TRIP Assistance Program (TAP)
What is the "TAP" program and how does it work?
Regenerative Outcomes created a convenient regulatory service called TAP (TRIP Assistance Program), which is an interface with the FDA program called TRIP (TRG Rapid Inquiry Program) designed by subject matter specialists experienced in working with FDA. We will create and submit an expert compliance inquiry dossier to FDA on your behalf for the purpose of rapidly obtaining a preliminary assessment as to how your HCT/Ps are appropriately regulated, and whether other aspects of your practice or technology are FDA compliant.
How does it Work?
We strategically gather, interpret, assemble, format and submit a summary dossier FDA requires under its new TRG Rapid Inquiry Program (TRIP).
Within 3-5 business days FDA will provide one of the following 4 responses:
The product being produced and/or used requires an IND or BLA.
The product is exempt from an IND or BLA under 361 3) The product is NOT an HCTP, and is therefore considered a biologic, regulated under an IND or BLA.
The product is NOT an HCTP and is therefore considered a biologic, regulated under an IND or BLA.
The information provided is insufficient to make a response.
Then, we assist those who submit inquiries in interpreting the FDA’s response. Our team of scientists, regulatory affairs experts, and clinicians possess the key competencies to determine early on where cell therapy providers and manufacturers are positioned for FDA compliance. We offer this service as a turn-key solution to the fullest extent possible.
After Phase I and if needed, our trained auditors will follow up by assisting you on-site, rectifying all areas of non-compliance and re-submit to FDA on your behalf. Once all areas have been rectified, you will receive documentation confirming this from the FDA and certification of approval from Regenerative Outcomes.
Is there an FDA imposed timeline?
Despite a history of debate, time is running out to establish the legality of your therapy or to pursue IND. In November 2017, the FDA announced its comprehensive regenerative medicine framework. At that time, the FDA also announced that until November 2020, the agency generally intends to exercise enforcement discretion for certain HCT/Ps, with respect to FDA’s investigational new drug application (IND) and premarket approval requirements, focusing first on the use of products that raise the potential of significant safety concerns. Many cell therapy providers and manufacturers have generally interpreted the FDA’s stated intent to mean there is a dependable window of non-enforcement policy that applies to the industry as a whole.
Recently, however, FDA has quickly assembled a program they describe as an opportunity for potential sponsors in the cell therapy clinic and biotech manufacturing space to get a preliminary, informal determination of whether that therapy or product requires an IND or BLA.
Interestingly, they have recently begun stating in press interviews and published statements that they are “disappointed” by what they are characterizing as a general lack of responsiveness on the part of cell therapy providers and other manufacturers.
Why are these facts relevant?
FDA may be signaling that they will use the temporary program, called “TRIP” (TRG Rapid Inquiry Program) to cut short their enforcement discretion policy, in order to make the argument that their best efforts at gaining cooperation from “rogue” clinics and shoddy product are not responding to FDA’s efforts to engage them.
The TRIP program has a hard end date of December 31, 2019, eleven months short of the 36-month “window”. FDA’s action could be a “final” push to get would-be sponsors aboard one more time as what may be a hail Mary gesture to engage Providers to pursue compliance. If they determine this effort is unsuccessful, they will be poised to begin enforcing, both formally and by proxy. They will have no reason or incentive to delay. This evidence suggests the FDA will not wait until November of 2020 to initiate an enforcement action. FDA’s TRIP program terminates at the end of this year, indicating this may be the new deadline.
What does this mean to physicians and companies offering cell therapy products and services?
Providers will know better where they stand, what to plan for, and how to proceed in the short term regarding the therapies they offer or the products they buy from distributors. FDA also looks favorably upon Providers who have initiated steps to ensure FDA compliance, versus attempting to remain under the "perceived" radar. Regenerative Outcomes has confirmed with the FDA that there IS NO RADAR. FDA has stated they are already aware of all of the practitioners and companies who may be operating in a non-compliant manner, opening themselves up to near-term possible to enforcement action.
Time is of the essence.
Enforcement action may intensify swiftly beginning early 2020, and so our experts at Regenerative Outcomes are prepared to help those interested to engage our TAP process strategically, with seasoned guidance, and in a way that positions them well with regulatory authorities moving forward.
Do I have to identify myself and my suppliers to get a determination?
No. We have gained clearance with the FDA to offer submission of these dossiers on behalf of providers and to do so with identifying information removed. FDA will still provide an informal answer.
How much time will it take to complete the TAP evaluation and get an answer from the FDA?
Depending upon your availability to complete the details of the assessment, which can be done by phone, we can submit your dossier packet to FDA within 7 days from the initial phone call. After we have completed the assessment, we estimate the time it will take for you to answer questions and supplement the information will be 3-5 hours of staff time.
How does moving forward with TAP benefit me and other providers or manufacturers?
Proactive association to compliance commitment remains in good standing with the FDA by avoiding enforcement action while assigning legitimacy.
What are the risks to providers and manufacturers who chose not to engage the FDA?
FDA has already taken enforcement action against several cell therapy providers and manufacturers, which includes but is not limited to, the shut-down of all operations, warning letters, fines, and penalties and product recall.
We have a therapy we think has promised to treat many diseases, not just one. Where do we start? How do we pick?
Our team of world-class scientists and regulatory experts will help you choose a strategic indication, that may permit for the treatment of more than just one disease, and qualify for a low-cost, fast-track approval pathway.
Can I market and distribute my product?
FDA often lets innovators begin marketing their cellular therapy after proving safety in a concurrent Phase I + Phase II trial.
Will Regenerative Outcomes follow my progress?
Regenerative Outcomes is committed to the long-term picture to secure a future for those who are serious about pursuing safe and effective regenerative medicine therapies. For those engaging in our P-CAP program, we will commit to an ongoing compliance strategy as part of our next service in the continuum of our program.
How do I Secure my Place to Receive the Service?
I encourage you to take our text-based Virtual Compliance Evaluation to begin moving forward NOW. This convenient, interactive method of gathering the “bones” to create a robust request and avoid FDA responding with “we need more information” will survey you using a text message format.
To begin, using your smartphone or tablet, text: rapid fda4 (all lowercase, space between rapid and fda4) to: 31996
Then, you’ll have the opportunity to download materials and to complete an initial evaluation.
At the end of the evaluation, you will be given an opportunity to sign up and pay for our services. We will timestamp your evaluation, and order our list accordingly on a first-come, first-served basis.
After signing up, you will receive a call from a subject matter expert.