The US Food and Drug Administration (FDA) continues to provide several announcements, edicts and advisements daily about COVID-19 and its impact on the pharmaceutical industry. These measures are designed to help accelerate treatments and protect public safety.
Off-label treatments
This week, the agency issued a Drug Safety Communication recommending caution in the use of hydroxychloroquine and chloroquine in treating COVID-19 patients. Medical professionals have reported several serious side effects, including potentially life-threatening heart rhythm problems, in people that have received the drugs, which have not been approved as treatments for the virus.
“We understand that health care professionals are looking for every possible treatment option for their patients and we want to ensure we’re providing them with the appropriate information needed for them to make the best medical decisions,” said FDA commissioner Stephen Hahn. “We encourage health care professionals making individual patient decisions closely screen and monitor those patients to help mitigate these risks.”
EUA explanation
The FDA released a video explaining Emergency Use Authorizations (EUAs), one of the tools the FDA is using to help accelerate treatments, tests, and vaccines for COVID-19. The video relates how EUAs work, and how they are designed to improve the timeliness of drugs and other solutions geared toward fighting this virus and other health emergencies.
Bioequivalence studies
The FDA also shared information and resources intended to help manufacturers submitting generic drug applications with bioequivalence studies that may be impacted during COVID-19. This move, according to the agency, is because the pandemic is impacting conduct of such studies geared toward submission of Abbreviated New Drug Applications (ANDAs).
Such challenges caused by the pandemic likely will arise from quarantines, and shelter-in-place orders, site closures, travel limitations, supply chain interruptions, and other considerations. What’s more, interruptions to bioequivalence studies for ANDAs could require changes to the protocol and impact collection of necessary data.
Sham COVID-19 treatments
The agency continues to issue warnings to shady manufacturers in an attempt to curb the flow of fake, ineffective virus treatments and preventatives on the market. There are currently no FDA-approved products to prevent or treat COVID-19.
The latest fraudulent products falsely claiming to fight COVID-19 include:
- Conventional hand sanitizer branded as having the ability to actually treat COVID-19 infections
- Essential oils and herbal concoctions touted as being able to prevent or treat COVID-19
- Transdermal patches containing a “composition of botanical oils” purported to block and cure the virus
Diagnostics update
The agency issues daily updates on the progress of diagnostic applications and product development.
- More than 380 test developers have notified the agency intention to submit EUA requests for COVID-19 detection products.
- To date, the FDA has issued 50 individual EUAs for to test manufacturers and labs.
- A total of 22 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs).
- The agency has received notification from more than 230 laboratories that they have begun testing on such products.
