Mylan CEO on Inflating EpiPen Prices: I Wasn’t Going to Apologize ‘for Operating in the System’

Heather Bresch, the CEO of Mylan N.V., argued she and her company, which drew controversy for increasing the price of EpiPen devices by nearly 500 percent, had nothing to apologize for since they were "operating in the system that existed."

Bresch, who is also the daughter of Democratic Sen. Joe Manchin (W.Va.), appeared Monday on CNN's "Boss Files" podcast with Poppy Harlow to discuss her tenure at the helm of the pharmaceutical giant.

Mylan first sparked controversy in 2016 when it came to light the company raised the price of a two-pack EpiPen injector from around $100 in 2007, when it first acquired the life-saving treatment, to over $600 in 2016, when it controlled 85 percent of the drug's the market share. The company's decision to hike the price of EpiPen 15 times, nearly 500 percent, in less than a decade drew widespread rebuke and accusations of price-gouging.

In between commenting about the "ambition gap" between men and women in corporate America, and the need to properly "classify" paid parental leave, Bresch was asked what drove Mylan's decision to hike the price of EpiPen's to historic highs.

The CEO claimed it was important to grasp the "broken [pharmaceutical] system," where prices rise annually, to understand why Mylan acted in such a manner.

"First, in context, I do think it's important — and I have again said this — that to understand the system, and it is a broken system for sure," Bresch said. "But the system, of the fact, that prices increase for every product … It's the only industry that price goes up every year, whether you're on the market 30 years, 40 years, 50 years."

She added that pharmaceutical companies often use the profits made from increasing prices on the drugs they manufacture to reinvest in their companies.

"There's a lot of reasoning for that," Bresch said. "Taking those dollars, you're reinvesting them in the product itself, you're re-investing them to bring other products to the market. There's a whole portfolio of reasons about why these prices increases happen and what then that money goes to [in terms of] reinvestment."

The CEO admitted that Mylan used the profits increased from hiking EpiPen prices to invest in "brand awareness" in an effort to ensure her drug was purchased in greater volume.

"Mylan, at the time, we had invested, over this decade that the prices increases happened, we had invested about a billion dollars back into EpiPen and to the awareness," Bresch said. "I realize that people were very ill prepared for an anaphylactic event, in fact, were very ill-informed about anaphylaxis … so we did brand awareness, we changed the product design … we did a lot of things."

http:// freebeacon.com/issues/mylan-ceo-on-inflating-epipen-prices-i-wasnt-going-to-apologize-for-operating-in-the-system/

Holder: A ‘Blue Wave’ Is Coming but It Might Not ‘Reach the Shore’

Former Obama administration Attorney General Eric Holder spoke in New Hampshire on Friday where he seemed to throw cold water on the idea of a coming "blue wave" this election cycle.

Holder, who has considered mounting a campaign for the 2020 Democratic presidential nomination, was the keynote speaker at the "Politics & Eggs" series hosted by the New Hampshire Institute of Politics at St. Anselm College. The event, convening business leaders and grassroots activists, has long been a staple for aspiring presidential candidates seeking to introduce themselves to the New Hampshire electorate, which, following the Iowa caucuses, casts its primary ballots before any other state.

While discussing his work as chair of the National Democratic Redistricting Committee (NDRC) – a D.C. based political advocacy group dedicated to "enacting a comprehensive, multi-cycle" Democratic Party redistricting strategy – Holder asserted a "blue wave" was imminent but added that it might not result in legislative victories.

The former attorney general claimed that gerrymandering, the process by which the boundaries of legislative districts are drawn by the party in power, could serve to thwart the "blue wave."

"You know, we talk about this blue wave," Holder said. "I think there's going to be a blue wave, but I think the Democrats should understand that blue wave is going to be running headlong into this gerrymandered system."

"The question is whether or not that blue wave will actually reach the shore," he added.

He pointed to the 2017 legislative elections in Virginia, where Democrats ran a concerted, multi-million dollar effort to flip the House of Delegates and came up short, as reason for being cautious.

"There was a 10-point differential between the votes obtained by Republicans and Democrats," Holder said. "Democrats got 10 percent more votes yet were unable to take the lower house there as a result of the gerrymandered districts."

"I worry about that happening here," he stated.

Holder's remarks come as the Democratic Party has witnessed its lead on the generic congressional ballot evaporate from a 13 point advantage in December of 2017 to within the margin of error.

