US FDA slow in debarring clinical investigators, should extend authority to devices
This article was originally published in RAJ Devices
The US Food and Drug Administration fails to debar quickly enough clinical investigators convicted of contravening medical product regulations from engaging in research, a Government Accountability Office report has revealed1. The report also calls for the FDA’s debarment authority to be extended to medical devices so that it is consistent with the agency’s debarment authority for drugs and biologics; the agency’s current debarment authority does not fully extend to involvement with medical devices.
More than half of the 18 FDA debarment proceedings that the GAO reviewed took four or more years, with one debarment taking as long as 11 years, said the report. For the 52 disqualification proceedings the GAO reviewed, the length of time from initiation of a proceeding to its conclusion ranged from 26 days to more than a decade, with about one-third taking more than two years.
The report, which said that factors contributing to the delays included “internal control weaknesses in the debarment process and competing priorities among responsible staff”, also highlighted problems relating to the agency’s debarment and disqualification authority.
The FDA’s debarment authority does not prevent those who have engaged in misconduct involving drugs or biologics from involvement with medical devices. In addition, FDA regulations do not extend disqualification for drugs and biologics to medical devices and vice versa. They allow an investigator who is disqualified for conduct related to medical devices to serve as a clinical investigator for drugs and biologics. Likewise, an individual disqualified for conduct related to drugs or biologics remains able to serve as an investigator for medical devices.
Recommendations
The GAO urged the FDA to improve its timeliness and enhance the scope of its debarment and disqualification processes for investigators. Among its recommendations it said the agency commissioner should pursue extending the FDA’s debarment authority and extend disqualification to include drugs, biologics and medical devices.
The GAO also recommended that the agency ensure the timely completion of debarment and disqualification proceedings. It noted that the agency had in 2008 and 2009 established new time frames related to debarment and disqualification procedures, but said that its report had focused on procedures that generally took place prior to issuance of the new timeframes. “It is too soon to tell whether these efforts will be effective,” the GAO said, adding that the new time frames could be “challenging” because some of them are “substantially shorter than the times FDA actually took in the proceedings we reviewed”.
The GAO added: “Given the agency’s competing priorities, it remains to be seen whether FDA will dedicate sufficient resources to debarment or disqualification proceedings to meet the time frames.” It recommended that the agency monitor compliance with the recently established time frames for debarment and disqualification proceedings and take appropriate action when those are not met.
Responding to the report, which was released on 22 October, the FDA said it agreed with the GAO’s recommendations and would endeavour to incorporate them into its procedures. It said it intended to pursue the revision of its regulations concerning extending clinical investigator disqualification to all types of medical products.
Earlier this year, the agency had begun initiating steps to streamline further and make more transparent its new procedures for preventing noncompliant clinical investigators and others from participating in the development of new drugs and medical devices2. In the GAO report, the agency said it was drafting guidance to explain the disqualification process, the consequences of disqualification on the clinical investigator and the impact on any ongoing and completed clinical trials in which the disqualified investigator participated.
A new bill
Congressman Joe Barton (Republican – Texas), who asked the GAO to investigate the FDA debarment and disqualification proceedings, said3: “The problems at FDA are daunting, but I think that a little common sense and some modest legislating can ensure that American families will be safe.” On 27 October, Representative Barton, together with several co-sponsors, introduced a bill to give the FDA the power it currently lacks to remove researchers convicted of wrongdoing related to drug or device research4,5. The Strengthening of FDA Integrity Act (HR 3932) would:
- give the FDA authority to debar any company or individual who is convicted of crimes relating to any drug or device;
- give the FDA authority to debar a medical device company; it currently only has authority to ban drug companies;
- give the FDA authority to debar companies for any misconduct relating to a drug or device, not just over misconduct that takes place during a drug or device’s development or approval;
- provide greater accountability by requiring the FDA to bring debarment actions within one year of the date of conviction; and
- require the FDA to report to Congress on the number of debarment proceedings initiated and imposed each year.
An earlier version of the bill had been introduced into the House of Representatives in 20086.
References
1. GAO, Oversight of Clinical Investigators, Action Needed to Improve Timeliness and Enhance Scope of FDA’s Debarment and Disqualification Processes for Medical Product Investigators, September 2009, www.gao.gov/highlights/d09807high.pdf
2. RAJ Pharma online, 11 August 2009, www.rajpharma.com/productsector/pharmaceuticals/p-US-FDA-acts-against-misconduct-in-drug-and-device-development-process-p-173360?autnID=/contentstore/rajpharma/escenic/a48d892e-8653-11de-aa79-abbaa4ad7b58.xml
3. Press release, 22 October 2009, http://republicans.energycommerce.house.gov/News/PRArticle.aspx?NewsID=7491
4. Press release, 27 October 2009, http://republicans.energycommerce.house.gov/news/PRArticle.aspx?NewsID=7501
5. HR 3932, Strengthening of FDA Integrity Act of 2009, http://republicans.energycommerce.house.gov/Media/file/News/102709_FDA_Debarment_Bill.PDF
6. RAJ Pharma online, 17 July 2008, www.rajpharma.com/home/news/Enforcement-171735?autnID=/contentstore/rajpharma/codex/2008aug7050.XML