CDER, Office of Prescription Drug Promotion Issued 47 Warning Letters in 2015

The FDA said last week that its Center for Drug Evaluation and Research and the Office of Prescription Drug Promotion issued 47 warning letters last year, compared with 52 in 2014.

The FDA’s data did not include its district office warning letters, which will be issued at a later date.

The most active was CDER’s Office of Manufacturing Quality, which issued 20 warning letters — 13 related to cGMP issues, including 10 to manufacturers of active pharmaceutical ingredients. OMQ issued 19 warning letters in 2014.

Half of OMQ’s warning letters were directed to drugmakers in India for various allegations of improper lab controls, data integrity failures and lack of documentation. India has been plagued with warning letters over data integrity issues. Three of the warning letters OMQ issued went to drugmakers in China, and two went to U.S.-based companies.

The FDA’s Office of Compliance issued 11 letters in 2015, most for failure to pay GDUFA fees, others for improperly producing tablets or herbal products and creams. It issued 12 in 2014.

The Office of Scientific Investigations issued five warning letters — three targeting clinical investigations and two for improper disclosure of sponsors. It issued 12 in 2014.

The Office of Drug Security, Integrity and Recalls issued two warning letters, both claiming unlawful sale of unapproved and misbranded drug products over the Internet. None were issued last year.

The Office of Prescription Drug Promotion issued seven untitled letters and two warning letters in 2015, claiming false or misleading advertising. It also issued nine letters in 2014.

Read the report here: www.fdanews.com/01-20-16-WarningLetters2015.pdf.