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.”
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