In a speech on February 4, 2010, Dr. Margaret Hamburg, commissioner of the FDA, spoke about the risks and challenges of a globalised world. Up to 40% of the pharmaceutical products, which Americans take, are imported and up to 80% of the active ingredients in these pharmaceutical products derive from abroad.
In 1938, when today's FDA was founded, only a small amount of the products, which were used in the USA, were imports. The system for the inspection of the goods, which come into the country, reflects that - even to this day!
Extreme changes are necessary to enable the FDA to keep pace with the globalised economy. In 2010 approx. 20 million deliveries of products, which fall under the regulations of the FDA (foodstuffs, pharmaceutical products, medical devices, cosmetics, etc.), are expected.
In order to meet the challenges, a fundamental "paradigm shift" is necessary. In this regard, Dr. Hamburg specifically named the following three items as part of a new strategy:
1. Improved inspections in the places where the products are manufactured,
2. Import companies are made responsible for the compliance with the supply chain,
3. The FDA wants to use its own resources as strategically as possible.
Regarding improved inspections, Dr. Hamburg referred to the offices, which the FDA has now set up in many countries, among others, China, India, Costa Rica and Chile.
With regard to the second item, Dr. Hamburg stated that the companies must be able to verify that the safety, quality and compliance with international and US standards are ensured for the products themselves as well as for the basic materials contained therein and for each individual step in the manufacturing process.
In this context, Dr. Hamburg announced a new FDA programme for the third item, with which the FDA will be able to inspect imported goods more effectively and efficiently. The system, which is now to be implemented, is called PREDICT (the Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting). A respective pilot programme was initiated in Los Angeles. Currently, the system is being launched in New York and the nation-wide application of this system is planned in the spring.
"PREDICT" is a highly developed IT system for application during inspections at the national borders. Using this new system, products are to undergo a more reliable inspection on the location of their import and aim is taken at products with the highest risk. Using "PREDICT", the inspectors will still only be examining a small percentage of all import deliveries however, intelligent decisions are made using the system, which deliveries have to be inspected. PREDICT applies a series of evaluation systems in order to sort the goods determined to be imported according to their actual risks.
Dr. Hamburg explicitly emphasised: "I can assure you that it will be one of my top priorities for the FDA to tackle the problem of the global safety of the supply chain and to transform the existing approach of reacting to an approach of preventing!"
You can find Dr. Hamburg's entire speech here.
You can obtain further information from the FDA at the conference of the University Würzburg, "Strategies against Counterfeit Medicines", from April 26th - 28th, 2010, at which there will be two speakers from the FDA.
Janice M. Soreth from the European office of the FDA in London will be introducing the current measures and future strategies of the FDA in the battle against counterfeit medicines in detail.
And, Frederick L. Fricke will be presenting the activities of the FDA Forensic Chemistry Centre for the analytical examination of counterfeit medicines.
Other important representatives of government agencies at this conference are:
Dr. Günter Brendelberger
On behalf of the European Compliance Academy (ECA)