Abstract
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Introduction: On April 16, 2021, the U.S. Court of Appeals for the District of Columbia Circuit issued a decision stating ‘‘[e]xcepting combination products, . . . devices must be regulated as devices and drugs—if they do not also satisfy the device definition—must be regulated as drugs.’’ The Food and Drug Administration (FDA) has decided not to appeal this decision. Implementation of this decision will require FDA to transition some approved products from drug status to device status. The purpose of the study was to evaluate the potential impacts of transitioning FDA-approved radioactive drugs, especially those used in positron emission tomography (PET), to medical devices.
Methods: Congressional reports, statutes, regulations, FDA guidances, and other publications related to regulatory aspects for PET drugs and medical devices were reviewed and compared. Focuses were placed on identifying differences between the drug regulatory requirements and device regulatory requirements. Futhermore, how the regulatory variances would impact the operational management and future supply of these important medical products.
Results: Current Good Manufacturing Practice (CGMP) The quality system (QS) regulation is set forth as medical device CGMP; however, it applies to finished device for commercial distribution. Contrarily, PET drug CGMP regulation applies to all PET drugs. Although QS regulation is flexible, it lacks FDA-published guidance explicitly for it. PET drug CGMP regulation gives producers of investigational or research PET drugs another option of following United States Pharmacopeia General Chapter <823> which allows even more flexibility which is essential in the development of new PET drugs. There are certain QS exemptions for medical devices whereas there are no such exemptions for PET drugs. Product Classifications FDA has established classifications for approximately 1,700 different generic types of medical devices and grouped them into 16 medical specialities referred to as panels. No such complex classifications exist for radioactive drugs. Approval Process Compared to device, it appears that drugs are subject to a more rigorous per-market review process, as well as different post-market compliance requirements. User Fees In general, drugs are also subject to much more expensive user fees. Nevertheless, there are waivers or reductions for small businesses, orphan drugs, drugs that qualify under the public or barrier-to-innovation provision, or a State or Federal government entity that does not commercially distribute PET drug. There are no such waiver or reduction mechanisms for medical products. Radioactive Drug Research Committee (RDRC) Human research using a radioactive drug or biological product may be conducted as a basic research under an RDRC and without the need for an IND. IDE (Investigational Device Exemption) is never mentioned in the RDRC program. Human Drug Compounding Section 505 “New Drugs” of the Federal Food, Drug, and Cosmetic Act is one of the Federal requirements for the compounding laws. New drug application and abbreviated new drug application pathways are stipulated in section 505 which are not applicable to medical devices.
Conclusions: Burdens from operational and financial aspects are real, especially for those academic and not-for-profit sites that only produce a small number of products with 1-2 “transitioned” device(s). The dual compliances of different requirements are prone to errors with mix-ups and/or unintended uses of medical products. Consequently, these sites might cease the production of these “transitioned” device(s) which could be vital to patient care.
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