FDA’s Approach to Globalization

On Feb 4, 2010, Dr. Margaret Hamburg explained in detail the enormous problem facing the FDA. Globalization has made the task of monitoring imports and suppliers daunting and nearly impossible. The huge number of products imported, the vast number of foreign companies that create regulated products, and the increased complexity of the supply chain from the manufacturer to consumer with more repackagers and redistributors has created a gargantuan task for the FDA. Dr. Hamburg used the following facts to describe the severity of the problem:

· FDA-regulated products are currently imported from more than 150 countries, with more than 130,000 importers of record, and from more than 300,000 foreign facilities.

· In 2010, we expect that nearly 20 million shipments of food, devices, drugs, and cosmetics will arrive at U.S. ports of entry. Just a decade ago, that number was closer to 6 million, and a decade before only a fraction of that. Of those 20 million shipments, less than 500 inspectors will be handling them.

· Up to 40% of the drugs Americans take are imported, and up to 80% of the active pharmaceutical ingredients in those drugs come from foreign sources.

· Current estimates are that FDA inspects only about 8% of foreign drug manufacturing establishments each year.

After absorbing these facts, it is not surprising that in the past few years there have been some frightening drug and food events that caused death and injury. The melamine-tainted pet food and infant formula from China in 2007, the contaminated heparin from China, lead based paints from China, and outbreaks associated with melons, peppers, raspberries, and seafood have all caused concern for the safety of fellow Americans not to mention the economic costs. Dr. Hamburg stated that these events are symptoms of a larger problem and since globalization has altered our market so vastly, “massive, [fundamental and systemic] change will be required for FDA to be able to keep up with a globalized economy.” In addition to the dramatic events that have occurred are the multitude rejections from FDA regulators of products that contain illegal drug residues, bacterial contamination, unapproved food additives, pesticides, heavy metals and more. Dr. Hamburg further encouraged that “We must move from an approach based on reacting to problems… to one that proactively prevents such problems from ever occurring.” Dr. Hamburg said that the new approach needs to be “an approach that takes into account the entire supply chain and its complexity; an approach that will address product safety by preventing problems at every point along the global supply chain… from the raw ingredients… through production… and distribution… all the way to U.S. consumers.”

Dr. Margaret Hamburg explained the FDA’s new 3 pronged approach to meet this problem.

1. Better controls at the point of production – FDA has been expanding the number of offices and employees in other regulatory systems around the world which will ensure a regional presence around the world. FDA has also been collaborating more with countries that have established regulatory systems. In addition, there are more than 30 agreements with foreign organizations to share inspection reports and other non-public information. This will help focus the FDA’s efforts on the higher risk companies, sites, and products.

2. Hold importing companies responsible for their supply chain – Not all companies excel in demonstrating quality, compliance, and safety in all steps of the production process. In order to strengthen the safety of their supply chains, the FDA will work with the companies to set standards and make sure that they have been met. However, if the company sells contaminated products because they have not ensured that standards have been met they will be held responsible and, as Dr. Hamburg stated, they “need to face serious penalties.”

3. Import inspections will be efficient and effective – PREDICT–the Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting is a new program that has been piloted in Los Angeles since 2007 and should be running around the country by the end of spring of 2010.

PREDICT is a technology system that will analyze data such as:

· Information about the manufacturer

· Country of origin

· Recall history

· Security risk

· Past inspections of the company

· Weather

· Market conditions

The data collected will generate and assign a score to a company. The PREDICT system will allow regulators to spend their precious time on higher risk companies and products, and the companies that have a good score will be able to avoid timely delays.

PREDICT allows tainted/unacceptable product to be destroyed before reaching the public, better ensuring the safety of the Americans.PREDICT is a system that is a result of the FDA internalizing its own quality systems approach; a CAPA system at its best.

During her speech Dr. Margaret Hamburg used the word responsibility seven times. She discussed;

· the responsibility of the FDA for the products they oversee,

· the responsibility among manufacturers for the quality and safety of their products,

· the responsibility of companies for their supply chain, and

· the shared sense of responsibility that is necessary to have a truly safe global supply chain.

She also mentioned that companies will be held accountable for what goes into their products as well as the products they produce.

Dr. Margaret Hamburg concluded her speech by saying, “I can assure you that addressing the problem of global supply chain safety, and shifting the existing paradigm from reaction to prevention, is one of my highest priorities for FDA.” She also said that public health protection is a global endeavor.

Though there has been concern about the efficacy of government agencies in the past due to the fearful quality events that have occurred in the past few years, thankfully the FDA is facing this daunting dilemma with practical action steps and positive change. I am hopeful that this change along with Dr. Hamburg’s heightened enforcement policy will create measurable modifications in the industry.

Please call Coda Corp USA offices to schedule an audit of your quality systems (866.872.2070).

© Coda Corp USA 2009. All rights reserved.



Corrine R. Knight








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