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Howard Sklamberg

FDA Compliance

The FDA Forms New Partnerships to Ensure Product Safety

Creating global alliances to meet the challenge

Published: Tuesday, June 21, 2016 - 16:05

Globalization is posing challenges for public health. For the U.S. Food and Drug Administration (FDA), part of that challenge is the ever-increasing volume and complexity of FDA-regulated products coming to America’s shores.

In fiscal year 2015, there were more than 34 million shipments of FDA-regulated products into the United States, up from just 15 million a decade ago. These products are handled by 130,000 importers, and are manufactured, processed, or packaged at more than 300,000 foreign facilities.

We know this global trade expansion has ramifications for our nation’s public health. We also know we can’t be the inspectors for the world. Hence, we need to effectively direct our resources in a risk-based manner as we grapple with this tremendous volume of imported goods.

How? One way is to identify foreign regulators that we can rely on to partner with in verifying that safety standards are being met, and then construct an approach that will meet the requirements of multiple regulatory jurisdictions. We’re currently engaged in three innovative programs to meet this challenge.

The Medical Device Single Audit Program

The Medical Device Single Audit Program (MDSAP) is an international approach to auditing and monitoring the manufacture of medical devices to ensure their safety and efficacy. This audit program will allow a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions.

Currently, five nations—Australia, Brazil, Canada, Japan, and the United States—are participating in the MDSAP Pilot. It began 18 months ago and will run through the end of 2016. The program’s goals include:
• Enabling regulatory oversight of medical device manufacturers’ quality management systems
• Promoting more efficient use of regulatory resources through work-sharing and mutual acceptance among regulators

Mutual recognition agreements

In 2014, the FDA launched the Mutual Reliance Initiative (MRI), a strategic collaboration between the FDA and the European Union member states. The goal of the program is to determine if the FDA and the European Union can agree to recognize each other’s drug good manufacturing practice (GMP) inspections, a potentially time-saving approach.

If successful, we could rely upon EU experts to inspect facilities within their own borders, a more practical way of overseeing the large number of drug manufacturing sites outside of the United States. And it would be similarly more practical if the EU relied on FDA experts to inspect facilities within the United States.

Both the European Union and the FDA are in the process of evaluating each other’s processes. EU representatives have visited several of the FDA’s district offices and one drug laboratory in the United States, and evaluated the work they do. The FDA has a different challenge since each country in the EU has at least one inspectorate, and in Germany, each state has its own inspectorate. To date, the FDA has observed eight audits—in Sweden, Greece, Croatia, Germany, Hungary, Italy, the Czech Republic, and the United Kingdom—and will continue to observe audits of other EU member states this year and in 2017.

Food safety Systems Recognition

Preventing problems at relevant points along the global food supply chain can be a daunting job. The FDA is soliciting help by leveraging foreign food safety systems that are similar to our own.

The agency’s Systems Recognition program determines whether another country has comparable regulatory programs and public health outcomes to what we have in place in the United States

A major advantage of Systems Recognition is that it allows the FDA to be more risk-based in its oversight of imported food, and we can more wisely plan our overall inspection activities, including foreign facility inspections, import field exams, and import sampling.

Thus far, New Zealand and the U.S. signed a Systems Recognition agreement (in 2012), and recently another agreement was signed with the Canadian Food Inspection Agency.

What’s next?

The three initiatives I’ve briefly outlined represent the best of FDA innovation and expertise in grappling with the increasing amount of imported FDA-regulated products. Our work will focus on a continued careful reliance on trusted foreign partners; a move away from duplicative work; more risk-based inspections; better data; and the minimization of public health risks globally.


About The Author

Howard Sklamberg’s picture

Howard Sklamberg

Howard Sklamberg is FDA’s deputy commissioner for global regulatory operations and policy, and he is the directorate comprising the Office of Regulatory Affairs and the Office of International Programs. Sklamberg provides executive oversight, strategic leadership, and policy direction to FDA’s domestic and international product quality and safety efforts, including global data-sharing, development and harmonization of standards, field operations, compliance, and enforcement activities. Sklamberg played leadership roles in global drug supply chain security, pharmacy compounding oversight, pharmaceutical quality, and expanded cooperation with international regulatory partners. Sklamberg has degrees from Harvard Law School, Yale University, and Fletcher School of Law and Diplomacy.