At a joint session of the PharmTech Conference and the 4^th Annual Manufacturing Execution System in Life-Sciences Congress earlier this month, during my opening remarks, I discussed FDA’s proposed budget increase of $166 million 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 conference keynote, Gerald Migliaccio, Vice President of Quality, EHS and Agility at 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. 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 said.

According to Mr. Migliaccio, strong supply chain security strategies benefit both patients and industry by:

–      Preventing adulteration

–      Preventing and detecting counterfeits

–      Preventing product diversion

These strategies should include the following key elements:

Supply-chain security  measures

–      Financial viability of business partners throughout the supply chain

–      Ethical business practices throughout the supply chain

–      Physical security

–      Container/freight movement security

–      Personnel security

Supply-chain quality systems

–      Supplier / contractor evaluation and selection

–      Supplier / contractor management and oversight

–      Supplier / contractor management of their supply chain

Counterfeit prevention

–      Overt measures

–      Covert and semi-covert measures

–      Forensic covert measures

–      Counterfeit detection

–      Surveillance programs

–      Support for law enforcement agencies

Business intelligence

Proactive analysis of pricing and supply trends to predict potential areas of criminal activity

Internal and external collaborations

–      Crossfunctional 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 

In its report, Safer Medical Products: Investments for Supply Chain Safety and Security, FDA states its interest in ensuring safety and security. This will prevent harm to the public by achieving greater compliance with safety standards, as well as detecting and correcting safety risks. To this end, the FDA report states the agency’s plan to “implement new approaches and conduct new activities to effectively regulate the supply chain. The priorities proposed in this initiative will assure the safety and security of foreign and domestic sources of ingredients, components, and finished products at all points in the supply chain, including their eventual use by American consumers.

“Supply Chain Safety and Security relies on risk-based prevention with a verification-focused approach to hold all segments of industry accountable for ensuring that their products meet U.S. safety standards, with FDA verifying compliance with standards.”

To meet these objectives:

 –      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.

In my opinion, although industry and regulators have different roles in securing the Medical Product Supply Chain, we will all benefit through their efforts. 

In Gerry Migliaccio’s words, “while we have been very successful at advancing science and risk-based approaches to quality, all of our efforts can be rendered moot if we cannot secure the supply chain.”

Daniel R. Matlis is president of Axendia, Inc., and editor of Life-Science Panorama. He can be reached by phone: (267) 249-0431, via e-mail: info@axendia.com , on the Web at www.axendia.com  and on twitter: http://twitter.com/axendia.