Dataset Information

Freedom of Information Act Access to an Investigational New Drug Application.

ABSTRACT: We report our experience working with the US Food and Drug Administration (FDA) to obtain access to an abandoned investigational new drug (IND) application and subsequent application documents submitted by Hoffman-La Roche, Inc. to the agency. Contrary to others' experience and in response to our specific request, FDA provided the IND application number and 464 pages of relevant material, including the initial pharmacology review by the agency and an annual report consisting of an investigational drug brochure, clinical study protocol and amendments and detailing clinical experience with drug treatment. It may be possible to bring application files of additional drugs previously submitted to the agency into the public record to help bolster repurposing efforts and realize our shared public interest in benefiting from previous human clinical studies.

SUBMITTER: Southall NT

PROVIDER: S-EPMC7089016 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Freedom of Information Act Access to an Investigational New Drug Application.

Southall Noel T NT

ACS pharmacology & translational science 20190820 6

We report our experience working with the US Food and Drug Administration (FDA) to obtain access to an abandoned investigational new drug (IND) application and subsequent application documents submitted by Hoffman-La Roche, Inc. to the agency. Contrary to others' experience and in response to our specific request, FDA provided the IND application number and 464 pages of relevant material, including the initial pharmacology review by the agency and an annual report consisting of an investigationa ...[more]

PMID: 32259081

Similar Datasets

Project description:ObjectivesTo assess the use and utility of the Freedom of Information Act (2000) in healthcare research since 2005 and to determine if any particular feature of studies found led to greater data acquisition.DesignPRISMA compliant systematic review.ParticipantsAn extensive literature search was performed of EMBASE, MEDLINE, CINAHL, psychINFO, BNI, AMED, HMIC and Health business elite databases from January 2005 to January 2013 using terms 'Freedom of information', 'Freedom of information act' and 'Freedom of information act 2000'. Papers were considered for publication if they described utilising the UK Freedom of information act to gather data for healthcare research. 16 articles met these criteria.Primary and secondary outcome measuresPrimary outcome was the number and characteristics of studies utilising the Freedom of Information Act to collect the data for healthcare research. Secondary outcome measures were any features that improved data acquisition rates (including to whom the request was made, the number of questions asked per request, etc.)Results16 articles described utilising the Freedom of Information Act for healthcare research, and these investigated a broad range of topics. The median number of requests made was 86 (range 1-172), the total number of requests was 1732. A total of 15 817 pieces of data were retrieved by all studies. The amount of data collected was defined as the number of questions asked multiplied by the number of full responses. A median of five questions were asked per study (range 5-6.5) and the overall response rate was 86%. The National Health Service litigation authority responded to 100% of requests, while Primary Care Trusts had the lowest response rate of 81% for healthcare bodies. A positive correlation between number of requests made and data obtained (0.508, p<0.05) and number of requests made and increased response rate (0.737, p<0.01), both reached the statistical significance.ConclusionsResearchers should make greater use of the Act to access the information they need that is not otherwise disclosed. We discuss the issues with the research utilising the Act and how future research of this type could be optimised.

Project description:BackgroundThe Freedom of Information Act (FOIA) provides access to unreleased government records that can be used to enhance the transparency and integrity of biomedical research. We characterized FOIA requests to Department of Health and Human Services (HHS) agencies, including request outcomes, processing times, backlogs, and costs.MethodsUsing HHS FOIA annual reports, we extracted data on the number of FOIA requests received and processed by HHS agencies between 2008 and 2017, as well as request outcomes. Processing times were reported in three time increments, < 1-20, 21-60, or 61+ days, and trends in backlog status were also described. Information about costs and fees collected were aggregated.ResultsBetween 2008 and 2017, 69.6% of 530,094 HHS FOIA requests were received by the Centers for Medicare and Medicaid Services (CMS), 18.9% by the Food and Drug Administration (FDA), and 11.6% by all other HHS agencies. During this period, CMS processed 374,728 requests, FDA 114,938, and other HHS agencies 61,890. CMS and FDA reduced backlogged requests by 9396 (89.7%) and 4289 (65.3%), respectively, leaving backlogs of 1081 and 2279 requests at the end of 2017. CMS fully or partially granted 60.3% of requests whereas FDA fully or partially granted 72.4%. Of all requests to CMS, 82.0% were considered simple and 18.0% complex; 82.2% of simple requests and 54.9% of complex requests were processed in 20 days, and 5.6% and 29.9% were processed in 61+ days. In contrast, 60.2% of requests to FDA were considered simple and 39.8% complex; 28.8% of simple requests and 9.0% of complex requests were processed in 20 days, and 58.3% and 81.5% were processed in 61+ days. The costs to HHS associated with FOIA requests totaled $446.4 million ($809 per processed request), increasing from $28.1 million ($423 per request) in 2008 to $53.3 million ($1544 per request) in 2017. In total, HHS collected $8.5 million in fees (1.9% of total costs).ConclusionsFOIA is frequently used to obtain information about HHS and its agencies. With growing costs, minimal fees collected, and lengthy processing times, HHS agencies' FOIA programs might be made more efficient through greater proactive record disclosure.

Dataset Information

Freedom of Information Act Access to an Investigational New Drug Application.

Publications

Freedom of Information Act Access to an Investigational New Drug Application.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets