The South African Health Products Regulatory Authority, known as SAHPRA, stepped up in a major way allowing for compassionate use of the economical anti-parasite drug Ivermectin. While the regulatory authority still awaits additional clinical data before it can issue any formal approval, the agency did communicate on a Jan. 27 press briefing that the nation’s population will now benefit from a compassionate use access program via the legal framework of section 21 of the Medicines and Related Substances Control Act in South Africa. SAHPRA plans on publishing guidance on how the compassionate use program will actually work. As Ivermectin for human use isn’t registered in the nation, too many issues and risks were surfacing with a nascent black market for the drug. The authority will utilize this compassionate access program to collect mission-critical data on the actual performance of the drug in South African patients via the COVID-VG reporting platform. In this way, physicians can secure access and prescribe Ivermectin and the results can be tracked in near real time for a source of real world data. SAHPRA takes the lead worldwide in showing a creative path forward to avail the population an early onset treatment for COVID-19.
Regulatory Body Shows Some Humanity
Initially, SAHPRA took a far more draconian stance to use the drug for the treatment of COVID-19. Initially, the drug was even criminalized in that country, as TrialSite reported; a Islamic faith-based hospital was even raided.
But in their most recent communication SAHPRA shared that it “…appreciates the frustration and pain experienced by healthcare practitioners, patients, and families given the limited availability of evidence-based options for the prevention and treatment of COVID-19.”
So although the agency still takes the stance that there isn’t sufficient safety and efficacy data as of yet for the anti-parasite drug, they remind all that they are simply aligned with key peer agencies such as U.S. FDA, EMA and MHRA in the UK yet they are now ready to embrace a creative program that offers compassionate use options while tracking data in real time for real world evidence.
The Concern: Illicit Use
As SAHPRA explained because the country doesn’t have any registered Ivermectin for human use the purported product used for treating COVID-19 was either being derived illicitly from veterinary product or illegally imported. Rightly, the regulatory body was and is concerned about the widespread unregulated use of the product, posing risk to human health. Furthermore to date there is no standardization of dose or indication for actual use in the nation. The agency has reports of misrepresentation and fraud occurring at least in some cases as well.
Monitoring for Evidence
The agency will continue to monitor the various clinical trials ongoing along with the World Health Organization and others. Moreover, SAHPRA encourages clinical researchers focused on Ivermectin to submit proposals to the agency for review and potential authorization. SAHPRA commits to expedited review of such trials.
Call to Action: SAHPRA should be commended for their action. Although some argue that existing meta analyses provide sufficient evidence for emergency approval now, others counter that there are still too many open questions and additional trial data is needed. Given all the conflicting positions, SAHPRA moved in the right direction.