Researcher Disqualifications on the Rise Despite Case Delays

June 12, 2008
Angie Drakulich
ePT--the Electronic Newsletter of Pharmaceutical Technology

The number of clinical-trial investigators overstepping their bounds has grown in the past few years. And, says Congress, the US Food and Drug Administration is taking too long to wrap up unresolved cases.

The number of clinical-trial investigators overstepping their bounds has grown in the past few years. And, says Congress, the US Food and Drug Administration is taking too long to wrap up unresolved cases.

In addition to regulating the safety and effectiveness of drugs, FDA oversees the conduct of doctors and clinicians who carry out drug studies. Clinical-study investigators are required to follow certain statutes and regulations to ensure the integrity of their data and to protect individuals participating in the trials.

The agency has disqualified more than 130 such investigators since 1964. Twenty-five of those have been disqualified since 2001, and seven of them were disqualified in the first half of this year.

Beyond the fact that the number of disqualifications seems to be on the rise, some Congressman are concerned that cases remain open too long-as much as a decade, according to Bloomberg News.

US Reps. Joe Barton (R-TX) and John Shimkus (R-Ill.) have been wrangling the Government Accountability Office (GAO) to push FDA to take action against corrupt researchers more quickly.

“The FDA’s delay in initiating disciplinary proceedings is a critical one, as clinical investigators who have engaged in misconduct are still eligible to receive investigational drugs until the FDA disqualifies them,” the Representatives told the GAO in a letter dated March 11, 2008.

According to Bloomberg, the agency has 12 pending disciplinary action suits against researchers who allegedly violated rules to protect patients and ensure accurate data.

FDA has the right to disqualify or “totally restrict” a clinical-study investigator from conducting further research if he or she repeatedly or deliberately fail to comply with current requirements, or if the researcher repeatedly or deliberately submits false information to the trial sponsor or to FDA itself. Once disqualified, the researcher can no longer receive investigational drugs, biologics, or devices.

FDA can also apply a lesser “restricted” classification to individuals. These investigators are still able to work with investigational products, but they have some limitations which are they agree to with FDA. The agency can elect to reinstate researchers.

The latest person to receive the so-called Scarlet letter, is Maria Anne Kirkman Campbell, who pleaded guilty to fraud in 2003 after working on a Sanofi-Aventis SA antibiotic study. Even though her case took place five years ago, Campbell just received her disqualification status last month.

Read more on this topic:
http://blog.pharmtech.com/?p=83

Check out FDA’s disqualified list:
www.fda.gov/ora/compliance_ref/bimo/disqlist.htm