To conduct a study entitled, "risk evaluation and mitigation strategy (REMS) programs to promote appropriate medication use and knowledge "
Ended Definitive Contract Awarded Last action
- Contract number
- 75F40120C00044
- Awardee
-
Brigham & Womens Hospital Inc. UEI QN6MS4VN7BD1 Part of Partners Healthcare System Incorporated
- Awarding agency
-
Food and Drug Administration
Department of Health and Human Services
- Obligated
- $4,419,354
Award facts
- Opportunity
-
- FDABAA1800123N Solicitation number
- Contract value 100% obligated
- $4,419,354.00 Current and potential, with all options
- Completion date 100% complete
- Current and potential, with all options
- Contracting staff
- NAICS code
- 541713 Research and Development in Nanotechnology
- Set-aside
- No set-aside
- Competition
- Full and Open Competition · 1 offer Negotiated Proposal / Quote
- Pricing
- Firm Fixed Price
- Place of performance
- Boston, MA 02115, USA
- Legislative mandates
-
- Employment Eligibility Verification (E-Verify) FAR subpart 22.18
Award details come from SAM.gov/FPDS.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Other Administrative Action | $0 | |
| Other Administrative Action | $0 | |
| Other Administrative Action | $0 | |
| Other Administrative Action | $0 | |
| Supplemental Agreement for work within scope | $0 | |
| Other Administrative Action | $0 | |
| Original award | $4,419,354 |
About this award
Brigham & Women's Hospital Inc. received a $4.42 million firm fixed-price contract from the Food and Drug Administration on July 13, 2020, to conduct a study entitled "Risk Evaluation and Mitigation Strategy (REMS) Programs to Promote Appropriate Medication Use and Knowledge." REMS programs are FDA-mandated risk management plans designed to ensure that the benefits of certain medications outweigh their risks by restricting distribution or requiring specific safety measures. The contract, which was completed on October 12, 2024, involved analyzing existing quantitative and qualitative data to assess patient experiences with REMS programs, the content of risk communication materials, and physician interactions with risk communication protocols. No small business set-aside was utilized for this award.
The project was conducted in collaboration with Harvard Pilgrim Health Care Inc., which provided specialized expertise through Dr. Ameet Sarpatwari, an Assistant Professor of Population Medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute. Dr. Sarpatwari, an epidemiologist and lawyer with extensive background in prescription drug pricing and market-based health policy reforms, served as a co-investigator and contributed to manuscript development on REMS program design and impact. The research supports the FDA's broader mission to monitor and evaluate post-market medication safety and inform evidence-based policy regarding risk communication and medication access strategies.
Subawards
| Subcontractor | Amount | Awarded |
|---|---|---|
| Harvard Pilgrim Health Care, Inc. | $59,702 |
Quick answers
Who was awarded contract 75F40120C00044?
75F40120C00044 was awarded to Brigham & Womens Hospital Inc. by Food and Drug Administration (Department of Health and Human Services) on July 13, 2020.
How much is contract 75F40120C00044 worth?
The government has obligated $4,419,354 on 75F40120C00044.
Was contract 75F40120C00044 competed?
The extent of competition for 75F40120C00044 was full and open competition. The government received 1 offer.
On GovTribe
See this award's full record
- Every transaction and funding action
- The awardee's other awards and teaming partners
- Similar awards and recompete opportunities
- Ask GovTribe AI about this award