Since departing the Obama administration, Holder has cultivated an increasingly higher profile with the goal of leading "the legal resistance" to President Donald Trump’s political agenda. Apart from his efforts on behalf of the NDRC, the former attorney general has signed on as an advisor to the California State Legislature in order to help the overwhelmingly Democratic body counter the Trump administration.

http:// freebeacon.com/politics/holder-blue-wave-coming-might-not-reach-shore/

>>1637120

Maybe he hopes everyone forgot about his fast and furious moves and ohhh, there's the liddle thing of censoring, which, he so proudly proclaimed, he didn't take lightly. Seems to me he hasn't suffered much for his crimes, yet, but soon….I don't believe he has any credibility whatsoever.

Microsoft has reportedly acquired GitHub

Microsoft has reportedly acquired GitHub, and could announce the deal as early as Monday. Bloomberg reports that the software giant has agreed to acquire GitHub, and that the company chose Microsoft partly because of CEO Satya Nadella. Business Insider first reported that Microsoft had been in talks with GitHub recently.

GitHub is a vast code repository that has become popular with developers and companies hosting their projects, documentation, and code. Apple, Amazon, Google, and many other big tech companies use GitHub. Microsoft is the top contributor to the site, and has more than 1,000 employees actively pushing code to repositories on GitHub. Microsoft even hosts its own original Windows File Manager source code on GitHub. The service was last valued at $2 billion back in 2015, but it’s not clear exactly how much Microsoft has paid to acquire GitHub.

Microsoft has been rapidly investing in open source technology since Satya Nadella took over the CEO role. Microsoft has open sourced PowerShell, Visual Studio Code, and the Microsoft Edge JavaScript engine. Microsoft also partnered with Canonical to bring Ubuntu to Windows 10, and acquired Xamarin to assist with mobile app development.

Microsoft is also using the open source Git version control system for Windows development, and the company even brought SQL Server to Linux. Microsoft’s Visual Studio Code, which lets developers build and debug web and cloud applications, has soared in popularity with developers. Microsoft’s GitHub acquisition will likely mean we’ll start to see even closer integration between Microsoft’s developer tools and the service. At Build last month, Microsoft continued its close work with GitHub by integrating the service into the company’s App Center for developers.

There will likely be questions around Microsoft’s GitHub acquisition, especially among some open source advocates who are wary of Microsoft’s involvement. If Microsoft does indeed announce this acquisition on Monday then developers won’t have too long to wait to get a better idea of Microsoft’s GitHub plans.

https:// www.theverge.com/2018/6/3/17422752/microsoft-github-acquisition-rumors

>>1637200

I don't know if that was the reason, but it did catch my eye, especially with this boards connection to github.

>>1637204

I agree Anon, we need to keep a close eye out and watch so that we never live to see another day of someone deciding something is too big to fail.

>>1637242

I believe so, I don't trust this company one bit. Interesting to note is I found this on an Asian site, didn't see anything in the American news, yet anyway.

>>1637262

I agree, but what, measures can be taken to prevent sideline takeovers, I wonder.

>>1637280

I just feel as though we are told this is better for this reason and then later down the line, we find out it was totally wrong, leaving us holding the bag on the losing side of things. I hope this doesn't become a problem.

Kratom advocates fight FDA crackdown

Opponents of the Food and Drug Administration’s expanding dragnet of the herbal supplement kratom are arguing that the agency is eliminating a vital way to fight the opioid crisis.

Scientists and activists say the agency’s ban on kratom, which is derived from tree leaves native to Southeast Asia, is not scientifically sound and that the agency is taking away a tool that millions of people use to help manage pain and drug withdrawal symptoms.

The FDA says there is no scientific evidence that kratom can help treat opioid withdrawal and that the herb has significant safety issues. FDA Commissioner Scott Gottlieb said in February that 44 deaths have been linked to kratom use, and the agency has recommended that the Drug Enforcement Administration place kratom as a controlled substance in schedule 1, the same category as heroin and marijuana.

The agency has told five companies to stop marketing and selling kratom. Another company has agreed to voluntarily recall and destroy their products.

Kratom can be taken as a raw powder to mix, a leaf to be brewed, a capsule or an extract.

In the midst of the crackdown, the American Kratom Association, a grassroots group formed in 2014, has been pushing back against the FDA and Drug Enforcement Administration’s targeting.

The group said last month that the problem isn’t kratom itself, but vendors that trump up health claims about the herb or manufacture it irresponsibly.

“Those enemies hand the FDA their daily headlines to smear legitimate kratom vendors, and they hand the FDA the weapons to demonize kratom as an unsafe plant,” David Herman, chairman of the association, wrote on the association’s website May 23.

Grassroots groups are trying to pressure the FDA to end its crackdown on the drug, which the group estimates is used by three to five million people.

"It is not something that we believe should be banned," said Peter Candland, the association's executive director. "It should be definitely regulated and keep it safe but keep it legal."

Congress also has stepped in at times. The DEA tried to schedule kratom as schedule 1 in 2016, but a bipartisan outcry from lawmakers prompted it to halt the effort.

