Posts Tagged “Generic”

Lawmakers accuse drugmakers Mylan, Teva of ‘coordinated obstruction’

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Lawmakers accuse drugmakers Mylan, Teva of ‘coordinated obstruction’

U.S. lawmakers on Wednesday accused three major pharmaceutical companies of “coordinated obstruction” and “apparent efforts to stonewall” an investigation on generic drug prices launched in 2014. Chairman of the House Committee on Oversight, Elijah Cummings, D-Md., along with Sen. Bernie Sanders, I-Vt., sent letters to Mylan, Teva Pharmaceutical and Heritage Pharmaceuticals asking them to turn over documents, according to a joint statement Wednesday. The lawmakers said they decided to open an investigation following findings in a lawsuit filed by 44 states in May that accused the drugmakers and others of inflating drug prices and stifling competition for generic drug versions.

“Not only did your company’s apparent obstruction undermine our investigation, but it may have caused further harm to patients and health care providers by delaying the discovery of evidence about the companies’ price-fixing,” Cummings and Sanders wrote in each of the letters, dated August 13. Shares of Mylan and Teva Pharmaceutical were each down roughly 8% on Wednesday. A spokesperson for Mylan said the company, with the help of outside counsel, is investigation the allegations made in the states’ lawsuit.

“We have not found any evidence to corroborate the allegations. We are prepared to make our case in a court…

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Opioid epidemic: Prescription pills were made and sold ‘like Doritos’

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Opioid epidemic: Prescription pills were made and sold ‘like Doritos’

Much of the responsibility for the opioid epidemic has been directed at Purdue Pharma, and not without good reason. Purdue introduced OxyContin in the mid-1990s and marketed it aggressively. Its sales representatives lied about its addictive qualities. Its executives downplayed reports of abuse. Its owners grew rich while thousands of people died and countless families were shattered. But documents pried loose last month, thanks to legal action by The Washington Post and the Charleston Gazette-Mail, confirm that there is plenty of blame to go around for the opioid crisis , much of it falling on other drugmakers and distributors.

The data, compiled in the Drug Enforcement Administration’s Automation of Reports and Consolidated Orders System database , shows that from 2006 to 2012 America was saturated with an astonishing 76 billion prescription opioid pills — about 230 for every adult and child in the country. Even as more people became addicted and deaths involving opioids skyrocketed (from 8,048 in 1999 to 18,515 in 2007 to 47,600 in 2017), more companies ramped up the business of making, distributing and dispensing generic forms of powerful painkillers such as oxycodone and hydrocodone. Among drugmakers, Purdue actually ranked fourth (2.5 billion pills) in the ARCOS…

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Price Of Snakebite Drugs Still Sky-High, Despite Competition : Shots – Health News : NPR2

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Price Of Snakebite Drugs Still Sky-High, Despite Competition : Shots – Health News : NPR2

Dr. Steven Curry, a medical toxicologist and professor at the University of Arizona, has treated snakebites since the 1980s — long enough to remember when the treatment represented its own form of misery. The first medication Curry used sometimes caused an immune reaction called serum sickness — patients broke out in a severe, itchy rash. Then, about 20 years ago, the snake antivenin CroFab entered the market and dramatically reduced the adverse reactions associated with treatment, he says.

But the drug came with a sky-high price tag. In one case reported by NPR and Kaiser Health News , an Indiana hospital last summer charged nearly $68,000 for four vials of CroFab. Now, CroFab faces competition from a snake antivenin called Anavip . Curry says the health system he works for in Phoenix — Banner Health — is using the new drug as its first line of treatment. It is switching, he says, because Anavip could reduce readmissions by better controlling bleeding associated with a snakebite and lead to “substantial savings” for the hospital.

But few experts who study drug laws and drug prices expect this competition to reduce the cost for patients. Legal wrangling, the advantageous use of the…

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USA: The Fight To Lower Soaring Drug Prices Turns Bitter Between States And The Feds

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USA: The Fight To Lower Soaring Drug Prices Turns Bitter Between States And The Feds

Frustrated by federal inaction, state lawmakers in 41 states have proposed detailed plans to lower soaring prescription drug costs. Some measures would give state Medicaid agencies more negotiating power. Others would disclose the pricing decisions of the drug manufacturers and the companies that administer prescription drug plans.

