US FDA to increase misdemeanour prosecutions of medtech executives
This article was originally published in RAJ Devices
Pharmaceutical and medtech executives responsible for assuring compliance with relevant US Food and Drug Administration regulations for products manufactured by their companies may face increased “misdemeanor prosecutions” if they fall short in their designated role.
An internal FDA committee comprising senior leadership, including the Office of the Commissioner, the Office of Chief Counsel and the Office of Criminal Investigations (OCI), has recommended that the agency “increase the appropriate use of misdemeanor prosecutions,” providing a valuable enforcement tool to hold responsible corporate officials accountable, FDA commissioner Margaret Hamburg says in a letter to congressman Chuck Grassley (Republican – Iowa)1.
Misdemeanour convictions do not require proof of intent to violate the Federal Food, Drug, and Cosmetic Act and can result in fines and/or imprisonment of up to one year for each offence2. The maximum fine for a misdemeanour by an individual that results in death is $250,000 per offence. For a misdemeanour that does not result in death, an individual can be fined up to $100,000 per offence.
Building on the committee’s recommendation, Dr Hamburg says, the FDA has now developed criteria “for consideration in selection of misdemeanor prosecution cases” and these will be incorporated into the agency’s revised policies and procedures.
The exercise forms part of an agency-wide initiative to improve the performance of the OCI, which was conceived in 1991 in response to a generic drug scandal in the 1980s.
The OCI’s work has been questioned by the Government Accountability Office, which released a report in early March saying that the FDA lacked clear performance measures to assess whether the “OCI is achieving its desired results”3. Senator Grassley had asked the GAO to review the FDA’s oversight of OCI and Office of Internal Affairs investigations, including the offices’ policies and procedures and resources for such investigations because of concerns about, among other things, accountability and increases in funding at a time when resources were limited for other parts of the FDA4. While the FDA’s budget has increased by 71% in the last six years, the number of arrests and investigations by the OCI, it was pointed out, have decreased.
Dr Hamburg told Senator Grassley that the FDA agreed with the findings in the GAO report. In addition to developing meaningful performance measures for the OCI, she said, the agency was implementing other procedures (based on the internal committee’s recommendations) that would enhance co-ordination between the OCI and other agency components.
The FDA will assess its progress six months after these new procedures (that would standardise information sharing between the OCI and other agency components) have been adopted.
Debarment and disqualification
The FDA is also taking steps to ensure that sponsors involved in the testing and development of new medical products have ready access to information about clinical investigators that have been formally debarred/disqualified by the agency.
In August 2009, the agency announced major changes to improve its debarment and disqualification process to prevent non-compliant clinical investigators from participating in new medical product development5. Dr Hamburg says the FDA will clarify the circumstances in which such administrative actions may proceed concurrently with pending criminal investigations and prosecutions.
Welcoming the new measures that Dr Hamburg announced in response to the GAO report, Senator Grassley said these would make the “FDA’s investigative unit live up to its significant responsibilities”6.
References
1. FDA Commissioner’s letter to Senator Charles Grassley, 4 March 2010, http://finance.senate.gov/press/Gpress/2010/prg030410b.pdf
2. FDA, Types of FDA Regulatory Actions, Page last updated 28 October 2009, www.fda.gov/AnimalVeterinary/ResourcesforYou/FDAandtheVeterinarian/ucm077392.htm
3. GAO-10-221, Food and Drug Administration: Improved Monitoring and Development of Performance Measures Needed to Strengthen Oversight of Criminal and Misconduct Investigations, January 2010 (released on 4 March 2010), www.gao.gov/new.items/d10221.pdf
4. The Regulatory Affairs Journal – Pharma, 2009, 20(1), 61-62
5. The Regulatory Affairs Journal – Devices, 2009, 17(5), 384-385
6. Senate Committee on Finance, Grassley Statement on GAO report about FDA Inspections, 4 March 2010, http://finance.senate.gov/press/Gpress/2010/prg030410.pdf