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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HHS: Mylan Overcharged Medicaid $1.27B. DOJ: Nothing to See Here, Move On!

HHS: Mylan Overcharged Medicaid $1.27B. DOJ: Nothing to See Here, Move On! | Pharmaguy's Insights Into Drug Industry News |

Mylan may have overcharged taxpayers as much as $1.27 billion over 10 years for its signature EpiPens, according to an analysis released Wednesday by the Department of Health and Human Services’s watchdog.


The pharmaceutical company has been in hot water for potentially misclassifying its signature epinephrine auto-injector in a way that enabled it to charge a higher price to Medicaid (read “Mylan ‘Gamed the System’ and Refuses to Testify at Senate Hearing About EpiPen Costs to Medicaid”; Because the pens were classified as generic, rather than brand-name products, Mylan paid Medicaid a 13 percent instead of a 23 percent rebate — despite the company being told its classification was incorrect. That allegation came to light in the fall.


In October, it was reported that Mylan agreed to a $465 million settlement over these accusations, although the status of this settlement remains unclear.


The new calculation of unpaid rebates underscores earlier concerns that taxpayers may get shortchanged by the proposed settlement. As Sen. Chuck Grassley (R-Iowa) noted in a statement, the $465 million settlement is much less than the $1.27 billion Mylan allegedly overcharged.


Now the first hard estimate of the overcharging, from the Office of the Inspector General for HHS, reveals that taxpayers may have paid as much as $444 million from 2006 to 2014, and $826 million from 2015 and 2016 — amounting to $1.27 billion in all. Letters from the inspector general stress that these estimates are limited because they do not take into account “supplemental rebates” that individual states may have received.


The Department of Justice declined on comment on the settlement Wednesday, saying that “there is no settlement to report.”


Further Reading:

Pharma Guy's insight:

Boy! Pharma Sis is lucky Trump won and saved her ass by appointing a do-nothing Dept of Justice (DOJ) leader!

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Democratic Lawmakers Introduce Bills Designed to Lower Drug Prices, Increase Transparency & Eliminate Tax Credits for Advertising

Democratic Lawmakers Introduce Bills Designed to Lower Drug Prices, Increase Transparency & Eliminate Tax Credits for Advertising | Pharmaguy's Insights Into Drug Industry News |

Nearly two dozen lawmakers introduced identical bills in the House and Senate Wednesday that take a kitchen sink approach to tackling the rising cost of medicines, from allowing Medicare to negotiate prices to removing tax breaks that drug makers receive for advertising expenses.


Dubbed the Improving Access to Affordable Prescription Drugs Act, the legislation comes amid mounting controversy over prescription drug prices, a hot-button issue that has put the pharmaceutical industry on the defensive as a growing number of polls show Americans want the government to take action.


Although President Trump has talked tough about high drug prices, his administration has yet to make a concrete proposal. And so, the lawmakers — all of whom are Democrats, but for Senator Bernie Sanders (I-Vt.) — have collected a wish list of ideas, including a few that have appeared in earlier bills.


Some of the proposals contained in the legislation:


  • Drug makers would be required to disclose R&D, manufacturing, and marketing costs; acquisitions, federal investments; revenues; and other factors that influence prices to the Department of Health and Human Services, which would make it publicly available in a searchable format;
  • The HHS would be allowed to negotiate with drug makers, and prioritize negotiations on specialty and other high-priced drugs.
  • Marketing exclusivity that is awarded by the FDA to brand-name drug makers would be amended. The bill modifies exclusivity for new types of drugs so the FDA can accept a generic application after three years rather than five. And exclusivity for biologics would be cut to seven years from 12 years. Also, exclusivity would be ended for any drug whose maker violates criminal or civil law through a federal or state fraud conviction or settlement in which the manufacturer admits fault;
  • It would be illegal for brand-name and generic drug makers make pay-to-delay deals in which lower-cost generics are delayed from reaching consumers. And the FDA could remove the 180-day generic exclusivity period from any company that enters into such a deal with a brand-name manufacturer;
  • Tax breaks that drug makers receive from the federal government for expenses related to direct-to-consumer advertising would be eliminated;
  • The Federal Trade Commission would have to submit a report to Congress on the economic impact of so-called product hopping, which refers to tweaks made to existing products by drug makers that file new patents that extend their monopolies.


