Inspections by the U.S. Food and Drug Administration (FDA)—as well as by the U.S. Drug Enforcement Administration (DEA) or related federal and state agencies—can have a significant impact on companies that market, or seek to market, drugs, biologics, medical devices, and dietary supplements. When those inspections go awry, the consequences can be devastating, including the withholding of approval of a new drug application, biologic license application, or medical device marketing authorization, and/or the issuance of Warning Letters, importation restrictions, seizures, injunctions, or civil monetary or criminal penalties.
Epstein Becker Green’s Life Sciences team includes attorneys with significant FDA regulatory and compliance experience ready to respond to regulatory authority inspections and enforcement matters. We deftly navigate clients through every phase of their regulatory compliance encounters with government agencies—from inspections to the courtroom.
Leading the Response
Compliance with current Good Manufacturing Practices (cGMPs) is a critical component of ensuring the successful commercialization of new medical therapies in the United States. Approval of a new drug or biologic by the FDA may be conditioned on the agency’s inspection of the applicant’s manufacturing facility. While most are routine audits of the contractor’s plant, equipment, and systems, any adverse finding on the FDA’s inspection report (Form 483) requires a response within 15 days.
If there are adverse findings, our team works closely with a client under this deadline to create a strong response that aims to reduce the likelihood of an FDA enforcement action by convincing the FDA of adequate remediation while legally protecting the client.
Resolving Issues to Avoid Further Government Action
When the FDA wants a company to promptly comply with its regulations, the company may receive a Warning Letter. For clients that receive Warning Letters, we help prepare a response and develop an appropriate corrective action program. We are also experienced at negotiating with the Office of Chief Counsel at the FDA, as well as counterparts in other agencies, and interacting with investigators and compliance officials to prevent and resolve issues.
Providing Civil and Criminal Defense: We Try Cases
When clients find themselves the subject of an investigation or enforcement action by the FDA (via the U.S. Department of Justice (DOJ)) for alleged violations of the Food, Drug, and Cosmetic Act (FDCA), they turn to us. We represent clients in investigations, and, as experienced courtroom lawyers, we vigorously defend them if litigation ensues. We have successfully defended a multitude of clients on DOJ charges relating to FDCA violations in civil, criminal, and administrative cases and represented clients in hundreds of motions before courts and agencies. Clients also come to us to represent them in injunction actions and seizures, and we have litigated or negotiated favorable consent decrees so that our clients can resume their product manufacturing and distribution operations. In addition, we successfully brought legal action against the FDA when it was necessary to protect a client’s interests.
Anticipating Areas of Concern
We also do preventative work. When clients are concerned about possible compliance issues, they often call on us to conduct audits, and to assist them in avoiding a problematic regulatory authority inspection. They trust us to understand the FDA’s complex regulatory requirements and expectations, assess regulatory risks, and help them identify and implement best practices going forward. Our combined years of experience in representing clients in FDA inspections and remediation enable us to understand the complexities of cGMPs and how they translate to our client’s organizations.
- Successfully litigated against the FDA for (i) improper decision of a citizen petition, (ii) improper approval of competitor products, (iii) improper interpretation of the regulation for generic approval, and (iv) arbitrary and capricious actions. We also successfully sued the FDA on a writ of mandamus (which is seldom used against the agency) and declaratory actions.
- Helped a client respond to multisite FDA inspections that resulted in multiple Form FDA-483s, DOJ and DEA involvement, untitled letters, and Warning Letters. We then assisted the client with structuring and executing a company-wide remediation plan to improve compliance with FDA requirements.
- Helped a global biotechnology company respond to multiple FDA inspections that resulted in 483s with dozens of observations. After extensive remediation and communication with the FDA, the agency was satisfied with the company’s remediation efforts and declined to pursue enforcement action against the company.
- Assisted an international biotechnology company in responding to an FDA Warning Letter issued to the company and its contract manufacturer. Observations related to aseptic processing, visual inspection, and supplier qualification and management. No further enforcement action was taken by the FDA.
- Assisted a pharmaceutical company in updating its response to a FDA Form 483. The prior response had led to an immediate classification of the inspection as “Official Action Indicated.” After reviewing the update, the FDA agreed to a prompt follow-up inspection that was classified as “No Action Indication.”
- Served as the principal health regulatory counsel for a multibillion-dollar medical device company during a multi-year quality and regulatory remediation effort. We provided legal advice and guided a multidisciplinary team of scientists, quality experts, regulatory advisors, and lawyers who improved quality and regulatory systems and helped the company avoid significant sanctions.