A single Chinese supplier was the focus of 61 complaints from various drugmakers, drawing warning letters from the U.S. Food and Drug Administration and bans on some of its products used as key components by other drugmakers.
Japanese drugmakers--and many others around the world as well--routinely face steep declines in revenues when their products go off patent, or fall off the "patent cliff" as a recent Nikkei report termed it, and these companies are now turning to technology as one way to stave off the decline in cash flow. Still others are renegotiating licensing deals with global partners to keep the cash coming in.
Cadila Healthcare last week got out in front of bad news by announcing it had received a warning letter from the FDA for two of its Indian plants but was doing all that was asked by the agency. What it didn't explain in the announcement is that it had yet to satisfy the FDA even after responding 15 times to FDA concerns, or that the FDA was particularly troubled by its manufacturing of the blood thinner warfarin.
Hearing aids aren't particularly useful or affordable for most Americans who need them, but the U.S. Food and Drug Administration is hoping to help change that. It has disclosed new efforts to advance hearing aid technology and patient access to the devices. And a top med tech industry venture firm, NEA, has already made at least a trio of bets in the hearing aid category.
In 2015, the OPDP issued just 9 letters, down from 10 the previous year. While the one-year drop is small, a further look back points to an ongoing decline since 2010, when there were 52 action letters sent. In the years between, there's been an annual decline in the number of letters. There were 31 sent in 2011; 28 in 2012 and 24 in 2013.
The FDA approved a nonalcoholic formulation of docetaxel, freeing cancer patients from the risk of intoxication after treatment with the intravenously delivered med.
The FDA is doubling down on transvaginal mesh devices, responding to growing safety concerns by slapping the products with its most serious designation and calling for additional information from manufacturers before signing off on related devices.
As part of a draft guidance issued almost two weeks ago, the FDA is asking pharma companies to take part in a program that will review new, cutting-edge pharmaceutical manufacturing technology. The regulatory agency said the program is for companies submitting investigational drug applications, original or supplemental new drug applications, abbreviated new drug applications or biologic license applications.
The FDA is continuing its efforts to raise the standards of India's pharma industry, closing out the year with a warning to Cadila Healthcare, the company acknowledged in a report to the Bombay Stock Exchange. The citation follows warnings last year for a host of Indian drugmakers including Sun Pharmaceutical, Dr. Reddy's Laboratories and Mylan's sterile injectable operations in India.
As the U.S. Food and Drug Administration continues to crack down on manufacturers in China and India, the agency looks set to add at least 5 inspectors to the subcontinent to rein in cases of fake drugs and falsified tests that have already cost India millions of dollars in lost sales and that have put several Chinese bulk manufacturers on watch lists for contaminated products.