The more ambitious proposals would bump up against federal authority, such as legislation that would allow importing drugs from Canada or alter federal statutes on the prices states pay for drugs in Medicaid. They likely would have to survive a challenge in federal court. And many likely would face resistance from a deep-pocketed pharmaceutical industry.

According to the National Institute on Money and Politics, a nonprofit that collects campaign finance data, the pharmaceutical industry in 2018 contributed nearly $19 million to state campaigns, and $56 million to federal ones.

“States are limited in power in this area,” said Rachel Sachs, a health law expert at Washington University in St. Louis School of Law. “But one of the impacts of these efforts is to put pressure on the federal government, and force it to justify its actions to stymie the states.”

President Donald Trump has criticized soaring drug prices, and on Thursday the Department…

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Efforts to advance the development of complex generic drugs

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Efforts to advance the development of complex generic drugs

The FDA has released a statement highlighting practices to improve the development of complex generic drugs in order to promote drug competition and patient access.

The FDA Commissioner Scott Gottlieb wrote: ‘As part of the FDA’s efforts to promote drug competition and patient access, we’ve advanced many policies aimed at making it more efficient to bring generic competition to the market. We’ve been especially focused on a category of medicines known as complex drugs. These are drugs that, by nature of their formulation, delivery systems or the complexity of their active ingredients, for example, are harder to “genericise” under traditional approaches. As a result, these complex drugs often face less competition.

‘As a category, there are a number of complex drugs that are no longer protected by patents or exclusivities that would forestall generic approval, yet they continue to face no generic competition owing to the difficulty of developing generics. The agency has advanced many new policies to help promote generic competition to complex medicines once patents and exclusivities have lapsed, and we’re planning additional policy steps in 2019.

‘To understand the challenges posed by complex generics, we need to go back to the pathway developed in 1984 under the…

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WHO Report Flags Distortion of Investment and Innovation in Cancer Research

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WHO Report Flags Distortion of Investment and Innovation in Cancer Research

The report says pharmaceutical companies set prices according to their commercial goals and focus on extracting the maximum amount that a buyer is willing to pay.

High prices of cancer drugs hurting desperate patients have caught the attention of policymakers everywhere. But do high prices of medicines that provide huge financial returns to pharmaceutical companies also distort innovation?

A new cancer report by World Health Organisation (WHO) has both countries and the pharma industry debating on just how much profit cancer drugs generate for pharmaceutical companies. At stake is not only how much money the drug industry makes from high priced cancer drugs, but also, as the report suggests – is this investment really efficient? Is too much money chasing too few cancer drug candidates with only marginal benefits, diverting funds away from other therapeutic areas?

The technical report that minced no words, said that “pharmaceutical companies set prices according to their commercial goals, with a focus on extracting the maximum amount that a buyer is willing to pay for a medicine”. The industry denounced the report as flawed.

The report showed that in some cases, the return on investment on research and development fetched companies as much as $14…

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USA: On Both Ends of Capitol, Both Parties Warn Big Pharma on Drug Prices

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USA: On Both Ends of Capitol, Both Parties Warn Big Pharma on Drug Prices

Members of Congress from both parties served notice on pharmaceutical companies on Tuesday that the days of unchecked drug-price increases were over and that they would be held politically accountable for exorbitant prices.

The new reality became apparent at simultaneous but separate hearings of House and Senate committees where lawmakers said that the relentless increases were unsustainable and unacceptable.

“There is a strong bipartisan consensus that we must do something to rein in out-of-control price increases,” said Representative Elijah E. Cummings, Democrat of Maryland and the chairman of the House Committee on Oversight and Reform. “Drug companies make money hand over fist by raising the prices of their drugs — often without justification and sometimes overnight — while patients are left holding the bill.”

On the other side of the Capitol, Senator Charles E. Grassley, Republican of Iowa and the chairman of the Finance Committee, and Senator Ron Wyden of Oregon, the senior Democrat on the panel, denounced drug company executives who they said had refused to testify voluntarily.

