Jason Velligan
Associate Editor
Loyola University Chicago School of Law, JD 2024
The Supreme Court is currently reviewing a 5th Circuit decision to roll back 2016 and 2021 expanded indications of mifepristone, a drug originally approved by the Food and Drug Administration (FDA) in 2000. Given the Supreme Court’s hostility toward administrative agencies in the current term, a judge from a United States District Court may substitute their knowledge for that of agency scientific experts in United States FDA v. Alliance for Hippocratic Medicine.
Drug Approval Process
Congress established a rigorous FDA drug approval process based on scientific standards, which manufacturers rely on to produce necessary medicines that enhance and maintain human health. Statutes, and agency regulations promulgated pursuant to statute, govern the strict FDA drug approval process, and it can take up to 10-15 years and cost billions of dollars. The process begins with drug discovery and development, followed by animal studies, then an investigational new drug application (IND), three phases of clinical trials, post clinical trial FDA review meeting, new drug application (NDA), FDA application review, drug labeling, and after drug approval, post market surveillance studies to identify unintended effects of a new drug. The FDA Center for Drug Evaluation and Research (CDER) reviews the NDA to determine the drug’s safety and efficacy. This CDER review team comprises agency experts include physicians, statisticians, chemists, pharmacologists, and other scientists. To broaden the indications of an existing market drug, a manufacturer may submit a Supplemental NDA.
Increasing Consumer Access to Drugs
Provision of safe and effective treatments through the least restrictive methods is how patients gain access to medicine. Mechanisms are in place for manufacturers to request permission for prescription drugs to be sold over-the-counter (OTC). The CDER prescription to OTC list includes commonly used drugs such as Narcan, Nasonex, Xyzal, Voltaren, Flonase, Nexium, Allegra, Mucinex, Prilosec, Miralax, Claritin, etc. The CDER after reviewing supplemental NDA on adverse events from post market surveillance, and other sources, can decide to relax prescribing restrictions and expand drug indications.
In 2016, the CDER approved the manufacturer supplemental NDA allowing mifepristone prescriptions by non-physician providers, adjusting the dosage, extending the prescription period, and modifying the method of administration. This CDE decision came after evaluating scientific evidence gathered over 16 years of use and three post-approval studies. In 2021, the FDA did not enforce the in person dispensing requirement of mifepristone. During Covid, many drugs were be allowed to be prescribed via telehealth.
Upending the Established Regulatory Process
Many prescription drugs go through the supplemental NDA process, which involves requests to lessen restrictions on use and expand indications. A search of the FDA non-rulemaking docket provides no other discernible examples where a group petitioned to roll back a supplemental NDA or an FDA’s nonenforcement decision. In Heckler v. Chaney, (1985), the Supreme Court (Rehnquist) found that the FDA’s decision not to take enforcement action was not subject to judicial review, but here we are in 2024 and well settled principles of law are being reconsidered.
This case created a situation creating unlikely alignment with lobbyists and partners that share a common goal but come from different angles. The American Bar Association, NAACP, Pharmaceutical Research and Manufacturers of America, American Civil Liberties Union, Legal Voice The National Domestic Violence Hotline. and many others each filed friend of the court briefs in support of the FDA. On the one hand, there are groups aligned with the goal of restricting a women’s access to healthcare, and on the other hand, groups based on legal, racial, financial, constitutional, and social issues aligned for different reasons. This is not a case where the Alliance for Hippocratic Medicine is trying to make the FDA better, for the sake of society. They are not trying to obtain access to medication for people suffering from a rare disease. The ‘Alliance’ is pushing an unpopular agenda and only because of the locale where the case was filed did it make it to the Supreme Court.
Associate Editor
Loyola University Chicago School of Law, JD 2024
The Supreme Court is currently reviewing a 5th Circuit decision to roll back 2016 and 2021 expanded indications of mifepristone, a drug originally approved by the Food and Drug Administration (FDA) in 2000. Given the Supreme Court’s hostility toward administrative agencies in the current term, a judge from a United States District Court may substitute their knowledge for that of agency scientific experts in United States FDA v. Alliance for Hippocratic Medicine.
Drug Approval Process
Congress established a rigorous FDA drug approval process based on scientific standards, which manufacturers rely on to produce necessary medicines that enhance and maintain human health. Statutes, and agency regulations promulgated pursuant to statute, govern the strict FDA drug approval process, and it can take up to 10-15 years and cost billions of dollars. The process begins with drug discovery and development, followed by animal studies, then an investigational new drug application (IND), three phases of clinical trials, post clinical trial FDA review meeting, new drug application (NDA), FDA application review, drug labeling, and after drug approval, post market surveillance studies to identify unintended effects of a new drug. The FDA Center for Drug Evaluation and Research (CDER) reviews the NDA to determine the drug’s safety and efficacy. This CDER review team comprises agency experts include physicians, statisticians, chemists, pharmacologists, and other scientists. To broaden the indications of an existing market drug, a manufacturer may submit a Supplemental NDA.
Increasing Consumer Access to Drugs
Provision of safe and effective treatments through the least restrictive methods is how patients gain access to medicine. Mechanisms are in place for manufacturers to request permission for prescription drugs to be sold over-the-counter (OTC). The CDER prescription to OTC list includes commonly used drugs such as Narcan, Nasonex, Xyzal, Voltaren, Flonase, Nexium, Allegra, Mucinex, Prilosec, Miralax, Claritin, etc. The CDER after reviewing supplemental NDA on adverse events from post market surveillance, and other sources, can decide to relax prescribing restrictions and expand drug indications.
In 2016, the CDER approved the manufacturer supplemental NDA allowing mifepristone prescriptions by non-physician providers, adjusting the dosage, extending the prescription period, and modifying the method of administration. This CDE decision came after evaluating scientific evidence gathered over 16 years of use and three post-approval studies. In 2021, the FDA did not enforce the in person dispensing requirement of mifepristone. During Covid, many drugs were be allowed to be prescribed via telehealth.
Upending the Established Regulatory Process
Many prescription drugs go through the supplemental NDA process, which involves requests to lessen restrictions on use and expand indications. A search of the FDA non-rulemaking docket provides no other discernible examples where a group petitioned to roll back a supplemental NDA or an FDA’s nonenforcement decision. In Heckler v. Chaney, (1985), the Supreme Court (Rehnquist) found that the FDA’s decision not to take enforcement action was not subject to judicial review, but here we are in 2024 and well settled principles of law are being reconsidered.
This case created a situation creating unlikely alignment with lobbyists and partners that share a common goal but come from different angles. The American Bar Association, NAACP, Pharmaceutical Research and Manufacturers of America, American Civil Liberties Union, Legal Voice The National Domestic Violence Hotline. and many others each filed friend of the court briefs in support of the FDA. On the one hand, there are groups aligned with the goal of restricting a women’s access to healthcare, and on the other hand, groups based on legal, racial, financial, constitutional, and social issues aligned for different reasons. This is not a case where the Alliance for Hippocratic Medicine is trying to make the FDA better, for the sake of society. They are not trying to obtain access to medication for people suffering from a rare disease. The ‘Alliance’ is pushing an unpopular agenda and only because of the locale where the case was filed did it make it to the Supreme Court.