ectd submissions of 2253's
TRANSCRIPT
Pyxa Solu*ons, LLC Transi*oning from paper to eCTD for 2253 Submissions
2
The Industry is shiAing..
10/6/16
M1 ini*a*
ve
The updated 2253 dra7 guidelines for AdPromo submissions is an example of the FDA encouraging sponsors to adopt prac*ces that will benefit industry as a whole. A
step
in th
e rig
ht dire
c*on
SubmiJng video, audio and images as DVD media by mail in an age of such impressive compu*ng power at low cost is much too tedious for sponsor and Agency.
Mod
erniza*o
n By upda*ng the specifica*on, upda*ng the technology, and encouraging a rethinking of internal processes, the FDA is moving toward a more modern business reality.
A “MORE MODERN BUSINESS” REALITY FOR 2253’S
..are you shiAing with it?
3 10/6/16
Quan*fying the shi7 in 2253 submissions from paper to eCTD
Since the Office of Prescrip*on Drug Promo*on (OPDP) started accep*ng electronic submissions in June 2015 through the middle of February 2016 (in the first 8.5 months), it has received 400 AdPromo submissions containing more than 1,000 promo*onal pieces*.
Since then (in the 3 months that followed) these numbers have doubled**.
As of now (end of April 2016), approximately a couple dozen companies have already made the transi*on**.
**Source: Confidential to Pyxa Solutions LLC ** NOTE: The “couple dozen companies” is inclusive of partnerships and subsidiaries.
*Source: presentation from Roberta Szydlo from the ODPD during the DIA Marketing Pharmaceuticals 2016 conference
4 10/6/16
Why some Companies are deciding to shi7 to eCTD before the dra7 guidance is final and before the mandated deadline
Proac*vely shiAing from paper to eCTD for 2253
Submissions
Strategic Considera*ons
Opera*onal Considera*ons
FDA Considera*ons
Compliance Considera*ons
5 10/6/16
Strategic Considera*ons Why companies are shi7ing now…
Review
ers like it!
An overwhelming # of reviewers in OPDP that review 2253’s and associated promo*onal materials like to receive it in eCTD format
Improves m
anageability
The granular format of eCTD AdPromo submissions improves manageability and helps companies more clearly and succinctly organize their informa*on
Ope
n Dialogue
w/ A
gency
The agency is seeking open dialogue and is providing some leeway for companies. They want companies to no*fy them of formats that fall outside the guidance
Influ
ence Change
Commen*ng period is over, however FDA is s*ll taking comments on board and may update the guidance with clearer statements to remove ambiguity Save *me and eff
ort The ability to submit
grouped submissions will save *me and effort by allowing one submission to mul*ple applica*ons that share the same informa*on.
Beher insig
ht!
With AdPromo being eCTD, companies can easily link to the various applica*ons in order to have beher oversight and improved decision making.
6 10/6/16
Opera*onal Considera*ons Why companies are shi7ing now…
Subm
it high volum
e 2253s Opportunity for
companies to develop streamlined processes to submit high volume 2253s electronically over the electronic submission gateway (ESG)
Lifecycle Ope
ra*o
ns
Take advantage of the convenience and visibility afforded when performing Lifecycle opera*ons in eCTD. (e.g. If part of the original submission is rejected, the sponsor may file an amendment with only the missing or rejected component, instead of submiJng the en*re 2253)
Redu
ced Manual Effo
rt
Preparing Ad Promo submissions would not require as much manual effort. There would be no coun*ng of hard paper copies and burning media to discs.
Faster Pub
lishing-‐Review
Publishing is faster and cheaper. Submission through the gateway allows reviewers to assess submission rapidly. This process is faster then Paper.
7 10/6/16
FDA Considera*ons Why companies are shi7ing now…
Alignment with
Submission Process
Alignment with submission process for other submissions in CDER
Improve processing efficiency
Due to extensive metadata collection allows submission information to be automatically populated into tracking software to improve processing efficiency
BeVer Insights
Electronic search and filtering capabilities. FDA has more insight, the FDA can now do searches of the submission to extract the information they need.
Faster and More
Efficient
Faster and more efficient delivery to the reviewer - With the new Module 1, the ability to accept Form 2253 submissions in eCTD format via the ESG
Ability to receive high volume 2253’s
Opportunity for streamlined processes and ability to receive high volume 2253s from companies electronically over the electronic submission gateway (ESG)
Availability for All
Reviewers
Submission is available for all staff to see, therefore secondary review and consultation of other offices is more efficient
Product Applica*on Info Quickly Available
Product application information is in one location, will be quickly available for all reviewers as needed.
