What's Coming in 2018: FDA's Regulatory Agenda
The US Food and Drug Administration (FDA) published its fall 2017 agenda of proposed and final rulemakings this week, with several expected on drug compounding, allowing foreign clinical data to bring medical devices to market and new ways to market nonprescription drugs.
On the compounding front, FDA plans to issue a proposed rule in August 2018 that would set minimum current good manufacturing practice requirements 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.
In terms of increasing access to a wider variety of nonprescription drug products, FDA is planning a proposed rule, also in August 2018, to allow applications to be submitted to FDA for approval of a nonprescription drug product "with a requirement that ensures consumers' 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."
Sometime in May of next year, FDA also plans to propose a rulemaking, discussed last February, "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."
For the medical device industry: By March 2018, FDA also seeks to finalize a rule first proposed in 2013 that would update FDA requirements to allow the use of clinical data from outside the US.
Other highlights of the Unified Agenda include a proposed rule, part of the ongoing implementation of track-and-trace requirements, to establish national standards for the licensing of prescription drug wholesale distributors and third-party logistics providers.
And the agency also said it will finalize a rule, lingering since 2003, that would amend the postmarketing safety reporting regulations for human drugs and biological products, including blood and blood products, to better 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."
Regulatory cuts, Gottlieb noted, 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."
Current Regulatory Plan and the Unified Agenda of Regulatory and Deregulatory Actions