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Prior to beginning work on this discussion, review the two
articles: The Best of Best Practices: Critical Success Factors for
Identifying and Measuring Industry-Leading Management
Solution
s and Understanding Victory: Adapting Operational Design to
Address Resource Management Challenges. Define the
terms process and process integration. Use these definitions to
describe at least one process you deploy at your current place of
employment or any previous place of employment. Be specific
and use course concepts and principles to support the positions
that you take. Your initial post should include examples and be
at least 200 to 250 words. Respond to at least two of your
classmates’ posts.
Guided Response: Review several of your peers’ posts. Respond
to at least two of your fellow students’ posts and provide
information or perspective based on your experience. You are
encouraged to post your required replies earlier in the week to
promote more meaningful and interactive discourse in this
discussion forum. Continue to monitor the discussion forum
until 5:00 p.m. (Mountain Time) on Day 7, and respond with
robust dialogue to anyone who replies to your initial post.
Mark Bosco
9 Mar 20209 Mar at 18:49
Manage discussion entry
Process- A set of instructions or formal direction to push
production from beginning to end.
Process Integration- The procedure of putting instruction into
practice. Company management is to develop a plan of action.
The plan of action is then carried out through the training
program. The training program trains the employees to get them
prepared for daily operations.
I work in a factory and there are many different stations that go
into the production of our product. To ensure that new hires are
prepared for the tasks themselves there is a training area that
has smaller versions of all the work areas that new hires spend
their first day working within. The training area gives the new
hires the opportunity to gain a basic understanding before going
to the production floor. However, the training area limits the
experience procedure itself, it does not teach the pace of the
production floor. To train the new hires about the pace of the
production floor, new hires are typically stationed in more of
the less strenuous tasks first. Then as they become more
comfortable with the pace of production they are transitioned to
the more pivotal workstations. This multitiered integration
helps make process training more seamless for new hires. It is a
very effective plan of action.
Amircal webb
10 Mar 202010 Mar at 2:28
Manage discussion entry
Hey Class,
According to the text Process is the method for getting work
done and consist of a series of steps that turn inputs into
outputs. “Process integration is the sharing and coordination of
key process between companies in a supply chain
(Wisner,2017).”
One process that I deployed at my previous place of
employment was the recruit accountability as I mentioned
previously in my introduction post. The method was to
coordinate with each battalion to notify them to submit their
daily count to headquarters by noon. The series of steps
included a spreadsheet sent out to each battalion at 7am from
headquarters. The five battalions would input their count on the
spreadsheet provided in detail of where each recruit stood in in
training. Additionally, the count would include numbers of new
recruits received, the number of recruits who were held back in
training and the number of recruits who graduated. The end
result would provide accountable results which included the
total of remaining recruits in that battalion. Each battalion
would be tasks with filling out the same information and
sending the information to the headquarters to integrate the five
battalions. After a total count is received the battalion
commander is briefed and is able to determine when the next
graduation was or how many documents he needed to sign to
send “broken recruits” back home.
“By enabling networking experiences for participants,
organizations can foster communities of practice that give rise
to new best practices and successful business alliances (Carter
& Carmichael, 2011).” The newly developed process that was
created for recruit accountability was more effect and accurate.
References
Carter, L. L., & Carmichael, P. (2011). The best of best
practices: Critical success factors for identifying and measuring
industry-leading management solutions. TD 65(8), 40-46.
Retrieved from https://www.td.org/td-magazine
Wisner, J. D. (2017). Operations management: A supply chain
process approach. Retrieved from https://content.ashford.edu
QUESTIONS:
1)
Is the price increase justified as argued by Mylan, or is there a
case to be made that this is price gouging?
PLEASE READ THE CASE STUDY, AND PREPARE THE PPT
FOR THE ABOVE QUESTION.
Mylan and the EpiPen: Increased Access or Price Gouging?
In September of 2016, Heather Bresch, the Chief Executive
Officer of Mylan, was called to testify before the House
Oversight and Government Reform Committee, part of the U. S.
Congress. The committee planned to ask Bresch questions about
the $608 price tag that was attached to the two-pack of EpiPens
sold by her company. Bresch had worked her way up through
the company, and she considered EpiPen important to her as she
had personally championed the brand over the years.
Bresch was proud of EpiPen’s success, and she did not plan to
admit that the company was at fault (George, 2016). After all,
companies like Mylan existed to make money and create a profit
for their shareholders. And, in this case, the insurance
companies were partly to blame because consumers had to pay
more out-of-pocket for medications. However, despite her plan,
Bresch wondered if her answers would satisfy the House
Oversight and Government Reform Committee members? How
would they judge her and Mylan’s actions?
Mylan
Bresch’s company, Mylan, was founded in 1961 with the
mission of “helping people in small West Virginia towns and
rural communities gain access to affordable medicine” (Mylan
is a global healthcare company, n.d.). By 2007, Mylan had
grown to become a global firm by having purchased Merck’s
generic pharmaceutical division and it touted that its most
valuable asset was its global workforce. Its mission was as
follows (About us, n.d.):
At Mylan, we are committed to setting new standards in
healthcare. Working together around the world to provide 7
billion people access to high-quality medicine, we:
· Innovate to satisfy unmet needs;
· Make reliability and service excellence a habit;
· Do what’s right, not what’s easy;
· Impact the future through passionate global leadership.
