FDA’s or Industry’s Responsibility?By Daniel R. Matlis
During my opening remarks at the 4th Annual Manufacturing Execution System in Life-Sciences Conference, I discussed FDA’s proposed budget increase of 166 Million Dollars and 346 FTEs toward Medical Product Supply Chain Safety and Security Oversight.
The globalization of manufacturing and supply of medical products has created unique and demanding challenges for industry and FDA alike. Yet, according to a recent Axendia study on QMS trends in Life-Sciences, only 34% of respondents reported view global quality data in real time.
In the complex and ever-changing environment driven by globalization, license holders and regulators must seek out new approaches to ensure the safety of medical products.
The Industry’s Role:
In his Keynote, Gerald Migliaccio, Pfizer’s Vice President of Quality, EHS and Agility - Pfizer Global Manufacturing, addressed Supply Chain Security from an industry perspective.
“Supply chain security is the responsibility of all parties involved in procurement, sourcing, manufacturing, packaging and distribution of raw materials, intermediates and final product,” commented Mr. Migliaccio. “Ultimately, the marketing authorization holder(industry) is responsible for assuring that all parties in the supply chain fulfill their responsibilities for delivering safe and effective medicines to customers” he added.
According to Mr. Migliaccio, strong supply chain security strategies benefits both patients and industry by:
- Preventing Adulteration
- Preventing and Detect Counterfeits
- Preventing Product Diversion
These strategies should include the following key elements:
Financial viability of business partners throughout supply chain
Ethical Business practices throughout supply chain
Container/freight movement security
Supply Chain Quality Systems:
- Supplier / contractor evaluation and selection
- Supplier / contractor management and oversight
- Supplier / contractor management of their supply chain
- Overt measures
- Covert and semi-covert measures
- Forensic covert measures
- Counterfeit Detection
- Surveillance programs
- Support for Law Enforcement agencies
Proactive analysis of pricing and supply trends to predict potential areas of criminal activity
Internal and External Collaborations:
Cross-functional collaboration between manufacturing, quality, security, logistics, marketing and others to drive Supply Chain Security efforts
Industry collaboration through PhRMA, EFPIA, ISPE, and industry coalitions, such as RX-360
Collaboration with suppliers, contract manufacturers, transporters and distributors
Collaboration with Law Enforcement and Regulatory Authorities
The Agency’s Role:
For its part, the FDA plans to increase its oversight of the Supply Chain to ensure safety and security. This will prevent harm to the public by achieving greater compliance with safety standards, detecting and correcting safety risks.
FDA is proposing a budget increase of $166,433,000 and 346 FTEs to improve medical product Supply Chain Safety and Security.
FDA will increase medical product safety and security by enhancing oversight of entities in the supply chain.
FDA will use traditional and innovative mechanisms that include FDA inspections and field exams, integrated federal-state oversight, and greater access to inspection data and results acquired from trusted foreign regulatory authorities.