Texas Congressman Seeks to Give FDA More Power to Remove Researchers

In response to a report released by the Government Accountability Office that found the U.S. Food and Drug Administration (FDA) often took at least four years to ban researchers whose studies had been tainted by illegal actions, Congressman Joe Barton Texas (R-Texas) has introduced legislation that would give FDA the power to remove those convicted of wrongdoing related to drug or device research faster, according to a statement released from his office.

The bill, “The Strengthening of FDA Integrity Act,” H.R. 3932:

• Gives FDA the authority to debar any company or individual who is convicted of crimes relating to any drug or device.

• Gives FDA the authority to debar a medical device company. It currently has the authority to ban drug companies.

• Gives FDA the authority to debar companies for any misconduct relating to the drug or device, not just over misconduct that takes place during a drug or device’s development or approval.

• Requires the FDA to bring debarment actions within one year of the date of conviction.

• Requires the FDA to report to Congress on the number of debarment proceedings initiated and imposed each year.

Co-sponsors of the bill are Congressmen John Shimkus (R-Ill.), Mary Bono Mack (R-Calif.), Greg Walden (R-Ore.), Lee Terry (R-Neb.), John Sullivan (R-Okla.), Michael Burgess (R-Texas) and Marsha Blackburn (R-Tenn.)

“The FDA had failed to make its debarment authority work, and now the GAO report offers the latest details of a record of the agency’s weakness and failures. I think it is especially inexcusable that the agency can’t seem to quickly and consistently debar even convicted felons,” said Barton.

Among the findings:

• More than half of the 18 debarment proceedings FDA has initiated since receiving debarment authority took four or more years to complete.

• The time FDA takes to complete disqualification varies widely, from 26 days to more than 10 years, with a median of 1.1 years.

• GAO found that FDA lacked procedures to help ensure communication of conviction information so that proceedings could be started or establish timeframes.

• Debarred individuals are prohibited from involvement with drugs and biologics—but not from working or serving in any capacity for a medical device company, or for any other FDA-regulated product, such as a cosmetic company.

• Under federal regulations, a clinical investigator who is disqualified for misconduct relating to drugs or biologics is still able to serve as an investigator for devices. Similarly, an investigator disqualified for misconduct for devices can still serve as an investigator for drug and biologic studies.

• Because FDA’s disqualification authority is not across the board, but product specific, one disqualified investigator for drugs and biologics— who had falsely reported that infants had been vaccinated when they had not, and also failed to report that study participants had been hospitalized—can still serve as an investigator for medical devices or other FDA-regulated products.

To view a copy of the bill, go to http://republicans.energycommerce.house.gov/Media/file/News/102709_FDA_Debarment_Bill.PDF