From The New York Times

Novartis Hid Manipulated Data While Seeking Approval for $2.1 Million Treatment

August 6, 2019

The drug maker Novartis concealed manipulated data from the Food and Drug Administration while applying for approval of an extremely expensive gene therapy treatment and then delayed reporting the issue, the agency said on Tuesday.

Officials said the inaccurate data, which involved testing in mice of two different strengths of the treatment, did not affect the safety or efficacy of the therapy, Zolgensma, used to treat a rare, often fatal genetic disease called spinal muscular atrophy.

The drug maker Novartis concealed manipulated data from the Food and Drug Administration while applying for approval of an extremely expensive gene therapy treatment and then delayed reporting the issue, the agency said on Tuesday.

Officials said the inaccurate data, which involved testing in mice of two different strengths of the treatment, did not affect the safety or efficacy of the therapy, Zolgensma, used to treat a rare, often fatal genetic disease called spinal muscular atrophy.

Approved in May, the treatment’s price — set at $2.1 million — stoked concerns about the astronomical costs of potential cures for rare diseases and upset parents who initially could not get insurance coverage for the breakthrough treatment….

Read the full The New York Times article

House Votes to Repeal Obamacare Tax Once Seen as Key to Health Law

July 17, 2019

In the heat of the legislative fight over the Affordable Care Act, Obama administration officials argued that including a steep tax on high-cost, generous health insurance plans was critical to the law because it would hold down soaring costs while helping to pay for its expanded health benefits.

On Wednesday, that feature, once considered central to Obamacare, was dealt a blow by an unlikely foe: Democrats.

In the heat of the legislative fight over the Affordable Care Act, Obama administration officials argued that including a steep tax on high-cost, generous health insurance plans was critical to the law because it would hold down soaring costs while helping to pay for its expanded health benefits.

On Wednesday, that feature, once considered central to Obamacare, was dealt a blow by an unlikely foe: Democrats.

The House voted almost unanimously to repeal the tax, which was intended to prompt employers to rein in such costly plans and force employees to spend more of their own money on their care. It was expected to be a key cost-containment provision in President Barack Obama’s signature health law and one of the main ways it was supposed to pay for itself.

It was not to go into effect until 2022, but the unions never liked it, nor did business groups or Republicans….

Read the full The New York Times article

Trump’s Assault on Obamacare Could Undermine His Own Health Initiatives

July 11, 2019

In court, the Trump administration is trying to get all of Obamacare erased. But at the White House, President Trump and his health officials are busily using the law to pursue key proposals.

Last week, the president highlighted a policy in the works meant to narrow the gaps between what drugs cost in the United States and overseas. On Wednesday, he signed an executive order to transform care for patients with kidney disease.

In court, the Trump administration is trying to get all of Obamacare erased. But at the White House, President Trump and his health officials are busily using the law to pursue key proposals.

Last week, the president highlighted a policy in the works meant to narrow the gaps between what drugs cost in the United States and overseas. On Wednesday, he signed an executive order to transform care for patients with kidney disease.

Both measures were made possible by a provision in the Affordable Care Act, and both would be effectively gutted if the administration’s position prevailed in court.

In between, administration lawyers told a receptive panel of judges in New Orleans that the entire Affordable Care Act should be overturned….

Read the full The New York Times article

Botox Maker Allergan Is Sold to AbbVie in $63 Billion Deal

June 25, 2019

The drugmaker AbbVie said on Tuesday that it planned to buy Allergan, the maker of Botox, for about $63 billion, in one of the biggest mergers in the health care industry this year.

The deal represents a classic response to a perennial drug industry challenge: how to recover when a blockbuster drug is losing its patent protection. In acquiring Allergan, AbbVie gets to bypass the risky process of research and development by buying a portfolio of popular products as it faces the loss of patent protection for Humira, a treatment for rheumatoid arthritis that is the world’s top-selling drug.

The drugmaker AbbVie said on Tuesday that it planned to buy Allergan, the maker of Botox, for about $63 billion, in one of the biggest mergers in the health care industry this year.

The deal represents a classic response to a perennial drug industry challenge: how to recover when a blockbuster drug is losing its patent protection. In acquiring Allergan, AbbVie gets to bypass the risky process of research and development by buying a portfolio of popular products as it faces the loss of patent protection for Humira, a treatment for rheumatoid arthritis that is the world’s top-selling drug.

“This is the age of blockbusters,” said David Maris, an analyst for Wells Fargo who follows the drug industry. “And when blockbusters start to go away, companies don’t have too many things they can do….”

Read the full The New York Times article

Teva and Other Generic Drugmakers Inflated Prices Up to 1,000%, State Prosecutors Say

May 11, 2019

Leading drug companies including Teva, Pfizer, Novartis and Mylan conspired to inflate the prices of generic drugs by as much as 1,000 percent, according to a far-reaching lawsuit filed on Friday by 44 states.

The industrywide scheme affected the prices of more than 100 generic drugs, according to the complaint, including lamivudine-zidovudine, which treats H.I.V.; budesonide, an asthma medication; fenofibrate, which treats high cholesterol; amphetamine-dextroamphetamine for A.D.H.D.; oral antibiotics; blood thinners; cancer drugs; contraceptives; and antidepressants.

Leading drug companies including Teva, Pfizer, Novartis and Mylan conspired to inflate the prices of generic drugs by as much as 1,000 percent, according to a far-reaching lawsuit filed on Friday by 44 states.

The industrywide scheme affected the prices of more than 100 generic drugs, according to the complaint, including lamivudine-zidovudine, which treats H.I.V.; budesonide, an asthma medication; fenofibrate, which treats high cholesterol; amphetamine-dextroamphetamine for A.D.H.D.; oral antibiotics; blood thinners; cancer drugs; contraceptives; and antidepressants.

“We all know that prescription drugs can be expensive,” Gurbir S. Grewal, the New Jersey attorney general, said in a statement. “Now we know that high drug prices have been driven in part by an illegal conspiracy among generic drug companies to inflate their prices….”

Read the full The New York Times article