Jill Wechsler

"Enforcement will increase," warned Deborah Autor, director of the Office of Compliance in FDA's Center for Drug Evaluation and Research (CDER), at the April annual meeting of the Food and Drug Law Institute (FDLI). She pointed to a rise in injunctions, investigator disqualifications, and warning letters and advised companies to avoid the big stick by "being proactive about compliance."

This emphasis reflects the attitude of FDA's new leadership. Principal deputy commissioner Joshua Sharfstein, who was acting commissioner until Margaret (Peggy) Hamburg was confirmed to the top spot in May, made it clear that a new sheriff is in town. Soon after coming to FDA in March, Sharfstein initiated a fast and more aggressive recall of pistachio products at the first sign of salmonella contamination. He also responded to criticism of FDA's process for regulating medical devices by supporting a review of research requirements for device classes.

As former director of FDA's Center for Biologics Evaluation and Research (CBER), Goodman has been active in vaccine development and global health issues. In addition to heading up FDA response to the flu outbreak, Goodman will oversee FDA's National Center for Testing and Research in Arkansas and several agency-wide public health and science programs, including pediatric therapeutics, combination products, women's health, critical path programs, good clinical practices, and the sentinel safety initiative. A number of hot topics fill Goodman's plate: comparative effectiveness research, biomarker identification, clinical trial design, and personalized medicine.

Building on FDAAA

Congressional leaders also support a more aggressive FDA. The Senate Health, Education, Labor and Pensions (HELP) Committee moved quickly last month to facilitate Hamburg's confirmation as FDA commissioner, stressing the need for a strong agency to deal with the swine flu outbreak, as well as food and drug safety issues.

Several legislative proposals before Congress would further enhance enforcement powers already bolstered by the FDA Amendments Act (FDAAA) of 2007, which increased fines and criminal penalties for violative activities. So far, FDA has not brought a case under these new authorities, Autor said, "but when we need to use it, we will."

Autor's staff has grown to 250 from 150 five years ago, which increases its ability to take regulatory action; CDER had issued almost 40 warning letters as of April 14, 2009, nearly half of the 87 sent out in all of 2008. These include more warnings to clinical investigators for violating good clinical research practices and a jump in investigator disqualification actions. The trend raises questions about the quality of oversight by sponsors and contract research organizations, Autor said. She also emphasized the importance of data integrity, citing the need for due diligence by companies involved in corporate mergers and acquisitions to verify the quality of submissions to FDA.

An example of more "swift, aggressive action" in enforcement cases, said Autor, is how quickly it issued a warning letter to Coast IRB following revelations that Coast had approved a fictitious study presented in a sting operation by the Government Accountability Office. Only a few weeks after the malfeasance was revealed at a heated hearing on Capitol Hill, FDA instructed Coast to halt oversight of some 300 active trials and to cease operations until it remedies its problems. The case has focused attention on the quality of review provided by independent IRBs, and on FDA's capacity for auditing IRBs and other entities entrusted with oversight of human subject research.