The FDA Response to COVID-19 and the Impacts It’s Having on the Pharmaceutical Industry

The United States Food and Drug Administration (FDA) has been adapting its approach in response to the rapidly-evolving COVID-19 pandemic. The coronavirus and its associated quarantine have impacted not only our daily lives but also how we conduct our business.

The pharmaceutical industry will be experiencing the significant impact of the FDA’s newest developments. It’s worth going over the potential changes individual companies and the market as a whole will face during the next few months.

The Coronavirus Treatment Acceleration Program (CTAP)

With death tolls potentially rising to hundreds of thousands in the U.S. alone, vaccines in development by companies like Sanofi and Johnson & Johnson may not arrive in time.

In order to quicken the development of new drugs for treating COVID-19, the FDA has released a statement on its new program, CTAP. In a nutshell, the government entity aims to:

• Dedicate medical and regulatory staff to trial reviews of coronavirus therapies
• Streamline the review of drug trials so that they can commence as quickly as possible
• Prioritize responding to requests by companies in the industry working on treatments
• Give researchers the ability to request emergency experimental drugs

Also, the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are both providing regulatory guidance and technical support to help get these studies going promptly.

The Result of the CTAP Initiative

While many experts still believe a true vaccine could take over a year to transpire, drugs that can impede or partially treat COVID-19 may arrive earlier. CTAP will ideally expedite the drug approval process, which previously took a cautious but slow approach.

With no treatment currently available for the virus, there’s no doubt that a faster methodology is necessary. However, some concerns arise over experimental drugs entering the market prematurely without enough evidence to back up their safety and effectiveness.

What CTAP Means for Pharmaceutical Companies

The Biomedical Advanced Research and Development Authority has spearheaded the FDA’s attempts to accelerate trials. It recently allowed pharmaceutical company Johnson & Johnson to proceed with Phase 1 testing of its candidate vaccine, as well as promote the large-scale manufacturing of over 300 million doses in the coming year.

In addition, Phase 2 and 3 trials for the SARS-CoV-2 mRNA-1273 vaccine will proceed earlier than anticipated. At this rate, the company believes it may have a cure released by early 2021, several months before previous estimates.

Other potential treatments for COVID-19 include:

• Anti-inflammatory drugs Actemra and Kevzara, which can help patients experiencing respiratory distress
• Interleukin-6 (IL-6) receptor inhibitors for reducing lung inflammation
• Antibodies from the blood of recovered patients
• Chloroquine and hydroxychloroquine, malaria drugs with possible applications to COVID-19

The Growing Importance of Education

It’s obvious that the pharmaceutical industry is changing significantly as a result of the coronavirus and how the government is responding to it.

All businesses in this sector need to keep their staff up to speed on new developments. The Center for Professional Innovation and Education (CfPIE) continues to offer pharmaceutical training and certification courses to professionals across the market.

We’re now offering specialized online learning options for any attendees that have been impacted by COVID-19.

Contact CfPIE today by calling 1-610-648-7550 or if you’d like to learn more about our pharmaceutical courses and certifications, or if you have questions about our online accessibility options during this pandemic.