2014 CBER Update: Advertising & Promotional Labeling Compliance Alpita Popat, PharmD, MBA Consumer Safety Officer Advertising & Promotional Labeling Branch Division of Case Management Office of Compliance and Biologics Quality
Agenda Organization Jurisdiction Submissions Compliance action Common violations New contact information 2
Advertising & Promotional Labeling Branch Lisa Stockbridge, Ph.D. (Branch Chief) Michael Brony, Pharm.D. CDR Oluchi Elekwachi, Pharm D. Kristine Khuc, Pharm.D. Dana Martin LCDR Loan Nguyen, Pharm.D. Alpita Popat, Pharm.D., M.B.A. CDR Sonny Saini, Pharm.D., M.B.A.
OCBQ Director, Mary Malarkey OCBQ - Deputy Director Mark Schwartz CBER/OCBQ/DCM/APLB Division of Case Management DCM Director, Bob Sausville Division of Inspections and Surveillance DIS Director, Gill Conley Division of Manufacturing and Product Quality DMPQ Director, Jay Eltermann DMPQ Deputy Director Laurie Norwood Division of Biological Standards and Quality Control DBSQC Director - Dr. Bill McCormick
CBER Products blood and blood components vaccines allergenic extracts human tissue & cellular products (cord blood) gene therapy products biological devices and test kits
Regulations for CBER Product Labeling 21 CFR 201.56 and 201.57 21 CFR 208.20 21 CFR 610.60-610.67 (container and package) 21 CFR 801 and 809 (biological devices) 21 CFR 1271 (cells, tissues)
Promotional Material FY10 - FY14 (through August 31, 2014)) 6000 5000 4000 3000 2000 FY10 FY11 FY12 FY13 FY14 1000 0 2253 Submissions
Material Types in 2013 1600 1400 1200 1000 800 600 400 200 0
e-breakdown other banner banner e commerce website e mail e commerce mobile video social media social media mobile e mail video website other
2009 vs. 2013 1600 1400 37% 40% 1200 1000 800 600 400 Internet Sales Aid Television Broadcast 200 0 2009 2013
Compliance Actions
Vampire Facelift
RegenKit -THT Website Patient brochure RegenPlasma TM Unleashed! Professional Brochure RegenPlasma TM Unleash the Power of PRP in Your Practice!
RegenKit THT (continued)
RegenKit -THT Claims With a simple, quick and advantageous RegenLab process, your own blood is safely prepared on the physician s premises and is delivered to your skin within the same treatment session. RegenPlasma is regenerative medicine and works best aesthetically when it is introduced into the skin. The use of RegenPlasma has long been known in a variety of aesthetic, surgical and wound care fields of medicine. RegenPlasma is a carefully designed leading edge product that has been scientifically verified for aesthetic applications The results have proven to be superior!
RegenKit -THT Instructions for Use The RegenKit THT is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of blood at the patient s point of care. The PRP is mixed with autograft and/or allograft bone prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements.
RegenKit -THT Untitled Letter Adulterated Because there is no approved premarket application (PMA) or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g) for the new intended uses of this device. Misbranded Because there has been no notice or other information with respect to the new intended uses for the device provided to FDA, as required by section 510(k) of the Act, 21 U.S.C. 360(k). Claims concerning use in cosmetic surgery are evidence of intended uses that are not consistent with the 510(k) clearance for RegenKit THT and represent a major change or modification in the intended use that requires the submission of a PMA or a 510(k).
Most Common Violations Indication Risk Efficacy 18
Resources Guidances http://www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulat oryinformation/default.htm http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/g uidances/default.htm Compliance Letters http://www.fda.gov/cber/efoi/adpromo.htm APLB Website http://www.fda.gov/biologicsbloodvaccines/developmentapprovalproces s/advertisinglabelingpromotionalmaterials/ucm164120.htm
NEW Contact Information Food and Drug Administration Center for Biologics Evaluation and Research Document Control Center 10903 New Hampshire Ave WO71 G112 Silver Spring, MD 20993 0002 Phone: 240 402 9158