of the funded intermediaries like benefit managers and insurers rather than reaching directly. The controversy led to expanded patient assistance programs and eventual FDA approvals for generic versions in 2018, though legal settlements followed, including a $264 million agreement in 2022 related to EpiPen pricing claims. Executive compensation emerged as another point of contention. Bresch's total pay package climbed to $13.3 million in and $18.5 million in , including salary increases and incentives tied to metrics. Over her CEO period from 2012 to , she realized approximately $113.6 million in compensation, amid concerns over that saw initial gains but subsequent declines due to pricing fallout and generic market erosion. Bresch announced her retirement effective upon the completion of 's merger with Pfizer's unit, revealed on July 29, 2019, forming expected mid-2020. The deal, valued at around $20 billion in equity, aimed to create a global generics powerhouse with combined revenues exceeding $20 billion annually, marking the culmination of her strategy to scale amid evolving industry dynamics.

Merger with Upjohn and Retirement from Viatris

On July 29, 2019, N.V., with Heather Bresch serving as chief executive officer, announced an all-stock merger of equals with , Inc.'s off-patent medicines division, to create a new global healthcare company focused on generics, biosimilars, and branded medicines. The transaction was valued at approximately $35 billion in enterprise value and positioned the combined entity to generate expected annual revenues exceeding $20 billion, leveraging complementary portfolios in over 165 countries with a workforce of more than 45,000 employees. 's endorsed the deal, citing its strategic fit to enhance scale, R&D capabilities, and market access amid competitive pressures in the generics sector. As part of the merger agreement, Bresch, who had joined Mylan in 1992 and ascended to CEO in 2012, announced her retirement effective upon transaction close, concluding a 27-year tenure marked by the company's expansion into a multinational generics leader. The combined company was named Viatris Inc. in November 2019, with headquarters in Canonsburg, Pennsylvania, and Mylan's chairman Robert J. Coury slated to serve as executive chairman; a search for Viatris's CEO ensued separately from Bresch's exit. The merger received regulatory approvals from bodies including the U.S. and , closing on November 16, 2020, after which Bresch formally retired as Mylan's CEO, transitioning leadership to the new entity without assuming a role at . Mylan's board commended her contributions to the company's growth and the merger's execution in a public statement. launched operations that day, integrating Mylan's generics expertise with Upjohn's established portfolio including drugs like Lipitor and Viagra.

Business Strategies and Company Growth

Key Acquisitions and Expansions

During Heather Bresch's tenure as CEO, executed several strategic acquisitions to bolster its generics and specialty pharmaceuticals portfolio, enhance manufacturing capabilities, and expand into high-growth therapeutic areas and geographic markets. These deals, totaling billions in value, focused on injectables, , and established market presence in and emerging economies, contributing to revenue growth from approximately $6.9 billion in 2012 to over $11.5 billion by 2018. In February 2013, Mylan announced the acquisition of Agila Specialties, the injectables business of Strides Arcolab, for $1.6 billion in cash, which closed in December 2013 after FTC approval with divestiture conditions to preserve in certain U.S. injectable markets. This added nine manufacturing facilities across , , and , along with a pipeline of over 50 injectable products, establishing as a top global player in sterile injectables and supporting expansion into hospital and critical care segments. Mylan further diversified in 2015 by acquiring ' established medicines business in 40 emerging markets outside the U.S. for approximately $5.3 billion in stock, completed in 2015. This transaction integrated over 130 products, including branded generics, strengthening 's foothold in high-growth regions like , , and the , with immediate revenue contributions exceeding $500 million annually. Later that year, acquired Famy Care's women's health businesses in November 2015, adding intrauterine devices and oral contraceptives manufactured in and , forming a dedicated franchise in reproductive . In December 2015, it purchased Jai Pharma, gaining a U.S.-focused women's care portfolio and specialized capabilities. The largest deal came in February 2016 with the $7.2 billion acquisition of Swedish firm Meda AB (cash and stock), finalized in August 2016, which Bresch highlighted for adding scale in branded generics and over-the-counter products across and other markets. Complementing this, acquired Pharmaceuticals' U.S. topicals business in June 2016, enhancing dermatology offerings. These moves expanded Mylan's therapeutic breadth and global infrastructure, though a $29 billion hostile bid for in 2015 ultimately failed amid regulatory and shareholder opposition. Expansions beyond acquisitions included facility upgrades and market entries, such as new injectables production lines in and post-Agila, and deepened penetration into biosimilars and complex generics markets, aligning with Bresch's emphasis on for cost efficiencies and . By 2019, these initiatives had positioned with operations in over 165 countries and a diversified revenue stream less reliant on any single product.