When Mylan purchased Merck’s generic pharmaceutical
division, the company acquired EpiPen, a treatment for
anaphylaxis (i.e., a serious allergic response). Its website stated
that “At Mylan, we put people first, trusting that profits will
follow” (Social responsibility at Mylan, n.d.). This philosophy
corresponded with the efforts associated with corporate social
responsibility (CSR), which “encompassed not only what
companies do with their profits, but also how they make them”
(Harvard Kennedy School, 2014).
Anaphylaxis
Anaphylaxis is a life-threatening condition in which a person
has an acute allergic response to something in their
environment. Being allergic to foods, such as shellfish, wheat,
tomatoes, and nuts is thought to be the most common driver of
anaphylaxis, although bug bites/stings and medications also
caused reactions. Researchers have reported that 7.7% of the
population had experienced anaphylaxis and, in some cases, this
condition had resulted in death (Rance
· Goldberg, 2015). Furthermore, an estimated 200,000 people
had been hospitalized from anaphylaxis each year with less than
100 of them dying from the condition (Cassels, 2016).
Anaphylaxis is a serious medical issue because of its rapid
onset and the person who was reacting often does not realize
that they were experiencing the condition. The patient needs to
quickly recognize the symptoms when anaphylaxis sets in.
Studies had shown that, of the people who had anaphylaxis,
only 42% sought treatment for their symptoms within 15
minutes of onset, with many risking death by delaying treatment
(Rance & Goldberg, 2015).
Most of the time, anaphylaxis had happened at home or in other
contexts outside of the doctor’s office, such as in school or the
workplace. Reports indicated that one out of every 13 children
had a food allergy (Wilson, 2015) and the incidence of allergies
among children had continued to rise over time (Petti, 2016).
While food preparers attempted to prevent allergic reactions by
not serving foods that cause anaphylaxis, cross-contamination
could easily happen if the same utensil, counter tops, or dishes
were used in the kitchen.
The Treatment
A Japanese chemist named Jokichi Takamine was the first
person to identify adrenaline as its own chemical (Ramsey,
2016). Not long after his discovery, adrenaline began to be used
for medical therapy and took on the name of epinephrine. Early
on, epinephrine was used as an emergency medicine for the
heart and lungs, and later it began to be used to treat asthma
attacks and allergic reactions. When treating allergic reactions,
epinephrine was injected into the thigh of the patient using a
vial and syringe.
In the 1970s, a biomedical engineer named Sheldon Kaplan was
tasked with creating a device that the military could give to
soldiers to quickly inject the antidote into themselves when
exposed to nerve gas during chemical warfare. After developing
the auto-injector, called the ComboPen, Kaplan realized that his
invention could be utilized by consumers to administer
epinephrine to themselves during an emergency. Kaplan
received no royalties for his invention, as he worked for a
company called Survival Technology that owned the patent on
the invention. Survival Technology was renamed Meridian
Medical Technologies, and the company applied for a medical
patent on Kaplan’s auto-injector, now called the EpiPen, in
1980. The drug and device to distribute the medication to the
consumer (now known as EpiPen) was approved by the FDA in
1987 (Ramsey, 2016).
Meridian Medical Technologies introduced the EpiPen to the
market, and in 1997, sold the exclusive marketing and
distribution rights to Dey Pharma, a subsidiary of Merck
(Carrier & Minniti III, 2016). Then, in 2007, Mylan acquired
Merck’s generic pharmaceutical division, which included
EpiPen as part of its product line.
For people with anaphylaxis, the doctor prescribed two
epinephrine auto-injectors, such as the EpiPen, annually. Using
an auto-injector proved to be better than the traditional vial and
syringe approach because the device gave the exact dosage and
the person who administered it was less likely to hit a nerve
during insertion. Although some doctors and consumers
reported that epinephrine could last much longer than a year,
the expiration on the auto-injectors was limited to one year
(Cassels, 2016). Furthermore, the doctor prescribed two
injectors because patients had to always have two with them at
one time. Sometimes it took a second dose of the epinephrine
for the symptoms to subside (Rance & Goldberg, 2015). Thus,
Mylan initially sold a single EpiPen but eventually sold them
only in two-packs, because of the medical community’s
recommendation for an individual to always carry two.
Mylan and the EpiPen
Initially, Mylan was not excited about acquiring the EpiPen
brand; a single EpiPen was selling for $50 at the time. The
company viewed EpiPen as an old brand that was not generating
a significant amount of revenue. (Note, in 2007 EpiPen
generated $200 million in revenue for Mylan.) The company
considered selling off the brand but instead decided to try to
revive EpiPen by investing in marketing. Bresch was the
company’s chief lobbyist at the time, and she pitched a
marketing plan that included the idea of targeting parents of
children with allergies who were concerned about the safety of
their children (Rubin, 2016). Moreover, the marketing campaign
included an intense public awareness marketing effort to inform
the public about the seriousness of child allergies (Koons &
Langreth, 2015).
