Is the EpiPen Price Elevation Just the Tip of the Iceberg in the Pharmaceutical Industry?

14089039_950180028444990_5005403533221290633_nIs it really true that manufacturers of pharmaceuticals really take advantage of the US population. A comparison study of cash prices of several drugs was done a few years ago in the US vs Canada: the Canadian non-subsidized drugs (same manufacturers as in the US) cost 1/3 as much as the US drugs, for both generics and name brands. Why do the manufacturers do this? Is it because they can. The US Government believes it is perfectly acceptable for the pharmaceuticals to charge whatever they want while maintaining their government monopoly on name brand drugs. Generic manufacturers have in the past 10 years followed suit- escalating their prices sometimes to within a few dollars of the name brand. In the US, it is all about $$$$$$$$$$. Nothing else matters to pharmaceutical manufacturers. Nothing. Not even people whose lives depend on rapid availability of injectable epinephrine.

Consider that latest insult, Members of Congress are in an unusual position as they demand an explanation for Mylan NV’s 400 percent price hike for the EpiPen and focus attention squarely on its CEO: Heather Bresch.

If lawmakers follow the usual script, Bresch could get called up to Capitol Hill next month to explain her company’s justification for raising the price on the life-saving allergy shot. But that could be awkward, since she’s the daughter of Democratic Senator Joe Manchin of West Virginia.

The scrutiny on EpiPen intensified Wednesday after Democratic nominee Hillary Clinton called the price increase “outrageous,” sending Mylan’s stock down as much as 6.2 percent. The intense political pressure could lead regulators to speed up their review of a rival product by Teva Pharmaceutical Industries Ltd., according to some analysts, or force Mylan to curb prices — in both cases hurting revenue and profits.

While CEO Bresch’s family ties may mute the ire of some lawmakers, others are already asking the company about taxpayers having to foot the bill for these price increases — particularly after Bresch and the company successfully pushed legislation to encourage use of the EpiPen in schools nationwide.

Mylan is the latest drug maker to provoke congressional ire for steep price hikes. Martin Shkreli and executives from the company he used to lead, Turing Pharmaceuticals AG, and executives from Valeant Pharmaceuticals International Inc. were called before congressional committees earlier this year to explain why they bought the rights to older drugs that lacked competition and raised the prices.

The Mylan controversy fits a similar pattern. Mylan has increased the price of its EpiPen from about $57 a shot when it took over sales of the product in 2007 to more than $600 for two auto-injectors. But the company’s EpiPen is a more mainstream drug used to treat life-threatening allergic reactions from bee stings, food allergies or other triggers, which could give the issue a larger constituency.

Mylan declined to comment when asked to explain the price hike or Bresch’s role in promoting legislation. Manchin’s office also didn’t respond to requests for comment. Members in both chambers expressed outrage this week. “I am deeply concerned by this significant price increase for a product that has been on the market for more than three decades, and by Mylan’s failure to publicly explain the recent cost increase, which places a significant burden on parents, schools and other purchasers of the EpiPen,” Senator Mark Warner, a Virginia Democrat, said Tuesday in a statement, noting that he is a parent of a child with severe allergies.

On Wednesday, the Senate Special Committee on Aging asked Bresch to turn over information used by Mylan’s board of directors related to the price increases. The panel wrote a letter to Bresch asking her to “provide a briefing to Committee staff on the pricing of EpiPen at a mutually convenient time no later than two weeks from today.” The committee’s chairman, Republican Senator Susan Collins of Maine, and its top Democrat, Claire McCaskill of Missouri, signed the letter.

Senator Richard Blumenthal, a Connecticut Democrat who has asked the company to lower its prices, is holding an event on Wednesday where he will call for investigations by the Senate Judiciary Committee and the Federal Trade Commission into potential antitrust violations and deceptive and illegal trade practices.

The issue of the price increase became presidential campaign fodder after Clinton issued her statement. “Since there is no apparent justification in this case, I am calling on Mylan to immediately reduce the price of EpiPens,” Clinton said in a statement from her campaign.

Mylan’s shares, which have dropped this week as the scrutiny increased, fell further after Clinton’s comments. The stock was down 6.1 percent to $42.86 at 3:25 p.m. in New York, bringing the three-day losses to more than 11 percent.

The company’s tactics in pushing legislation that helped boost the use of EpiPens may fuel congressional anger.

