GMP, Rules

Fall Regulatory Agenda: FDA Delays Release of Several Proposed Rulemakings

The latest regulatory agenda for the US Food and Drug Administration (FDA) was released on Wednesday, announcing the delays of several proposed rulemakings, and one new but expected addition on the importation of prescription drugs.

On importation, the proposed rule, which has been under review at the Office of Management and Budget since the beginning of November and is expected to be released by January, would allow pharmacists and wholesalers to import prescription drugs from Canada if the imports pose no additional risks and will save money.

The proposed rule is expected to have several key limitations (i.e. only facilities that also manufacture API for the FDA-approved version would be allowed) and exclusions (no costly biologics, drugs with a REMS or infused or injected drugs) that may raise questions about what drugs could be imported and how much could be saved.

And as the latest agenda says, this regulatory action “will be likely to have international trade and investment effects,” and Canadian pharmacists and Health Canada officials have pushed back against the proposal. FDA is also expected to release draft guidance to allow manufacturers to voluntarily import US versions of drugs sold in foreign countries.

Some Proposed Rulemakings Delayed

All of the other proposed and final rulemakings in the fall regulatory agenda were previously published in prior agendas, including the agenda from last May. But this latest agenda shows how a few of the proposed rulemakings are being held up.

For instance, in April 2020, FDA expects to publish a proposed rule on the modernization of the quality system regulation for medical devices. FDA previously said it would publish the proposed rule last September.

FDA also delayed its proposed rulemaking on excluding certain medical software functions from the definition of a device until next May. The agency previously said the proposed rule was coming in December.

The proposed rulemaking on the annual summary reporting requirements under the Right to Try Act were also delayed from last September to sometime this month.

The agency further held the release of its rulemaking on post approval changes to approved drug and biologic applications from next March to next September.

The fall agenda also includes a proposed rulemaking on pediatric study plan requirements for new drug and biologic applications, which is due for release in September 2020, but which had a legal deadline of July 2013.

And another proposed rulemaking to better define and clarify the roles and responsibilities of those engaged in the initiation, conduct and oversight of clinical investigations subject to IND requirements was also pushed back from April 2020 to September 2020.

Other proposed rulemakings have stayed the course since last May, including one on clinical holds in medical device investigations, which is due in February 2020, one on biologics regulation modernization, which is still slated for December and one on patent term restoration due in February 2020.

Final Rules

Some of the final rules expected to be released later this year or in 2020 also reveal how long or how quickly it can take a rulemaking to go from proposal to finalization.

For instance, a proposed rulemaking on changes to the way risks are presented in direct-to-consumer drug advertising may end up taking more than a decade to go from proposal through three comment periods to finalization next June.

A proposed rulemaking on postmarket safety reporting requirements for drugs and biologics has been lingering since 2003, but is expected to be re-proposed next June.

In contrast, the so-called “deemed to be a license” rule transitioning some new drug applications to biologic license applications is expected to go from proposal to finalization in less than a year. Similarly, a proposed rule on the de novo classification process for medical devices is expected to be finalized in June after being first proposed last December.

Fall 2019 Unified Agenda of Regulatory and Deregulatory Actions

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