FDA

FDA To Hold DSCSA Public Meeting

2016-04-05 14.11.09.reducedThe FDA is almost 10 months behind in the release of guidance documents for the Drug Supply Chain Security Act (DSCSA) as scheduled by Congress (see “FDA DSCSA Deadline Passes Quietly”, “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”, “FDA Speaks At GS1 Connect”, and “FDA Plans Busy Second Half of 2016 With Six DSCSA Draft Guidances Expected”).  So far this year the FDA has held one public meeting to collect public and stakeholder input on the pilot that the law mandates (see “FDA To Hold DSCSA Pilots Workshop”, and “The 2016 FDA Pilots Workshop”).  The DSCSA requires the FDA to hold at least five public meetings “…to enhance the safety and security of the pharmaceutical distribution supply chain and provide for comment.”

This morning, the FDA announced that they will hold what appears be the first of those five public meetings on Friday, October 14, 2016 at their Silver Spring, MD headquarters (see the FDA announcement with full details here).  The title of this meeting is “Progress toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act”.

“This public meeting is intended to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to share information with FDA about the efforts underway to implement the Drug Supply Chain Security Act’s (DSCSA’s) product identification requirements, including the use of product identifiers to enhance tracing at the product level.”

The meeting will be held on Friday, October 14, 2016, from 9 am to 4 pm at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, Silver Spring, MD 20993.  In addition to the public meeting, FDA will open a docket under the same name for stakeholders to submit written material (see the announcement for details).

According to the FDA announcement,

“The main topic FDA is interested in discussing at the public meeting is the supply chain’s progress toward implementing the DSCSA’s product identification requirements, including best practices in each sector of the pharmaceutical distribution supply chain to conduct product tracing, verification, and product identification. This may include the processes needed to utilize the product identifiers to enhance tracing of product at the package level, including allowing for verification, aggregation, and inference, as necessary.”

…

“Other topics of interest to FDA that may be presented at the public meeting include, but are not limited to:

  • An assessment of the steps taken by supply chain members to build capacity for a unit-level system for electronic product tracing, including the impact on (1) the ability of the health care system to maintain patient access to medicines; (2) the scalability of such requirements, including as it relates to product lines; and (3) the capability of different sectors and subsectors, including both large and small businesses, to affix and utilize the product identifier; and

  • information related to the secure, interoperable electronic data exchange among sectors within the pharmaceutical distribution supply chain.”

Registration is free and open to the public, but I can assure you that the room will fill up and the FDA will be forced to limit the number of attendees per company as well as the total number of people given passes to attend, so if you wish to attend, make your decision now and submit your registration information today.

The full registration details are in the announcement.  If you wish to be considered for delivering a presentation on something related to the meeting topic, include your wish in your registration email and specify the topic(s) that you will cover.  If they receive too many requests to present than the time available, FDA may conduct a lottery to select which presentations are added to the agenda and which are declined.  No product-specific promotional presentations please (that’s the FDA’s request, but it’s also my request as an attendee).

For those of you who cannot make it, don’t want to travel, or who don’t register in time, portions of the meeting will be recorded and webcast “…on the day of the meeting.”  I assume it will be webcast in realtime as they have in the past, but it’s hard to tell from the announcement.

See you there.

Dirk.