Definition
QIDP (Qualified Infectious Disease Product) is an FDA designation created by the GAIN Act of 2012 to incentivize development of new antibiotics and antifungals for serious or life-threatening infections. QIDP provides expedited development pathways and extended market exclusivity.
How QIDP Works
Sponsors request QIDP designation before NDA submission. FDA evaluates whether the drug treats a qualifying infection and grants automatic Fast Track status along with other benefits.
Eligibility Criteria
- Antibacterial or antifungal drug (including biologics)
- Treats serious or life-threatening infection
- Infection involves qualifying pathogen (resistant organisms, hospital-acquired)
- Includes drugs for biodefense
QIDP Benefits
| Benefit | Details |
|---|---|
| Automatic Fast Track | Granted with QIDP designation |
| Priority Review | 6-month review goal |
| Additional Exclusivity | +5 years added to any existing exclusivity |
| Expedited Development | Enhanced FDA engagement |
Exclusivity Extension Example
| Exclusivity Type | Base Period | With QIDP | Total |
|---|---|---|---|
| NCE | 5 years | +5 years | 10 years |
| Orphan Drug | 7 years | +5 years | 12 years |
| New Clinical Studies | 3 years | +5 years | 8 years |
Why BD Teams Track QIDP
For business development professionals, QIDP signals antibiotic pipeline value:
- Deal Implication: Extended exclusivity significantly enhances product economics
- Due Diligence Focus: Verify qualifying infection status and competitive antibiotic landscape
- Opportunity Signal: Antimicrobial resistance is global priority; QIDP products attract attention