Focus on Generic Pharmaceuticals

Under Heather Bresch's leadership as CEO of from 2012 to 2019, the company maintained a primary focus on generic pharmaceuticals, positioning itself as a global leader in producing affordable, bioequivalent alternatives to branded drugs to enhance access and reduce healthcare costs. 's strategy emphasized heavy investment in , development, and manufacturing for generics, including complex formulations that required advanced technical capabilities, such as inhalers and injectables, to compete in markets dominated by innovator products. Bresch advocated for policies supporting generic drug development, testifying before Congress in 2012 in favor of the Generic Drug User Fee Amendments (GDUFA), which aimed to expedite FDA approvals and update outdated regulations to facilitate faster market entry for generics. This legislative push aligned with Mylan's business model, as the company derived the majority of its revenue from generics, enabling it to serve over 165 countries with a portfolio exceeding 1,400 products by the mid-2010s. In 2016, Mylan expanded its generic offerings through the acquisition of Renaissance Acquisition Holdings LLC's topical pharmaceuticals business for $1 billion, bolstering its dermatological generics segment and integrating complementary manufacturing assets. The company also prioritized biosimilars—generic-like versions of biologic medicines—and complex generics to address patent cliffs and unmet needs, with Bresch highlighting pipeline advancements like a generic equivalent to GlaxoSmithKline's Advair inhaler during her tenure. In response to market pressures, Mylan launched an authorized generic version of its EpiPen auto-injector in August 2016 at half the branded price ($300 for a two-pack), aiming to increase volume while maintaining profitability in a competitive generics landscape. These efforts contributed to Mylan's growth as a generics powerhouse, though they occurred amid broader scrutiny of pharmaceutical pricing dynamics, where generics' lower margins necessitated scale and efficiency to sustain R&D investments.

Product Innovation and Portfolio Development

During Heather Bresch's tenure as CEO from 2012 to 2019, prioritized (R&D) investments to advance complex generics and biosimilars, aiming to differentiate from commoditized simple generics amid increasing market competition. The company allocated substantial resources to R&D, including approximately $1.2 billion in for R&D and enhancements, equivalent to about $3 million daily. This supported expansion of global R&D facilities, such as a commitment of up to $100 million annually in Ireland starting in 2012 to bolster capabilities and create 500 jobs. A core focus was biosimilars development, often through partnerships like with Biologics, yielding multiple FDA approvals. In June 2018, Mylan launched Fulphila (pegfilgrastim-jmdb), the first U.S.-approved to Amgen's Neulasta, addressing chemotherapy-induced . Earlier, in 2017, settlements enabled progress on (Ogivri, approved December 2017 as trastuzumab-dkst), targeting HER2-positive treatment. By 2018, 's pipeline encompassed 16 and insulin analogs in development or market, including candidates for rituximab and , with European launches anticipated that year. Mylan also advanced complex generics, involving intricate formulations like inhalers and injectables requiring specialized manufacturing. The company pursued an inhaled /long-acting beta for and , culminating in FDA approval of Wixela Inhub (fluticasone propionate and salmeterol powder) in January 2019 as the first generic equivalent to GlaxoSmithKline's Advair Diskus. Portfolio diversification extended to emerging markets with targeted innovations, such as an eight-product line in launched in June 2013, emphasizing hormones and nutrition, and an 11-regimen antiretroviral portfolio in introduced in February 2013 for adult and pediatric treatment. By 2016, these efforts contributed to a U.S. portfolio of 635 products, delivering over 21 billion doses annually, reflecting sustained emphasis on therapeutic breadth in generics, specialty pharmaceuticals, and biologics. This R&D-driven strategy positioned to address unmet needs in high-barrier categories, though execution faced challenges from regulatory hurdles and litigations.

