Going back to the early 1980s when deaths from tainted Tylenol capsules led to the Federal Anti-Tampering Act to the New England Compounding Center crisis, the U.S. Food and Drug Administration has and continues to address health issues.
Beyond their tragic consequences, such events can also be viewed as problem-solving opportunities for public health in the pharmaceutical community, said Duane Satzger, Director, Forensic Chemistry Center, FDA, during opening remarks at PharmaLink 2015.
Amidst the hoopla of playing in the “Sweet 16” of this year’s NCAA men’s basketball tournament, Xavier University hosted the sixth PharmaLink Conference, with some 185 attendees focusing on the pharmaceutical industry and the latest news concerning FDA and global regulations.
Sister/Dr. Nancy Linenkugel, Interim Dean, College of Social Sciences, Health & Education at Xavier noted, “Healthcare is a ministry—we can never forget there is a patient,” noting that patients represent the ultimate focus for the pharmaceutical and healthcare industries.
Globalization
Ellen Morrison, Assistant Commissioner for Operations, Office of Regulatory Affairs, FDA, pointed to the agency’s growing challenges, including the following:
• FDA will need to transform from a domestically centered safety agency to a globally focused agency that is prepared for a regulatory environment in which national borders are less relevant to product safety than they have been in the past. The agency intends to build international coalitions of regulators.
• FDA-regulated products now account for approximately 10% of all imports to the U.S. Imports of FDA-regulated products are projected to triple between 2007 and 2015.
• Some 30% of medical devices and about 80% of APIs are now imported. The agency is active within approximately 150 countries and within 300,000 facilities.
Morrison also addressed the development of a Medical Device Single Audit Program that aims to provide more effective, efficient, and less burdensome regulatory oversight of the quality management systems of medical device manufacturers. This effort includes Australia’s Therapeutics Goods Administration, Brazil’s Agencia Nacional de Vigilancia Sanitaria, Health Canada, and the FDA.
Inspection protocols
A new Inspection Protocols Project was discussed in which the goals for successful inspections would be to add value and encourage manufacturing quality.
Morrison illustrated the agency’s future direction for risk modeling by ranking sites for inspection to provide a focus on the “measurement and ascertainment of the state of quality of production and quality systems in the inspected facility.”
Related to the inspection process and work product requirements, another goal is to “support quality risk assessment and risk-based inspection as envisioned by FDASIA and required to achieve meaningful mutual reliance.”
FDASIA, the Food and Drug Administration Safety and Innovation Act, was signed into law in 2012 and strengthens the agency’s authorities and ability to advance public health.
Morrison also related the following details to the PharmaLink audience:
• Nearly 20 firms have recalled compounded drugs in the past year, many due to conditions and practices resulting in lack of sterility assurance of their drugs.
• Over 10 firms have temporarily or permanently ceased sterile operations in the last year.
• FDA has issued some 25 Warning Letters in the past year.
• Last October, FDA released program action plans that Office of Regulatory Affairs (ORA) and each respective Center/Directorate developed for FY 2015. Each plan addresses how ORA and each Center will work together to facilitate operational and program alignment as the agency transitions to distinct commodity-based and integrated regulatory programs.
ORA serves as the lead office for all FDA field activities. ORA inspects regulated products and manufacturers, conducts sample analyses of regulated products and reviews imported products offered for entry into the U.S., according to its website.
Xavier will host the next PharmaLink event March 15-18, 2016.