Bresch was the daughter of U. S. Senator Joe Manchin, a West
Virginia Democrat, and Gayle Manchin, the head of the
National Association of School Boards (Tuttle, 2016). She
started out as a secretary at Mylan and worked her way up the
corporate ladder to Chief Lobbyist and eventually CEO. Bresch
was not new to controversy in her professional career. For
example, when she was first appointed to CEO of Mylan, the
official company press release stated that she had an MBA from
West Virginia University (WVU). It was later revealed, through
investigative
reporting, that Bresch had not completed her MBA at WVU and
several university officials were complicit in creating grades for
courses that she did not complete and falsifying her transcripts
(Garde, 2016).
Also, in 2015 under Bresch’s leadership, Mylan purchased
Abbott Laboratories and moved some of its operations overseas
to buildings owned by Abbott in the Netherlands, in order
obtain a more favorable tax rate for the company. Mylan, which
was known for being a drug company that cared about its
stakeholders and promoted corporate social responsibility, was
criticized by the press and government officials (President
Obama included) for taking advantage of this tax loophole
(Garde, 2016, p. 4).
Thus, like other times in her professional career when Bresch
faced adversity, she planned to fight for EpiPen, as she believed
the brand was a winner. The goals of Bresch’s marketing plan
were to increase awareness of anaphylaxis, improve
preparedness for consumers, and expand access to treatment for
those living with severe allergies (Willingham, 2016). The
major point of emphasis for Mylan among these goals was to
ensure access to epinephrine among as many consumers as
possible. To achieve these goals, Mylan ramped up its
advertising efforts that depicted children whose lives were
saved because they had access to the 2-pack EpiPen when they
had an allergic reaction (Mylan EpiPen TV commercial, n.d.).
The message was clear: EpiPens were essential for the well-
being of children with serious allergies.
Mylan also expanded its sales force and began to lobby
Congress to pass a law requiring schools to keep EpiPens on
hand for their students to use in an anaphylactic emergency
(Hopkins, 2016). Advertising expenditures increased by 450%;
the sales force was expanded by 40%; and lobbying efforts
increased significantly (Hopkins, 2016; Lee, 2016; Tuttle,
2016). According to Bresch, the total amount Mylan spent on
these marketing efforts exceeded $1 billion (CBS News, 2017).
One of the unique aspects of Mylan’s marketing campaign was
its lobbying. Bresch was a former lobbyist and wanted to
increase the education of legislators about anaphylaxis and
epinephrine. Her mother, Gayle Manchin, also spearheaded an
effort by the National Association of School Boards to
encourage states to require that schools stock EpiPens in case
there is an anaphylactic emergency among its students (Freeley
& Langreth, 2016). Some thought this was a good idea because
there had been a highly publicized case of a young girl dying
from an anaphylactic reaction at school (Moisse, 2012).
Mylan’s lobbying, in conjunction with Gayle Manchin’s school
board efforts, led to Congress passing the School Access to
Emergency Epinephrine Act in November of 2013. Under this
law, the Department of Health and Human Services prioritized
funding preferences to states for asthma-treatment grants if they
required that public schools stocked an emergency supply of
EpiPens and developed a plan for training school personnel to
administer the medication in case of an emergency (Rubin,
2016).
Upon passage of the law, Mylan created the EpiPen4Schools
program in which the company would donate four EpiPens at no
cost to a participating school each year. If a school chose to
purchase additional EpiPens during the year, it could pay a
“discounted price,” or it could obtain
a “deeper discount” if the school “certified that it would not
purchase competitive products to EpiPen during the following
12 months” (Tuttle, 2016, p. 3). As part of its EpiPen4Schools
program, Mylan donated more than 800,000 pens to over 70,000
schools across the whole United States (CBS News, 2017). The
marketing campaign efforts were successful as well in
increasing its product sales to more than schools. In 2014, Walt
Disney agreed to stock EpiPens in Disney’s theme parks and on
its cruise ships (Gough, 2014).
At the same time as Mylan was expanding its marketing efforts,
the company had begun to also raise its prices on the EpiPen.
Recall that in 2007, the price for an EpiPen was approximately
$50 for one pen. By 2009, Mylan now sold only a two-pack, and
the price was $124. By the end of 2012, the price for the two-
pack had risen to $241. At the end of 2013, EpiPen’s price was
$304, and in 2015 it was $461 (Herper, 2016). By 2016, the
price for a two-pack of EpiPens was $608 (CBS News, 2017).
The result was EpiPens had generated $200 million in 2007;
sales read $1 billion by 2015 (Johnson & Ho, 2016).
The Consumer’s Reaction
As Mylan was steadily raising the price of EpiPens each year,
many consumers did not initially notice the price increase,
partially because the difference was absorbed by insurance
companies. Furthermore, even though consumers may not have
directly realized the price increase, it still was bearing out in
the form of higher insurance premiums for employers,
employees, and the end consumer (Herper, 2016).