Mylan spent about $4 million in 2012 and 2013 on lobbying for access to EpiPens generally and for legislation, including the 2013 School Access to Emergency Epinephrine Act, according to lobbying disclosure forms filed with the Office of the Clerk for the House of Representatives. Mylan also was the top corporate sponsor of a group called Food Allergy Research & Education that was the key lobbyist pushing for the bill encouraging schools to stock epinephrine auto-injectors, of which EpiPen is by far the leading product.

But Bresch’s connections to Capitol Hill already have some lawmakers tiptoeing around the usual Washington blame game. For example, Blumenthal, a member of the Senate Judiciary Committee and a co-sponsor of the 2013 schools bill, asked Bresch in a letter Monday to explain the “shocking price increases.”

However, in an interview Tuesday, he was less eager to talk about Bresch herself or the prospect that she might soon be testifying to the committee.

He initially answered during one telephone call that he was unaware that she had any direct involvement in the pricing. Then, in a follow-up call, Blumenthal responded when asked again about the possibility of her coming before Congress by saying, “I am just not going to comment on that.”

Bresch, 47, has been CEO of Mylan since 2012 and previously held other senior posts at the company, including as head of government relations. Last year, she had to defend the company after it moved its corporate address overseas to lower its U.S. taxes in a transaction known as an inversion. Now incorporated in the Netherlands, its principal executive office is in Canonsburg, Pennsylvania.

Ross Baker, a political scientist at Rutgers University in New Jersey, said Tuesday that he assumes Bresch’s father, Manchin — who is not on the Judiciary Committee — would recuse himself “and put a lot of distance between himself and any investigation” into the matter. “He’d be unwise to rise to the defense of Mylan,” Baker said.

Senate Judiciary Chairman Chuck Grassley of Iowa, who is running for re-election, also wrote a letter to Mylan saying he was “concerned that the substantial price increase could limit access to a much-needed medication,” asking for an explanation by Sept. 6, the day the Senate returns from its seven-week summer recess. Jill Gerber, Grassley’s spokeswoman, said in an e-mail that he wants to hear back from Mylan before considering holding a hearing.

Mylan has given away more than 700,000 free EpiPen’s to schools since 2012 under a program that allows them to receive four free auto-injectors, the company said in a statement. Yet schools have to use their own funds to purchase additional pens. Mylan declined to comment on the price increases coinciding with legislation to encourage EpiPen use.

Senator Amy Klobuchar, a Minnesota Democrat, asked the Federal Trade Commission on Monday to look into whether Mylan had done anything to deny competitors access to the market in order to keep raising prices. She pointed to a competitor product, Adrenaclick, that she said is less expensive but has only minimal sales. Klobuchar was also a co-sponsor of the schools bill.

In the House on Tuesday, majority and minority staff members of the Oversight and Government Reform Committee held a meeting after receiving a letter from Representative Grace Meng, a New York Democrat, requesting the panel hold a hearing.

The majority staff scheduled a call with the company, though Democrats on the committee said they were waiting to hear back on whether a hearing will be scheduled.

A spokeswoman for committee Chairman Jason Chaffetz of Utah, said that as of Tuesday afternoon no hearing was scheduled. “And no comment beyond that,” said the spokeswoman, M.J. Henshaw.

The top Democrat on the Oversight Committee, Elijah Cummings of Maryland, said Tuesday that he wants a hearing when lawmakers return from their summer break to Washington in September.

“The recent price increase for EpiPens places a financial burden on those who desperately need this drug to prevent life threatening allergic reactions, which is why we have expressed our desire for an investigation of this issue and for the Committee to hold a hearing in September,” Cummings said Tuesday in a statement.

Liz Claman published an article pointing out that the Pittsburgh-based pharmaceutical giant at the center of a major drug pricing storm over the EpiPen, managed to pull off a tax-ducking corporate inversion just a year and a half ago.

And now the FOX Business Network has learned that allergy advocates are preparing to use the inversion strategy to convince lawmakers to investigate the company’s EpiPen.

“I definitely think Congress needs to get involved.  There needs to be an investigation,” Robyn O’Brien, founder of Allergy Kids Foundation told FOX Business Network.

O’Brien represents millions of families in America who depend on EpiPens to save lives in the case of deadly exposure to allergens.  The EpiPen is an auto-injecto device that delivers epinephrine, the drug that counters the effects of a fatal allergic reaction.  When Mylan bought the company that manufactures the EpiPen back in 2007, the cost for a single EpiPen was $57 dollars.

