Blog | Thursday, April 5, 2012

QD: News Every Day--13 steps needed for safer drugs, devices and food


The Institute of Medicine (IOM) recommended 13 specific steps federal and international agencies can take in the next five years to bolster the safety of drugs, devices and foods imported from overseas.

More than 80% of active pharmaceutical ingredients and 40% of finished drugs come from abroad, as does 85% of the country's seafood, the agency said. It cited a counterfeit version of the cancer drug Avastin as an example of how imports increasingly dominate the American market and create new challenges.

A second incident of fake Avastin occurred later via a British supplier who purchased products from Turkey, highlighting the complex international supply chain that agencies are seeking to track more accurately.

Internationally, agencies should:
--invest more in strengthening regulatory systems in developing countries,
--identify third parties, such as science academies, to convene the element of regulatory systems,
--share inspection reports among countries with stringent regulatory agencies to avoid duplicating each other’s work, "especially when a vast number of facilities go uninspected,"
--share internal inspection results among industry associations,
--provide (both directly and through international agencies) technical support for strengthening surveillance systems in developing countries.

Domestically, the IOM recommended that the Food and Drug Administration:
--apply risk management methods for its entire operation, not merely for inspections,
--develop an informatics strategy that will allow it to do risk-based analysis, monitor performance metrics, and move toward paperless systems,
--facilitate training for regulators in developing countries,
--lead in the development and adoption of international and harmonized standards for food and medical products,
-- require for medicines, biologics and devices that same trace requirements it has for tracking food shipments,
--along with the U.S. Department of Agriculture, encourage businesses and academia to research and develop innovations for low-cost, appropriate fraud prevention, intervention, tracking, and verification technologies along the supply chain,
--ensure an adequate mix of incentives to importers of food and medical products that are confirmed to meet U.S. regulatory standards, such as the 2-year FDA Secure Supply Chain pilot program.

Also, over the next 10 years, 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 agency said.