Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Mylan Achieved an ROI of 2.7 by Overcharging Medicaid for EpiPen!

Mylan Achieved an ROI of 2.7 by Overcharging Medicaid for EpiPen! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Mylan will pay $465 million to settle claims that it overcharged states for its signature EpiPen, according to a Thursday Department of Justice press release. The company also signed an agreement with the federal government to enter into a review of its Medicaid pricing practices.

 

For years, Mylan classified EpiPen in a way that forced Medicaid to overpay for the product, according to the Centers for Medicare and Medicaid Services. The company may have overcharged taxpayers as much as $1.27 billion over 10 years, the Department of Health and Human Services’s watchdog organization said in May.

 

Lawmakers slammed the federal agencies on Thursday for letting Mylan get off the hook too easily with the settlement. Sen. Richard Blumenthal (D-Conn.) called it “completely insufficient,” and Sen. Chuck Grassley (R-Iowa) cast is as “disappointing” in statements. Mylan, meanwhile, called the settlement, “the right course of action,” and said that the product has been reclassified under Medicaid as of April 1.

 

[“Mylan ripped off the government big time,” said Public Citizen, “and the U.S. Department of Justice is letting the company get away with it. Mylan misclassified EpiPen in such a way as to provide less generous discounts to Medicaid purchasers than the law requires.

 

Today’s shameful settlement is for barely a third of the amount of the rip-off, and it fails to include an admission of guilt – an appalling omission for a decade-long scheme that enabled Mylan to fatten its bottom line by more than a billion.]

 

Further Reading:

  • “Letters to "Pharma Sis" to Cut EpiPen Price to Improve Goodwill Will Fall on a Tin Ear”; http://sco.lt/8mfk5x
  • “Mylan CEO Bresch, aka "Pharma Sis," Defends Price Gouging, Tax Evasion as Job Savers”; http://sco.lt/7uKmLB
  • “FDA is Cause of Mylan's Monopolistic Pricing of EpiPen, Says WSJ. Allergist Has Cure.”; http://sco.lt/7F88nJ
  • “Mylan's Patient Assistance is a "Convoluted Scheme," Says Public Citizen”; http://sco.lt/8NWO0H
  • “Sarah Jessica Parker to Stop Shilling for Mylan Because of EpiPen Pricing: What Did She Expect?”; http://sco.lt/7oM4HZ
  • “Awash in Criticism, Mylan Has Decreased its Fearmongering Awareness Advertising”; http://sco.lt/6WeuSv
  • “Mylan, EpiPen Price Gouger, Ranks No. 2 in U.S. #Pharma Exec Pay!”; http://sco.lt/6lVvf7
  • “Is There No End to Mylan's Shenanigans? Paying Off Patient Groups to Lobby!”; http://sco.lt/6Sl0ld
  • “Mylan CEO's Mom Used Position with Education Group to Boost EpiPen Sales Nationwide”; http://sco.lt/8tL3kP
  • “Yes, Mylan DID "Misclassify" EpiPen as a Generic, Says Medicaid”; http://sco.lt/5aJWEb
  • “Mylan "Gamed the System" and Refuses to Testify at Senate Hearing About EpiPen Costs to Medicaid”; http://sco.lt/4mtPaj
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Novartis Must Reveal Details of Alleged 79,200 “Sham” Physician Speaker Events

Novartis Must Reveal Details of Alleged 79,200 “Sham” Physician Speaker Events | Pharmaguy's Insights Into Drug Industry News | Scoop.it

After a year-long battle, a federal judge ordered Novartis to turn over to the Department Justice documents containing details of allegedly 79,200 “sham” speaking events the drug maker used to encourage doctors to prescribe several blood pressure medicines.

 

The decision stems from a whistleblower lawsuit, which was initially filed six years ago by a former Novartis sales rep, contending the drug maker violated federal anti-kickback laws for nearly a decade. The Justice Department later joined the lawsuit, which alleged Novartis paid bribes to boost prescriptions and, as a result, caused federal health care programs to overpay for medicines (read “U.S. Seeks Records of 80,000 Novartis `Sham' Events for Doctors”; http://sco.lt/5PtPkX). 

 

The Justice Department initially received documents from the company about the speaking events, doctors who spoke at or attended the events, and the effect these events had on sales and market share on several blood pressure medicines. The Justice Department last year sought more information about event budgets and incentives that Novartis sales reps received for arranging the events.

