Clinical trials of drugs, treatments and vaccines that are not related to Covid-19 could suffer going forward, former Food and Drug Administration (FDA) Commissioner Scot Gottlieb on Friday. As the agency continues to focus its resources more on addressing coronavirus, clinical trials of drugs and treatments for other diseases could get delayed from now on.
Clinical trial of drugs and treatments related to other diseases and ailments have already taken a backseat as researchers, scientists and pharmaceutical companies across the globe are speeding up development of a potential vaccine to treat the deadly coronavirus. So far, more than 5.8 million have tested positive for coronavirus globally, with more than 360,000 deaths.
Delays to Last Longer
The FDA wants to give priority to drugs and treatments related to Covid-19 over other diseases and ailments. Given that resources are limited, it makes sense that FDA could delay the approval of drugs, vaccines and treatments for non-Covid-19 related diseases.
"With many staff members working on COVID-19 activities, it is possible that we will not be able to sustain our current performance level in meeting goal dates indefinitely," the agency said in the document. Gottlieb also said that a lot of drug companies have put clinical trial of vaccines that are not related to Covid-19 on hold.
With more staff shifting toward Covid-19 related work, FDA thinks that it's possible it may not meet the goals set forth in the Prescription Drug User Fee Act (PDUFA). The PDUFA sets a time frame goal for FDA make a decision on marketing applications for drugs. However, it is likely that the agency will not be able to meet the deadline this time around.
Drugmakers Too Focus on Covid-19 Vaccine
Durmakers across the world are trying to develop a vaccine to treat the deadly coronavirus. This has seen many halting clinical tests of their other drugs and vaccines as nothing much has been achieved in tackling the virus. Gottlieb also said that many durgmakers aren't going forward with planned trials, which FDA is keeping an account of.
Presently, the agency is still listing the standard PDUFA goal date in letters to drugmakers — eight months for a priority review and 12 months for a standard review — and doesn't plan to extend currently established goals. However, for generic drug companies, the FDA is focusing on approvals for drugs for conditions for which there are drug shortages.
