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FBO DAILY ISSUE OF MAY 01, 2008 FBO #2348
SOURCES SOUGHT

H -- Initiative for Maximizing the Benefit of Passive Adverse Event Collection throughout a Product's Life Cycle

Notice Date

4/29/2008
 

Notice Type

Sources Sought
 

NAICS

541690 — Other Scientific and Technical Consulting Services
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
 

ZIP Code

20857-0001
 

Solicitation Number

REQ1041457
 

Point of Contact

Jaclyn Stielper,, Phone: 301-827-7153, Patricia M Pemberton,, Phone: 301-827-1022
 

E-Mail Address

jaclyn.stielper@fda.hhs.gov, patricia.pemberton@fda.hhs.gov
 

Description

“Initiative for Maximizing the benefit of Passive Adverse event Collection Throughout a product’s life cycle” (IMPACT) 2. INTRODUCTION The Food and Drug Administration (FDA) is soliciting information to identify potential approaches to assess the impact of spontaneous adverse event reports on regulatory decision-making throughout the product life cycle. The purpose of this Request for Information (RFI) is to identify and learn more about potential research organizations that would be interested in and have the appropriate capabilities to conduct research described below. This information will then be used to assist the FDA in developing a more targeted and structured Request for Proposal (RFP). The FDA wishes to express its appreciation in advance to all organizations that choose to provide information in accordance with this announcement. 3. BACKGROUND A crucial part of FDA’s mission is to perform pre-market and post-market safety and efficacy assessments of human drugs and therapeutic biologics (pharmaceutical products). Clinical trials that lead to formal marketing approval only begin to characterize the safety of a given pharmaceutical product. The collection and analysis of safety data by FDA staff must occur throughout the entire life cycle of the product in order to identify undesirable occurrences associated with the use of pharmaceutical products in humans that could not have been predicted by clinical trial data prior to approval. These undesirable occurrences, called adverse events, must be reported to FDA in order for the agency to carry out its mission of performing post-marketing safety surveillance. The 1962 Harrison-Kefauver Amendment to the Food, Drug and Cosmetic Act required approval of the safety and effectiveness of new drugs and reporting of adverse events to the FDA by the applicants. The regulations for postmarketing reporting of adverse events are stated under 21 CFR (Code of Federal Regulation) 314.80 & 81 for Drugs and 600.80 & 81 for Biologics. This established the basis for the current system, which is a passive surveillance system. This passive surveillance system is one in which FDA receives adverse event reports from manufacturers, health care professionals and patients. Most of the reports received by FDA are submitted by the manufacturers and fewer are reported directly by consumers and healthcare professionals. Monitoring spontaneous reports to identify early safety signals is a critical part of the FDA’s postmarket pharmaceutical product surveillance program to assure the safety of all U.S. marketed products. Information received through FDA’s passive surveillance system has also been an important source for other FDA centers and federal agencies, pharmaceutical manufacturers, medical community and stakeholders, and national and international health organizations such as the WHO. The FDA has been using passive surveillance as the cornerstone for pharmacovigilance for many years. In order to fully understand the role of passive surveillance in supporting postmarketing safety evaluation throughout the life cycle of a product, FDA is interested in conducting a formal evaluation of its current passive surveillance system. The results of such an evaluation will be used to determine the most appropriate and effective role for passive surveillance within the armamentarium of postmarketing safety assessment tools. 4. DESCRIPTION FDA is launching an “Initiative for Maximizing the benefit of Passive Adverse event Collection Throughout a product’s life cycle” (IMPACT) The first step in this public health initiative is to evaluate the impact of collecting and using spontaneous adverse event reports throughout the product life cycle for detection and characterization of drug safety risks supporting regulatory decisions to protect patient safety. The FDA held a public meeting on January 29, 2008 to obtain broad input from public and private organizations on the scope, goals, and available methodologies to evaluate the utility of spontaneous adverse event (AE) reports submitted to the Agency. At this meeting, panel members reiterated that spontaneous reporting provides valuable information for detecting adverse events, particularly those that are rare. However, under-reporting, the often poor quality of reports, and the lack of systematic feedback to healthcare providers and consumers limit the full utility of the information. The panel also discussed that now is a timely opportunity to evaluate the impact of passive surveillance on patient safety as the FDA begins to explore and develop new strategies for surveillance. In addition, FDA presented preliminary work (see docket) that demonstrated safety-related regulatory actions occur throughout the life cycle of new drug products. This research, however, was not able to address the source of data and/or the evidence (e.g. spontaneous reports and clinical trial data) on which the FDA takes regulatory action. This preliminary work has begun to provide some answers. At the same time, much more work needs to be done. In order to fully understand the role of passive surveillance in supporting postmarketing safety evaluation throughout the life cycle of a product, FDA is interested in conducting a formal evaluation of its current passive surveillance system. The scope of IMPACT includes, but is not limited to, the following research questions: 1.What is the value to patient safety of collecting AEs through a passive surveillance system over the marketed life cycle of a product? a.How are these data best used in regulatory decision-making? 