Major Controversies

EpiPen Pricing and Market Dynamics

Mylan acquired the rights to EpiPen, an epinephrine auto-injector for treating , from Merck in 2007. At that time, the wholesale acquisition cost for a two-pack was approximately $93.88. Under 's ownership, the company implemented multiple price increases, with the list price rising to $608.61 for a two-pack by 2016, representing a cumulative increase exceeding 500% over the decade. Specific hikes included a 5% increase in 2008 and a 20% increase in 2009, followed by eight 10% annual adjustments in subsequent years, with a notable jump from $265 to $609 in the three years leading up to 2016. These escalations occurred amid limited market competition, as EpiPen held a dominant position due to regulatory barriers for auto-injector devices, including FDA approval processes for complex delivery mechanisms rather than the generic epinephrine compound itself. A key competitor, Auvi-Q, captured about 10% market share before its voluntary in October 2015 due to dosing inaccuracies, allowing to consolidate control without immediate rivals. benefit managers (PBMs) and insurers further shaped dynamics through rebate negotiations, where high list prices enabled larger discounts that benefited intermediaries but obscured net revenues for manufacturers; reported netting $274 per two-pack after rebates and fees, with production costs around $69 for two units. Heather Bresch, Mylan's CEO from 2012 onward, defended the pricing during a , 2016, U.S. House Oversight Committee hearing, attributing increases to investments in reliability, device improvements, and programs rather than alone. Critics, including lawmakers, highlighted —Bresch's pay rose 671% to nearly $19 million in 2015 amid the hikes—arguing it reflected inadequate competitive pressures. In response to scrutiny, launched a generic version in 2016 at a lower $300 list price and expanded patient assistance, though brand EpiPen prices remained elevated until generic entrants like Teva's in 2018 began eroding market share. Longer-term, the episode underscored causal factors in pharmaceutical , including device patents, slow generic approvals, and rebate-driven incentives that decoupled list prices from patient costs, culminating in a 2022 $264 million class-action settlement over alleged anticompetitive rebate tactics. Empirical data from spending showed EpiPen costs rising from $349 in 2014 to $609 in 2016, a 74% nominal increase, amid broader debates on how regulatory exclusivity sustains monopolies absent robust .

Executive Compensation Scrutiny

Heather Bresch's at drew significant scrutiny from shareholders, lawmakers, and proxy advisory firms, particularly amid the company's EpiPen pricing controversy, as her pay packages were seen by critics as excessively tied to revenue growth driven by price increases rather than broader performance metrics. From 2007 to 2015, Bresch's total annual compensation rose from $2.45 million to $18.93 million, a 671% increase, comprising , bonuses, awards, and other incentives linked to company financial targets such as and revenue. In 2015 specifically, her reported total reached $18.9 million, down from $25.8 million in 2014, primarily through performance-based equity grants. Shareholders expressed dissatisfaction through advisory "say-on-pay" votes, with Mylan's 2016 proposal receiving only 65.2% approval, falling short of typical thresholds for endorsement and signaling concerns over the alignment of executive rewards with amid regulatory and public backlash. In , a majority of shareholders rejected the compensation program for the second consecutive year in a non-binding vote at the annual meeting, targeting packages for Bresch and other executives despite board re-elections; proxy advisor (ISS) recommended against approval, citing poor pay-for-performance linkage and excessive incentives. Critics, including lawmakers during congressional hearings, argued that Bresch's multimillion-dollar payouts—often justified by Mylan's revenue expansion—overlooked ethical issues in pricing strategies for essential medications, though company spokespeople defended the structure as standard for the industry and approved by compensation committees based on peer benchmarks. The compensation framework emphasized long-term incentives, with stock options and restricted units vesting upon meeting adjusted earnings and total shareholder return goals relative to pharmaceutical peers, but detractors highlighted how EpiPen-related revenues inflated these metrics without corresponding investments in or . Despite the votes, maintained the programs, attributing scrutiny to external pressures rather than structural flaws, and Bresch's base salary remained stable at $1.3 million from 2016 onward, with total pay varying based on annual incentives.