 

But the drug maker argued the government was unfairly expanding the scope of its inquiry to a larger number of speaking events and that the request was “extraordinarily burdensome,” according to court documents. However, US District Court Judge Paul Gardephe decided that Novartis failed to prove the feds waived the right to seek documents pertaining to the nearly 80,000 speaking events.

 

The drug maker often treated doctors to expensive dinners at high-end restaurants, according to the documents. In one instance, a dinner for three, including the speaker, at a Washington, D.C., restaurant cost $2,016, or $672 per person. At another event held on Valentine’s Day in 2006, Novartis paid $3,127 for a meal for two at a West Des Moines, Iowa, restaurant.

 

Read "Novartis Wines -- er, Beers -- and Dines Docs at Hooters!"; http://bit.ly/PMBalbum042713

 

Novartis and a former employee are cleared of exaggerating drug claims in Japan

During the 10-year span, Novartis spent more than $65 million and ran more than 38,000 speaker programs for three of its blood pressure drugs. Speakers were paid an average of between $750 and $1,500, although some received $3,000 per program, according to the court documents. The feds also allege that Novartis had few checks on whether sales reps accurately reported attendance.

Pharma Guy's insight:

I love the story about the speaker event Novartis hosted at a Hooter's restaurant. I can only imagine what went on there between the docs and waitress staff! Perhaps the documents will reveal that my imagination is "somewhat vindicated."

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The Pharma Criminal & Civil Penalty Challenge!

Public Citizen released additional data on pharmaceutical industry criminal and civil settlements, stemming from its March report tallying all settlements with both federal and state governments from 1991 through 2015. The new data provide company-specific totals for the most recent 10-year period (2006-2015), which demonstrate that, for most companies, the vast majority of penalties were paid out in those 10 years since 2006. During the 10 years from 2006-2015, 21 companies entered into two or more settlements with the federal government.

The Challenge: Can you rank the Top 10 of those companies in terms of the amount paid over those 10 years? Try it here. Afterward, you'll see a chart of the actual data and see how good your ranking was.

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Pfizer Gets Lucky: Will Pay Only $784M to DOJ for Overcharging Medicaid

Pfizer Gets Lucky: Will Pay Only $784M to DOJ for Overcharging Medicaid | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Pfizer is forking over $784 million to settle claims that it overcharged Medicaid for its heartburn med Protonix. The agreement marks one of the biggest settlements to date from drugmakers who are facing similar allegations.


Pfizer, which inherited the case after buying Wyeth in 2009. That year, the U.S. Department of Justice (DOJ) filed a lawsuit against Wyeth over Medicaid rebates for Protonix. The DOJ claimed that between 2001 and 2006, the company did not give state Medicaid programs the same discounts for the drug that it did for nongovernment customers, running afoul of federal law.

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Have Hefty DOJ Fines Made Pharma Marketers More Compliant with FDA Regulations?

Have Hefty DOJ Fines Made Pharma Marketers More Compliant with FDA Regulations? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Is the number of warning letters low because pharmaceutical marketers have learned to be more compliant with FDA regulations or is there some other reason?


Could it be that pharma marketers have become more compliant with FDA regulations because their MLR people became more assertive after many major pharma companies, which do a lot of drug marketing, were fined billions of dollars for inappropriately, and in some cases illegally, promoting prescription drugs?

Pharma Guy's insight:


DOJ fines are much more persuasive than "slap on the wrist" notice of violation letters from the FDA. As they say, "money talks, nobody walks." 

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Pharma Guy's curator insight, March 31, 2016 6:25 AM

 

DOJ fines are much more persuasive than "slap on the wrist" notice of violation letters from the FDA. As they say, "money talks, nobody walks." 

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Johnson & Johnson’s Legal Woes Continue to Escalate as DOJ Targets Its Rx Drug Marketing Practices

Johnson & Johnson’s Legal Woes Continue to Escalate as DOJ Targets Its Rx Drug Marketing Practices | Pharmaguy's Insights Into Drug Industry News | Scoop.it

As if Johnson & Johnson didn’t have enough legal woes already, with the mounting number of cases claiming a link between its talcum powder and ovarian cancer (read “J&J Bites the Talc-powder Dust in Another Trial - Ordered to Pay $110 Million”; http://sco.lt/6E8DnV), the pharma giant now faces a fresh round of investigations into its marketing practices.

