Earlier this month, FDA released its Unified Agenda with proposed and final rule-makings on the docket for 2018. These include new rules on drug compounding, foreign clinical data and new ways to market nonprescription drugs.
We've summarized FDA's 2018 agenda items into a quick-read guide below.
The Agency plans to issue a proposed rule in August of 2018 which would set minimum current good manufacturing practice (cGMP) for human drug products compounded by an outsourcing facility.
"We want to make sure that outsourcing facilities clearly understand which drugs they may compound and allow these firms to adopt more efficient, streamlined manufacturing standards, while ensuring they observe necessary safety and quality measure," FDA Commissioner Scott Gottlieb said in a statement.
View "Current Good Manufacturing Practice for Outsourcing Facilities" at reginfo.gov →
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FDA also plans to increase access to a wider array nonprescription drug products through a rule proposed for August of 2018. This would allow manufacturers to submit applications for FDA approval of a nonprescription drug product "with a requirement that ensures customers' appropriate self-selection, appropriate actual use, or both in order to obtain the drug without a prescription."
Gottlieb added, "examples of such conditions could include use of self-selection questions on a mobile medical app prior to permitting access to the drug, or other innovative technologies to improve safety. Through use of these types of additional conditions, we hope to create a new paradigm of drug safety with greater flexibility that will benefit patients and public health."
View "Requirement for Access or Safe Use of Certain Nonprescription Drug Products" at reginfo.gov →
In May of 2018, the Agency also plans to propose a new rule "to require clear and concise written prescription drug product information presented in a consistent and easily understood format to help patients use their prescription drug products safely and effectively."
View "Medication Guides; Patient Medication Information" at reginfo.gov →
Within the medical device industry, FDA expects to finalize a rule next March, which was first proposed in 2013 aimed at updating FDA's requirements to allow the use of clinical data from outside the United States.
Also included in the Unified Agenda is a proposed rule to establish national standards for the licensing of prescription drug wholesale distributors and third-party logistics providers.
FDA said it will finalize a rule first proposed in 2003 that amends the postmarketing safety reporting regulations for human drugs and biological products, including blood and blood products, to align FDA with International Council on Harmonisation (ICH) guidelines "and to update reporting requirements in light of current pharmacovigilance practice and safety information sources and enhance the quality of safety reports received by FDA."
Gottlieb noted the regulatory cuts include a proposal "to remove an outdated inspection provision for biologics and outdated drug sterilization requirements to remove barriers to the use of certain sterilization techniques."