Mr. Grassley expressed “displeasure at the lack of cooperation from the pharmaceutical manufacturers” and vowed to insist on their testimony in coming months.

Mr. Wyden said: “Even the Big Tobacco C.E.O.s…

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USA: UPMC, AstraZeneca Enter Value-Based Pharmaceutical Contract

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USA: UPMC, AstraZeneca Enter Value-Based Pharmaceutical Contract

UPMC Health Plan and AstraZeneca are taking on the challenge of a value-based pharmaceutical contract for one of the manufacturer’s cardiovascular medications.

Reimbursement for prescriptions of BRILINTA, a drug intended to help heart attack patients forestall or lessen the impact of subsequent events, will be connected to cardiovascular outcomes for targeted populations, the two organizations stated.

“In alignment with our commitment to ensuring patient access, lowering patient costs and sustaining innovation, AstraZeneca is pleased to collaborate with UPMC Health Plan on this novel agreement to lower out-of-pocket costs for UPMC for Life Medicare patients through dual-sided risk and proud to stand behind the value of BRILINTA® in improving patient outcomes,” said Rick R. Suarez, senior vice president, US Market Access, AstraZeneca.

The agreement builds on a new genre of value-based reimbursements slowly taking hold in the industry: tying payments for costly medications to how well they achieve stated goals.

The contract was developed by Value-Based Pharmacy Initiatives, the UPMC Insurance Services Division’s nonprofit research group in collaboration with AstraZeneca and leaders from the UPMC health system.

“This type of contract reflects the innovative work that we are leading at the Center for Value-Based Pharmacy Initiatives,” said Chronis Manolis, RPh, chief pharmacy officer at UPMC Health…

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USA: Democrats Are About to Give Big Pharma the Big Tobacco Treatment

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USA: Democrats Are About to Give Big Pharma the Big Tobacco Treatment

Since flipping the House of Representatives in last year’s midterms, Democrats have been waiting to see real oversight return to the halls of Congress. That arrived on Tuesday, with the Committee on Oversight and Reform’s first hearing of 2019. But the subject at hand may have disappointed those who were hoping for a dramatic broadside against the Trump administration.

“Our first witness today is not President Trump’s personal lawyer Michael Cohen,” said chairman Elijah Cummings. “It’s not someone from the White House or even the Trump administration… The first witness is Antoinette Worsham.”

Worsham, a working mother from Cincinnati wearing a T-shirt reading “Patients Over Profits,” told the committee about her two daughters, both of whom were diagnosed with Type 1 diabetes. When the oldest, Antavia, turned 21, she was kicked off the Bureau for Children of Medical Handicaps, a state program that helped pay for her insulin. Unable to afford the medication, Antavia began to ration it. Eventually, she died. Worsham’s second child, Antanique, a freshman at the University of Toledo, fears the same fate.

“In two years my daughter will be 21,” Worsham told the committee, her voice cracking. “I am crying out and asking for you to…

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USA: Congress starts to go after big pharma

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USA: Congress starts to go after big pharma

Congress jumped into its first round of hearings on drug prices for the year, vowing to take action on a problem that the president and the public see as a top concern for the country.The Senate Finance Committee and the House Oversight Committee began hearings Tuesday morning aimed at investigating the causes of high drug prices.

Sen. Chuck Grassley, R-Iowa, who became chairman of the Finance Committee this year, said in opening remarks that tackling high prescription drug costs is a priority for him, and blasted drug companies for agreeing to speak to lawmakers privately but not publicly at the hearing. The committee, he said, would extend an offer to the companies appear again in the future but would be “more insistent next time.”

“I want to express my displeasure at the lack of cooperation from the pharmaceutical manufacturers recently ,” he said.

Testimonies came instead from Doug Holtz-Eakin, president of the American Action Forum and former head of the Congressional Budget Office; Mark Miller, vice president of healthcare at the Laura and John Arnold Foundation; Dr. Peter Bach, director of Memorial Sloan Kettering Center for Health Policy and Outcomes; and Kathy Sego, the mother of a child who needs…

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