Today, just 9 years later, the cost has skyrocketed to as much as $700 for a pack of two. Many insurance companies cover some or most of the cost; however, Medicare, which is paid for by the American taxpayer, must cover millions of children of families who cannot afford insurance. Others saddled with high deductibles find themselves shelling out thousands of dollars for just a few packs of the device.

Mylan’s corporate inversion could now be used as a weapon against it.

Known officially as Mylan N.V., Mylan bought the small generic specialty drug arm of Abbott Labs (ABT) in early 2014.  That estimated $5 billion dollar purchase enabled the much larger Mylan (which has a current market cap of $24 billion dollars) to ‘move its headquarters’ to the Netherlands, a more tax-friendly country.

Mylan was able to complete one of the last corporate inversions before Congress, President Obama and Republican presidential nominee Donald Trump launched a full court press to demonize the practice which involves Company A (in this case Mylan) buying Company B (usually based in a foreign country with a lower tax rate) in order to lower Company A’s tax bill.

In Mylan’s case, it appears the company moved its corporate address to the Netherlands, but still maintains most of its offices in a suburb of Pittsburgh, PA, enjoying the benefits of taxpayer-funded police, fire and other city services.

President Obama has lashed out against the practice of inversion, calling it “one of the most insidious tax loopholes out there.” Trump, too, has ripped corporate inversions, calling them a “huge problem.”  What makes the Mylan case so problematic is that the company CEO Heather Bresch is the daughter of Democratic Senator Joe Manchin of West Virginia. Democrats, led by Democratic presidential nominee Hillary Clinton, have loudly denounced corporate inversions.

“They’ve built the business model on the backs of our kids, moving the headquarters to the Netherlands to avoid paying taxes into the US and as her own father said, something like that should be illegal,” said O’Brien. Calls by FOX Business to Mylan’s press department were not returned.

Complaints about onerous price hikes in the pharmaceutical industry are age-old and often go unanswered by the companies who hold the patents.  As patents expire, generic drug companies often jump in. But oddly, Israeli-based Teva Pharmaceuticals (TEVA) attempted to present a generic version but was soundly swatted down by the FDA, which cited “certain major deficiencies” to Teva’s product.  O’Brien smells a rat.

“There is no competition. They have a monopoly. The barriers to entry are really high and right now there’s a low cost alternative trying to work its way through the FDA. I’ve been in this for 11 years. We’ve seen Twin-ject come and go, Auvi-Q (by Sanofi US) come and go. Auvi-Q was recalled because of 26 unconfirmed reports. There needs to be an investigation into how (Mylan) has been able to maintain this monopoly that it has and yes, these are life saving devices but they can come in a lot of different forms and a healthy marketplace means healthy competition,” said O’Brien.

For now, Mylan has remained relatively silent after issuing an initial statement blaming insurance companies, co-pays and deductibles while offering coupons of $100 for the device. Investors, however, have done anything but remain silent. Milan shares fell 4.7% during Tuesday’s session and have lost 11% over the past 12-months.

Matt Krantz in his article last week pointed out that people might be shocked at how high drug prices have gotten. But equally lucrative are the compensation packages hauled in by drug company CEOs.

CEOs of the 14 biotech and pharmaceutical companies in the Standard & Poor’s 500 that served all of 2015 pulled down median compensation packages valued at $18.5 million in 2015, according to a USA TODAY analysis of data from S&P Global Market Intelligence. That was 71% greater than the median $10.8 million hauled in by S&P 500 executives in all industries in 2015, according to an analysis by Equilar.

“We all know drug prices are high,” says Eleanor Bloxham, CEO of compensation analysis firm The Value Alliance. “Companies award (the CEOs) very generous packages.” Health care CEOs received the highest median pay packages of any of the 10 sectors, according to the Equilar analysis.

Seeing such staggering pay packages for the titans of companies producing life-saving drugs stands out as lawmakers take a closer look at prices for drugs. Most recently, Mylan (MYL) found itself in the center of the controversy over drug prices following its roughly 500% increase in prices for its popular EpiPen allergy drug since 2007. Heather Bresch, who has been CEO of Mylan since early 2012, was paid $18.9 million last year, well above the median for the S&P 500 and up 109% since 2013.