MBA Degree Verification Dispute

In December 2007, the inquired with (WVU) to verify Heather Bresch's executive MBA, listed in Mylan's corporate biography, after her promotion to a senior role. WVU's registrar initially informed the newspaper that Bresch had completed an undergraduate degree and some graduate coursework but had not finished the MBA requirements. Later that day, university officials reversed course, asserting Bresch had earned the degree in December 1998, attributing the initial denial to a records error, amid Bresch's father, , serving as West Virginia's governor. WVU launched an internal investigation in early , forming a five-member faculty panel to review Bresch's academic record. The panel's April report concluded that Bresch's degree was "seriously flawed," as she had completed only about half the required credits—approximately 21 of 48—and officials had waived remaining coursework, exams, and a business project without proper documentation or justification. Administrators, including then-President James F. Gainer, had retroactively facilitated the degree's conferral in 2007 to align with Mylan's claims, despite lacking evidence of fulfillment. The controversy prompted resignations, including WVU President David C. Hardesty Jr. in June 2008, who cited the scandal's toll after five months of scrutiny, and Provost Gerald D. Thornton earlier that year. WVU ultimately declined to award Bresch the degree, effectively nullifying it, though she was allowed to retain an undergraduate business degree from the institution. Bresch maintained she had completed the necessary work through a non-traditional executive program blending classes, , and professional experience, insisting in a 2016 Fortune interview, "I certainly to this day feel like I got my MBA." The episode highlighted procedural lapses at WVU but did not result in legal action against Bresch, who continued her career at without the credential.

Advocacy and Policy Influence

Leadership in Generic Drug Associations

Heather Bresch held multiple leadership positions within the Generic Pharmaceutical Association (GPhA), the primary trade organization representing manufacturers of generic drugs in the United States. She served as chair of the GPhA board of directors in 2004 and 2005, followed by vice chair roles in 2003 and 2006. In February 2016, Bresch was elected chair of the GPhA board for a one-year term, leveraging her position as CEO of N.V., a major generics producer. During this period, she highlighted the generics sector's adaptation to evolving regulatory challenges, stating that the industry had "evolved significantly" since her prior terms amid heightened complexity in approvals and market dynamics. Her leadership focused on advocating for policies that supported accessibility, including streamlined FDA pathways to enhance competition and reduce costs for consumers. GPhA underwent a to the Association for Accessible Medicines (AAM) in February 2017, emphasizing broader advocacy for affordable medications, including biosimilars. Bresch was succeeded as AAM chairman by Jeff Watson of Inc., marking the transition under the new name, though publicly endorsed the change as aligning with its mission to improve patient access. She remained engaged with AAM, serving on its in 2018 alongside executives from other firms like Impax Laboratories and Fresenius Kabi. These roles underscored her influence in shaping industry positions on regulatory reforms and market competition during Mylan's expansion in generics.

