Good Clinical Practice: A Question & Answer Reference Guide - May 2013 - (Page 523)

Section 16: Fraud, Negligence, and Regulatory Non-Compliance 16.1 Q. Many were surprised when the U.S. Justice Department announced that it had charged a former GlaxoSmithKline vice president and attorney with making false statements and obstructing a federal investigation into marketing practices for the antidepressant drug Wellbutrin for unapproved uses. To what degree are government attorneys expected to focus on corporate executives for regulatory noncompliance and fraud outside of the drug marketing area, which had seemed to be the focus previously? A. The U.S. Justice Department’s November 2010 announcement of charges against Lauren Stevens, 60, and the possible jail time associated with a resultant conviction (the obstruction charge carries a maximum penalty of 20 years in prison, and each of four false-statement counts carries a maximum penalty of five years in prison), certainly caught the attention of many in the pharmaceutical industry. And this was despite the fact that the medical industry has long anticipated a federal government focus on top industry officials in its enforcement efforts. Today, that focus has extended to other areas of enforcement, including cases of serious clinical trial noncompliance and fraud. In response to a March 2010 Government Accountability Office report entitled, “Food and Drug Administration: Improved Monitoring and Development of Performance Measures Needed to Strengthen Oversight of Criminal Misconduct Investigations,” the FDA formed a senior-level committee “to enhance coordination and strategic alignment between the FDA’s Office of Criminal Investigations and other Agency components.” Among the committee’s recommendations was “to increase the appropriate use of misdemeanor prosecutions, a valuable enforcement tool, to hold responsible corporate officials accountable,” FDA Commissioner Margaret Hamburg, M.D., noted in a March 2010 letter to Sen. Charles Grassley, the ranking member of the Senate Committee on Finance. “Criteria have not been developed for consideration in selection of misdemeanor prosecution cases and will be incorporated into the revised policies and procedures that cover appropriate use of misdemeanor prosecutions.” In early 2011, the FDA incorporated into its Regulatory Procedures Manual (RPM) the series of criteria that the agency will consider in deciding whether to ask federal prosecutors to pursue cases against company officials rather than simply the companies themselves when compliance with food and drug law are at issue. An individual’s authority/role in the company, the seriousness and obviousness of the violation, the degree to which the violation is widespread or part of a pattern of illegal acts, the public health implications of the violation, and the quality of the legal/factual support for a possible prosecution are among the factors that the FDA identifies. The FDA’s RPM revision does not make clear, however, whether a company official can be considered for prosecution based simply on his/her position with a violative company, or whether a specific degree of evidence will be necessary to establish a company official’s prior awareness of, direct involvement in, or negligence regarding a legal violation. “As the Supreme Court has recognized, it would be futile to attempt to define or indicate by way of illustration either the categories of persons that may bear a responsible relationship to a violation or the types of conduct that may be viewed as causing or contributing to a violation,” the agency states in the revised RPM. 16.2 Q. What is the FDA’s Pharmaceutical Fraud Pilot Program, and does this effort have any implications for clinical trial compliance? A. During FY2010, the FDA received $1.7 million from HHS for what it called the FDA Pharmaceutical Fraud Pilot Program (PFPP), which is intended to enhance the health care fraud-related activities of the agency’s Office of Criminal Investigations and Office of General Counsel. Designed to detect, prosecute, and prevent pharmaceutical, biologic, and medical device fraud, the PFPP focuses on fraudulent marketing schemes, application fraud, clinical trial fraud, and flagrant manufacturing-related violations. According to the “HHS and Department of Justice Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2010,” through the PFPP, “FDA has opened, within a relatively short time, criminal investigations that FDA continues to investigate.” These include: • A clinical trial fraud matter where study documents are alleged to have been falsified by a study coordinator. • A contract research organization that reportedly falsified study documents related to research studies conducted for pharmaceutical manufacturers. 523

Table of Contents for the Digital Edition of Good Clinical Practice: A Question & Answer Reference Guide - May 2013

Good Clinical Practice: A Question & Answer Reference Guide - May 2013
Table of Contents
Introduction
Section 1: GCP Regulations, Standards and Guidelines for Clinical Research
Section 2: Investigators/Sites
Section 3: Form FDA-1572/Statement of the Investigator
Section 4: Study Sponsors and Clinical Trial Monitoring
Section 5: Informed Consent
Section 6: Source Data/Documentation
Section 7: Clinical Trial Protocols/Protocol Changes/Protocol Violations
Section 8: Institutional Review Boards
Section 9: Drug/Study Safety and Safety Reporting
Section 10: FDA Inspections, Quality Assurance Activities, and Study Auditing
Section 11: Computerized Systems, e-Clinical Trials, and Electronic Records Rules
Section 12: Patient Recruitment
Section 13: Conflicts of Interest/Financial Disclosure
Section 14: The HIPAA Privacy Rule and FDA-Regulated Clinical Trials Including the 2013 Omnibus HIPAA Rulemaking
Section 15: Drug Accountability, Administration, and Labeling
Section 16: Fraud, Negligence, and Regulatory Non-Compliance
Section 17: Subject Diaries
Section 18: GCP and Clinical Research Standards in the European Union and An Interview with Fergus Sweeney, Ph.D., EMA Head of Sector, Compliance and Inspection
Section 19: Clinical Trial and GCP Standards in Selected Leading Countries/Regions: Latin America, India, China, Russia, Ukraine, and Canada
Section 20: GCP Compliance Statistics and Trends (Data on U.S. FDA Inspections)
Index

Good Clinical Practice: A Question & Answer Reference Guide - May 2013