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.

Every year, around October, children begin dreaming of the gifts they want for the holidays and put them on their wish lists. Due to the economy, however, many children were disappointed in 2009. Like the children, the US Food and Drug Administration (FDA), along with other federal agencies, publishes its wish list called the Semiannual Regulatory Agenda. The Regulatory Flexibility Act of 1980 and Executive Order 12866 require the publication of this semiannual inventory of the rulemaking under development, and the US Department of Health and Human Services (HHS) publishes this wish list for the FDA. The latest came out on Dec. 7, 2009. This author always notices when the list comes out since the questions begin regarding the dates on the list, especially those asking whether the dates are for real. Like all wishes and dreams, sometimes they do come true, but the FDA’s batting average is well below the Mendoza Line—i.e., less than 200, or 1 in 5 (which, of course, is poor).

Most of the trouble with the Unified Agenda is caused when someone from the FDA speaks publically and is asked far-reaching questions such as, “When will the Final Monograph on insect drugs be issued?” to which the speaker responds with what items are included in the Unified Agenda. Once audience members hear the agenda, they expect those items to be acted upon and when they are not, like the children, they are disappointed. Therefore, please note that the following items are listed in the Unified Agenda but this should not be used as a basis for marketing or sales plans; while on the agenda, they are rarely completed, as will be shown.

The Latest Unified Agenda
Of all the agenda items, following are the four that are relevant to personal care, in the order in which they appear. With regard to the FDA’s language throughout, it should be noted that a final action refers to issuing a Final Rule on a given topic; anything else is merely proposed.

1. Prerule stage: Item one on the Unified Agenda, in the “prerule stage,” addresses OTC drug labeling requirements. In 1999, the FDA published its final rule stating that a standardized labeling format would significantly improve the readability of OTC labels by familiarizing consumers with the information included and the location of the information. In addition, a standardized appearance with standardized content, including user-friendly visual cues, would help consumers to locate important health and safety information, thus allowing them to quickly and effectively compare and select products. This became known as the “Drug Facts” box, which is required for all OTC drugs with the exception of the current stay for new sunscreens.

Following this decision, the FDA is initiating a review of these rules to determine whether they should continue without change or whether they should be further amended or rescinded to minimize adverse impacts on a substantial number of small entities. The FDA is soliciting information and will consider comments on the following:

• The continued need for the regulation in part 21 CFR 201.66;
• The nature of the complaints or comments from the industry received by the FDA concerning the regulations;
• The complexity of the regulations;
• The extent to which the regulation overlaps, duplicates or conflicts with other federal, state or governmental rules; and
• The degree to which technology, economic conditions or other factors have changed for the products, which are still subject to the labeling regulations.