Dr. Binzak Blumenfeld has capitalized on her unique training in law, molecular biology, and biomedical ethics to provide legal and regulatory advice to her clients. She routinely counsels clients on drug, device, and combination product approval strategies, and works with clients in the emerging field of regenerative medicine and stem cell therapies. Dr. Binzak Blumenfeld also has expertise in counseling clients on compliance with the Drug Supply Chain Security Act (DSCSA) and Risk Evaluation and Mitigation Strategies (REMS).
Education: Cardinal Stritch University (B.A., 1993, Biology with Chemistry minor, magna cum laude); Mayo Graduate School (Ph.D., Molecular Biology); Case Western Reserve University (J.D., 2003, cum laude, Certificate in Health Law); Case Western Reserve University (M.A., 2003, Biomedical Ethics)
Admissions: District of Columbia; Maryland
Mr. Garvin’s experience includes reviewing and revising the labeling of drugs, medical devices, foods, and dietary supplements to ensure compliance with the FDA law and regulations. He works with clients to petition the FDA to ensure the safety and effectiveness of drug products on the market. He also assists in providing input to members of Congress regarding proposed legislation and highlighting arbitrary enforcement actions by federal and state agencies. Mr. Garvin is also co-head of the firm’s Cannabis Group, where he assists companies in navigating federal and state law issues related to the promotion and sale of cannabis-related products.
Education: University of North Carolina at Chapel Hill (B.A., 2000, Journalism and Political Science); The George Washington University Law School (J.D., 2003, high honors)
Admissions: District of Columbia; Virginia; U.S. District Court for the District of Columbia; U.S. Court of Appeals for the District of Columbia Circuit
Barbara A. Binzak Blumenfeld Ph.D. and William Garvin are shareholders in the FDA & Biotechnology practice group at Buchanan Ingersoll & Rooney in Washington, DC. They help their clients on issues related to the approval, regulation, promotion, sale, and reimbursement of virtually all FDA-regulated products, including drugs, biologics, medical devices, foods, and cannabis-related products. Both have experience advising clients on various recall-related issues.
Pharmaceutical recalls are disruptive to the normal course of business and can result in heightened regulatory scrutiny. Nonetheless, they are necessary to ensure continued patient safety. Given the impact on business operations, companies must first decide if a recall is warranted and, if so, have a plan for execution and a strategy for mitigating any potential damage caused by the recall.
Generally, companies should remove from the market any products in distribution that are beyond their control and that are determined to be in violation of the Federal Food, Drug, and Cosmetic Act or U.S. Food and Drug Administration (FDA) regulations. The mechanism used to remove the violative product from the market will depend on the nature and extent of the violation. The two primary mechanisms are recall and market withdrawal.
“Recall” is the “removal or correction” of a marketed product that FDA would deem to violate the law (e.g., that is adulterated or misbranded). If FDA chose to do so, it could take enforcement action against the product because of its statutory powers and could mandate a recall. In most cases, however, companies choose to conduct voluntary recalls. For example, an out of specification result during expiration testing that occurs at a time period before the labeled expiration date would be considered a recall situation.
Any company deciding to voluntarily initiate a recall must notify FDA and provide certain information outlined in the regulations, including the product involved and the reason for recall; the company’s risk evaluation of the problem; the total amount of product in distribution; the proposed recall strategy; and a copy of the proposed or distributed recall communication. In conjunction with FDA, companies typically consider whether the recall is considered a Class I, II, or III recall event. Classification is necessary to determine how “deep” a recall extends (e.g., to direct accounts or to the consumer level) and what the recall follow-up plan should look like.
If a company does not voluntarily conduct a recall that FDA believes is warranted, then FDA can mandate the recall. In this case, FDA will conduct a health hazard evaluation to determine the recall class and will inform the company of its decision.
In contrast to a recall, a “market withdrawal” is the “removal or correction” of a marketed product involving either no violation (e.g., normal stock rotation) or only a “minor violation” that would not make the product subject to FDA enforcement action. Unlike recalls, market withdrawals do not require FDA notification.
When considering whether a recall is warranted—and, if so, what steps to take—companies should keep several things in mind.
Thankfully, recalls do not happen every day. When they do, they are stressful events that take resources and people away from their normal business activities. It is therefore important to make sure that you understand what is required during a recall and have an experienced team in place to execute on a recall plan.
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