FDA Status Updates On Citizen Petitions Would Not Signal Decision Pending

FDA dockets-management staffers are preparing to add live status updates and a listing of all pending citizen petitions to the agency's website. The move potentially could provide some reassurance to sponsors.

Proponents for changes in FDA regulations and other authors of citizen petitions soon may be able to determine exactly where the agency is in responding to their requests.

The notoriously opaque process is about to receive some sunlight. FDA's dockets-management staff is preparing to add live status updates and a listing of all pending citizen petitions to the agency website.

John Wright, an administrative proceedings specialist, said the list will not provide reasons for petitions being overdue, but will give a clearer sense of the volume of requests that each FDA center is handling. He said the change was being made per a division initiative rather than a mandate.

"What this means is that the centers as well as the public will know how many petitions are overdue," Wright said during a talk at the recent Food and Drug Law Institute Annual Conference in Washington. "It will give people the opportunity to see the extent of the problem or lack of a problem depending on the center."

Wright said a version of the update is ready but is going through FDA review for approval, and it likely will be six months before the petition updates become publicly available. Status updates are expected to be in the dockets management portion of the FDA website.

Knowing that a petition is still pending years after being submitted may not benefit stakeholders greatly, but public visibility into the agency's work on petitions, or lack thereof, likely will increase pressure on FDA to issue decisions or otherwise resolve concerns raised in petitions.

When implemented, the list should be a welcome increase in agency transparency. The cosmetics industry has been waiting on a response from FDA regarding trace lead in personal-care products for more than five years (Also see "FDA Balks At CIR Public-Private Partnership In FY 2017 Budget Request" - HBW Insight, 15 Feb, 2016.).

The Personal Care Products Council proposed a 10-ppm cap on lead content in cosmetics in its 2011 petition, a move that would bring regulatory authority to industry's position that lead at such levels is not a danger to human health.

Generic drug companies likely will be interested in the status of petitions that could block or delay market entry of their products. Advocates for changes to the OTC drug monograph framework and stakeholders seeking action on specific OTC drug ingredients stand to benefit from the updates as well.

Improved transparency in its own activities and the wider industry has been a leading FDA priority in recent years. Consistent with that objective the agency has supported making clinical trial data public, as has been done by the European Medicines Agency. However, progress in the area has been limited to date (Also see "Open Trial Databases Not Widely Popular – Yet – Duke Researcher Finds" - Pink Sheet, 11 Apr, 2016.).

How Much Comfort Would Status Updates Provide?

Even if FDA offers status updates, that will not necessarily address the core problem that has plagued many petitioners. The agency was required by the 2012 FDA Safety and Innovation Act to respond to citizen petitions within 150 days, down from the previous deadline of 180 days.

But Marc Scheineson, a partner at Alston & Bird LLP and head of the firm's food and drug law practice, said at the FDLI meeting that the majority of petition responses at deadline simply state that FDA has not reached a decision.

"The problem with that procedurally is it takes FDA off the clock," Scheineson said.

If the only thing the tracking site notes is that a petition is still pending, it may be of little service to sponsors.

A citizen-petition tracker maintained by law firm Hyman, Phelps and McNamara PC shows dozens of petitions submitted in 2013 still pending or with only interim responses from FDA.

Of 47 petitions listed as being filed in 2016, FDA has decided on two – both denials. Another 135 were filed in 2015, and FDA has reached a decision on 80 of them.

Knowing that a petition is still pending years after being submitted may not benefit stakeholders greatly, but public visibility into the agency's work on petitions, or lack thereof, likely will increase pressure on FDA to issue decisions or otherwise resolve concerns raised in petitions.

And members of Congress intent on improving FDA efficiency, among other stakeholders, may be interested to know how long the agency has been stalled on particular questions posed by petitions.

[Editor's note: "The Pink Sheet" DAILY also published this article. "The Rose Sheet" brings selected complementary coverage from our sister publications to our subscribers.]