From The New York Times

Trump Administration Sues Gilead, Maker of H.I.V.-Prevention Drugs

November 7, 2019

The Trump administration on Wednesday sued Gilead Sciences, a pharmaceutical company that sells H.I.V.-prevention drugs that can cost patients up to $20,000 a year, accusing the company of earning billions from research funded by taxpayers without paying taxpayers back.

The government said the company infringed upon patents owned by the Department of Health and Human Services, and had refused attempts by the department to license its patents and collect royalties. The company sells two drugs, Truvada and Descovy, that can be taken once daily to prevent H.I.V. infection, a strategy called pre-exposure prophylaxis, or PrEP.

The Trump administration on Wednesday sued Gilead Sciences, a pharmaceutical company that sells H.I.V.-prevention drugs that can cost patients up to $20,000 a year, accusing the company of earning billions from research funded by taxpayers without paying taxpayers back.

The government said the company infringed upon patents owned by the Department of Health and Human Services, and had refused attempts by the department to license its patents and collect royalties. The company sells two drugs, Truvada and Descovy, that can be taken once daily to prevent H.I.V. infection, a strategy called pre-exposure prophylaxis, or PrEP.

Wider access to PrEP is central to the government’s goal, announced in February, to reduce new H.I.V. infections by 75 percent over five years, and to “end the H.I.V. epidemic in America” by 2030. Critics have said the drug’s lofty price tag has limited its accessibility to high-risk people with low incomes, thwarting the government’s efforts….

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U.S. Blames Drug Shortages on Low Prices and a ‘Broken Marketplace’

October 29, 2019

Chronic drug shortages that threaten patient care are caused by rock-bottom prices for older generic medicines and a health care marketplace that doesn’t run on the rules of supply and demand, among other factors, according to a federal report published on Tuesday.

The report, the work of a task force led by the Food and Drug Administration and comprising representatives from various federal agencies, recommended that buyers like hospitals consider paying higher prices for older generic drugs.

Chronic drug shortages that threaten patient care are caused by rock-bottom prices for older generic medicines and a health care marketplace that doesn’t run on the rules of supply and demand, among other factors, according to a federal report published on Tuesday.

The report, the work of a task force led by the Food and Drug Administration and comprising representatives from various federal agencies, recommended that buyers like hospitals consider paying higher prices for older generic drugs.

Paying more would encourage drug companies to prioritize drugs like vincristine, a critical cancer medicine for children that now sells for just $8 a vial. To the consternation of cancer specialists, supplies of the drug recently have been scarce….

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That New Alzheimer’s Drug? Don’t Get Your Hopes Up Yet

October 23, 2019

Biogen, the drug company, said on Tuesday that it would ask the Food and Drug Administration to approve an experimental drug, aducanumab, to treat people with mild cognitive impairment and the earliest signs of Alzheimer’s disease.

About 10 million Americans might qualify for treatment if the drug were approved, according to Michel Vounatsos, the company’s chief executive. Even so, it is not quite time for these patients to celebrate.

Biogen, the drug company, said on Tuesday that it would ask the Food and Drug Administration to approve an experimental drug, aducanumab, to treat people with mild cognitive impairment and the earliest signs of Alzheimer’s disease.

About 10 million Americans might qualify for treatment if the drug were approved, according to Michel Vounatsos, the company’s chief executive. Even so, it is not quite time for these patients to celebrate.

The company has not published the most recent analyses, and experts are mostly in the dark as to how well the drug works. It neither prevents nor cures Alzheimer’s; the company claims only that aducanumab may slow cognitive decline in some patients….

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Drug Giants Close In on a $50 Billion Settlement of Opioid Cases

October 17, 2019

The nation’s three largest drug distributors and two manufacturers have agreed with multiple states on a framework to resolve thousands of opioid cases with a settlement worth nearly $50 billion in cash and addiction treatments, according to three people familiar with the negotiations.

The agreement would release AmerisourceBergen, Cardinal Health and McKesson Corporation, which together distribute about 90 percent of the country’s medicines, along with Johnson & Johnson and Teva, the Israel-based manufacturer of generic drugs, from a rapidly growing list of more than 2,300 lawsuits that they face in federal and state courts.

The nation’s three largest drug distributors and two manufacturers have agreed with multiple states on a framework to resolve thousands of opioid cases with a settlement worth nearly $50 billion in cash and addiction treatments, according to three people familiar with the negotiations.

The agreement would release AmerisourceBergen, Cardinal Health and McKesson Corporation, which together distribute about 90 percent of the country’s medicines, along with Johnson & Johnson and Teva, the Israel-based manufacturer of generic drugs, from a rapidly growing list of more than 2,300 lawsuits that they face in federal and state courts.

Although the states have agreed in principle to the framework, cities and counties across the country have not yet fully embraced it, said lawyers for a committee that represents thousands of municipal governments. They are seeking more information about how the money will be distributed, whether it will be directed to relief measures or end up in general funds for state legislatures, and “when they could expect the financial support to start,” the lawyers said in a statement….

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Johnson & Johnson Hit With $8 Billion Jury Verdict in Risperdal Suit

October 8, 2019

A Philadelphia jury on Tuesday hit Johnson & Johnson with an $8 billion verdict over its marketing of the anti-psychotic drug Risperdal, siding with a Maryland man who argued that the health care giant downplayed risks that the drug could lead to breast growth in boys.

The verdict in the Philadelphia Court of Common Pleas was the first to award punitive damages against Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, said Thomas R. Kline, a lawyer who is part of a legal team representing the man and more than 10,000 people in similar lawsuits.

A Philadelphia jury on Tuesday hit Johnson & Johnson with an $8 billion verdict over its marketing of the anti-psychotic drug Risperdal, siding with a Maryland man who argued that the health care giant downplayed risks that the drug could lead to breast growth in boys.

The verdict in the Philadelphia Court of Common Pleas was the first to award punitive damages against Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, said Thomas R. Kline, a lawyer who is part of a legal team representing the man and more than 10,000 people in similar lawsuits.

Compensatory damages of $680,000 were already awarded in the case in March 2016….

Read the full The New York Times article