Increasingly, however, people were moving to high-deductible
insurance plans in which they were personally responsible for
paying the full price for many medications, such as the EpiPen.
In fact, approximately 25% of Americans were on high
deductible plans in 2016, compared to just 4% of people in 2006
(Khazan, 2016). Also, the average deductible for a worker in
2016 was approximately $1300. Thus, to an increasing number
of consumers, the cost of EpiPens appeared to be exorbitant.
Compounding the situation, most parents who purchased
EpiPens had multiple sets for the car, home, camps, and other
locations (such as a babysitter’s house, grandma’s house, or
after-school daycare settings). In addition, some families had
multiple children with allergies and thus needed, even more,
sets of pens. Pens had to be replaced annually, due to expiration
dates, and a person had to buy two at once (even if they have
only used one pen in the set). The stress of the high prices even
caused some parents to consider not purchasing the pens for
their children (Parker-Pope & Peachman, 2016).
Concerned people created a petition in July 2016 complaining to
Congress about the high cost of EpiPens to consumers (i.e.,
http://www.petition2congress.com/20720/stop-epipen-price-
gouging). People wondered how a hundred-year-old drug,
epinephrine, could be so expensive. In fact, the epinephrine
itself cost less than one dollar per milliliter. Also, in other
countries, a two-pack of EpiPens cost much less. For example,
the cost was $85 in France, $119 in the United Kingdom, and
$131 in Canada (Cheeseman, 2016).
When asked about the $608 price tag of the two-pack of
EpiPens in the United States, Bresch stated that $334 of that
amount went to players within the channel of distribution, such
as middlemen and pharmacy benefit managers. She stated that
the company garnered $274 for each purchase and the net profit
to Mylan was approximately $100 after accounting for expenses
(CBS News, 2017).
The Competition (Or Lack Thereof)
Some consumers speculated that the cost of the auto-injector
and the additional marketing expenses were not the only reason
that Mylan charged an exorbitant amount for the two-pack of
EpiPens. Mylan appeared to have a monopoly over the market,
as there were virtually no competitors (Rubin, 2016). In 2012,
for example, EpiPen was the dominant brand and enjoyed a 95%
market share (Hopkins, 2016).
In the 1990s, there were zero competitors to the EpiPen. But in
2003, the first competitor entered the market, Twinject.
Twinject was produced by various companies over the years and
eventually was renamed to Andrenaclick. As of March of 2015,
a company named Impax owned the right to market and
distribute Andrenaclick. The price of Andrenaclick was much
less than that of EpiPen, at around $142. However, Impax had
not had much success in selling the product, which resulted in
only a 5% market share (Carrier & Minniti III, 2016).
Doctors and consumers often preferred the EpiPen brand
because Andrenaclick used a different technology for the
administration of the epinephrine. The two devices worked
differently, and the Adrenaclick injector was not automated.
Once consumers learned how to use one of the two
technologies, it was difficult to convince them to switch and
take the time to learn a new method of administration.
Additionally, doctors worried that while trying to learn a new
system, user error would increase, potentially risking the life of
the person having an anaphylactic reaction (Willingham, 2016).
Starting in January of 2013, another drug company, Sanofi,
developed another competitor to the EpiPen, initially called the
“e-cue.” The e-cue was later renamed the Auvi-Q and this
technology utilized a recorded voice to instruct the user on how
to inject the epinephrine (Carrier
· Minniti III, 2016). However, Sanofi voluntarily recalled all of
its Auvi-Q injectors when the
Food and Drug Administration (FDA) determined that the
product had “major deficiencies” because the auto-injector
sometimes delivered an inaccurate dosage of the epinephrine to
the person having the anaphylactic reaction (Rubin, 2016). Once
the product was pulled from the channel of distribution, it was
unclear when (if ever) the Auvi-Q would return to the
marketplace.
Although not yet on the market, in 2009, Teva (another drug
company) applied for FDA approval of yet another potential
competitor to the EpiPen. However, soon after filing for
approval, Mylan sued Teva for patent infringement. The two
companies settled out of court and, “while the terms of the
settlement were confidential, a Mylan Press release indicated
that in the settlement Teva agreed to delay entering the market
until June of 2015” (Carrier & Minniti III, 2016, p. 5). In 2011,
another competitor, Sandoz Pharmaceuticals, also applied for
FDA approval to enter the EpiPen market, and again, Mylan
filed suit for patent infringement. As of
2016, Sandoz’s application with the FDA was “ongoing and the
litigation was on hold” (Carrier
· Minniti III, 2016, p. 5). Thus, like the Auvi-Q, it was also
unclear when (and if) Sandoz Pharmaceuticals would enter the
market with their own version of the EpiPen.
The Right Thing?
Heather Bresch, Chief Executive Officer of Mylan, had
completed her testimony to the House Oversight and
Government Reform Committee. She staunchly defended
Mylan’s actions and the pricing structure for EpiPen. Bresch
explained that the company had increased access for consumers
and made an important contribution to society by teaching
people about life-threatening anaphylaxis. The company utilized
a variety of marketing techniques to increase access and that, in
turn, increased the price of EpiPens.
