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News
Fungus in Vials Sparks NIH Crisis
Fungus found growing in two medicine vials in an NIH hospital pharmacy 19 months ago has escalated into a crisis. It has stalled medical trials for prostate cancer, melanoma, and gastrointestinal and chest tumors. There have been delays for scores of patients, including those seeking a new colon-cancer treatment that in December completely reversed metastatic colon cancer in a patient and could help tens of thousands more.
NIH Director Francis Collins, MD, asked outside experts to review practices at the NIH hospital, known as the Clinical Center. Next, he ordered changes in safety procedures and personnel that closed drug-producing labs while they responded. Within NIH, some senior doctors and scientists say Collins overreacted, triggering months-long delays in research and treatment and they are critical of an outside report Collins commissioned.
http://www.wsj.com/articles/mystery-fungus-sparks-nih-crisis-imperiling-trials-patients-and-its-boss-1484753489
Chinese Drug Company Faked CoAs
The FDA has increased its inspection presence in China and has issued warning letters to a Chinese drugmaker and an active pharmaceutical ingredients (API) supplier. They found the company was selling APIs in the U.S. that were from another supplier claiming it had manufactured them itself. The big problem was the original supplier of some of those was on an FDA import alert list at the time.
Suzhou Pharmaceutical, the FDA said in its June 2016 inspection, was creating fake certificates of analysis (CoA) for the products it was selling by copying and pasting analytical results from the original API manufacturer, replacing the manufacturer's information with its own letterhead, then issuing the CoAs to its customers.
http://www.fiercepharma.com/manufacturing/chinese-api-company-found-faking-coas-selling-potentially-tained-products
FDA Has Never Inspected a Backlog of 1,000 Foreign Plants
Even though the FDA in the last eight years has nearly doubled the number of annual foreign plant inspections it conducts, the agency still has a huge backlog of foreign plants that have never been seen. Since safety concerns were realized during the last decade, slow and steady improvements were made in foreign production oversight. The FDA has dramatically reduced its catalog of uninspected foreign plants that ship to the U.S. but about 1,000 still have never seen a U.S. inspector.
http://www.fiercepharma.com/manufacturing/fda-has-a-backlog-1-000-foreign-plants-have-never-been-inspected-gao-report-finds
England Considers Drug Rationing
England's patients have legal access to drugs that have been approved by the cost watchdogs at National Institute for Care and Excellence (NICE), but that could change. They may face yet another barrier to access as a tough budget situation has forced the country's healthcare system to consider rationing costly drugs.
The country's pharmaceutical association, ABPI, chief executive Mike Thompson, described a �20 million budget cap for drugs as "both heavy-handed and unrealistic," adding in a statement that it "will mean more patients face delays in accessing appropriate NHS care."
http://www.fiercepharma.com/pharma/u-k-weighs-drug-rationing-as-nhs-england-s-budget-tightens-report
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