The FDA's 'Wish List': A Unified Agenda

By: David Steinberg, Steinberg & Associates

Posted: March 30, 2010, from the April 2010 issue of Cosmetics & Toiletries.

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The second action relates to food handler products and the third action addresses testing requirements. Finally, the fourth action addresses consumer products. The final actions listed will address health care, consumer and first aid antiseptic drug products, respectively. Except for the fourth action relating to consumer products, these issues are expected to be completed by December 2010.

Comments
To prove that these items are mere wishes on the FDA’s latest list, some evidence is required, which the previous Unified Agenda, issued on May 11, 2009, provides. As can be seen in Table 1, none of the action items from the previous Unified Agenda were completed; although those marked TBD will happen at some undisclosed time. In relation it may also be helpful for the reader to see where all the OTC drugs are at in the process, which was only supposed to take 6 years to complete but was started in the early 1970s (see Table 2).

It is clear that the FDA has significant work to do to in order complete these issues. The failure to advance TEAs makes little sense, especially in the case of sunscreens; the TEA process begins by the FDA comparing a submission with a simple check-off list to determine whether the requirements for the submission are met. This process should take no more than 5 min to complete since the submission either has the correct information or does not. However, the FDA typically takes a year to complete this process.

After the submission has been found to meet the requirements and is approved, a call goes out for safety and efficacy data. These are the dates listed in Tables 1 and 2. To date, none of these TEAs have advanced past this stage.When it comes to sunscreens, the process should be simple since no efficacy data is needed for the submission. As the FDA states in its Final Monograph for sunscreens, efficacy, as defined by SPF testing, is determined on the final formulation. Further, each individual active in the sunscreen must increase the SPF by 2. Therefore, efficacy is not an issue because if the active does not work in a formulation, the product manufacturer cannot use it. This is why many Category I filters are either not used or are not even produced—they simply do not work.

Removing efficacy as an issue leaves only the safety of UV filters for consideration. In this author’s opinion, if the FDA lacks the time and personnel to review the safety data, a simple solution would be to outsource this function and review the reports. This lack of approvals for second and third generation UV filters has placed the United States as the least progressive market in offering consumers effective UVA and UVB protection. Recall, however, at the beginning of this column, that the Unified Agenda was not described as a list of when the FDA will address these concerns and issue new rules; it really is more of a wish list and should not be taken as more than that.