Furthermore, Bresch explained to the committee that, if anyone
was to blame, it was a broken healthcare system in which
consumers now had to pay very high deductibles and cover the
full cost of medication out of their own pockets. The committee
listened carefully to Bresch’s testimony and was going to issue
a statement about their findings next month. Would the
committee judge Mylan’s actions as acceptable? Did Bresch and
the company act ethically? And what was the future of EpiPen?

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Prior to beginning work on this discussion, review the two article.docx

  • 1. Prior to beginning work on this discussion, review the two articles: The Best of Best Practices: Critical Success Factors for Identifying and Measuring Industry-Leading Management Solution s and Understanding Victory: Adapting Operational Design to Address Resource Management Challenges. Define the terms process and process integration. Use these definitions to describe at least one process you deploy at your current place of employment or any previous place of employment. Be specific and use course concepts and principles to support the positions that you take. Your initial post should include examples and be at least 200 to 250 words. Respond to at least two of your classmates’ posts. Guided Response: Review several of your peers’ posts. Respond to at least two of your fellow students’ posts and provide information or perspective based on your experience. You are encouraged to post your required replies earlier in the week to promote more meaningful and interactive discourse in this discussion forum. Continue to monitor the discussion forum until 5:00 p.m. (Mountain Time) on Day 7, and respond with robust dialogue to anyone who replies to your initial post.
  • 2. Mark Bosco 9 Mar 20209 Mar at 18:49 Manage discussion entry Process- A set of instructions or formal direction to push production from beginning to end. Process Integration- The procedure of putting instruction into practice. Company management is to develop a plan of action. The plan of action is then carried out through the training program. The training program trains the employees to get them prepared for daily operations. I work in a factory and there are many different stations that go into the production of our product. To ensure that new hires are prepared for the tasks themselves there is a training area that has smaller versions of all the work areas that new hires spend their first day working within. The training area gives the new hires the opportunity to gain a basic understanding before going to the production floor. However, the training area limits the experience procedure itself, it does not teach the pace of the production floor. To train the new hires about the pace of the production floor, new hires are typically stationed in more of the less strenuous tasks first. Then as they become more comfortable with the pace of production they are transitioned to the more pivotal workstations. This multitiered integration
  • 3. helps make process training more seamless for new hires. It is a very effective plan of action. Amircal webb 10 Mar 202010 Mar at 2:28 Manage discussion entry Hey Class, According to the text Process is the method for getting work done and consist of a series of steps that turn inputs into outputs. “Process integration is the sharing and coordination of key process between companies in a supply chain (Wisner,2017).” One process that I deployed at my previous place of employment was the recruit accountability as I mentioned previously in my introduction post. The method was to coordinate with each battalion to notify them to submit their daily count to headquarters by noon. The series of steps included a spreadsheet sent out to each battalion at 7am from headquarters. The five battalions would input their count on the spreadsheet provided in detail of where each recruit stood in in training. Additionally, the count would include numbers of new recruits received, the number of recruits who were held back in
  • 4. training and the number of recruits who graduated. The end result would provide accountable results which included the total of remaining recruits in that battalion. Each battalion would be tasks with filling out the same information and sending the information to the headquarters to integrate the five battalions. After a total count is received the battalion commander is briefed and is able to determine when the next graduation was or how many documents he needed to sign to send “broken recruits” back home. “By enabling networking experiences for participants, organizations can foster communities of practice that give rise to new best practices and successful business alliances (Carter & Carmichael, 2011).” The newly developed process that was created for recruit accountability was more effect and accurate. References Carter, L. L., & Carmichael, P. (2011). The best of best practices: Critical success factors for identifying and measuring industry-leading management solutions. TD 65(8), 40-46. Retrieved from https://www.td.org/td-magazine Wisner, J. D. (2017). Operations management: A supply chain process approach. Retrieved from https://content.ashford.edu QUESTIONS:
  • 5. 1) Is the price increase justified as argued by Mylan, or is there a case to be made that this is price gouging? PLEASE READ THE CASE STUDY, AND PREPARE THE PPT FOR THE ABOVE QUESTION. Mylan and the EpiPen: Increased Access or Price Gouging? In September of 2016, Heather Bresch, the Chief Executive Officer of Mylan, was called to testify before the House Oversight and Government Reform Committee, part of the U. S. Congress. The committee planned to ask Bresch questions about the $608 price tag that was attached to the two-pack of EpiPens sold by her company. Bresch had worked her way up through the company, and she considered EpiPen important to her as she had personally championed the brand over the years. Bresch was proud of EpiPen’s success, and she did not plan to admit that the company was at fault (George, 2016). After all, companies like Mylan existed to make money and create a profit for their shareholders. And, in this case, the insurance companies were partly to blame because consumers had to pay more out-of-pocket for medications. However, despite her plan,