[“This is one of the most comprehensive reforms of the pharmaceutical industry ever proposed,” said Peter Maybarduk, director of Public Citizen’s Access to Medicines Program. “Medical treatment rationing is a painful reality for millions of Americans. Americans are splitting pills, skipping pills and making impossible decisions about when we can afford to pay for groceries versus when we can afford to pay for the medical care our families need. The core problem is monopoly power. We can change it and make medicine affordable for all. This legislation is a deep challenge to the corrosive political influence of the pharmaceutical industry.”]

Pharma Guy's insight:

A veritable smorgasbord of reforms that have been proposed for many, many years but never seen the light of day and probably won't under the Trump administration. Interestingly, allowing importation of drugs from Canada not included. Perhaps that is why Bernie Sanders did not sign on to this bill.

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#Pharma Execs Who Did Speak, Gave "Fuzzy" Responses to Congress on Drug Pricing

#Pharma Execs Who Did Speak, Gave "Fuzzy" Responses to Congress on Drug Pricing | Pharmaguy's Insights Into Drug Industry News |

Executives from Valeant and Turing had a hard time explaining to members of the House Oversight and Government Reform Committee their rationales for exorbitant price hikes of older drugs in recent months. Their fuzzy explanations of pricing practices, moreover, cast a shadow over the broader pharmaceutical industry.

The central attraction was Turing former CEO Martin Shkreli, who appeared before the Committee as commanded, but smirked through repeated denials to answer questions. Unless you use your current fame to influence drug price reductions, advised Rep. Elijah Cummings of Maryland, ranking Democrat on the panel, “you can go down in history as the poster boy for greedy drug company executives.” Shkreli was dismissed early from the hearing, with a squad of lawyers in tow, tweeting about the “imbeciles” on the panel.  

Turing “chief commercial officer” Nancy Retzlaff killed off any credibility by claiming that she didn’t know how much stock Shkreli now had in Turing. Equally unpersuasive was her claim that the firm was reinvesting 60% of its profits in R&D.

Committee members offered a range of strategies for preventing and addressing extreme price hikes in prescription drugs, besides faster FDA approvals. A “poison pill” policy would allow suspension of product exclusivity on products that experience Turing-like price hikes, proposed Rep. Steven Lynch (D-Mass.), Turing and other bad actors, he said, thus are responsible for causing Congress to impose heavy regulations on good pharmaceutical companies, which could “choke off” good drugs coming through the pipeline.

Others urged greater transparency in pharma pricing on websites, and how much companies actually spend on research. And there was mention of FDA authorizing use of compounded drugs to create more competition, as done in some cases of severe drug shortages, and support for speedy development and market approval of biosimilars.

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A Look at Major Drug-Pricing Proposals: The Good, The Bad, and The Defeated

A Look at Major Drug-Pricing Proposals: The Good, The Bad, and The Defeated | Pharmaguy's Insights Into Drug Industry News |

Several bills that seek to tackle the high cost of prescription drugs are moving through Congress, and the Trump administration has also signaled that it may take action.


Here’s a list of the major drug-pricing proposals under consideration.


Speeding approval of generic drugs.


Requiring notice when drug prices go up.

  • “#Pharma Lobbying Wins: California Drug Price Transparency Bill is Scrapped”;


Importing drugs from outside the United States.

  • “PhRMA Lobbying Pays Off Again: Senate Panel Rejects Proposal to Allow Importation of Rx Drugs from Canada”;
  • “Senators Start a New Effort to Allow Importation of Certain Drugs from Canada. Will Trump Play Security Card?”:


Requiring pharmacy benefit managers to be more transparent.

