Posts Tagged “FDA”

MDMA, Used In Therapy, May Help People Heal From PTSD

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MDMA, Used In Therapy, May Help People Heal From PTSD

The first time Lori Tipton tried MDMA, she was skeptical it would make a difference. “I really was, at the beginning, very nervous,” Tipton remembers. MDMA is the main ingredient in club drugs ecstasy or molly. But Tipton wasn’t taking pills sold on the street to get high at a party. She was trying to treat her post-traumatic stress disorder, with the help of licensed therapists. Tipton was given a dose of pure MDMA. Then she lay down in a quiet room with two specially-trained psychotherapists, one woman and one man. They sat next to Tipton as she recalled some of her deepest traumas, like discovering her mother’s body after a murder-suicide. “In the embrace of MDMA,” as she describes it, Tipton could revisit this moment without the usual terror and panic. “I was able to find such empathy for myself. I realized how much I was thinking this was my fault,” she says.

The synthetic psychoactive chemical MDMA is emerging as a promising — if unconventional — treatment for PTSD. Scientists are testing how pharmaceutical-grade MDMA can be used in combination with psychotherapy to help patients who have a severe form of PTSD that has not responded to…

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USA: 6 cancer patients developed rare blood infection after nurse tampered with opioids

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USA: 6 cancer patients developed rare blood infection after nurse tampered with opioids

Six patients at the Roswell Park Comprehensive Cancer Center in Buffalo, N.Y., were infected with a bacterium known as Sphingomonas paucimobilis between June and July of 2018, according to a New England Journal of Medicine report . Three of the six were diagnosed within one week of each other, it noted. Sphingomonas paucimobilis is typically found in water and soil. It’s rarely known to cause blood infections, even in those with compromised immune systems, the report says. Baffled, medical professionals at the facility initially assumed the infection was caused by contaminated medication. Officials subsequently contacted pharmaceutical vendors and checked with the U.S. The Food and Drug Administration (FDA) over recall alerts in an attempt to find a source of the outbreak.

Doctors then evaluated “intravenous fluids and medications” including syringes of the opioid hydromorphone, which were locked in a drawer that was connected to an automated medication dispensing system at the facility. The syringes tested positive for the bacterium that had infected the patients’ bloodstreams. It was determined that one of the center’s nurses, who was not identified in the New England Journal of Medicine report, allegedly had been tampering with the syringes to remove some of the opioids legally…

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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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Elizabeth Warren and Bernie Sanders just slammed the Swiss drug giant Novartis over a new controversy swirling around the world’s most expensive drug

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Elizabeth Warren and Bernie Sanders just slammed the Swiss drug giant Novartis over a new controversy swirling around the world’s most expensive drug

Elizabeth Warren and Bernie Sanders were two of five senators who condemned Novartis’ AveXis for submitting falsified data to the FDA. Mary Schwalm/Reuters Elizabeth Warren and Bernie Sanders are among a group of five senators who slammed Novartis’ AveXis for submitting manipulated data to the FDA ahead of the approval of its gene-therapy drug. The FDA revealed the data-manipulation issue earlier this week, saying that it affected only a small portion of product-testing data and that the regulator was confident the drug, Zolgensma, should keep being sold. “This scandal smacks of the pharmaceutical industry’s privilege and greed, and Americans are sick of it,” the senators wrote in a letter to Ned Sharpless, the acting head of the FDA. Novartis said it first learned about the data problem in March. But the Swiss drug giant informed the FDA months later, after the gene therapy was approved, the FDA said . The five senators encouraged the FDA to “use your full authorities to hold AveXis accountable for its malfeasance,” adding that “anything short of a forceful response would signal a green light to future pharmaceutical misbehavior.” Visit Business Insider’s homepage for more stories . Five senators, including Elizabeth Warren and Bernie Sanders,…

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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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Both parties want lower drug prices but gridlock prevents reform

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Both parties want lower drug prices but gridlock prevents reform

I went to Walgreens recently to pick up my three-month supply of a prescription I have been using for years. Ho hum. Until I saw what it was going to cost.

All of a sudden the price had gone up by more than 20 percent. I paid it, of course, grumbling. But I decided to do some research into what’s going on with America’s prescription drug prices.

Bloomberg News looked into drug prices last year and found that “255 brand name drugs had increases between Feb.1 and July 13 … the most common increase was for 9 to 10 percent.”

It also tracked the prices for 40 commonly used drugs in six categories — diabetes, cancer, HIV, multiple sclerosis, asthma and chronic pulmonary disease, and autoimmune diseases such as rheumatoid arthritis and psoriasis — over a three-year period from June 2015 to June 2018. During this period the consumer price index went up by 5.6 percent.

“For all six categories of drugs,” Bloomberg found, “list prices rose far faster than inflation.”