  • 6. Bresch wondered if her answers would satisfy the House Oversight and Government Reform Committee members? How would they judge her and Mylan’s actions? Mylan Bresch’s company, Mylan, was founded in 1961 with the mission of “helping people in small West Virginia towns and rural communities gain access to affordable medicine” (Mylan is a global healthcare company, n.d.). By 2007, Mylan had grown to become a global firm by having purchased Merck’s generic pharmaceutical division and it touted that its most valuable asset was its global workforce. Its mission was as follows (About us, n.d.): At Mylan, we are committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high-quality medicine, we: · Innovate to satisfy unmet needs; · Make reliability and service excellence a habit; · Do what’s right, not what’s easy; · Impact the future through passionate global leadership. When Mylan purchased Merck’s generic pharmaceutical division, the company acquired EpiPen, a treatment for
  • 7. anaphylaxis (i.e., a serious allergic response). Its website stated that “At Mylan, we put people first, trusting that profits will follow” (Social responsibility at Mylan, n.d.). This philosophy corresponded with the efforts associated with corporate social responsibility (CSR), which “encompassed not only what companies do with their profits, but also how they make them” (Harvard Kennedy School, 2014). Anaphylaxis Anaphylaxis is a life-threatening condition in which a person has an acute allergic response to something in their environment. Being allergic to foods, such as shellfish, wheat, tomatoes, and nuts is thought to be the most common driver of anaphylaxis, although bug bites/stings and medications also caused reactions. Researchers have reported that 7.7% of the population had experienced anaphylaxis and, in some cases, this condition had resulted in death (Rance · Goldberg, 2015). Furthermore, an estimated 200,000 people had been hospitalized from anaphylaxis each year with less than 100 of them dying from the condition (Cassels, 2016). Anaphylaxis is a serious medical issue because of its rapid onset and the person who was reacting often does not realize
  • 8. that they were experiencing the condition. The patient needs to quickly recognize the symptoms when anaphylaxis sets in. Studies had shown that, of the people who had anaphylaxis, only 42% sought treatment for their symptoms within 15 minutes of onset, with many risking death by delaying treatment (Rance & Goldberg, 2015). Most of the time, anaphylaxis had happened at home or in other contexts outside of the doctor’s office, such as in school or the workplace. Reports indicated that one out of every 13 children had a food allergy (Wilson, 2015) and the incidence of allergies among children had continued to rise over time (Petti, 2016). While food preparers attempted to prevent allergic reactions by not serving foods that cause anaphylaxis, cross-contamination could easily happen if the same utensil, counter tops, or dishes were used in the kitchen. The Treatment A Japanese chemist named Jokichi Takamine was the first person to identify adrenaline as its own chemical (Ramsey, 2016). Not long after his discovery, adrenaline began to be used for medical therapy and took on the name of epinephrine. Early on, epinephrine was used as an emergency medicine for the heart and lungs, and later it began to be used to treat asthma
  • 9. attacks and allergic reactions. When treating allergic reactions, epinephrine was injected into the thigh of the patient using a vial and syringe. In the 1970s, a biomedical engineer named Sheldon Kaplan was tasked with creating a device that the military could give to soldiers to quickly inject the antidote into themselves when exposed to nerve gas during chemical warfare. After developing the auto-injector, called the ComboPen, Kaplan realized that his invention could be utilized by consumers to administer epinephrine to themselves during an emergency. Kaplan received no royalties for his invention, as he worked for a company called Survival Technology that owned the patent on the invention. Survival Technology was renamed Meridian Medical Technologies, and the company applied for a medical patent on Kaplan’s auto-injector, now called the EpiPen, in 1980. The drug and device to distribute the medication to the consumer (now known as EpiPen) was approved by the FDA in 1987 (Ramsey, 2016). Meridian Medical Technologies introduced the EpiPen to the market, and in 1997, sold the exclusive marketing and distribution rights to Dey Pharma, a subsidiary of Merck (Carrier & Minniti III, 2016). Then, in 2007, Mylan acquired Merck’s generic pharmaceutical division, which included
  • 10. EpiPen as part of its product line. For people with anaphylaxis, the doctor prescribed two epinephrine auto-injectors, such as the EpiPen, annually. Using an auto-injector proved to be better than the traditional vial and syringe approach because the device gave the exact dosage and the person who administered it was less likely to hit a nerve during insertion. Although some doctors and consumers reported that epinephrine could last much longer than a year, the expiration on the auto-injectors was limited to one year (Cassels, 2016). Furthermore, the doctor prescribed two injectors because patients had to always have two with them at one time. Sometimes it took a second dose of the epinephrine for the symptoms to subside (Rance & Goldberg, 2015). Thus, Mylan initially sold a single EpiPen but eventually sold them only in two-packs, because of the medical community’s recommendation for an individual to always carry two. Mylan and the EpiPen Initially, Mylan was not excited about acquiring the EpiPen brand; a single EpiPen was selling for $50 at the time. The company viewed EpiPen as an old brand that was not generating a significant amount of revenue. (Note, in 2007 EpiPen generated $200 million in revenue for Mylan.) The company
  • 11. considered selling off the brand but instead decided to try to revive EpiPen by investing in marketing. Bresch was the company’s chief lobbyist at the time, and she pitched a marketing plan that included the idea of targeting parents of children with allergies who were concerned about the safety of their children (Rubin, 2016). Moreover, the marketing campaign included an intense public awareness marketing effort to inform the public about the seriousness of child allergies (Koons & Langreth, 2015). Bresch was the daughter of U. S. Senator Joe Manchin, a West Virginia Democrat, and Gayle Manchin, the head of the National Association of School Boards (Tuttle, 2016). She started out as a secretary at Mylan and worked her way up the corporate ladder to Chief Lobbyist and eventually CEO. Bresch was not new to controversy in her professional career. For example, when she was first appointed to CEO of Mylan, the official company press release stated that she had an MBA from West Virginia University (WVU). It was later revealed, through investigative reporting, that Bresch had not completed her MBA at WVU and several university officials were complicit in creating grades for courses that she did not complete and falsifying her transcripts (Garde, 2016).