Engagement with U.S. Policy and Legislation

Heather Bresch, as CEO of N.V., testified before the U.S. Special Committee on Aging on July 20, 2006, advocating against legislative proposals that would restrict manufacturers from engaging with brand-name holders, arguing such measures could hinder and access to affordable medications. In her prepared remarks, she emphasized the role of generics in reducing costs and supported policies fostering innovation without undue barriers to market entry. Bresch played a key role in the passage of the Generic Drug User Fee Amendments (GDUFA) of 2012, testifying before on February 9, 2012, in support of the legislation that established user fees paid by generic manufacturers to fund accelerated FDA reviews of abbreviated new drug applications. The act, which she helped persuade industry peers to back despite initial resistance to the fees, aimed to address FDA backlogs and improve approval timelines, resulting in over 1,000 additional generic approvals annually by enhancing agency resources. During her tenure, under Bresch's leadership engaged in efforts to influence FDA policies, including successful advocacy in the early to update anaphylaxis treatment guidelines prioritizing auto-injectors like EpiPen over alternative syringes, thereby extending market exclusivity amid competition threats. On September 21, 2016, Bresch appeared before the U.S. House Committee on Oversight and Government Reform to address EpiPen price increases from $94 in 2007 to $609 by 2016, defending the hikes by detailing a $100 cost breakdown per unit—including $50 in profit, , and R&D investments—and highlighting Mylan's distribution of 700,000 free EpiPens to schools over four years via patient assistance programs. Committee members, including Rep. , pressed her on profitability and access, but Bresch maintained the pricing reflected through authorized generic competition and rebates covering 80% of patients. In January 2017, Bresch publicly endorsed aspects of President-elect Donald Trump's proposed drug pricing reforms aimed at but opposed of Medicare and prices, arguing it would stifle innovation in generics. Mylan's overall expenditures, which rose under her to $3.4 million in 2015, focused on FDA approvals and trade policies favoring generics.

Promotion of Market-Based Healthcare Solutions

Bresch advocated for regulatory reforms to accelerate approvals, positioning them as a mechanism to foster competition and reduce healthcare costs. In a , 2012, before the U.S. House Energy and Commerce Subcommittee on Health, she endorsed the Generic Drug User Fee Amendments (GDUFA), a program requiring generic manufacturers to pay user fees to the FDA in exchange for expedited reviews and inspections. She argued that these fees would enable the FDA to hire additional staff and shorten approval timelines from an average of 30 months, thereby increasing the supply of low-cost generics, which accounted for 84% of U.S. prescriptions by volume but only 27% by expenditure in 2011. Bresch urged to update the Federal Food, Drug, and Cosmetic Act to prioritize generic competition, stating that 's business model depended on such efficiencies to deliver affordable medicines without compromising quality. Her support for GDUFA extended to lobbying efforts that secured bipartisan backing, including from generic industry peers she persuaded to contribute fees despite initial resistance, as the program aimed to address FDA backlogs hindering market entry. Implemented in and reauthorized in 2017, GDUFA facilitated over 1,000 generic approvals annually by 2016, contributing to a 90% average price drop for generics upon launch compared to branded equivalents. Bresch framed this as a market-oriented solution, emphasizing that faster competition, rather than , drives long-term affordability and in pharmaceuticals. During the EpiPen pricing scrutiny, Bresch defended market dynamics by highlighting Mylan's launch of an authorized generic epinephrine auto-injector at a $300 for a two-pack—50% below the branded EpiPen—intended to provide immediate consumer relief amid limited rivals. In her September 21, , House Oversight Committee testimony, she detailed $1.2 billion annual investments in generic R&D and , asserting that such expenditures sustain competitive supply chains producing billions of doses at low unit costs (e.g., 25 cents per dose). She coupled this with voluntary initiatives like distributing 700,000 free EpiPens to 66,000 schools over four years and patient savings cards reducing out-of-pocket costs to $0 for many, presenting them as private-sector alternatives to enhance access without distorting market incentives. Bresch consistently attributed pricing pressures to systemic factors like R&D demands and complexities, rather than endorsing direct interventions, and stressed that generic expansion under competitive markets had saved the U.S. healthcare system $1.68 trillion from to 2015. Her positions aligned with industry arguments that regulatory streamlining and innovation investments, not caps or rebates alone, best balance affordability and reliability in devices.

