Prior to joining DLA Piper, Perham Gorji worked at the US Food & Drug Administration (FDA) in the Office of Chief Counsel (OCC) as the Deputy Chief Counsel for Litigation. He also served as a trial attorney for the Department of Justice, Consumer Protection Branch (CPB); an assistant US Attorney in the US Attorney's Office for the District of Columbia; a law clerk to the Honorable R. Barclay Surrick of the US District Court in the Eastern District of Pennsylvania; and as an associate for a highly regarded, national law firm.
At CPB, Perham was the lead attorney for numerous civil and criminal matters in federal courts nationwide, representing the FDA, Federal Trade Commission (FTC) and Consumer Product Safety Commission (CPSC). He investigated and prosecuted violations of federal fraud-related statutes, with specific emphasis on health care fraud, off-label promotion of medical products and false advertising. He defended client agencies from lawsuits challenging agency action and rulemaking. Perham litigated several significant matters against drug manufacturers for failing to comply with good manufacturing practices and to ensure data integrity in product applications and testing. He was the Department of Justice's (DOJ) lead attorney in matters involving regulation of biological medical products and related enforcement.
As Deputy Chief Counsel for Litigation at the FDA, Perham directly supervised the FDA's civil and criminal matters, including seizures, injunctions, administrative actions, civil money penalties, subpoena responses, judicial defensive matters and criminal investigations related to violations of the Federal Food, Drug and Cosmetic Act (FDCA), the Public Health Service Act (PHSA) and related federal statutes. Perham oversaw and managed more than 40 litigation attorneys who provide legal guidance to the FDA's civil inspection officials and criminal agents, as well as supported the DOJ in litigating civil matters and criminal prosecutions in federal courts. He directly supervised FDA attorneys on over 100 enforcement actions, both civil and criminal, and dozens of lawsuits against the agency. These matters have spanned the range of products FDA regulates, including food, drugs, medical devices, biological medical products, tobacco products and animal-related products. His most significant matters included securing consent decrees, injunctions and seizures on behalf of the FDA; criminal prosecutions; representing the FDA's interests in False Claims Act (FCA), qui tam matters; advising the FDA on numerous warning letters and other regulatory notices; and defending lawsuits against the agency.
With his unique level of experience, Perham has the judgment and skills necessary to guide clients through an investigation and to help them manage the significant litigation and reputation risks that an investigation or litigation might present. In addition to managing a firm's response to an enforcement action, his administrative and regulatory experience at the FDA enables him to help clients properly respond to and resolve warning letters and import alerts.
Perham has a keen understanding of the factors that inform agency decisions to move matters from the regulatory inspection phase, to warning letters and/or enforcement. With his experience and judgment, he is able to advise clients as they navigate the FDA inspection process, including product application inspections, routine inspections, for cause inspections and supervision inspections pursuant to an FDA consent decree or other agreement with the government.
Perham's work has involved the full gamut of FDA regulated products, and he has the experience and skills necessary to evaluate these product offerings and manufacturing processes for compliance with the statutes and regulations that govern them. He is able to assist clients to establish and maintain robust compliance programs and attain a long-term culture of adhering to the US Department of Health and Human Services (HHS) and FDA regulatory requirements.