  • 12. Also, in 2015 under Bresch’s leadership, Mylan purchased Abbott Laboratories and moved some of its operations overseas to buildings owned by Abbott in the Netherlands, in order obtain a more favorable tax rate for the company. Mylan, which was known for being a drug company that cared about its stakeholders and promoted corporate social responsibility, was criticized by the press and government officials (President Obama included) for taking advantage of this tax loophole (Garde, 2016, p. 4). Thus, like other times in her professional career when Bresch faced adversity, she planned to fight for EpiPen, as she believed the brand was a winner. The goals of Bresch’s marketing plan were to increase awareness of anaphylaxis, improve preparedness for consumers, and expand access to treatment for those living with severe allergies (Willingham, 2016). The major point of emphasis for Mylan among these goals was to ensure access to epinephrine among as many consumers as possible. To achieve these goals, Mylan ramped up its advertising efforts that depicted children whose lives were saved because they had access to the 2-pack EpiPen when they had an allergic reaction (Mylan EpiPen TV commercial, n.d.). The message was clear: EpiPens were essential for the well- being of children with serious allergies.
  • 13. Mylan also expanded its sales force and began to lobby Congress to pass a law requiring schools to keep EpiPens on hand for their students to use in an anaphylactic emergency (Hopkins, 2016). Advertising expenditures increased by 450%; the sales force was expanded by 40%; and lobbying efforts increased significantly (Hopkins, 2016; Lee, 2016; Tuttle, 2016). According to Bresch, the total amount Mylan spent on these marketing efforts exceeded $1 billion (CBS News, 2017). One of the unique aspects of Mylan’s marketing campaign was its lobbying. Bresch was a former lobbyist and wanted to increase the education of legislators about anaphylaxis and epinephrine. Her mother, Gayle Manchin, also spearheaded an effort by the National Association of School Boards to encourage states to require that schools stock EpiPens in case there is an anaphylactic emergency among its students (Freeley & Langreth, 2016). Some thought this was a good idea because there had been a highly publicized case of a young girl dying from an anaphylactic reaction at school (Moisse, 2012). Mylan’s lobbying, in conjunction with Gayle Manchin’s school board efforts, led to Congress passing the School Access to Emergency Epinephrine Act in November of 2013. Under this law, the Department of Health and Human Services prioritized
  • 14. funding preferences to states for asthma-treatment grants if they required that public schools stocked an emergency supply of EpiPens and developed a plan for training school personnel to administer the medication in case of an emergency (Rubin, 2016). Upon passage of the law, Mylan created the EpiPen4Schools program in which the company would donate four EpiPens at no cost to a participating school each year. If a school chose to purchase additional EpiPens during the year, it could pay a “discounted price,” or it could obtain a “deeper discount” if the school “certified that it would not purchase competitive products to EpiPen during the following 12 months” (Tuttle, 2016, p. 3). As part of its EpiPen4Schools program, Mylan donated more than 800,000 pens to over 70,000 schools across the whole United States (CBS News, 2017). The marketing campaign efforts were successful as well in increasing its product sales to more than schools. In 2014, Walt Disney agreed to stock EpiPens in Disney’s theme parks and on its cruise ships (Gough, 2014). At the same time as Mylan was expanding its marketing efforts, the company had begun to also raise its prices on the EpiPen. Recall that in 2007, the price for an EpiPen was approximately
  • 15. $50 for one pen. By 2009, Mylan now sold only a two-pack, and the price was $124. By the end of 2012, the price for the two- pack had risen to $241. At the end of 2013, EpiPen’s price was $304, and in 2015 it was $461 (Herper, 2016). By 2016, the price for a two-pack of EpiPens was $608 (CBS News, 2017). The result was EpiPens had generated $200 million in 2007; sales read $1 billion by 2015 (Johnson & Ho, 2016). The Consumer’s Reaction As Mylan was steadily raising the price of EpiPens each year, many consumers did not initially notice the price increase, partially because the difference was absorbed by insurance companies. Furthermore, even though consumers may not have directly realized the price increase, it still was bearing out in the form of higher insurance premiums for employers, employees, and the end consumer (Herper, 2016). Increasingly, however, people were moving to high-deductible insurance plans in which they were personally responsible for paying the full price for many medications, such as the EpiPen. In fact, approximately 25% of Americans were on high deductible plans in 2016, compared to just 4% of people in 2006 (Khazan, 2016). Also, the average deductible for a worker in 2016 was approximately $1300. Thus, to an increasing number