Achievements and Recognitions

Corporate Milestones Under Leadership

During Heather Bresch's tenure as CEO from January 1, 2012, achieved substantial revenue expansion, with third-party net revenues guided at $6.8 billion to $7.2 billion for 2012, representing 14% projected growth at the midpoint. By , annual revenues reached $9.4 billion, reflecting more than 50% growth from her initial year as CEO. This trajectory continued, with full-year 2019 revenues reported at levels supporting a midpoint projection of $12 billion, up approximately 4% from prior expectations amid segment-wide gains. Strategic acquisitions bolstered Mylan's portfolio and global footprint. In 2014, the company completed a $5.3 billion acquisition of ' established pharmaceuticals business in emerging markets, enabling reincorporation in the as part of a tax optimization strategy. In February 2016, Mylan announced a €6.5 billion ($7.2 billion) acquisition of Swedish firm Meda AB, adding branded and generic products to strengthen its European operations and overall scale. Later that year, on June 15, it finalized a $1 billion purchase of Acquisition Holdings' dermatology portfolio, including key topicals like Differin Gel, enhancing specialty offerings. Product commercialization drove notable successes, particularly with EpiPen, which Mylan had acquired rights to in 2007 and grew into a blockbuster generating over $1 billion in annual U.S. net sales by 2016 through expanded marketing and distribution. A pivotal capstone was the July 29, 2019, announcement of a merger with Pfizer's division via a reverse Morris Trust transaction, forming N.V. with combined revenues exceeding $20 billion and a focus on generics and biosimilars; the deal closed in November 2020, after which Bresch retired. These moves positioned as the third-largest generic pharmaceutical company globally by employee count and market presence, with over 20,000 workers by 2014.

Industry Awards and Honors

Heather Bresch received the EY Global Impact Award as part of the 2014 Entrepreneur of the Year program for the and region, recognizing her in expanding Mylan's global operations and access to affordable medications. Bresch was named to Fortune magazine's annual Most Powerful Women in Business list multiple times, including in 2012, 2013, 2014 (ranked #31), 2016, and 2018 (ranked #29), highlighting her influence as CEO of a major generic pharmaceutical firm. In 2017, she was honored as a recipient of the Albert Schweitzer Leadership Award by the chapter, acknowledging her contributions to global health initiatives through . Under her tenure, received the Americares Power of Partnership Award in 2018 for its donations exceeding 100 million doses of medicine to humanitarian efforts, with Bresch emphasizing the company's commitment to underserved populations in her acceptance remarks.

Broader Impact on Pharmaceutical Accessibility

Under Heather Bresch's leadership as CEO of from 2012 to 2020, the company expanded its portfolio of generic drugs, which accounted for over 90% of its products and contributed to broader access to affordable medications globally. 's efforts included launching the first generic version of Bristol-Myers Squibb's Sustiva () tablets in the U.S. in February 2018, facilitating lower-cost treatment for . Internationally, signed agreements such as one with in August 2012 to produce and distribute generic single-tablet regimens for in 115 resource-limited countries, including all low-income and least-developed nations, aiming to accelerate access to high-quality, affordable antiretrovirals. These initiatives aligned with 's commitment to generics as a mechanism for reducing treatment costs in developing regions, where branded drugs often remain prohibitively expensive. Bresch advocated for policies enhancing availability, including her testimony before in February 2012 supporting the Generic Drug User Fee Act (GDUFA), which established user fees to expedite FDA reviews and approvals of generics, thereby increasing competition and lowering prices. As chair of the Generic Pharmaceutical Association (GPhA) from 2016, she led the organization's rebranding to the Association for Accessible Medicines in 2017, emphasizing generics' role in healthcare savings; a GPhA study during this period highlighted that generics had saved the U.S. healthcare system over $1 trillion by enabling affordable alternatives to branded drugs. She also pushed for a single quality standard for all U.S.-sold drugs to streamline approvals without compromising safety, further promoting timely access. These efforts contributed to systemic improvements in pharmaceutical accessibility, though critics noted inconsistencies, such as Mylan's past opposition to certain authorized generics that could have competed with its own products. Overall, generics under Bresch's tenure at helped expand treatment options for chronic conditions in underserved markets, supporting global health initiatives focused on affordability over branded exclusivity.

