FDA

FDA Announces New DSCSA Pilot Program and Public Meeting Series

Yesterday the FDA published a preview of two announcements related to the Drug Supply Chain Security Act (DSCSA).  One was announcing a new pilot program, “…to assist in development of the electronic, interoperable system that will identify and trace certain prescription drugs as these are distributed within the United States.”  That is, the system that will comprise the “Enhanced Drug Distribution Security” (EDDS) system in 2023.  The other announcement was for a series of DSCSA public meetings—also intended to work on the system in 2023.  Both announcements include a docket for use by stakeholders and the public to submit written comments to the FDA.

PILOT PROGRAM

The pilot program appears to be more substantial than last year’s public meeting that was about DSCSA piloting (see “The 2016 FDA Pilots Workshop”).  Certainly we can expect the FDA to use the information collected at that meeting to guide the actual pilots. 

“Particular program goals include assessing the ability of supply chain members to: Satisfy the requirements of section 582 of the FD&C Act; identify, manage, and prevent the distribution of suspect and illegitimate products as defined in section 581(21) and 581(8) of the FD&C Act, respectively; and demonstrate the electronic, interoperable exchange of product tracing information across the pharmaceutical distribution supply chain, in addition to identifying the system attributes needed to implement the requirements of section 582, particularly the requirement to utilize a product identifier for product tracing and verification purposes.”

FDA intends to “coordinate” with stakeholders to ensure the pilots reflect diversity in size and segment across the supply chain.

“FDA expects that participants will propose the design and execution of their pilot project in their submission to FDA; however, FDA intends to meet with all pilot project participants to ensure that the learnings from the pilot project(s) will be complementary in informing the direction of the development of the electronic, interoperable system that will go into effect in 2023. FDA encourages supply chain members to focus their proposed pilot project(s) on the DSCSA requirements related to the interoperable, electronic tracing of products at the package level. Specifically, the pilot project(s) should focus on the requirements for package-level tracing and verification that go into effect in 2023.”

The program is announced but it will not progress until the Office of Management and Budget (OMB) approves the proposed collection of information.  For more on the program, see the announcement here.

EDDS PUBLIC MEETING SERIES

The second announcement was for a series of public meetings called “Enhanced Drug Distribution Security under the Drug Supply Chain Security Act”.  The EDDS phase of the DSCSA starts on November 27, 2023.  Why is the FDA talking about requirements in 2023 when we haven’t even hit the serialization deadline for manufacturers?  The DSCSA provided very few details about the operation of the EDDS in 2023 but instructed the FDA to work with the industry to figure it out.  The FDA is obligated to hold at least five public meetings on specific topics and conduct at least one pilot.  All of those activities are designed to help the government and industry arrive at a workable way of meeting the few requirements that are spelled out in the DSCSA.  I’ll have more to say about all of that in future essays.

The three announced meetings will be held at FDA Headquarters in Silver Spring, Maryland on the following dates:

  • August 23, 2017
  • December 5-6, 2017
  • February 28, 2018

“The purpose of these public meetings is to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to discuss with FDA, and provide input on, strategies and issues related to the enhanced drug distribution security provisions of the DSCSA. These public meetings will focus on the following topics for discussion:

  • What supply chain security should look like in 2023

  • What is needed for enhanced drug distribution security

  • What is needed for electronic interoperability

  • Standards for product tracing

  • Data architecture options for an electronic interoperable system

  • The management and maintenance of product tracing data

  • The use of aggregation and inference for enhanced product tracing and verification

  • Building capacity for a unit-level system for product tracing and verification”

The topic of the first meeting will include:

  • Supply chain security in 2023
  • Enhanced drug distribution security needs

For more, see the announcement here.  Registration for each meeting will be held a few weeks prior to the dates listed above.  Registration is now open for the August meeting.  Register early because they will cut it off once they reach the capacity of the room.  In fact, you are really only applying for registration.  If you are accepted, you will be notified in an email about two weeks prior to the meeting.  To ensure a wide diversity of participants, FDA will also limit the number of people from each company.  Odds are that will be no more than two from each company, but if they are overwhelmed with applications, they could limit it to just one per company.  So, again, register early if you plan to go.

Alternatively, you could submit written comments for the FDA to consider.  Or, you can attend and then submit comments.  The docket for the first meeting will not close until September 22, 2017.  The FDA will apparently offer a webcast on the day of the meeting and a recording afterward, but only for portions of the meeting.

I hope to see you all there.

Dirk.