Hamburg takes a tough stance Credit: Synthetic Genomics

The US Food and Drug Administration (FDA) has gotten tough with investigators who flout the rules during the course of clinical studies. Researchers face debarment and disqualification if patient safety and public health is threatened under the agency's newly enhanced procedures announced on August 7, 2009. The initiative is intended to address perceptions that the agency has been performing poorly. Newly appointed FDA Commissioner Peggy Hamburg admitted in a speech that the agency has a reputation for “back and forth, stall and delay, let's see what the company does,” promising to take strong action. Efforts to expedite the disqualification and debarment processes began much earlier, in June 2007, when regulators noticed that penalties for misconduct were taking a long time to process. During this time the FDA implemented a series of changes but Joanne Less, director of the Office of Good Clinical Practice at FDA explains, “We had a backlog of pending disqualification matters in 2007, so in the beginning of 2008 we focused on clearing out that backlog.”

Disqualification is applied to a trial investigator who violates FDA regulations during the course of a clinical study. Debarment permanently bans individuals or companies from the drug industry who have been convicted of felonies or misdemeanors related to drug development. Notable violations include failure to obtain informed consent, falsification of data, fabrication of patient enrollees, lack of control or documentation of drug supply, and various administrative violations. Investigators targeted for disqualification or debarment receive a notice from the FDA and an opportunity to either correct the infraction or dispute the findings, depending on the situation.

Lists of disqualified and debarred entities will be available on the FDA website (http://www.fda.gov/)—an important resource for companies who are responsible for making sure their investigators are qualified to carry out studies. The agency's tougher standards also reward companies with good compliance practices. In general the new process is good for the industry and good for the public, but some of the regulations are complex, and ensuring compliance is challenging. Kim Egan, a partner in law firm DLA Piper's Life Sciences practice in Washington, DC, offers regulatory advice to pharma. “We're seeing a little uptick in FDA inspections. We help our clients maneuver through the issues there,” she says. “Small biotechs and startups have a challenge because they don't have a lot of resources.”