FDAs Expedite Regulatory Pathways for Medical Emergencies

While the world is tussling with COVID-19 pandemic, there’s an emergency need for its treatments and vaccines. Though, currently, there is no FDA approved therapy or vaccine for COVID-19, the agency has several tools to expedite the review and approval of a COVID-19 biologic treatment or vaccine, after it emerges.  

FDAs Tools

The rising concerns of COVID-19 outbreak, triggered FDA to accelerate the process for quick clinical trials based on pre-IND discussions and highly expedited initial reviews. It is encouraging the sponsors of investigational COVID-19 treatments to submit information and questions through the Pre-IND Consultation Program. Addressing the unmet medical emergencies in treating serious and life threating conditions, FDA has multiple programs to facilitate and expedite development, review and approval of therapies, including biologics.

If the therapies justify their benefits over the risks, they will be available in the market at the earliest with supportive FDA programs like,

  • Fast Track Designation
  • Breakthrough Therapy Designation
  • Priority Review Designation
  • Accelerated Approval Pathway

The animal rule and Emergency Use Authorization (EUA) are other FDA expedited approval programs.  

4 FDA Programs for Expedite Approvals

Therapies treating a “serious condition” are all qualified for the four expedited review programs. They include, the diagnostic products, vaccines and products that detect, prevent and treat the effects of serious conditions. Let us understand the programs in detail.

Fast Track Designation: It expedites the review of drugs with a potential to meet the medical emergencies. Demonstrating the drug potential, the sponsors may rely on non-clinical evidences, more frequent meetings and correspondence with FDA, and rolling review of completed sections of the marketing application.

Breakthrough Therapy Designation: Potential drugs showing improvement over existing therapies are provided faster approvals through this program. As there is no existing treatment or vaccine for COVID-19 currently, this program is irrelevant at this stage.

Priority Review Designation: It accelerates FDAs projected approval time from ten months to six, provided the drug exhibits effective prominence to treat a serious condition in terms of safety and effectiveness. Though the review is based on clinical trials comparing an investigational drug to a marketed drug, other scientifically valid information can also be used, where inadequate therapy currently exists.

Accelerated Approval Pathway: Diseases with long courses, such as, cancers, demanding excessive time periods to measure ultimate clinical efficacy with adequate and well-controlled clinical trials are reviewed here.   

Other Expedited FDA Approval Programs

Animal Rule: Unethical human efficacy studies or unfeasible field trials demand adequate and well-controlled animal studies for drug approvals. Though animal trials are highly probative for human efficacy, developing and validating a predictive animal model has its own unique challenges. For Covid-19 disease, where the human course is still being determined, some researchers are directly proceeding to human clinical trials of investigational vaccines and treatments.

Emergency Use Authorization (EUA): The FDA commissioner is permitted to approve the emergency use of a vaccine or treatment for a particular purpose, irrespective of not having a license. Relevantly, as COVID-19 is declared an emergency by the HHS (Health and Human Services) Secretary, the FDA commissioner may issue an EUA for a Covid-19 vaccine or treatment, after consulting with the directors of NIH (National Institutes of Health) and CDC (Centers for Diseases Control and Prevention) .

With the ongoing pandemic, there is a possibility that an EUA may be issued, if a highly promising COVID-19 vaccine or treatment is developed. Alongside, FDA is already granting EUAs for diagnostics and personal protective equipment for treating Covid-19.

Conclusion

Though, all the above programs are not appropriate for expediate approval of COVID-19 treatments and vaccines, the fast track and priority review designations may be the most germane pathways. As these programs don’t demand the comparison of investigational drug to available therapies, they stand promising for expedited approval of a treatment or vaccine for an emerging disease like Covid-19. Meeting the criteria, the sponsor may receive both priority review and fast track designations. The Emergency Use Authorization is a potential interim measure, though FDA reviews applications for investigational therapies and vaccines using its expedited programs.