Category:

Certain ranitidine medications used to treat heartburn—including some products sold under the brand-name Zantac—contain low levels of a nitrosamine impurity linked with cancer…The contaminant, N-nitrosodimethylamine (NDMA), is classified as a probable human carcinogen...The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines (angiotensin II receptor blockers)...The FDA has recommended numerous ARB recalls as it discovered unacceptable levels of nitrosamines...NDMA, a known environmental contaminant, is found in water, meats, dairy products, and vegetables...The FDA is investigating the source of the ranitidine impurity. The agency pledged to “take appropriate measures based on the results of the ongoing investigation.”...READ MORE

Americans now view big pharma with more distaste than any other industry, according to a new Gallup poll...Just 27% of Americans regarded the pharmaceutical industry positively, compared with 58% who hold a negative view, the poll found. That resulted in a net rating of minus 31, compared with plus 4 just five years ago...Even the federal government — which many Americans love to hate — has a better reputation than the drug industry, which now ranks the lowest out of 25 industries considered by Gallup. More than 1,500 Americans living in all 50 states and the District Columbia were included in the group's poll...READ MORE

Laura Joszt, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Genentech has called a truce with Taiwanese biosimilar firm JHL Biotech, which allegedly stole trade secrets to help it develop copycats to top-selling cancer drugs...The Roche unit said the settlement requires JHL “to abandon development of and destroy” all cell materials related to the cancer drug brands involved—namely Rituxan, Herceptin, Avastin and Pulmozyme—and stop using or sharing them in any way. To make sure JHL complies, Genentech has the right to unannounced checkups...JHL...posted, the Taiwanese firm “will reimburse Genentech for its legal fees and the cost of its investigation, but will not otherwise pay any damages.”...READ MORE

The U.S. Department of Justice examined using fentanyl in lethal injections as it prepared last year to resume executing condemned prisoners…The department revealed it had contemplated using the drug in a court filing last month, which has not been previously reported...In the end, it decided against adopting the drug for executions. Attorney General William Barr announced...his department instead would use pentobarbital...when it resumes federal executions later this year, ending a de facto moratorium on the punishment…READ MORE

The CMS administrator views her work as public service, aims to put patients in the center of the healthcare decision-making process, and hopes to curb healthcare costs...Verma, a daughter of immigrants from India, says she views her work as 'giving back to this country that has given so much to me.'...Verma emphasizes consumer empowerment and transparent competition as central parts of the solution to the U.S. healthcare system's cost problem…READ MORE

Purdue’s pending opioid settlement with thousands of cities and counties, worth between $10 billion and $12 billion, could rank as the largest deal ever inked by a pharma if it passes a Cleveland federal judge’s muster. But where do pharma’s other major settlements fall on that list?...READ MORE

Here’s the list of pharma’s top 10 largest U.S. settlements.

1. Purdue Pharma—$10 billion to 12 billion*
2. Merck & Co.—$4.85 billion
3. American Home Products Corp. (now Wyeth)—$3.75 billion
4. GlaxoSmithKline—$3 billion
5. Pfizer—$2.3 billion
6. Takeda—$2.3 billion
7. Johnson & Johnson—$2.2 billion
8. Abbott Laboratories—$1.6 billion
9. Eli Lilly—$1.42 billion
10. Reckitt Benckiser—$1.4 billion

Purdue Pharma...filed for bankruptcy...days after reaching a tentative settlement with many of the state and local governments suing it…The filing was anticipated before and after the tentative deal, which could be worth up to $12 billion over time, was struck..."This settlement framework avoids wasting hundreds of millions of dollars and years on protracted litigation," Steve Miller, chairman of Purdue's board of directors, said in a statement, "and instead will provide billions of dollars and critical resources to communities across the country trying to cope with the opioid crisis. We will continue to work with state attorneys general and other plaintiff representatives to finalize and implement this agreement as quickly as possible."...READ MORE

Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

Purdue Pharma, manufacturer of the blockbuster painkiller OxyContin, reached a tentative settlement...with 23 states and more than 2,000 cities and counties that sued the company over its role in the opioid crisis…Under terms of a plan negotiated for months, the Sacklers would relinquish control of Stamford, Conn.-based Purdue Pharma and admit no wrongdoing. The company would declare bankruptcy and be resurrected as a trust whose main purpose would be producing medications to combat the opioid epidemic...If the deal becomes final, it would be the first comprehensive settlement in the broad effort to hold drug companies accountable for their role in the opioid epidemic...READ MORE