Tomorrow, the FDA will issue a final rule (see prepublication document here) very similar to its proposed rule published in the Federal Register on September 12, 2018.
The notice states “[I]n this final rule, FDA repeals the irradiation regulation, which provided that any drug sterilized by irradiation was a new drug. OTC drugs marketed pursuant to the OTC Drug Review that are generally recognized as safe and effective, are not misbranded, and comply with all applicable regulatory requirements now can be marketed legally without an FDA-approved NDA or ANDA, even if the drugs are sterilized by irradiation.” The rule will become effective 30 days after official publication.
The Agency’s change of heart is based on the fact that OTC drugs must now be manufactured under current good manufacturing practices, the process for sterilization by irradiation is now well understood and controlled, and thus the Agency concludes that drug products sterilized by irradiation are no longer considered new drugs.
The original new drug designation for drugs sterilized by irradiation dates to a 1955 Federal Register notice declaring that applying such a sterilization process to drug products could not assure that such drugs would be safe and effective, causing the Agency concern about protecting the public health. Because of this, the Agency declared any drug subject to irradiation (including OTC products) to be new drugs under section 201(p) of the FDCA.
The notice goes on to describe a more detailed regulatory history and the reasons the Agency took certain actions. As times change, so does technology, and, as the understanding of technology advances, many of the unknown attributes of applying that technology become clear and demystified. I remember going into Buster Brown shoe company as a very young kid and sticking my feet into essentially a fluoroscope so my mom could be assured by the “highly trained” shoe salesman that the shoe fit. Clearly, looking back, the government was more concerned about drugs than my feet at the time.
The rule will save the Agency time and the industry money and will be welcomed by manufacturers of OTC monograph products.