They report:

“Prices for 10 commonly used diabetes drugs rose 25.6 percent, on average, while average prices for rheumatoid arthritis and other autoimmune treatments rose 40.1 percent. The latter category…

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FDA’s Gottlieb Aims To End Biosimilars Groundhog Day

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FDA’s Gottlieb Aims To End Biosimilars Groundhog Day

You have to wonder if key players in the biosimilars industry in the United States don’t feel like Phil Connors, the character played by Bill Murray in the 1993 classic movie Groundhog Day. (Is it safe to call it a classic?) Connors is condemned to relive the same events of February 2 until he transforms from being a jaded, binge-drinking souse to a charitable, conscientious person.

Those observing—and working in—the biosimilars industry might sometimes feel like the unrepentant Connors, waking to Sonny and Cher’s “I Got You Babe” every morning. For more than two decades, biosimilars in this country have been stuck in a repeat mode of potential and promise. Now hopes for breaking out of that loop are clinging to FDA Commissioner Scott Gottlieb and the “Biosimilars Action Plan”—or BAP—he announced last July. The idea is to dismantle the regulatory hurdles that have prevented the American health system from adopting biosimilars and cashing in on the price difference between the copycats and the brand-name medications. The problem is that even if Gottlieb’s BAP were to be fully implemented, there are still all sorts of legal and other obstacles in the way of biosimilars catching on.

FDA footdragging

Industry frustration…

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USA: Pfizer to Raise the Price of 41 Drugs on 15 January, 2019

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USA: Pfizer to Raise the Price of 41 Drugs on 15 January, 2019

Six months after rolling back proposed price increases following a public rebuke by President Donald Trump, Pfizer will raise the price of 41 prescription drugs in January.

The pharma giant issued a statement on Friday as part of a show of transparency over pricing. The company said its pricing is guided by the value it brings patients “and an understanding of the environment in which we operate.” Starting Jan. 15, 2019, Pfizer said it will increase the list price of 41 drugs, about 10 percent of its entire catalog of approved treatments. The increase to the majority of the 41 drugs will be 5 percent. Pfizer noted that there are a few exceptions, three drugs will only see a 3 percent increase in price and one will see a 9 percent hike, the company said in a statement on its website. The drug that will see the 9 percent increase was due to the “completion of two extensive development programs that have led to the recent FDA approvals of two new medical uses that meet unmet patient needs,” the company said.

The Wall Street Journal, which first reported Pfizer’s January price hikes, said that drug companies have increased the price…

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USA: Seven Hospitals incl. Mayo Clinic Launch Generic Drug Company called “Civica Rx”

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USA: Seven Hospitals incl. Mayo Clinic Launch Generic Drug Company called “Civica Rx”

In January 2018, a coalition of 6 hospitals reported that they would launch a generic drug company to address drug shortages and the high cost of lifesaving medications. Recently, the Mayo Clinic said it will join forces with the 6 other hospitals to back the nonprofit company, according to a statement from the health care system.

The company, Civica Rx, is financially supported by the 7 hospitals, as well as 3 philanthropies, and will produce 14 drugs that are frequently in shortage and rising in price. The generic company has already been FDA approved and plans to have products approved and available to both hospitals and the retail market as early as 2019, according to the statement.

Research on the cost of manufacturing generic drugs has determined that generic drug prices in hospitals are significantly higher than they should be because of both a lack of competition and a shortage in the generic market. A nonprofit generic manufacturer like Civica Rx could reduce the cost of generics to a fraction of their price and save both health care systems and patients hundreds of millions each year, according to the Mayo Clinic.

Civica Rx intends to prioritize patients by ensuring that…

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USA: Kaleo increases naloxone price by 600% over 4 years.

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USA: Kaleo increases naloxone price by 600% over 4 years.

In the midst of an unprecedented opioid epidemic, the price of one company’s version of a life-saving drug, naloxone, which can reverse the effects of an opioid overdose, has skyrocketed.

According to a new investigative report by Senators Rob Portman (R-OD) and Tom Carper (D-DE), drug company Kaleo has increased the price of its version of the drug (brand name: EVZIO) a whopping 600 percent, from $575 to $4,100, during the last four years. The drug can treat a narcotic overdose in an emergency situation.

The report’s executive summary states that Kaleo hiked the price of the drug in February 2016 and “launched its new distribution model planning to ‘capitalize on the opportunity’ of ‘opioid overdose at epidemic levels’ and a ‘well established public health crisis.’”

More than 70,000 people died due to drug-related overdoses in 2017, according to data from the US Centers of Disease Control and Prevention (CDC). At least two-thirds of those deaths were linked to opioid misuse.

In addition, the report states that the company’s sales force pressured doctors’ offices to sign paperwork (known as prior authorizations) in order to fill and cover EVZIO prescriptions, rather than prescribe generic versions of naloxone, which could be cheaper.

“This included paperwork indicating that EVZIO was medically necessary, which ensured the drug would be covered by government programs like Medicare and Medicaid for the Wholesale Acquisition…

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