In December, several lawmakers wrote to the FDA to express concern about its public health advisory about kratom. However, no legislation has been introduced this congressional session to protect it from the crackdown.

"The FDA must end its bogus ‘public health warning’ that has already led to several cities banning kratom," one of the signers, Rep. Jared Polis, D-Colo., said in December. "Patients need and deserve options.”

The association has been working to defeat proposed kratom bans in six states: Mississippi, Kansas, Tennessee, Illinois, West Virginia and Minnesota.

Candland said he hopes to meet with the FDA to determine the proper regulation of kratom.

"As an industry, we are adopting much more stringent guidelines and standards for manufacturers and vendors to adopt," he said.

The crackdown comes amid a salmonella outbreak that is linked to the product. The Centers for Disease Control and Prevention said last month that the outbreak sickened nearly 200 people.

https:// www.washingtonexaminer.com/policy/healthcare/kratom-advocates-fight-fda-crackdown

The White House's battle against botnets

The Trump administration's new report on botnets, which are networks of hijacked computers and devices that can unleash increasingly destructive cyber attacks, is a prelude to a cybersecurity strategy that will test the will and resourcefulness of federal agencies and private industry alike.

"If this doesn't work, we're screwed," said one industry source who has worked extensively with the federal government on cybersecurity issues.

The May 30 report was mandated by President Trump's 2017 cybersecurity executive order and drafted by the departments of Commerce and Homeland Security. The executive order identified botnets as one of the most dangerous threats facing the nation's critical infrastructure, including telecommunications systems, the financial sector and other targets that are being constantly bombarded by these automated cyber attacks.

“These threats are used for a variety of malicious activities, including distributed denial of service (DDoS) attacks that overwhelm networked resources, sending massive quantities of spam, disseminating keylogger and other malware; ransomware attacks distributed by botnets that hold systems and data hostage; and computational propaganda campaigns that manipulate and intimidate communities through social media,” the report said.

In the coming days, federal officials will detail how they plan to draft a “roadmap” for prioritizing and implementing the report's 24 action items in support of five overarching goals: promoting “a clear pathway toward an adaptable, sustainable, and secure technology marketplace”; encouraging innovation in response to “evolving threats” to the underpinnings of the Internet; promoting security innovation by so-called edge providers such as social media companies; promoting coalitions; and raising awareness of the threat.

The roadmap is due in 120 days and a progress report must be delivered to the president in one year.

The key to industry stakeholders, who helped DHS and Commerce develop the report, is that the strategic approach leans toward private-sector leadership and away from regulation. “The federal government will not lead the implementation of actions specific to industry,” the report states.

That wording came as a relief to industry.

But the cybersecurity challenge is growing amid increasingly sophisticated botnet and distributed denial of service attacks, one industry source noted, “and there's more pressure on federal agencies to make things happen.”

With that in mind, the source said, “This is an important opportunity to show that industry can take the initiative, work with government and show results.”

“There are things the U.S. government can do, but there are limitations,” said Kent Landfield of McAfee. “They need to pull in the industry stakeholder community,” he said, adding that the government heard and has responded to that message.

The report was originally expected to be released on May 11, the anniversary of the Trump executive order, but “it was worth waiting for,” said Robert Mayer, United States Telecom Association senior vice president for cybersecurity.

Mayer said the requirement for a status update to the president in 365 days shows “a serious effort to track progress.” The report also signals a recognition that “regulation is too static,” Mayer said.

https:// www.washingtonexaminer.com/policy/technology/the-white-houses-battle-against-botnets

Big Pharma faces rare day of reckoning as Trump pushes price cuts

The pharmaceutical industry's day of reckoning may have finally arrived.

President Trump and his administration are determined to move forward on a sweeping initiative to address the rising cost of prescription treatments and, for once, the drug lobby may be unable to block the effort. A blueprint revealed earlier this month contained a number of proposals — some more vague than others — that included allowing further private negotiation in the Medicare program and ending the drug rebate program.

Instead of a direct attack on the plan, Big Pharma hopes to craft policies that would quiet critics while avoiding potentially costly measures drugmakers have long opposed. It's planning to work behind the scenes with the White House, the Office of Management and Budget and the Department of Health and Human Services to find common ground on the final regulatory proposals.

The head of the industry's main lobbying group alluded to the strategy earlier this year.

"The real question is what's the right kind of change?" Stephen Ubl, president of the Pharmaceutical Research and Manufacturers of America, said at an event in May. "There are proposals in the president's suite of 50 ideas that have great potential. Everyone needs to come to the table with constructive ideas on how to evolve those proposals."