Ability to receive eCTD 2253 and non-2253 submissions over same electronic submission gateway (ESG)
Receive all Submissions through ESG
8 10/6/16
Compliance Requirements: FDA Guidance & Landscape Indicated by the use of the words MUST and REQUIRED, this document is NOT subject to the usual restricAons in FDA’s good guidance pracAce (GCP) regulaAons
FDA is not including this standard language in this guidance because it is not an accurate descrip*on of all the effects of this guidance.
This guidance contains both binding and non-‐binding provisions. Insofar as this guidance specifies the format for electronic submissions pursuant to sec*on 745A of the FD&C Act it will have binding effect.
FDA Guidance's ordinarily contain standard language explaining that guidance's should be reviewed only as recommenda*ons unless specific regulatory or statutory requirements are cited.
In sec*on 745A of the FD&C Act, congress granted explicit statutory authoriza*on to FDA to specify in guidance the format for the electronic submissions required under that sec*on.
9 10/6/16
Compliance Requirements: Upcoming Requirements In OPDP’s draL guidance, FDA is proposing pharmaceuAcal companies submit promoAonal materials for human prescripAon drugs to OPDP using its electronic common technical document (eCTD) format.
OPDP has tradi*onally required companies to submit promo*onal materials to it for review using Form FDA 2253—a paper-‐based form.
FDA explains "As of that date, paper hard copies will no longer be accepted for such submissions”.
In the mean*me, firms are "strongly encouraged" by FDA to begin submigng promo*onal materials using the eCTD immediately.
This requirement is changing, eCTD submissions for 2253 will be required two years aAer the guidance document is finalized.
10 10/6/16
Compliance Requirements: Risk of Non-‐Compliance FDA explains "As of that date, paper hard copies will no longer be accepted for such submissions”.
Not a point for nego*a*on with the FDA. Companies who do not comply with the upcoming eCTD requirements for submiJng their 2253s will find themselves in a posi*on where their submissions will be rejected or returned with comments (as would any submission made to the FDA that does not follow the regula*ons). This will result in delays with FDA review and therefore use of the materials in the field.
11 10/6/16
Value Proposi*on
Once the guidance is final, there will be NO other op*on but to implement the eCTD process Advance planning
allows all risks to be mi*gated and resources to be addressed prior to required “go-‐
live” date
Good Standing: Following FDA’s
strong recommenda*on to begin submiJng
promo*onal materials using the eCTD immediately
Documents available, easily accessible,
traceable and reportable
(throughout the lifecycle)
Preparing for and implementing (pilot or full go-live) a 2253 eCTD process before it is mandated by FDA
Implemen*ng the eCTD Process in advance will ensure
the process is implemented effec*vely and
efficiently prior to mandated deadline
12 10/6/16
Risks that can be avoided
Vendors not providing
materials in the correct format – Regulatory can take this on
Mis-‐management of life cycling of the pieces (and maintenance of
lifecycle)
Poor *meline management to ensure pieces are ready for
use
Under es*ma*on of
resources / skills when managing
electronic submissions
As part of the end-‐to-‐end eCTD process ensure measures are put in place to manage revised pieces or discon*nua*on of a piece.
As part of the end-‐to-‐end eCTD process ensure format and standards for promo*onal pieces are established and communicated to vendors – HAVE A BACK UP -‐ if you can not get vendors to take this on effec*vely and efficiently.
As part of the end-‐to-‐end eCTD process ensure *melines are clearly communicated to all func*ons involved in the process and the turn-‐around *me for “re-‐work” is understood so that submissions are not delayed .
As part of the end-‐to-‐end eCTD process ensure resources (people and tools) are in place to accommodate the required changes from paper to eCTD.
ConsideraAon: Eliminate large scale risk by implemenAng a small scale pilot (for one or more “not so acAve/criAcal” products to ensure the process is streamlined and miAgaAon plans are considered prior to full scale implementaAon
13 10/6/16
Industry Best Prac*ce – How Pyxa Can Support
✓
✓
Establish a vendor guide to ensure all Vendors providing promo*onal materials are following the required format / standards (ONLY if Vendors will be managing this for you)
Incorporate language in Vendor agreements to ensure vendors are contractually obligated to abide by the templates / standards guide provided to them (embed in the process) -‐ (ONLY if Vendors will be managing this for you)
✓ Ensure Regulatory QC performed on materials received from Commercial is inclusive of checks for submission readiness (built within a checklist to ensure consistency with each review)
✓ Establish internal standards (e.g. leaf *tles and file names; placement loca*on etc.) – as applicable
✓ Establish a lifecycle management approach to maintaining promo*onal pieces
Establish an end-‐to-‐end cross-‐funcAonal 2253 eCTD process to ensure consistent and efficient transiAon to meet the upcoming requirements
✓ Implement a pilot (Test Submission) to fine-‐tune processes before full implementa*on
✓ Determine if Vendors will provide promo*onal materials in the required format or if Regulatory Opera*ons will re-‐format pieces to the necessary standards