 

In a quarterly filing with the Securities and Exchange Commission, J&J disclosed new investigations by the U.S. Justice Department and the U.S. Attorney's Office in Massachusetts. The probes target arthritis drugs Remicade and Simponi, hepatitis C treatment Olysio and psoriasis drug Stelara.

 

Most recently, in April, J&J was subpoenaed by the Massachusetts district court, which is seeking documents related to copayment-support programs the company is offering for Olysio, Simponi and Stelara, according to the SEC filing. Investigators are seeking information about how J&J reports the prices of those products to the Centers for Medicare & Medicaid Services and how it discloses rebate payments to the state’s Medicaid agencies.

 

J&J had previously been pulled into a separate Massachusetts investigation that involves several pharmaceutical companies. The district attorney’s office has been collecting information about ties between drug companies and nonprofits that help fund prescription purchases for Medicare patients. The office has been doling out subpoenas over the last two years, targeting Biogen, Celgene, Regeneron, Gilead and others.

 

In February, Pfizer disclosed in its annual SEC filing that it received two subpoenas seeking information about its relationship with Patient Access Network Foundation and other nonprofit groups that provide copay assistance to underinsured patients.

 

J&J hasn’t disclosed which charitable organizations the district attorney’s office asked about, but all such relationships have come under fire recently. That’s because it’s against the law for pharmaceutical companies to link their products with charitable organizations and to offer direct copay subsidies to patients covered by government-run insurance plans.

 

Further Reading:

  • “Giving J&J an Ethics Prize is Like Giving Strom Thurmond a Civil Rights Award”; http://sco.lt/6RqBRB
  • “Johnson & Johnson Guilty Again! Ordered to Pay $1 Billion in Putative Damages, the Largest This Year”; http://sco.lt/5l207V
  • “The $70 Million Breast Job: That's What J&J Must Pay to Male Teen Who Took Risperdal and Developed Large Breasts”; http://sco.lt/8FrB5t
  • “America’s Most Admired Lawbreaker”; http://sco.lt/7Gz2q9
  • "How Gorsky Drove 46% - 66% of Risperdal Sales for Off-Label Use"; http://sco.lt/7gkFl3
  • “J&J Pleads Guilty for Knowingly Selling Tainted Children's Tylenol. A Failure of Corporate Accountability”; http://sco.lt/70aVsn
  • “J&J #Pharma Earnings Up 18.7% Despite Being Top Fined Drug Company!”; http://sco.lt/5ycMZF
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Giving J&J an Ethics Prize is Like Giving Strom Thurmond a Civil Rights Award

Giving J&J an Ethics Prize is Like Giving Strom Thurmond a Civil Rights Award | Pharmaguy's Insights Into Drug Industry News | Scoop.it

"Should a drug company that’s agreed to pay billions in criminal and civil fines for illegally marketing its drugs to children and dementia patients be honored with an ethics prize?"

 

Um, no.

 

The company is Johnson & Johnson, which has of course paid out a lot of cash in federal penalties for fraudulent marketing. That's not a problem for an organization called Fellowships at Auschwitz for the Study of Professional Ethics, or FASPE, which is honoring the company next month with an award for "ethical leadership." Art Caplan of NYU will be presenting the award. If you'd like to attend, you can get prime seating for your entire group for a mere $50,000.

 

Sheila Kaplan of Stat News has the story, but sadly, it's behind a paywall. Here is an excerpt:

 

FASPE Chairman David Goldman, an attorney in New York, said he was aware of the pharma giant’s various ethical tangles, but believes the company has moved beyond them. “We do think they’ve acknowledged their failures and taken the appropriate steps to resolve them,” he said. “They know what they’ve done; we talked to them about it and they’ve taken the right action.”

 

The award will be accepted by Dr. Joanne Waldstreicher, J & J’s chief medical officer. Goldman said she was “as committed to the ethics program and ethical behavior as anybody who we’ve seen.” He added: “We think we’ve got this right.”

 

Others disagree, noting that in 2013, J&J and its subsidiaries agreed to pay $2.2 billion to resolve criminal and civil allegations of improperly promoting several prescription drugs, including paying kickbacks to physicians. That was one of the largest health care fraud settlements in US history. The company has also lost recent product liability cases involving allegations of its talcum powder causing ovarian cancer.

