Emergency Use Authorization

• The agency has frequently come under fire for its drug approval decisions, but attacks on its decision-making process and science itself have increased during the COVID-19 pandemic.
• Recent challenges to the FDA’s authority have emerged in the context of reproductive rights.
• I am a legal scholar whose research focuses in part on the law and ethics of the FDA’s drug approval process.
• Examining the FDA’s history reveals the unprecedented nature of the current challenges to the agency’s authority.

Events shaping FDA’s focus on safety

• In its early years, the FDA focused primarily on balancing the competing goals of consumer safety with access to experimental treatments.
• For instance, at the turn of the 20th century, Congress passed the Biologics Control Act of 1902, providing the federal government the authority to regulate vaccines.
• This act marked the beginning of modern drug regulations and the birth of the FDA as a regulatory agency.

FDA’s turn toward expanding access

• During the 1970s, questions about the limits of safety versus an individual’s right to access arose when cancer patients who wanted access to an unapproved drug derived from apricots, Laetrile, sued the FDA.
• The 1980s, however, marks the FDA’s shift toward increasing access following reports of an emerging disease – AIDS – which primarily affected gay men.
• After massive protests, Dr. Anthony Fauci, then director of the National Institute of Allergy and Infectious Diseases, proposed a parallel track program allowing eligible patients access to unapproved experimental treatments.

Future of the FDA

• While the FDA approves drugs for consumer use, it does not regulate the general practice of medicine.
• Doctors can prescribe FDA-approved drugs off-label, meaning they could prescribe a drug with a different dose, in a different way or for a different use than what the FDA has approved it for.
• The mifepristone case has broad implications for the FDA’s future and could have devastating effects on health in the U.S. Due in part to FDA involvement, public health interventions have led to a 62% increase in life expectancy in the 20th century.

• PANAMO is one of the largest 1:1 randomized, double-blind placebo-controlled trials in invasively mechanically ventilated COVID-19 patients in intensive care units.
• A total of 369 patients were randomly assigned to the vilobelimab treatment group (six 800-mg infusions) or the placebo group.
• InflaRx continues discussions with FDA related to submission of a BLA for full approval of Gohibic in this COVID-19 indication.
• The Company is assessing all options for supplying drug to hospitals to enable the treatment of patients.

• The agreement allows AcelRx to participate in the long-term value expected to be created by Alora as they expand the commercialization of DSUVIA.
• Closing of the transaction is expected by the end of the month, and AcelRx will provide, and be reimbursed for, transition services during a period of up to 6 months post-closing.
• "We are proud to partner with AcelRx to continue the growth and distribution of DSUVIA to ensure access by patients.
• This product will help Alora Pharmaceuticals expand our pain management portfolio.

• Applied BioCode announced today its 2022 revenue $13MM, which marks 13% growth year over year, hitting the company’s historic high.
• Q4 revenue was just shy of $4MM representing 9% growth quarter over quarter.
• Applied BioCode, Inc. has also been granted an Emergency Use Authorization (EUA) from the U.S. FDA for its BioCode® CoV-2 Flu Plus Assay ⱡ, BioCode® SARS-CoV-2 Assay*, and an additional EUA for Pooled COVID-19 Testing*.
• Applied BioCode also partners with a variety of diagnostic companies with applications that include the infectious disease, autoimmune disease, allergy, gut microbiome, and veterinary markets.