The FDA has published a proposed rule regarding Time and Extent Applications (TEAs) that will establish timelines and metrics associated with their review.  Just to remind you, a TEA is now the preferred option to add a product to an over-the-counter (OTC) monograph for products that were initially marketed in the United States after the OTC review began in 1972 and for products with no US marketed experience.

This new proposed rule implements sections of the Sunscreen Innovation Act (SIA) of 2014 (albeit it excludes sunscreen products, that is because there are other provisions that address such products). “Section 586F(b) of the FD&C Act specifically requires FDA to issue regulations providing for the timely and efficient review of submissions under the TEA regulation, including establishing (1) reasonable timelines for reviewing and acting on such submissions for nonsunscreen OTC active ingredients and other conditions (non-sunscreen TEA conditions) and (2) measurable metrics for tracking the extent to which such timelines are met.” “FDA is also proposing to amend the TEA regulation to make the TEA process more efficient and predictable for both product sponsors and FDA by adding filing determination requirements and criteria and by addressing the withdrawal of consideration of TEA and safety and effectiveness data submissions.”  In addition, FDA is proposing to add a provision much like a “filing determination” for ANDAs and NDAs where the Agency performs an initial assessment as to whether the TEA contains sufficient information for the FDA to undertake a substantive scientific review.

The proposed rule goes on to discuss the history of the OTC process and the current TEA process. The proposed timelines and metrics are applicable to FDA and have only two exceptions; the first is for any ingredient or condition related to sunscreens (explained above) and the second is if the product was subject to a TEA submitted prior to the date of enactment of the SIA. And now for some FDA weasel words – “However, as provided in the SIA, any non-sunscreen TEA conditions determined to be eligible to be considered for inclusion in the OTC drug monograph system before the date of enactment of the SIA, for which the sponsor did not request a framework for review under section 586F(a)(1), will also be reviewed under the timelines set forth in §330.15(c) of this proposed rule (see FD&C Act section 586F(a)(1)(C)) (if finalized as proposed).” Maybe someone can help me figure this one out (read the proposed rule for more clarity here).

The proposed timelines are:

  • FDA will issue a notice of eligibility or post to the docket a letter of ineligibility, in accordance with § 330.14(d) and (e), within 180 days of submission of a TEA under § 330.14(c).
  • FDA will issue a filing determination in accordance with § 330.14(j) within 90 days of receipt by FDA of a safety and effectiveness data submission from the sponsor under § 330.14(f).

Note the 90-day filing determination will not begin until the sponsor confirms that a complete safety and efficacy data package are presented in the TEA (such statement must appear in the TEA at time of submission).

If FDA decides that the condition or ingredient is not GRASE, then they will issue a determination and notify the sponsor in 730 days (24 months)

If the determination is favorable and will include the new condition or ingredient in an existing monograph, or establish a new monograph, or make a determination that the new condition or ingredient must be submitted in an application under 505 of the Act before marketing – such decision will be made in a proposed rule and generally within 36 months.

FDA will issue a final rule within generally 30 months which will provide sufficient time for comments and FDA evaluation and formation of opinion on the proposed rule.

The rule goes on to explain how FDA arrived at the timeframes based on public health needs, available Agency resources, and the impact of public health interests. In addition, the proposed rule addresses the issues FDA considered in establishing the timelines.

Metrics include:

  • Number and percent of eligibility notices or ineligibility letters issued within 180 days of submission of a TEA.
  • Number and percent of filing determinations issued within 90 days of submission of a safety and effectiveness data submission
  • If applicable, number and percent of feedback letters issued within 730 days (generally 24 months) from the date of filing.
  • Number and percent of notices for proposed rulemaking issued within 1,095 days (generally 36 months) from the date of filing.
  • Number and percent of final rules issued within 912 days (generally 30 months) of closing of the docket of the proposed rulemaking.
  • Total number of TEAs submitted under § 330.14; FDA may also post a total number of TEAs that have been submitted in all previous years.

This is a big deal for FDA as timeline and metrics have not really been employed.  While the timelines are relatively long, especially if FDA needs to get to the proposed and final rule stages, at least industry will understand the time consideration for taking this route.  Remember a firm can always file a 505(b) application for first time marketing of an OTC product with PDUFA goal dates, but firms have tended to shy away from this avenue due to the cost on PDUFA fees and the potential additional data requirements that may exist.

Happy reading – but be certain you have some cookies and plenty of sugar when considering your TEA.