Opportunity Information: Apply for RFA FD 14 020
Apply for RFA FD 14 020
- The Food Drug Administration in the health science and technology and other research and development sector is offering a public funding opportunity titled "Prospective Studies on the Impact of Generic Immunosuppressants on Acute Rejection and Long Term Graft survivals (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103 Food and Drug AdministrationResearch.
- This funding opportunity was created on Apr 18, 2014 and posted on Apr 18, 2014.
- Applicants must submit their applications by Jun 21, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $4,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Independent school districts For profit organizations other than small businesses Private institutions of higher education Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) County governments City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Special district governments.
- Foreign Recipients
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Opportunity Summary:
This FDA cooperative agreement (U01) funding opportunity focuses on a long-running concern in solid organ transplantation: whether switching from brand-name immunosuppressant drugs to generics, or switching among different generic versions, could lead to meaningful changes in drug exposure that might affect safety and outcomes like acute rejection or long-term graft survival. While generic immunosuppressants can lower costs, improve access, and reduce financial burden for patients and payers, transplant care depends on maintaining a very tight balance of immunosuppression. Too little exposure can raise rejection risk, while too much can increase infections, toxicity, and other complications. The transplant community has debated whether small formulation-to-formulation differences, combined with patient-level variability and the narrow therapeutic range of several of these drugs, could translate into clinically important differences over time. FDA-supported studies had already examined pharmacokinetics (how the body absorbs and processes the drug), such as comparing generic tacrolimus to the brand product Prograf in stable adult kidney and liver transplant recipients with moderate to high immunologic risk. What had not been systematically addressed in well-controlled prospective clinical work, and what this grant targets, is whether the real-world introduction and use of generics changes longer-term clinical outcomes like graft survival.
The core objective is to run prospective clinical studies that directly evaluate the impact of generic immunosuppressants on (1) short-term outcomes, especially biopsy-proven acute rejection and its severity, and (2) long-term outcomes, including patient survival and graft survival. By generating prospective, multicenter evidence rather than relying only on retrospective database analyses, the study results are intended to speak to public and clinician concerns about interchangeability and to inform FDA thinking about whether generic review practices for these products need refinement. A secondary value of the work is that it can be compared against retrospective findings, giving a more complete picture of what happens in routine care versus what is observed when patients are followed under a structured study design.
The announcement suggests several "model drugs" that could be included, reflecting common maintenance regimens in transplant medicine. These include calcineurin inhibitors (tacrolimus and cyclosporine), antiproliferative agents (mycophenolate mofetil and mycophenolate sodium), and the proliferation signal inhibitor sirolimus. The project is envisioned as a prospective, open-label, randomized, multicenter, parallel study with an observational character, lasting at least three years (and potentially longer). It would enroll solid organ transplant recipients such as kidney, heart, and liver patients and could evaluate single drugs or combinations from the list. A key design feature is comparing groups based on exposure to brand-only immunosuppressants, generic-only immunosuppressants, or mixed use of brand and generic products. The FDA also explicitly encourages subgroup analyses in pediatric patients, adults, and African American recipients, reflecting both differing immunologic risk profiles and known disparities and variability in transplant outcomes and drug handling across populations.
Outcome assessment is expected to be comprehensive and practical, matching how transplant recipients are typically monitored. Efficacy endpoints include patient and graft survival, biopsy-proven acute rejection and its severity, and potentially other transplant-relevant measures. Safety is to be tracked through treatment-emergent adverse events along with routine clinical labs and vital signs collected at intervals appropriate to the transplanted organ type and the specific drug being evaluated. The announcement anticipates a mix of monitoring methods to ensure follow-up and capture events reliably, including scheduled transplant-center visits, phone monitoring, and patient self-monitoring approaches. Because medication-taking behavior can strongly influence outcomes and can become more complicated when pill appearance or manufacturer changes, the study is also expected to evaluate patient adherence to the immunosuppressive regimen, as well as how often and how much clinicians adjust doses over time. Finally, where therapeutic drug monitoring is standard practice (as it is for tacrolimus and cyclosporine in many settings), investigators are expected to collect and analyze drug concentration data to help interpret whether any observed clinical differences track with exposure differences, dosing changes, or variability introduced by switching products.
From an administrative standpoint, this was an FDA discretionary funding opportunity (CFDA 93.103) using a cooperative agreement mechanism, meaning FDA would likely have substantial scientific involvement or stewardship compared with a standard grant. The solicitation anticipated a single award, with an estimated total funding level of $4,000,000 and an annual or project-period award range listed with a floor of $750,000 and a ceiling of $1,000,000. Cost sharing was not required. Eligible applicants were broad and included public and private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status), state and local governments, tribal governments and organizations, public housing authorities, independent school districts, special district governments, and for-profit organizations other than small businesses, with foreign recipients also noted as eligible in the listing. The opportunity was posted April 18, 2014, with an original and final closing date of June 21, 2014, and an archive date of July 21, 2014.
Frequently Asked Questions (FAQs)
What is the main purpose of this FDA cooperative agreement (U01)?
The purpose is to support prospective clinical studies that evaluate whether switching from brand-name immunosuppressant drugs to generics, or switching among different generics, leads to clinically meaningful differences in outcomes for solid organ transplant recipients. The focus is on outcomes that matter to patients and clinicians, including acute rejection and long-term graft and patient survival.
Why is FDA interested in generic immunosuppressants specifically?
Immunosuppressants often have a narrow therapeutic range, meaning small changes in drug exposure can matter. Too little immunosuppression can increase rejection risk, while too much can increase infections, toxicity, and other complications. While generics can reduce costs and improve access, the transplant community has long debated whether formulation-to-formulation differences could translate into important clinical differences over time.
