Opening Up the FDA

Peter GroenThe President's Executive Order on Open Government Data states, "Government information shall be managed as an asset throughout its life cycle to promote interoperability and openness, and, wherever possible and legally permissible, to ensure that data are released to the public in ways that make the data easy to find, accessible, and usable." Interestingly, the Department of Health and Human Services (HHS), which includes the Food & Drug Administration (FDA), has a tradition of expansive disclosure of information and/or data it generates or collects – contrary to current practices at the FDA. Hopefully, changes being made to 'open up' the FDA will start to accelerate.

According to the recent Presidential Executive Order entitled "Making Open and Machine Readable the New Default for Government Information," openness in government strengthens our democracy, promotes the delivery of efficient and effective services to the public, and contributes to economic growth. As one vital benefit of open government, making information resources easy to find, accessible, and usable can fuel entrepreneurship, innovation, and scientific discovery that improves Americans' lives and contributes significantly to job creation.

In recent years, thousands of Government data resources across fields such as health and medicine, education, energy, public safety, global development, and finance have been posted in machine-readable form for free public use on Data.Gov.  As a result, entrepreneurs and innovators have developed a vast range of useful new products and businesses using these public information resources, creating good jobs in the process.

The President's new Executive Order states that "To promote continued job growth, Government efficiency, and the social good that can be gained from opening Government data to the public, the default state of new and modernized Government information resources shall be open and machine-readable. Government information shall be managed as an asset throughout its life cycle to promote interoperability and openness, and, wherever possible and legally permissible, to ensure that data are released to the public in ways that make the data easy to find, accessible, and usable."

In accordance with the Executive Order, all federal departments and agencies "shall implement the requirements of the Open Data Policy and shall adhere to the deadlines for specific actions specified therein."  Interestingly, the Department of Health and Human Services (HHS), which includes the Food & Drug Administration (FDA), has a tradition of expansive disclosure of information and/or data it generates or collects – contrary to current practices at the FDA.

FDA Drug Approval Process

A report on "Access to Pharmaceutical Data at the FDA: Sometimes the Silence Can Be Like the Thunder" states that those committed to the free exchange of scientific information have long complained about various restrictions on access to these pharmaceutical data and the resultant restrictions on open discourse. Such restrictions have included the selective publication of favorable results,  gag orders on corporate-funded research, and misleading presentations of data. Only in the last several years have these concerns penetrated public consciousness and begun to raise red flags in many quarters.

Some experts have suggested that a registry of clinical trials would shed more light on the drug-approval process. In theory, individuals or organizations forced to register their studies at the point-of-study initiation and ultimately to disclose their results would be more accountable to regulators, researchers, and patients. However, as reported by PublicCitizen.Org, a review of open-government procedures and litigation at the FDA demonstrates that the need for transparency at the agency extends well beyond the reach of any clinical trial registry. Efforts to expand openness and accountability must view trial registries as only one component of a broader 'Open Government' strategy.

Progress in science is based on the free publication of study results and on the public release of data, allowing scientists to build on the experiences of others. In contrast, the governing ethic in the corporate sector is secrecy -- the withholding of any information from which a competitor might benefit. There is perhaps no realm in which these competing viewpoints are presented more starkly than in the area of access to pharmaceutical data at the Food and Drug Administration (FDA).   -  PublicCitizen.Org

One way that the FDA has taken steps to adopt a more 'open' stance involves the establishment of the FDA  Adverse Event Reporting System (FAERS). It is a computerized information database designed to support the FDA's post-marketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses FAERS to monitor for adverse events and medication errors that might occur with these marketed products. It is also a useful tool for FDA to look for new safety concerns, evaluating a manufacturer's compliance to reporting regulations, and responding to outside requests for information. FAERS contains over seven million reports of adverse events and reflects data from 1969 to the present.Normally, at each step of the drug approval process, a variety of documents of potential relevance to the public health are generated. Unfortunately, numerous contentious legal battles have been waged over the years to obtain public access to information generated during various stages in this process, with FDA typically weighing in alongside the manufacturer and favoring non-disclosure. Obstacles to the release of information at each of these stages ought to be addressed if optimal transparency in the drug approval process is to be assured.

FDA Adverse Event Reporting

Reporting of adverse events from the point-of-care is voluntary in the U.S.  The FDA receives some adverse event and medication error reports directly from healthcare professionals (e.g. physicians, pharmacists, nurses) and consumers (e.g. patients, family members). Healthcare professionals and consumers may also report these events to the products' manufacturers. If a manufacturer receives an adverse event report, it is required to send the report to FDA as specified by regulations.  See FDA MedWatch, the Vaccine Adverse Event Reporting System (VAERS), and the Manufacturer and User Facility Device Experience Database (MAUDE).

Adverse drug events are the leading cause of morbidity and mortality in the U.S.; healthcare professionals report over one million adverse drug events annually. However, the FDA indicates that is only the tip of the iceberg — over 90% of events go unreported.   -  RxEvent

As Federal agencies develop their Open Government Plans and associated Open Data Policies (see HHS Open Government Plan) as required under the current administration, we hope to see the FDA further embrace transparency in a variety of ways – from the adoption of  'open source' software, providing 'open access' to publicly funded research and reports, collaborating on 'open standards', and placing more 'open data' sets online.

Consumers - remember to go online and use the FDA MedWatch system to report adverse drug events to the government. Let's all help to further 'Open Up' the FDA
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