2.How can safety issue identification and subsequent regulatory action be characterized in relation to time elapsed following product approval? a.Is this influenced by the type of regulatory action and /or the nature of the safety signal? 3.What is the role of serious and non-serious outcome reports in safety issue identification and subsequent regulatory action? a.How does the role of these report types change over the product’s marketed life cycle? 4.What is the role of reports by health care professional and consumers in safety signal detection? 5.Are there any types of AE reports that are not helpful to safety signal detection? 6.What do we know about non-reported AEs or characteristics associated with non-reporting? Government responsibilities to support this project will be as follows: •FDA will provide project oversight to facilitate information gathering and coordination of interviews with FDA personnel. Any information supplied by the FDA must all be returned to the FDA at the end of the project. •In conjunction with PhRMA, FDA will facilitate access to industry records. The objective of this RFI is to identify appropriate sources capable of performing this evaluation. http://www.fda.gov/ohrms/dockets/dockets/07n0480/07n0480.htm Docket No. 2007N-0480 After considering all input, the FDA will issue an RFP from outside organizations. 5. ORGANIZATIONAL CAPABILITY STATEMENT The FDA is looking for organizations with the capability to evaluate the role of FDA’s passive surveillance system in providing timely information to inform public health actions to maximize patient safety. Organizations with the capability to conduct this evaluation shall have documentation of the following: •organizational experience in evaluating public health surveillance systems •working knowledge of FDA and drug safety regulations •experience in framing and answering complex public health research questions •experience in developing innovative approaches and methodologies to address complex public health questions •experience in coordinating successful multi-organizational collaborative research efforts •organizational IT and data management infrastructure pertinent for program evaluation •relevant expertise of key personnel •experience working with and protecting highly sensitive and confidential information 6. RESPONSE INSTRUCTIONS Businesses or other organizations with the capability of providing relevant information are invited to submit, in writing, sufficient information that demonstrates the ability to fulfill these requirements. Based on the understanding of FDA’s needs, describe your general technical approach to perform the work in Section 4. Briefly describe your organization’s capabilities with regard to the areas detailed in Section 5 and any other information you deem relevant. Provide point of contact, including name, address, phone/fax number, and email. Small Business Participation - Small Businesses of all socioeconomic statuses (small, small disadvantaged, 8(a), women-owned, HubZone and Service Disabled Veteran owned) are encouraged to respond to this notice. Respondents shall complete the attached representations and certifications. Information gathered from the representations and certifications will be used to determine if the procurement will be set aside under one of the socioeconomic statuses cited at FAR Part 19. There are no minimum restrictions in the number of pages for the response; however your entire submission shall not exceed 10 pages. 7. DISCLAIMER This RFI is issued for information and planning purposes only and does not constitute a solicitation. The Government does not intend to award a contract on the basis of this RFI or to otherwise pay for information received in response to this RFI. All information received in response to this RFI that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. Information provided in response to this RFI will be used to identify and characterize organizations with the capability to evaluate the role of FDA’s passive surveillance system in providing timely information to inform public health actions to maximize patient safety. In accordance with FAR 15.201(e), responses to this RFI are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.
 

Web Link

FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=020c95ad37288c5fbcf5b11ce033cd67&tab=core&_cview=1)
 

Place of Performance

Address: 5600 Fishers Lane, Rockville, Maryland, 20857, United States

Zip Code: 20857
 

Record

SN01563435-W 20080501/080429220738-020c95ad37288c5fbcf5b11ce033cd67 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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