  • “Democratic Lawmakers Introduce Bills Designed to Lower Drug Prices, Increase Transparency & Eliminate Tax Credits for Advertising”;


Allowing the government to negotiate the price of drugs covered by Medicare.

  • “Lilly CEO David Ricks Likes Medicare Just the Way It Is: A ‘Good Model Going Forward’”:
  • “Did Big Pharma Just Convince Trump to Abandon His Push to Let Medicare Negotiate Drug Prices?”;


What will the Trump administration do?


On Thursday, Mick Mulvaney, the director of the Office of Management and Budget, said one option under consideration was to impose mandatory rebates on drugs purchased by Medicare, similar to the ones required through Medicaid, the government health care program for the poor.


[“Trump Will Need Unlikely GOP Support to Bring Down Drug Prices, If He Means What He Says”; ]


Dr. Scott Gottlieb, the newly confirmed commissioner of the F.D.A., has also said he is considering changes that would speed up the approval of generic drugs.


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Valeant's Pearson & Ackman Testify Before Congress: "Time to Slaughter Some Hogs"

Valeant's Pearson & Ackman Testify Before Congress: "Time to Slaughter Some Hogs" | Pharmaguy's Insights Into Drug Industry News |

Fresh off one of the biggest Wall Street drubbings in recent memory, Valeant Pharmaceuticals went to Washington on Wednesday to defend itself against accusations the company is little more than a price-gouging, drug industry hedge fund.


Michael Pearson, the architect of Valeant’s rise into a stock market darling, and his biggest booster, billionaire hedge fund manager Bill Ackman, testified in front of a Senate committee investigating its drug pricing practices. Former CFO Howard Schiller, who was Valeant’s finance head until he was fired in March, also testified.


In a rousing opening statement McCaskill said, “you can try to dress up this business model with do good sounding phrases… Its using patients as hostages. It’s immoral. It hurts real people. It makes Americans very very angry.”


“Pigs get fed. Hogs get slaughtered,” she added. “It’s time to slaughter some hogs.”



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After Taunting Politicians in DC, ‘Pharma bro’ @MartinShkreli Backs Down - Won't Visit Congress

After Taunting Politicians in DC, ‘Pharma bro’ @MartinShkreli Backs Down - Won't Visit Congress | Pharmaguy's Insights Into Drug Industry News |

According to Business Insider, the former hedge funder turned pharma CEO who has become the face of pharmaceutical corporate greed is refusing to turn over information to a Congressional committee looking at drug pricing and won’t testify unless legally compelled.

In a letter sent to both houses of Congress, Shkreli said that he “unable to provide certain numbers and data related to proprietary information,” on Daraprim, the drug he purchased before jacking up the price from $13.50 to $750 a pill.

While Shkreli has had no problem appearing on cable news broadcasts to explain the business rationale for increasing the price of a drug used to treat critically ill babies and AIDS patients over 5,000 percent, the CEO has drawn the line at voluntarily speaking with Congress.

“When my lawyers tell me I absolutely have to go, I’ll go,” he said in an interview. “They don’t have subpoena power until they’ve got widespread support. I don’t have to go to a hearing unless there’s widespread support.”

Responding to the Congressional requests for information, Turing Pharmaceutical released a statement reading: “We are reviewing the Committee’s request and, as we have and continue to do with similar congressional inquiries, we look forward to having an open and honest dialogue about drug pricing.”

Shkreli is not the only pharma exec avoiding appearing. Valeant Pharmaceuticals head J. Michael Pearson — whose company is also under attack for price gouging — is also balking at answering what promises to be hostile questions from lawmakers on both sides of the aisle.

Pharma Guy's insight:

Shkreli taunted politicians on Tweeter days before the Senate invite, saying he was "In DC. If any politicians want to start, come at me" (read "Senate Invites Turing CEO Shkreli to Visit. Just What He Wanted!") - a taunt typical of a Psychopath. Indeed, Shkreli has been called a "morally bankrupt sociopath," a "greedy sociopath," a "sociopathic bounty hunter," and an "evil sociopathic asshole."

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