The Institute of Medicine has come up with a raft of recommendations to improve the regulatory systems in developing countries and one of the most immediate calls for FDA, foreign regulators and industry to share inspection reports.

FDA commissioned the IOM to identify the core elements of food and medical products regulatory systems in developing countries, detect the main gaps in these systems, and design a strategy for FDA and other stakeholders to use to strengthen these systems abroad. The result is a 287-page report, “Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad,” that includes 13 recommendations.

At an April 4 public briefing, the members of the IOM committee that produced the report discussed their findings and what prompted their research.

“FDA has realized the world has changed” with regard to the products it regulates, said committee chair Jim Riviere, director of the Center for Chemical Toxicology Research and Pharmacokinetics at the College of Veterinary Medicine, North Carolina State University. He noted that 80% of active pharmaceutical ingredients are imported and more than 40% of finished drugs come from abroad. In addition, he said FDA has to keep track of 20 million import lines.

FDA cannot ensure the safety of foods and medical products alone, Riviere said. It has to “interface with partners that have similar abilities and develop a larger regulatory system.”

In preparing the report, the committee members went to Brazil, South Africa, China and India, where they held meetings with government regulatory authorities and other stakeholders. They also talked to people from several other countries.

Counterfeit Avastin Underscores Problems In Supply Chain

The report details the problems low- and middle-income country regulatory authorities face, including poor infrastructure, lack of pest control and refrigeration, a shortage of staff, poor surveillance systems and absence of laws governing product safety.

The day before the report was released FDA confirmed a second counterfeit version of Roche’s injectable cancer drug Avastin (bevacizumab) had been found in the U.S. That version was marketed as Altuzan, the brand name sold in Turkey. In February the agency warned health care professionals and patients about a different counterfeit Avastin that may have been purchased by medical practices in the U.S. Both counterfeits do not contain the active ingredient.

At the briefing the committee was asked if the Avastin problem would have occurred if its recommendations were in place. Riviere replied that the counterfeiting would have been less likely but that problems will always exist and there needs to be a constant effort to improve the regulatory system.

The committee was also asked which of its recommendations it would like to see implemented in the next three to 12 months. Riviere responded that the sharing of inspection reports is one of the items that could be adopted in the short term. He said there should be a push for an agreement between FDA and its partner regulators and also a push for industry sharing.

Riviere said industry associations should work out a way to share inspection information. He acknowledged that this is tricky because of trade secrets and noted that Rx-360, an international pharmaceutical supply chain consortium, is working on this issue.

IOM Cites Value Of Product Liability Suits Against Foreign Producers

FDA has also advocated sharing data and inspection responsibilities between regulators. At a recent conference on drug supply chain safety, John Taylor, FDA acting principal deputy commissioner, described the agency’s plan to partner with foreign regulators and build a global data system Also see "FDA Cloak And Dagger: GMP "Intelligence" Sought As Part Of Globalization Plan" - Pink Sheet, 15 March, 2011..

And in a report it issued last year, Pathway to Global Product Safety and Quality, the agency called for more reliance on other regulators, as well as certified third parties, in conducting inspections Also see "FDA Looks To Capitol Hill For New Authority For Globalization Plan" - Pink Sheet, 20 June, 2011..

The committee also noted that training of regulators could be implemented in the near future. Committee member Thomas Bollyky, senior fellow at the Council on Foreign Relations, said foreign regulators could be brought to the U.S. and junior staff members from FDA could be sent to regulatory agencies abroad to facilitate the sharing of information. He noted that the Centers for Disease Control and Prevention already has this kind of apprenticeship program.

The IOM report’s other recommendations include having international and intergovernmental organizations invest in improving the capacity of regulatory systems in developing countries; having FDA provide incentives to importers to meet U.S. regulatory standards; and having U.S. government agencies strengthen the ability of those harmed by unsafe products to hold foreign producers and importers liable in civil lawsuits (see chart for list of recommendations).

With regard to incentives for meeting U.S. standards, the report points to FDA’s Secure Supply Chain pilot program that rewards firms that trace their products from manufacture to entry into the U.S. The pilot program was initiated in 2009 to help prevent contaminated drugs from entering the country Also see "In Wake Of Heparin Deaths, FDA Set To Launch Pilot Project Aimed At Preventing Imports Of Adulterated Drugs" - Scrip, 13 February, 2009.. The pilot phase is to be completed in 2014 and IOM recommended that the results be evaluated with the goal of expanding the project to include more importers and more products in the next three to five years.

As for strengthening product liability, the report says FDA could require importers to maintain a staff person at each foreign production facility for high-risk products. The report says other options that scholars have raised include the issuance of bonded warranties obliging sellers to pay statutory damages to people injured by unsafe products and using discriminatory strict liability with damages based on the risk posed by the product and by the importer’s history.

IOM’s Action Plan To Strengthen Foreign Regulatory Systems
Recommendation	Details
International and intergovernmental organizations should invest more in strengthening the capacity of regulatory systems in developing countries.	Investments should aim to improve the participation of scientists from these countries in international standard setting. This should be added to the G20 agenda.
Regulatory authorities, industry and industry associations should have third parties, such as science academies, convene meetings to exchange scientific and technical information.	Regulatory authorities need to collaborate with industry and academia when designing and reviewing their policies.
Countries with stringent regulatory agencies should convene a technical working group on sharing inspection reports with the goal of establishing a system for mutual recognition of these reports.	This would prevent American and European inspectors from duplicating each other’s work.
Industry associations should define an acceptable protocol for sharing inspection results among their members.	In the next three to five years, associations can work with their members to decide what information to share and how to do so.
USAID, FDA, CDC and USDA should provide technical support for strengthening surveillance programs in developing countries.	This support could include development of surveillance tools, postmarket surveillance of medical products and training of national regulatory authority staff and national experts.
FDA should use risk management to inform its inspection, training, regulatory cooperation and surveillance efforts.	The agency should consider risk to determine how to allocate its resources to domestic and international programs.
FDA should develop an information and informatics strategy to do risk-based analysis, monitor performance metrics and move toward paperless systems.	FDA should establish a standard data collection format and vocabulary.
FDA should facilitate training for regulators in developing countries.	FDA can work through existing networks to train trainers. An apprenticeship program would also be valuable.
U.S. policy makers should integrate food and medical product safety objectives into their international development, trade, harmonization and public health work.	FDA can work with the U.S. Trade Representative to promote harmonized standards for foods and medical products.
FDA should hold a workshop on applying its tracking and tracing requirements for food to medicines.	Laws require food producers to identify the immediate prior and immediate subsequent recipient of all products in their supply chains. This one-up, one-back track and trace requirement should be expanded to drugs.
FDA and USDA should implement programs to encourage businesses and academia to research and develop innovations for low-cost fraud prevention, intervention, tracking and verification technologies along the supply chain.	The two agencies should pursue Cooperative Research and Development Agreements with private companies.
FDA should provide incentives for importers of food and medical products to meet U.S. regulatory standards.	FDA’s Secure Supply Chain pilot program should be expanded, if successful, to include a greater number of importers and more products.
U.S. government agencies should strengthen the ability of those harmed by unsafe food and medical products to hold foreign producers and importers liable in civil lawsuits.	The U.S. Trade Representative, Department of Treasury and Department of Justice should work to increase liability for unsafe foods and medical products.

Foreign Regulatory Systems Can Be Strengthened By Receiving FDA Inspection Data, IOM Says

More from Manufacturing

More from Compliance