COVID-19 - FDA and Pharmaceutical Companies
Emergency Use Authorization (EUA), guidance on conduct of clinical trials of medical products, compassionate use, Coronavirus Treatment Acceleration Program (CTAP), and punitive measures are insights surrounding how the FDA is holding pharmaceutical companies accountable during the COVID-19 pandemic. The detailed presentation of the insights is presented below.
Emergency Use Authorization (EUA)
- The FDA issued an Emergency Use Authorization (EUA) on March 28, 2020, meant to facilitate distribution and use of chloroquine phosphate and hydroxychloroquine sulfate products donations to the Strategic National Stockpile (SNS) for treatment of certain hospitalized COVID-19 patients.
- The issuance will enable the SNS to distribute the drugs to the different states where doctors dealing with COVID-19 patients will prescribe them to patients who meet the criteria.
- FDA amended the EUA to allow application of Battelle Decontamination System. They system is used in decontamination of the critical N95 respirators.
- The amendment allows healthcare personnel to reuse the decontaminated respirators in the COVID-19 pandemic. It helps in reducing the shortage of the respirators that has been a major challenge in dealing with the pandemic. Pharmaceutical companies are working with the regulation by donating chloroquine phosphate and hydroxychloroquine sulfate products to be used in COVID-19 treatment.
Guidance on Conduct of Clinical Trials of Medical Products
- The FDA issued the guidance to help sponsors, who may include pharmaceutical companies, in complying with good clinical practice, guaranteeing the safety of trial participants, and minimizing risks to the integrity of the trials throughout the COVID-19 pandemic.
- One of the main motivations for issuing the guidance was the realization that the pandemic could affect the conduct of clinical trials of the various medical products such as drugs, biological products, and devices. The guidance is subject to continuous updates depending on new questions that keep emerging.
- The pharmaceutical companies are working with the regulation by complying with the new FDA guidance, especially at these critical times.
- The FDA has introduced compassionate use or expanded access as a measure of helping in the treatment of COVID-19 patients. The move allows physicians dealing with patients with serious disease or life-threatening conditions to request for the use of experimental drugs that are yet to undergo clinical trials.
- While the compassionate use has a direct impact on physicians, it also affects pharmaceutical companies as they are responsible for producing the drugs and taking them through the requisite clinical trials.
- Pharmaceutical companies are working with the regulation by availing the experimental drugs when required.
Coronavirus Treatment Acceleration Program (CTAP)
- The FDA introduced the Coronavirus Treatment Acceleration Program (CTAP) whose purpose is to expedite the process of bringing coronavirus treatments into the market through enhancing cooperation between public and private organizations, such as pharmaceutical companies.
- Through CTAP, FDA will redeploy personnel and resources to provide private organizations, scientists, and researchers with technical assistance, guidance, and regulatory advice within the shortest time possible.
- Already, the CTAP has been put in action in various ways. For example, FDA links the developers and scientists seeking the development or evaluation of new biologic therapies and drugs with the appropriate FDA staff within 24 hours of receiving such requests.
- Moreover, the FDA is working closely with the applicants and regulatory agencies to accelerate quality assessments of products meant to treat COVID-19 patients. Pharmaceutical companies are working with the program by producing the drugs to meet the market demand.
- The FDA, in conjunction with other regulatory agencies, have also issued warnings to some pharmaceutical companies for selling and distributing unapproved products that are claimed to diagnose, treat, prevent, or mitigate COVID-19.
- Already, seven companies including Carahealth and Corona-cure.com have received warnings for selling such products with misleading claims.
- FDA continues to monitor online and store marketing of products claiming to diagnose or treat COVID-19 in close collaboration with retailers. If a pharmaceutical company is found selling such products with the misleading claims, the FDA will take immediate action ranging from sending warning letters to seizing the products and seeking injunctions against such companies, products, and people.
- Enhanced enforcement measures are also being applied at the ports of entry to prevent inflow of such fraudulent pharmaceutical products. Pharmaceutical companies are working with the regulation by ensuring that the claims they make about their products can be substantiated.