 

“It’s like giving Strom Thurmond a civil rights prize, or Wells Fargo an award for business ethics,” said Dr. Carl Elliott, a bioethicist at the University of Minnesota. “Of all the potential people or organizations to honor with an ethics award, why pick a company that has just paid a $2.2 billion federal penalty for fraud?”

Pharma Guy's insight:

Further reading:

  • “Johnson & Johnson Guilty Again! Ordered to Pay $1 Billion in Putative Damages, the Largest This Year”; http://sco.lt/5l207V 
  • “The $70 Million Breast Job: That's What J&J Must Pay to Male Teen Who Took Risperdal and Developed Large Breasts”; http://sco.lt/8FrB5t 
  • “America’s Most Admired Lawbreaker”; http://sco.lt/7Gz2q9
  • "How Gorsky Drove 46% - 66% of Risperdal Sales for Off-Label Use"; http://sco.lt/7gkFl3 
  • “J&J Pleads Guilty for Knowingly Selling Tainted Children's Tylenol. A Failure of Corporate Accountability”; http://sco.lt/70aVsn 
  • “J&J #Pharma Earnings Up 18.7% Despite Being Top Fined Drug Company!”; http://sco.lt/5ycMZF 
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Biogen Too "Patient-Centric?" Feds Investigating Its Patient-Assistance Programs

Biogen Too "Patient-Centric?" Feds Investigating Its Patient-Assistance Programs | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Biogen disclosed in its first-quarter earnings report that it has been subpoenaed by the federal government. The subpoena requests documents detailing its relationship with nonprofit foundations that assist patients taking drugs sold by the company. These foundations often provide financial support to patients who cannot afford their medications. Biogen said it is cooperating with the government inquiry.

It is illegal for drugmakers to give patients copay assistance if they are insured by federally funded healthcare programs. Some drugmakers fund outside foundations that, in turn, direct money towards patients for medications. These foundations are bound by rules that dictate the terms of this assistance; the foundations, for example, cannot restrict coverage to only one drug.

Patient-assistance programs have come under fire in recent months. During a House hearing, Rep. Eleanor Holmes Norton (D-DC) charged Turing Pharmaceuticals with using patient-assistance programs as a means of diverting attention from the high price of the company's toxoplasmosis treatment, Daraprim. Some critics contend that drugmakers create the need for patient-assistance programs by pricing their drugs too high.

Pharma Guy's insight:

Does this have anything to do with disappointing Tecfidera sales and Biogen's heightened direct-to-consumer promotion campaign? For more on that, read "Social Media Failed to Do the Job, So Biogen Turned to DTC to Promote Tecfidera"; http://sco.lt/98a1ZZ 

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J&J: America’s Most Admired #Pharma Lawbreaker - Chapter One

J&J: America’s Most Admired #Pharma Lawbreaker - Chapter One | Pharmaguy's Insights Into Drug Industry News | Scoop.it
A shocking story about the biggest company in the US's most profitable industry.


The Food and Drug Administration had prohibited Johnson & Johnson salespeople from trying to promote Risperdal to doctors to treat children because of its feared side effects, including hormonal disorders. The company was also not allowed to promote it to treat the elderly except for the most serious psychotic disorders; it was thought to cause strokes, diabetes and other ailments in that population. But by the time young Austin started growing breasts, Johnson & Johnson was reaping more than half of its Risperdal sales from prescriptions written for children to alleviate all kinds of behavior disorders, and for the elderly, who were given the drug for simple symptoms of dementia or restlessness.


Johnson & Johnson emails, sales training manuals and business plans produced as evidence in the case revealed that the company organized special sales units illegally targeting doctors who treated the elderly and children. State mental institutions treating children, whose drugs would be paid for by Medicaid, were targeted, too.


When it came time to explain their conduct at trials and to federal investigators, Johnson & Johnson executives and salespeople have unwaveringly, even indignantly, defended themselves. One salesman, who otherwise fit the salt-of-the-earth mold that R.W. Johnson had envisioned for his company’s employees, gave thousands of Risperdal samples in child-sized doses to Austin Pledger’s doctor in Birmingham, Alabama. Yet he insisted under oath in February he didn’t recall stepping around kiddie furniture and toys as he walked into an office with a sign that said “pediatric neurologist,” and that he had no way of knowing that the doctor wasn’t treating adults.

Pharma Guy's insight:

Meanwhile, you might want to read this: How J&J's Alex Gorsky Tried to Negotiate a Smaller DOJ Finehttp://bit.ly/1cjcp6s 

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