Agency relies on broad procedural interpretation, says evaluation ongoing
WASHINGTON, DC / ACCESSWIRE / August 1, 2023 / The Food and Drug Administration (FDA) has denied a Citizen Petition submitted by the Center for U.S. Policy (CUSP) aimed at protecting patients from being deprived of the prescription drugs they need. The petition asked the FDA to deem a widely used clinical decision support (CDS) software a misbranded medical device and to mandate a recall to prevent serious, adverse health consequences and death.
According to the petition, the problem with the software is that it generates patients' substance misuse "risk scores" yet provides health care professionals no way of evaluating the legitimacy of such scores. Upon viewing patients' risk scores, health care providers may change their prescribing decisions, despite patients' needs for medications, to avoid criminal or administrative enforcement actions for "inappropriately" prescribing controlled substances. The petition alleged the software has altered the practice of medicine to the detriment of patients with pain or opioid use disorder and other marginalized groups.
In its response letter, the FDA clarified that the denial was not based on the substantive issues CUSP raised in the Citizen Petition. Rather, the FDA cited its broad interpretation of the Citizen Petition regulation that states, "This section does not apply to the referral of a matter to a United States attorney for the initiation of court enforcement action and related correspondence."
The FDA wrote, "We appreciate the information that you provided … We take complaints seriously, and we will evaluate this matter to determine whether follow-up action is appropriate."
The decision based on procedural grounds does not diminish the importance of the health and safety concerns CUSP raised in the Citizen Petition.
"We encourage patients who have been harmed by substance misuse risk-scoring to report their adverse events to the FDA through the MedWatch Online Voluntary Reporting Form," said Lynn R. Webster, M.D., Senior Fellow at CUSP. "We also recommend that patients report their negative experiences with substance misuse risk-scoring to their state medical boards."
Read CUSP's Citizen Petition here.
Read the FDA's response letter here.
For more information on substance misuse risk scores, read "Dosing Discrimination: Regulating PDMP Risk Scores," written by Jennifer D. Oliva, Esq., and published in the California Law Review, available here.
For more information on disparities in controlled-medication prescribing, see:
- "Racial Inequality in Prescription Opioid Receipt - Role of Individual Health Systems," published in 2021 in The New England Journal of Medicine, available here;
- "Addiction Should Be Treated, Not Penalized," published in 2021 by the National Institute on Drug Abuse (NIDA), available here;
- "Buprenorphine Treatment Divide by Race/Ethnicity and Payment," published in 2019 in JAMA Psychiatry, available here; and
- "Access to Addiction Services Differs by Race and Gender," published in 2019 by NIDA, available here.
About the Center for U.S. Policy (CUSP)
CUSP is a nonpartisan, 501(c)(3) not-for-profit research and education organization dedicated to enhancing Americans' health, safety, and economic opportunity. CUSP's 2023 priorities include preventing substance use disorder and drug poisonings, and supporting people affected by substance use.
For more information, visit centerforuspolicy.org and follow @USPolicyCenter.
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SOURCE: Center for U.S. Policy
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