Report Says Intas Pharma Employees Violated Drugmaker Protocols
In response to an earlier inspection by the FDA of what Stat calls a "troubled plant," a recent warning letter was sent alleging that Intas employees tried to destroy manufacturing documents and that an employee failed to report all test results on product samples. Also in the news: a birth control pill recall and more.
Stat:
Intas Pharma Employee Used Acid To Destroy Manufacturing Records At Troubled Plant
Last November, an employee at Intas Pharmaceuticals, which makes several widely used chemotherapies that are in short supply, was seen pouring acetic acid in a trash bin containing documents at a manufacturing facility. Another employee failed to report all test results on product samples and, at times, printouts were tossed in the trash. Plastic bags filled with torn and discarded important production records were stashed under a stairwell and on a truck parked outside. (Silverman, 8/1)
More factory trouble —
FiercePharma:
Lupin Pharma Recalls Birth Control Pills Deemed Possibly Ineffective
Lupin Pharmaceuticals, the U.S. unit of India’s Lupin Limited, issued a voluntary recall of two lots of birth control pills due to the potential that they may not be effective in preventing pregnancy. The company is pulling two lots of Tydemy tablets due to out-of-specification test results at the 12-month stability time point, the company said in a July 31 press release. Testing on one of the lots found low levels of ascorbic acid and high levels of a “known impurity,” Lupin said. The company didn’t identify the impurity. ... Lupin is no stranger to recalls and run-ins with the FDA. Last November, the company disclosed it received a Form 483 at its active pharmaceutical ingredients plant in Mandideep, India, marking the fourth such admonition it received from the regulatory agency in a nine-week period. (Keenan, 8/1)
FiercePharma:
New York Manufacturer SterRx Shutters Plant, Lays Off 161
New York-based manufacturer SterRx has turned off the lights at its Plattsburgh, New York, plant and let go of 161 employees in the process. ... In July 2022, the agency slapped the facility with a warning letter, detailing numerous issues including products being exposed to “insanitary conditions" and other substandard manufacturing practices. (Becker, 8/1)
In other pharmaceutical updates —
Bloomberg:
Adderall Shortage Has US FDA, DEA Urging ADHD Drugmakers To Boost Production
US drug regulators and law enforcement officials asked pharmaceutical companies to manufacture more Adderall, an ADHD medication that has been in short supply for nearly a year. The Food and Drug Administration, which reviews drugs for safety and effectiveness, and the Drug Enforcement Administration, which polices controlled substances like stimulants, “have called on manufacturers to confirm they are working to increase production,” the agencies wrote in a letter Tuesday. (Swetlitz, 8/1)
Stat:
EQRx, Failed Developer Of Low-Priced Cancer Drugs, Is Sold For Cash
EQRx is done, sold for its cash. The once-buzzy but now dormant biotech company is being acquired by Revolution Medicines, a developer of cancer drugs, the companies announced Tuesday. The all-stock deal is essentially a balance-sheet transfer of $1 billion in cash from EQRx to Revolution. What was left of EQRx’s drug pipeline is being shelved. (Feuerstein, 8/1)
KFF Health News:
The Real Costs Of The New Alzheimer’s Drug, Most Of Which Will Fall To Taxpayers
The first drug purporting to slow the advance of Alzheimer’s disease is likely to cost the U.S. health care system billions annually even as it remains out of reach for many of the lower-income seniors most likely to suffer from dementia. Medicare and Medicaid patients will make up 92% of the market for lecanemab, according to Eisai Co., which sells the drug under the brand name Leqembi. In addition to the company’s $26,500 annual price tag for the drug, treatment could cost U.S. taxpayers $82,500 per patient per year, on average, for genetic tests and frequent brain scans, safety monitoring, and other care, according to estimates from the Institute for Clinical and Economic Review, or ICER. The FDA gave the drug full approval July 6. About 1 million Alzheimer’s patients in the U.S. could qualify to use it. (Allen, 8/2)
Also —
The Baltimore Sun:
Nobel Laureate, Hopkins Researcher Retracts Additional Articles, Bringing Total To Six In Two Years
Johns Hopkins Medicine researcher Dr. Gregg Semenza, a Nobel laureate recognized for his contributions to uncovering how cells adapt to changing oxygen levels, has retracted six articles from prominent scientific journals in the past two years after questions were raised about the integrity of images used in them. The questions about the images arose on PubPeer, an online platform for scrutinizing research post-publication. An additional 10 of Semenza’s papers have been corrected, according to PubPeer, and one has been marked with an “expression of concern,” alerting readers to a potential problem. (Roberts, 8/1)
