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In early August, the Food and Drug Administration released an updated guidance document for manufacturers of radiopharmaceuticals used in cancer research and treatment. The FDA’s recommendations are meant to provide companies with clearer guidelines on the development of nonclinical studies and product labeling in an era of rapid medical innovation. According to a 2019 report from QY Research, the global market for radiopharmaceuticals is currently valued at $4,900 million and is expected to reach $8,410 million by 2025. However, sustaining this positive growth will require pharmaceutical companies to keep pace with the FDA’s labeling guidelines and conform to best practices in their industry.
According to the FDA’s guidance, a radiopharmaceutical is “a product that contains a radionuclide and is used in patients with cancer to treat the disease or palliate tumor-related symptoms (e.g., pain).” In most cases, these drugs serve diagnostic or therapeutic purposes in a patient’s broader treatment plan. For example, oncologists often use radiopharmaceuticals in conjunction with cancer screening equipment to locate harmful tumors, per the International Atomic Energy Agency. After administering these compounds, medical experts are able to observe how the radiopharmaceuticals interact with different proteins and sugars inside a patient’s body. This allows them to make evidence-based treatment recommendations and track how the cancer responds to different medical procedures.
While the FDA’s guidance document applies to all radiopharmaceuticals, many of the guidelines are designed for new products that have not yet been approved for clinical uses. One of the key focus areas is on the development of nonclinical studies that are intended to support first-in-human trials. Before a radiopharmaceutical makes it to this testing phase, manufacturers should conduct proof-of-concept studies to demonstrate the intended effects and determine the maximum tolerated radiation dosage. Since these compounds are inherently radioactive, it’s also crucial to evaluate the long-term toxicity of radiopharmaceutical products and identify any unexpected side effects that may adversely impact patients post-treatment.
When it comes to labeling radiopharmaceuticals, companies must adequately describe the “potential for reproductive toxicity, genotoxicity and carcinogenicity.” This requirement ensures that patients are fully aware of the possible fertility issues that may result from the sustained use of radiopharmaceutical products. For example, the FDA recommends that medical professionals advise female patients to use contraception during treatment and for a set period after they have stopped taking the drug. The purpose of this requirement is to ensure all traces of the radiopharmaceutical and any “damaged follicles and oocytes” are released from the patients’ body before fertilization.
The agency’s updated guidance document also provides labeling recommendations for issues related to breastfeeding, as newborn infants are highly susceptible to radiation. Exposure to radiopharmaceutical compounds can lead to a host of developmental issues and should be minimized if at all possible. The FDA hopes that its clarification of existing labeling guidelines will help patients make more informed treatment decisions, though none of its recent recommendations are legally enforceable.
Keeping pace with labeling rules and regulations is difficult for companies in almost every commercial space, as a lack of oversight can lead to dropped productivity and costly enforcement actions. While the pharmaceutical industry has not been substantially impacted by the FDA’s updated guidance, there’s no telling when a new piece of legislation may turn the industry on its head. The best way to stay ahead of regulatory changes is to keep a close watch on federal and state-level agencies and make adjustments as soon as you are legally required. Building this sort of responsive labeling infrastructure can be challenging without the right tools at your disposal, which is why the DuraFast Label Company offers flexible, high-yield label printers that can fit into a range of production environments.