May 29, 2008 The Pump Handle 0Comment

by Susan F. Wood, PhD

Last year, Congress passed new legislation on the Food and Drug Administration, known as the FDA Amendments Act (FDAAA) of 2007.This legislation, while limited, made some significant steps forward, see here and here. It reauthorizes the user fee systems for drugs, biologics and medical devices, and expands FDA’s authority on labeling, requires new transparency for the Agency and establishes broader registries of clinical trials and requires results from clinical trials to be released to the public The public concern over the handling of medications like Vioxx and Ketek highlighted problems ranging from companies misleading FDA, to fraud by investigators, to FDA scientific management and lack of priority on safety studies. The new law provided some additional requirements on safety as well as some additional resources for this critical area. It also added some new requirements focused on reducing financial conflicts of interest of FDA Advisory Committee members.

When FDAAA was signed into law last fall, many thought that this would be the last major FDA legislation to be taken up by Congress for another 5 years.  But it seems we were mistaken.

The recent safety problems with Heparin, leading to a large recall of Heparin products earlier this year, highlighted different issues regarding drug (and other medical product) safety. Batches of heparin were contaminated by oversulfated chondroitin sulfate produced in 12 facilities in China. Questions about manufacturing quality, inspections and oversight by FDA of international facilities raised new concerns that are different from questions about post-market surveillance and safety of newly approved drugs or devices.

Congress has begun holding hearings – and new draft legislation is being considered in both the House and the Senate.

From Dr. Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research, testimony before the House Energy and Commerce Committee, April 29, 2008:


FDA increasingly faces challenges due to globalization of drug development and manufacturing. Not long ago, most drugs were developed, studied, and manufactured in the U.S. Today we routinely review and monitor drugs – both innovator and generic – that are studied or manufactured, at least in part, outside the U.S. The supply chain for finished drugs and active pharmaceutical ingredients now frequently links to manufacturing sites in China and India. With the globalization of the supply chain, FDA faces an ever-growing number of brokers, traders, distributors, repackagers, and other players involved in the import of pharmaceuticals. The changing world – including the fundamental challenges of many different languages and protocols – requires FDA to devise and evaluate more complex risk scenarios and apply more sophisticated technologies to screen and evaluate drugs entering the U.S. to ensure their quality.

Our generic drug program illustrates the dramatic changes during the last 10-15 years. Since 1992, we witnessed a 400 percent increase in the number of foreign establishments named in generic drug marketing applications. Today, in India alone, there are nearly 25 times as many drug establishments as there were eight years ago. Yet, FDA must be able to determine that facilities named in drug applications will meet FDA standards for marketed drug safety and effectiveness, no matter where they are located. FDA is taking many important steps to provide this assurance.”

The new draft legislation focuses on ensuring that foreign facilities are inspected at the same frequency and with the same rigor as domestic facilities (they currently are not). This would require inspections at a frequency of once every two years. A risk-based approach is also being considered, which would allow FDA to inspect at a different frequency depending on the level of risk of a particular product, what type of product and variables such as inspection history and whether the country where the facility is located has its own inspection system that is deemed adequate by FDA. This legislation would also set up a foreign inspectorate of scientists and inspectors specializing in international facilities and manufacturing.

A critical piece of FDA’s response and proposed solutions is having an adequate IT system that links the data from the different Centers (Drugs, Biologics, and Devices) with the inspections data and the information specific to facilities and batches of products. Currently, multiple disconnected systems exist and none are comprehensive.

FDA needs resources, authority, and the directives to tackle this aspect of medical product safety. Hopefully new legislation and adequate funding will jumpstart this process, that is already far behind.

Food safety is a separate but related issue – which FDA and Congress must tackle. There are various proposals addressing Food Safety on the table, but I’ll leave that for another day.

Susan F. Wood, PhD is Research Professor at George Washington University School of Public Health and Health Services, where she is part of the Project on Scientific Knowledge and Public Policy (SKAPP).  She also served as Director of the FDA Office of Women’s Health from 2000-2005 and is a member of the Board of Directors for Scientists and Engineers for America.

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