  • 16. of consumers, the cost of EpiPens appeared to be exorbitant. Compounding the situation, most parents who purchased EpiPens had multiple sets for the car, home, camps, and other locations (such as a babysitter’s house, grandma’s house, or after-school daycare settings). In addition, some families had multiple children with allergies and thus needed, even more, sets of pens. Pens had to be replaced annually, due to expiration dates, and a person had to buy two at once (even if they have only used one pen in the set). The stress of the high prices even caused some parents to consider not purchasing the pens for their children (Parker-Pope & Peachman, 2016). Concerned people created a petition in July 2016 complaining to Congress about the high cost of EpiPens to consumers (i.e., http://www.petition2congress.com/20720/stop-epipen-price- gouging). People wondered how a hundred-year-old drug, epinephrine, could be so expensive. In fact, the epinephrine itself cost less than one dollar per milliliter. Also, in other countries, a two-pack of EpiPens cost much less. For example, the cost was $85 in France, $119 in the United Kingdom, and $131 in Canada (Cheeseman, 2016). When asked about the $608 price tag of the two-pack of EpiPens in the United States, Bresch stated that $334 of that
  • 17. amount went to players within the channel of distribution, such as middlemen and pharmacy benefit managers. She stated that the company garnered $274 for each purchase and the net profit to Mylan was approximately $100 after accounting for expenses (CBS News, 2017). The Competition (Or Lack Thereof) Some consumers speculated that the cost of the auto-injector and the additional marketing expenses were not the only reason that Mylan charged an exorbitant amount for the two-pack of EpiPens. Mylan appeared to have a monopoly over the market, as there were virtually no competitors (Rubin, 2016). In 2012, for example, EpiPen was the dominant brand and enjoyed a 95% market share (Hopkins, 2016). In the 1990s, there were zero competitors to the EpiPen. But in 2003, the first competitor entered the market, Twinject. Twinject was produced by various companies over the years and eventually was renamed to Andrenaclick. As of March of 2015, a company named Impax owned the right to market and distribute Andrenaclick. The price of Andrenaclick was much less than that of EpiPen, at around $142. However, Impax had not had much success in selling the product, which resulted in only a 5% market share (Carrier & Minniti III, 2016).
  • 18. Doctors and consumers often preferred the EpiPen brand because Andrenaclick used a different technology for the administration of the epinephrine. The two devices worked differently, and the Adrenaclick injector was not automated. Once consumers learned how to use one of the two technologies, it was difficult to convince them to switch and take the time to learn a new method of administration. Additionally, doctors worried that while trying to learn a new system, user error would increase, potentially risking the life of the person having an anaphylactic reaction (Willingham, 2016). Starting in January of 2013, another drug company, Sanofi, developed another competitor to the EpiPen, initially called the “e-cue.” The e-cue was later renamed the Auvi-Q and this technology utilized a recorded voice to instruct the user on how to inject the epinephrine (Carrier · Minniti III, 2016). However, Sanofi voluntarily recalled all of its Auvi-Q injectors when the Food and Drug Administration (FDA) determined that the product had “major deficiencies” because the auto-injector sometimes delivered an inaccurate dosage of the epinephrine to the person having the anaphylactic reaction (Rubin, 2016). Once
  • 19. the product was pulled from the channel of distribution, it was unclear when (if ever) the Auvi-Q would return to the marketplace. Although not yet on the market, in 2009, Teva (another drug company) applied for FDA approval of yet another potential competitor to the EpiPen. However, soon after filing for approval, Mylan sued Teva for patent infringement. The two companies settled out of court and, “while the terms of the settlement were confidential, a Mylan Press release indicated that in the settlement Teva agreed to delay entering the market until June of 2015” (Carrier & Minniti III, 2016, p. 5). In 2011, another competitor, Sandoz Pharmaceuticals, also applied for FDA approval to enter the EpiPen market, and again, Mylan filed suit for patent infringement. As of 2016, Sandoz’s application with the FDA was “ongoing and the litigation was on hold” (Carrier · Minniti III, 2016, p. 5). Thus, like the Auvi-Q, it was also unclear when (and if) Sandoz Pharmaceuticals would enter the market with their own version of the EpiPen. The Right Thing?
  • 20. Heather Bresch, Chief Executive Officer of Mylan, had completed her testimony to the House Oversight and Government Reform Committee. She staunchly defended Mylan’s actions and the pricing structure for EpiPen. Bresch explained that the company had increased access for consumers and made an important contribution to society by teaching people about life-threatening anaphylaxis. The company utilized a variety of marketing techniques to increase access and that, in turn, increased the price of EpiPens. Furthermore, Bresch explained to the committee that, if anyone was to blame, it was a broken healthcare system in which consumers now had to pay very high deductibles and cover the full cost of medication out of their own pockets. The committee listened carefully to Bresch’s testimony and was going to issue a statement about their findings next month. Would the committee judge Mylan’s actions as acceptable? Did Bresch and the company act ethically? And what was the future of EpiPen?