Additional evidence will be needed to assess the value of histology-independent cancer drugs, according to a paper co-authored by staff at the U.K.’s National Institute for Health and Care Excellence (NICE). The paper, published in the British Medical Journal, looks at the challenge such drugs create for current appraisal processes. Instead of being tested for cancer in one part of the body, histology-independent cancer drugs are tested for several different tumors that have the same genetic mutation, regardless of where they’re located. Since the mutations are often rare, the clinical evidence on the effectiveness of the drugs is “based on immature data and on studies with extremely small sample sizes,” NICE said. The paper also explains how services like NICE Scientific Advice allows drug manufacturers to get advice on generating the evidence NICE may need to assess a drug’s value. Meanwhile, a National Institute for Health Research project is expected to provide recommendations on methods to appraise this new kind of cancer drug, NICE said.
The FDA is looking to expand its weekly entry filing program for U.S. imports coming from foreign trade zones (FTZ). Under the program, which currently is available only for some FDA-regulated products, filers could submit a single entry estimating the amount of merchandise they anticipate moving from an FTZ for U.S. consumption during a seven-day period. The weekly filing is expected to contain information for multiple products, which should be “significantly less burdensome on a per-product basis,” the FDA said in a notice scheduled for publication in Friday’s Federal Register. The agency is recommending that importers wanting to file a weekly entry of FDA-regulated products with U.S. Customs and Border Protection should first request a preliminary assessment from the FDA. Comments on the FDA’s proposed revision should be submitted by March 3.
The FDA slapped GPT Pharmaceuticals Private Ltd. with a warning letter last month, a day after it put the company’s finished drugs on import alert because of quality problems and data integrity issues at its manufacturing facility in Hyderabad, India. It’s not the first time the company has been on import alert. The FDA noted in the letter that GPT had been placed on import alert in the past for sourcing active pharmaceutical ingredients (APIs) from a vendor that was on import alert for refusing an FDA inspection. The quality of API was at issue again this time around. When initial testing of API batches from a vendor were out of specification for a residual solvent, GPT’s quality unit retested the API to obtain passing results and then released the batches for use in production, disregarding the original results without adequate scientific justification, according to the letter the FDA posted this week. The FDA investigator also found that dedicated manufacturing equipment had visible rust, dents and scratches on product contact surfaces. GPT responded that it didn’t verify the cleanliness of all surfaces because the manufacturing area and entire equipment train was dedicated. In addition, the investigator found that lab equipment lacked appropriate controls, so various employees used the Agilent Service Account login, with full administrative privileges, to abort high-performance liquid chromatography testing runs without attributing the action to a specific individual. The letter noted that GPT is using a consultant to audit its operation and rectify problems.