Enforcement Priorities and Actions - Background
Each year, the Office for Regulatory Affairs (ORA) issues ORA’s Annual Field Workplan (“ORA Workplan”). The ORA Workplan provides resource allocation and information regarding planned target activities, such as inspections, for the upcoming fiscal year. The numbers provided are estimates—FDA may change its priorities and resource allocations during the year for different reasons, including in response to a public health emergency.
FDA has the authority to pursue enforcement actions against regulated firms, individuals, and products that fail to comply with the Federal Food, Drug, and Cosmetic Act and other laws FDA enforces. FDA authority includes the use of actions such as seizures, injunctions, civil monetary penalties, and prosecution.
When the U.S. Department of Justice (DOJ) files a case on FDA’s behalf, the enforcement action may be announced in a press release issued by DOJ. DOJ may also issue a press release announcing the result of a case. FDA generally makes these press releases available on FDA’s web site, but currently there is not a comprehensive list of the court actions pursued by FDA available to the public. FDA also shares information about trends in agency enforcement actions, such as the number of enforcement actions filed during a year, at relevant public meetings.
Prior to taking an enforcement action, FDA does not publicly disclose any information about its decision to bring such an action.
Under certain circumstances, FDA also has the authority to “debar” individuals and corporations from certain activities. For example, FDA has the authority to debar individuals and corporations convicted of certain felonies or misdemeanors from providing services in any capacity to a person with an approved application or a pending application at FDA. In addition, FDA has the authority to disqualify clinical researchers who engage in certain conduct from receiving investigational drugs, biological products, and devices.
Actions to debar individuals and firms are published in the Federal Register, and lists of disqualified individuals and debarred individuals and firms are posted on the FDA Web site.