FDA, HHS Withdraws Notice as “Legally and Factually Inaccurate”

On Thursday, the Department of Health and Human Services and Food and Drug Administration (FDA) issued a notice in the Federal Register, 86 FR 28605 regarding a prior notice that was filed by the same entities on November 25, 2020, at 85 FR 75331 under former Secretary of the Department of Health and Human Services, Alex Azar II. The May notice ended the comment period for the November notice, which had an indefinite comment period. The May notice also withdrew the November notice as being “legally and factually inaccurate.”

The notices deal with a segment of the FDA’s policy regarding drugs that have been in use prior to 1938 and the founding of the FDA, but that have not gone through the FDA approval process for efficacy and safety. 

The regulations for efficacy and safety require affirmative blind studies prior to submission of the drug to the FDA as well as monitoring studies after approval to check for unexpected side-effects and other issues. The May notice includes several famous examples of drugs in this category, including Cabinoxamine, which was later required to have a restriction to not be prescribed for children under 2 years old due to fatalities, as well as Quinine, a common anti-malarial drug, which required extensive warnings as to proper levels of dosing due to cardiac and renal complications.

The FDA created a program known as the Unapproved Drugs Initiative in 2006, which was later modified in 2011 to deal with these grandfathered drugs. The program was designed to encourage these grandfathered drugs to go through the safety and efficacy testing that new drugs receive to improve the safe use of these drugs and affirmatively create proper warnings and restrictions. Part of how this is accomplished is by “rewarding” manufacturers who go through the testing process with a short period of exclusivity for distribution in the market place if the drug passes the standard, similar to the one that is granted for new drugs. The November notice found this problematic, as the period of exclusivity can result in higher prices for the drug as it gains a temporary monopoly status. 

The May notice acknowledged that higher prices can be a temporary effect of the UDI program, but noted that the prevention of death and serious medical complications is the goal and focus of the FDA, which can override temporary cost inflation. The notice also indicated that in light of the confusion around this area, new guidance will be forthcoming in accordance with the APA rules for comment making as the UDI program is re-established.