Personal Life

Family and Relationships

Heather Bresch is the daughter of , a longtime politician who served as from 2005 to 2010 and as a U.S. senator from 2010 to 2025, and , an education administrator who chaired the state Democratic Party and later led the . She has two siblings: a sister, Brooke Manchin, and a brother, Joseph Manchin IV. Bresch was first married to businessman Douglas Kirby in the early 1990s, following her college graduation. She later married Jeffrey J. Bresch, a and former partner at the firm , in 2002. The couple resides in , with their four children: Chloe, Jack, Kelsey, and Madeline Bresch.

Post-Retirement Activities and Interests

Following her departure from in November 2020 upon the completion of its merger with Pfizer's division to form , Heather Bresch has maintained a relatively low public profile, with limited documented involvement in high-visibility corporate or philanthropic endeavors. No records indicate current board directorships in major pharmaceutical or related firms as of 2025. Bresch has participated in political advocacy aligned with centrist perspectives, assisting her father, former U.S. Senator , in fundraising efforts for a new moderate political organization in 2023. This initiative sought to counter partisan extremes by promoting pragmatic policy solutions, with Bresch leveraging her business background in donor pitches. Personal interests appear centered on family life, as Bresch is a of four children, though specific post-retirement pursuits beyond this remain undisclosed in public sources. Self-described efforts to advocate for healthcare access and have been noted in professional profiles, but lack independent verification of ongoing projects.

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  103. https://www.thedaonline.com/bresch-degree-seriously-flawed/article_f84b775f-d377-5079-ba65-ea58a1739bc1.html
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  105. https://www.prnewswire.com/news-releases/mylan-ceo-heather-bresch-elected-chair-of-generic-pharmaceutical-association-300224192.html
  106. https://investor.mylan.com/news-releases/news-release-details/mylan-ceo-heather-bresch-elected-chair-generic-pharmaceutical
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  110. https://www.aging.senate.gov/download/heather-bresch-testimony-072006?download=1
  111. https://www.newyorker.com/business/currency/how-the-maker-of-the-epipen-made-government-its-ally
  112. https://www.statnews.com/2016/09/21/mylan-ceo-congress/
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  114. https://investor.mylan.com/news-releases/news-release-details/mylan-provides-blueprint-2012-and-beyond
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  116. https://www.post-gazette.com/business/healthcare-business/2019/07/29/mylan-merger-acquisition-pfizer-upjohn-heather-bresch-retirement-pharmaceutical-business/stories/201907290057
  117. http://archive.triblive.com/business/local-stories/mylan-ceo-bresch-sets-sights-on-growth/
  118. https://nextpittsburgh.com/business-tech-news/ey-announces-entrepreneur-year-2014/
  119. https://www.observer-reporter.com/business/2014/jun/23/area-business-leaders-win-entrepreneur-award/
  120. https://archive.triblive.com/news/ernst-young-names-entrepreneurs-of-the-year-for-w-pa-w-va-region/
  121. https://fortune.com/ranking/most-powerful-women/2014/heather-bresch/
  122. https://www.bizjournals.com/pittsburgh/news/2018/09/26/mylan-ceo-among-most-powerful-women-in-business.html
  123. https://www.facebook.com/HOBY/posts/last-chance-to-join-us-on-wednesday-may-31-2017-at-the-new-york-athletic-club-ne/10155337517371575/
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  131. https://medium.com/competing-by-saving-lives/the-role-of-generics-companies-in-improving-global-health-with-mylan-b4caaff33310
  132. https://www.imdb.com/name/nm8740416/bio/
  133. https://jacobin.com/2021/10/joe-manchin-daughter-heather-bresch-mylan-epipen
  134. https://en.geneastar.org/genealogy/manchinheat/heather-bresch
  135. https://www.gurufocus.com/insider/4095/heather-m-bresch
  136. https://www.cbsnews.com/news/joe-manchin-heather-manchin-bresch-centrist-political-group-donors/
  137. https://www.linkedin.com/in/heatherbresch
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