It's a departure from tactics employed in the past decade when the pharmaceutical lobby effectively killed most unfavorable policies through expensive ad campaigns across key congressional markets and grassroots advocacy efforts with industry-backed patient groups.

“The policy of trying to deal with this by defending the high prices, that’s not going to cut it anymore,” Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development, said in a recent interview. “All the stars are aligned right now for something to happen and the industry realizes they have to be part of the solution or they are going to end up with something they are not happy with.”

Companies may find it advantageous to act quickly, too, since doing so could appease a president who often just wants to notch a win. Trump said at a bill signing in May that he expected some pharmaceutical manufacturers to voluntarily lower the price of drugs by a “massive” amount in the coming weeks.

The industry's shift may also be an acknowledgment of the federal officials who are crafting the Trump administration’s plan. Individuals at the negotiating table for the federal government include former top executives from drug companies like Amgen Inc. and Eli Lilly & Co. who are knowledgeable of the complexities of the current pricing system and have an understanding of the industry’s position.

While key officials such as Health and Human Services Secretary Alex Azar and Food and Drug Administration Commissioner Scott Gottlieb haven’t shied away from criticizing the industry and advancing policy changes, the industry views them as preferable to the potential appointees of a liberal Democrat such as Sen. Elizabeth Warren, who's viewed as a potential presidential contender in 2020.

“Do you want to negotiate with Azar and Gottlieb or do you want to negotiate with whatever a President Warren puts together in 2021?" asked Craig Garthwaite, director of healthcare at the Kellogg School of Management at Northwestern University. "I think you have a better chance to try to look like you got something done now.”

https:// www.washingtonexaminer.com/business/pharmaceutical-industry-faces-rare-day-of-reckoning-as-trump-pushes-price-cuts

Trump's war on the Washington bureaucracy

Bill Valdez fired two people during his 20 years as a manager in the federal workforce.

One went quietly after an instance of undisputed misconduct. The other, accused of doing almost no work, refused to leave and used entrenched civil service protections to stay on the federal payroll for another eight years, claiming discrimination, disability, and unfair treatment.

Such long goodbyes have proved so arduous and frustrating that many managers just give up, essentially resigning their ability to manage their staff. But they are about to become much less common, as President Trump signed three executive orders last month gutting rules that allow bad workers to prevent legitimate firings, and ending lucrative perks for the labor unions that helped put them in place.

rump's sweeping reforms target union power. He is curbing subsidized work hours and free office space unions. This is the biggest splash yet in his promised effort to obliterate bureaucratic obstacles that have made the government in Washington a warehouse for many lazy and incompetent workers.

And Trump is eager to take on more and bigger reforms, members of the administration say.

“We’re not kicking the can down the road. We have a president who actually wants this sort of change so that the federal government can be the best it can be,” said Jeff Pon, who since March has led the civil service as director of the Office of Personnel Management.

Trump’s recent orders alone save an estimated $100 million a year in reduced union subsidies. They are described by officials as among the most aggressive civil service changes possible without Congress passing new laws.

Yet, big though they are, they are only a fraction of a grander vision within the Trump administration to reform and refocus the federal workforce.

Most of the work is being undertaken by the OPM, the White House Office of Management and Budget, and the White House Domestic Policy Council. Each is aggressively reforming the system through administrative and legislative action to make the notoriously bloated, pampered, and costly federal bureaucracy more efficient.

“If you think of [the civil service] as a seagoing vessel, you have a lot of barnacles, and growth and crust on the hull,” said a White House official who is part of the team setting administration policy. The official asked not to be named in order to freely discuss the policy. “What we are trying to do is basically power-wash those barnacles off the side of the civil service so it can operate more efficiently.”

Administration officials speak bullishly about comprehensive system improvements, including an ambitious update to the Civil Service Reform Act of 1978. But, this being Washington, realism tempers the most extravagant hopes.

Margaret Weichert, Deputy Director of the OMB, is a leading proponent of root and branch reform, and stresses the importance of her mission. “Since 1978 there has been no major attention given to how we operate our civil service, and that’s despite the fact that most of the jobs that people do today almost couldn’t have been conceived of in 1978,” she said.

Agencies all across the federal bureaucracy have become battlegrounds.

In March, the Department of Education unilaterally forced through a new union contract to break a negotiating impasse. At the Department of Veteran Affairs, resignations and firings are mounting after Congress passed agency-specific legislation, which the administration sees as a template for workforce-wide reform to hasten the firing of dud staff members.

https:// www.washingtonexaminer.com/news/white-house/trumps-war-on-the-washington-bureaucracy

>>1637528

There you go it works, that's the push to remove it, and cost affect as well. Rx companies can have you curing your own aliments, what on earth would you need them for:)

>>1637563

*can't