But Bresch is far from being the highest paid among the ranks of drug company CEOs. Leonard Schleifer, CEO of biotech Regeneron Pharmaceuticals (REGN), wins there. He was awarded a compensation packaged valued at $47.5 million last year. The 63-year-old executive has been CEO of the company since 1988 and got a 13% raise in his total pay last year. The company makes treatments for a number of serious medical conditions, including its drug to deal with macular degeneration.  The company’s pay has been subject of controversy before. Investors can vote on the suitability of the company’s compensation plan every three years. In June 2014, only 62% of shareholders approved of the 2013 compensation plan. In its proxy statement released this year, the company says it has “spent a significant amount of time speaking with some of our key shareholders about executive compensation” and says it has made modifications.

Jeffrey Leiden, CEO of Vertex Pharmaceuticals (VRTX), is the drug maker CEO with the next largest compensation package. Leiden, 60, has been CEO of the company since 2012 and pulled down $28 million last year. Last year, investors expressed less confidence in the company’s pay structure causing the company to respond, “we increased our level of engagement in response to the decline in support for our advisory say-on-pay proposal at our 2015 annual meeting.” A say-on-pay proposal is a non-binding vote to allow investors to say if they approve of the way executives are paid.  The company, in its proxy statement, says, “We have designed the company’s compensation programs to closely align management’s incentives with Vertex’s strategic long- and short-term goals and with the interests of Vertex’s shareholders.”

While drug maker CEOs might get paid more than the typical CEO, last year wasn’t a great one for raises. CEOs at the 13 biotech and pharmaceutical companies in the S&P 500 who served both 2014 and 2015 saw their median pay fall nearly 19%. That’s a much steeper drop than the 5% decline experienced by S&P 500 CEOs in 2015, Equilar says.

Meanwhile, shares of drug companies were flat last year on average and this year they’re down 6.3% as investors worry about the sustainability of profit growth and rumblings from Capitol Hill about drug prices.  “Considering how fast medical costs are rising, this is becoming a public policy issue,” Bloxham says., as pointed out in the lead into this post Canada and other countries have Epi-Pens, etc. at lower prices, so why not purchase them over the Internet? Another alternative is to order 1:10,000 epinephrine preloaded syringe and have the patient keep it in a small zipped medical kit. Epipens have 0.3mg of epinephrine so 3ml of the 1:10,000 IM should suffice in an emergency. These cost about $12 from Henry Schein. Another option is $144 for 0.3mg epinephrine in 3ml auto injector made by Lineage Therapeutics or Greenstone Ltd.

It is time for the US pharmaceutical patents to be voided completely or shortened to 2 years. The pharm industry screws Americans because it can. It is not based on the incomes of people in different countries, insurance coverage, socialized vs capitalist health systems, or any other metric other than the US citizen has no other choice. Congress has granted patent exclusivity that through legal maneuvers is extended for decades, and there are absolutely no limits on what can be charged or the rate of escalation of prices, even on critical lifesaving medications.

The expiration of patents produces huge spikes in prices before the generics come onto the market. For decades, drug manufacturers have engaged in collusion in violation of the Sherman Antitrust Act to control prices by agreeing to pay generic manufacturers to not bring their products onto the market. This happened because the FDA does not allow multiple generics to come on to the market initially…it restricts the generic to a single manufacturer for a period of time before allowing others onto the market. This created a system whereby the name brand manufacturer paid off the generic manufacturer approved by the FDA to enter the market for a product or created a co-conspiracy situation where the generics would buy the product from the manufacturer and brand it as a generic. The courts have recently ruled this behavior is illegal, so now we are seeing massive spikes in name brand prices prior to patent expiration. The FDA and the courts have also made the situation much worse by colluding with the name brand manufacturer to extend patents as in the case of Oxycontin, where the manufacturer successfully argued before the courts that the formulation they manufactured for over a decade was unsafe, and therefore generics using that formulation should be prevented from entering the market.

There are more culprits that just the FDA. The FDA is one of the big ones, but so is a system where the end user doesn’t pay for the product but rather a third party pays, and the third party owns the distributors, and the third party (the insurance company) is able to pass the end user price to the funding of the pool from which the end user cost comes from. The third party doesn’t care what the product costs because they raise the money from insurance premium payers while the distributors, which they own make money on the margin mark up. There are many culprits although if there were more manufacturers,clearly the problem would not be as acute.

But there is more blame to go around. Why the huge prices? Blame the litigious patients who demand complication free everything and the darn lawyers who will sue any company, suggesting that it is to save another victim.


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