What gaps in evidence is this opportunity trying to address?
FDA-supported work had already examined pharmacokinetic questions (for example, comparing generic tacrolimus to brand Prograf in stable adult kidney and liver transplant recipients with moderate to high immunologic risk). What had not been systematically addressed in well-controlled prospective clinical work is whether the real-world use and introduction of generics affects longer-term clinical outcomes such as graft survival. This opportunity targets that gap.
What kinds of studies are expected under this funding opportunity?
The announcement envisions prospective, open-label, randomized, multicenter, parallel studies with an observational character. Studies are expected to last at least three years (and potentially longer) and to directly compare outcomes associated with different patterns of brand and generic immunosuppressant use.
What are the primary outcomes the studies should evaluate?
The core objective is to evaluate the impact of generic immunosuppressants on (1) short-term outcomes, especially biopsy-proven acute rejection and its severity, and (2) long-term outcomes, including patient survival and graft survival.
Are there additional efficacy endpoints beyond rejection and survival?
The opportunity describes efficacy assessment as comprehensive and practical for transplant monitoring. It explicitly names patient and graft survival and biopsy-proven acute rejection (and severity) and indicates that other transplant-relevant measures may also be included.
How should safety be assessed in the proposed studies?
Safety is expected to be tracked through treatment-emergent adverse events and routine clinical labs and vital signs collected at intervals appropriate to the transplanted organ type and the specific drug being evaluated.
Which transplant populations are included in the scope of the studies?
The studies would enroll solid organ transplant recipients, with examples including kidney, heart, and liver transplant patients.
Which immunosuppressant drugs does the announcement highlight as potential "model drugs"?
The announcement suggests several commonly used maintenance immunosuppressants: calcineurin inhibitors (tacrolimus and cyclosporine), antiproliferative agents (mycophenolate mofetil and mycophenolate sodium), and the proliferation signal inhibitor sirolimus.
Do applicants need to study a single drug or can they study combinations?
Either approach is contemplated. The project could evaluate single drugs or combinations drawn from the listed model drugs, reflecting common maintenance regimens in transplant medicine.
What comparison groups does FDA expect in the study design?
A key design feature is comparing groups based on exposure to brand-only immunosuppressants, generic-only immunosuppressants, or mixed use of brand and generic products.
Is the study expected to be blinded?
No. The announcement describes an open-label design.
How long should follow-up last?
The solicitation anticipates studies lasting at least three years, with the possibility of longer follow-up.
Why does the announcement emphasize prospective, multicenter evidence?
The intent is to generate prospective, multicenter evidence rather than relying only on retrospective database analyses. Prospective evidence is meant to address public and clinician concerns about interchangeability and to inform FDA thinking about whether generic review practices for these products need refinement.
How does this work relate to retrospective studies?
The announcement notes a secondary value: results from a structured prospective design can be compared against retrospective findings, helping clarify what happens in routine care versus what is observed with standardized follow-up and monitoring.
Are subgroup analyses encouraged?
Yes. FDA explicitly encourages subgroup analyses in pediatric patients, adults, and African American recipients.
Why are pediatric patients, adults, and African American recipients specifically called out for subgroup analyses?
The announcement connects this emphasis to differing immunologic risk profiles and known disparities and variability in transplant outcomes and drug handling across populations.
How should investigators monitor participants and capture outcomes?
The opportunity anticipates a mix of monitoring methods to ensure follow-up and reliable event capture, including scheduled transplant-center visits, phone monitoring, and patient self-monitoring approaches.
Is medication adherence part of what the study should measure?
Yes. Because medication-taking behavior can strongly influence outcomes and can become more complicated when pill appearance or manufacturer changes, the study is expected to evaluate patient adherence to the immunosuppressive regimen.
Does the opportunity address dose changes over time?
Yes. The study is expected to assess how often and how much clinicians adjust doses over time, which can help interpret outcome differences in the context of real-world management.
Is therapeutic drug monitoring data expected to be collected?
Where therapeutic drug monitoring is standard practice (as it is for tacrolimus and cyclosporine in many settings), investigators are expected to collect and analyze drug concentration data.
What is the role of drug concentration data in interpreting outcomes?
Concentration data can help determine whether observed clinical differences align with differences in exposure, dosing changes, or variability introduced by switching products.
What funding mechanism is being used and what does it imply?
This is an FDA cooperative agreement using the U01 mechanism. A cooperative agreement generally implies that FDA would likely have substantial scientific involvement or stewardship compared with a standard grant.
What is the CFDA number for this opportunity?
The CFDA number listed is 93.103.
How many awards were anticipated?
The solicitation anticipated a single award.
What was the estimated total funding level?
The estimated total funding level was $4,000,000.
What was the listed award range?
The annual or project-period award range was listed with a floor of $750,000 and a ceiling of $1,000,000.
Is cost sharing or matching required?
No. Cost sharing was not required.
Who was eligible to apply?
Eligible applicants were broad and included public and private institutions of higher education; nonprofit organizations (including those with and without 501(c)(3) status); state and local governments; tribal governments and organizations; public housing authorities; independent school districts; special district governments; and for-profit organizations other than small businesses. Foreign recipients were also noted as eligible in the listing.
Were foreign organizations eligible?
Yes. Foreign recipients were noted as eligible in the listing.
When was the opportunity posted and what were the key dates?
The opportunity was posted April 18, 2014. The original and final closing date was June 21, 2014. The archive date was July 21, 2014.
Is this opportunity still open?
No. The final closing date was June 21, 2014, and the opportunity was archived on July 21, 2014.
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