TOP FDA NOTABLES 1st QUARTER 2015
Guidance Issued-Infection Prevention and Safety http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm437804.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
McNeil-PPC Inc. GUILTY PLEA
McNeil-PPC Inc. a subsidiary of Johnson & Johnson-Guilty Plea March 10, 2015 $25 million manufacturing adulterated Infants’ and Children’s Tylenol and Children’s Motrin. http://1.usa.gov/1AeQ2JS
MOBILE MEDICAL APPS-GUIDANCE
The Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff issued February 9, 2015 supersedes the September 25, 2013 issued guidance. It was updated for consistency with the guidance document Medical Devices Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices issued on February 9, 2015. See: 76 Fed. Reg. 140 (July 21, 2011). http://1.usa.gov/1DrPGXm
Examples of Mobile Apps-FDA Enforcement Discretion http://1.usa.gov/Px0cpU
DIRECT-to-CONSUMER GENETIC TESTING KIT APPROVED
23andMe, Inc. submitted a revised 510(k) application for its direct-to-consumer genetic testing service focusing on a single rare inherited condition. In 2015 (Feb.) FDA authorized marketing of 23andMe’s Bloom Syndrome carrier test, a direct-to-consumer (DTC) genetic test to determine whether a healthy person has a variant in a gene that could lead to their offspring inheriting the serious disorder. Additionally, FDA classified carrier screening tests as class II. Further, the FDA exempts these devices from premarket review. http://1.usa.gov/18SbIVz Interestingly, 23andMe received a two year $1.3 million NIH grant in 2014 (July) to support further development of its Web-based database and research engine to stimulate genetic discoveries. According to 23andME, the funding will enable it to use its stored genetic data on thousands of diseases and traits for over 400,000 people to pursue research endeavors and detect novel and rare genetic associations with health conditions.
BIOSIMILAR APPROVAL- NOVARTIS
The first biosimilar drug for cancer named Zarxio by Novartis AG received approval in early 2015. The ramifications of the approval of Novartis AG’s form of Amgen Inc.’s cancer drug, Neupogen, are huge. That is, this biosimilar approval means lower costs and patient access to less expensive treatments. Zarxio received FDA approval for all five conditions to treat associated to white blood cell counts. Novartis agreed to delay selling the biosimilar in the United States until April 10, 2015 due to a lawsuit with Amgen. An unresolved issue it that of naming. Generic drugs are named after the active ingredient for uniformity. The active ingredient in Neupogen is filgrastim and FDA determined that Zarxio’s name is filgrastim-sndz. http://1.usa.gov/1frRQcv
CONSENT DECREE- SPECIALITY COMPOUNDING LLC
A consent decree entered against Specialty Compounding LLC, of Cedar Park, Texas, and the company’s co-owners, Raymond L. Solano, III and William L. Swail. According to the complaint filed with the consent decree, Specialty Compounding manufactured purportedly sterile injectable drug products that tested positive for bacterial contamination. Veterinarians should be aware that Specialty Compounding also manufactured products intended for use in animals, and that these products are also affected by the consent decree. Specialty Compounding ceased sterile drug manufacturing operations in August 2013, and recalled all lots of its unexpired sterile drug products distributed since February 1, 2013.
STAY TUNED! Will post updated news next quarter 2015!