Right to Try and Right to Information More Important than Ever

June 16, 2020
By Nicole DeWitt

Last month, the New York Times editorial board wrote about the damage democracy suffers when government agencies refuse to do an important part of their job—fulfill public records requests. These requests are a necessary mechanism for citizens to hold government accountable, Frier Levitt and I are proud to be partnering with the Goldwater Institute to defend this essential right.

Throughout the country, the importance of the federal Freedom of Information Act (FOIA)[i], and various state freedom of information laws have come to the forefront of public dialogue as government operations, more than ever before, have a critical impact on the daily lives of Americans combatting the unprecedented COVID-19 pandemic. During this time of emergency, state and federal agencies are responsible for things like providing personal protective equipment, disseminating information about the disease, approving potential therapies and distributing relief funds. But, these agencies are still responsible for their statutory duties—including providing the public with access to information in a timely manner.

Ironically, with the imminent need for information on government action—particularly as it relates to medical issues and potential lifesaving treatments—various state and federal agencies have seemingly dismissed the public’s right to transparency. They are deferring or stopping responses to record requests—decisions which potentially impede timely disclosure of important information related to ongoing government operations. In Michigan, Governor Gretchen Whitmer entered Executive Order 2020-38 to temporarily suspend certain deadlines set forth in Michigan’s Freedom of Information Act, citing COVID-19 in-person work restrictions and social distancing practices. In my home state of New Jersey, the Open Public Records Act was amended—removing the requirement that government respond to a request within seven business days during a state of emergency as long as “reasonable effort” is used to respond. However, an agency using “reasonable effort” is not limited in the use of extensions and may reference numerous “extenuating circumstances” as justification for delay.

In other instances, litigation has been necessary to compel agencies to respond to COVID-19-related requests. In Arizona, various news outlets sued the Arizona Department of Health Services (AZDHS) seeking to compel production of the names of long term care facilities and the number of COVID-19 deaths associated with each facility. The AZDHS denied these requests for a variety of reasons, including state privacy laws and potential for business harm to these facilities, but none of these are greater than the public’s right to know.

Similarly, at the federal level, news organizations including the Washington Post, Bloomberg L.P., and The New York Times Company filed a lawsuit against the U.S. Small Business Administration (SBA) for its failure to produce records identifying recipients of federal public assistance funds authorized by the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The U.S. Department of Health and Human Services (DHS) and the Centers for Disease Control and Prevention (CDC) are also being sued by a nonprofit whose six records requests were denied on the purported basis that the requests were “overly broad” and lacked the required specificity for processing—a vague excuse often used by agencies to abdicate their role in providing information to the public. These are just a few of the many examples of COVID-19-related FOIA litigation occurring throughout the country.

Unfortunately, long before COVID-19, delays and denials of FOIA requests have resulted in litigation to force production of documents—notwithstanding the fact that access to government information is a fundamental legal right. The underlying purpose of FOIA is to inform the public about a government agency’s performance of its statutory duties. Agencies must disclose responsive information and documents to satisfy FOIA requests, unless that information is clearly exempt from disclosure under the statute. As noted by the United States Supreme Court[ii], under FOIA “the strong presumption in favor of disclosure places the burden on the agency to justify the withholding of any requested documents.”  

Sadly, in practice, many government agencies do not comply with the requirements of the Act. The U.S. Food and Drug Administration (FDA)—just one government agency—reports thousands of backlogged requests, some of which have been pending for several years. As far back as December 2005, an executive order was issued to require federal agencies to reduce the backlog of FOIA requests by a significant percentage annually, to increase staffing to process FOIA requests, and to take additional actions as necessary to streamline the processing of these requests.[iii] Despite these mandated efforts, hundreds of legal challenges are filed each and every year to force these agencies to do their job.

The Goldwater Institute has firsthand knowledge of the FDA’s delayed engagement. The Institute regularly files FOIA requests to hold government agencies accountable to their duties to the public including, but not limited to, the FDA’s role in protecting public health. Since fall 2019, I have represented the Institute in an appeal process to compel production of records requested three-and-a-half years prior. In early 2016, the Goldwater Institute, architect and long-time advocate of Right to Try laws, filed a FOIA request with the FDA seeking information on expanded access submissions and protocols for certain major medical institutions during a four-year time period. Expanded access is designed to enable terminally individuals to obtain investigational drugs outside of clinical trials, however, the FDA’s bureaucracy often bogs down this process—literally threatening Americans’ lives.

After several futile attempts to accommodate the FDA or otherwise narrow the scope of the request to obtain at least some of the information, the Institute filed an administrative appeal with DHS. In April 2020—more than four years after the initial request—DHS remanded the matter to the FDA to fill the Institute’s request. The Institute then asked for expedited processing, based on the compelling need for information, given current events. The FDA refused to expedite processing and simply indicated it would respond to the request in the order it was received.     

Information about the processing of expanded access submissions by the FDA is critical for patients with a life-threatening disease faced with no other option but the use of unapproved therapies. The FDA’s role in review of expanded access submissions, in which it either grants or denies patient access to a drug, is one of the core functions of the FDA. These patients simply do not have the luxury of time while expanded access applications are pending. The Goldwater Institute and I will continue to fight for terminally patients to expand meaningful access to unapproved therapies by informing the public about the FDA’s review of these requests.

Nicole M. DeWitt, Esq. is an Associate in Frier Levitt’s Litigation Department. Her practice focuses in the areas of healthcare, pharmaceutical, and insurance law, representing clients in connection with healthcare and commercial disputes, as well as counseling providers on reimbursement, network contracting, and out-of-network issues. She also counsels clients and provides analysis regarding practice issues, including the enforcement of restrictive covenants. Nicole advocates for her clients in order to ensure optimum results for their immediate concerns as well as their long-term goals. 

Prior to joining Frier Levitt, Nicole was an associate in a law firm handling healthcare provider reimbursement litigation in the Superior Court of New Jersey. She also settled countless medical provider claims in the New Jersey Division of Workers’ Compensation while dealing with the unique legal issues of medical providers rendering services to an injured employee. Before beginning her legal career, Nicole worked in the pharmaceutical industry as an Equipment Validation Scientist and Quality Assurance Supervisor at a manufacturing facility for a generic prescription medication provider.

[i] 5 U.S.C.A. § 552 (West 2016).

[ii] United States Department of State v. Ray, 502 U.S. 164, 173 (1991).

[iii] Exec. Order No. 13392, 70 Fed. Reg. 75373, 75374-75 (Dec. 14, 2005).