Drugs and medicines are definitely a topic of concern when it comes to healthcare and treating diseases and illnesses. It undergoes a multitude of trials and testings, in which all findings (efficacy, side effects, and alarming results) are reported to the Food and Drug Administration (FDA) for approval.
Even the COVID-19 vaccines went through these grueling steps to have them certified by the FDA for public use against the coronavirus. (Read: Duterte Allows FDA to Shorten Approval Time for COVID-19 Vaccine)
This is why many were confused after a drug that allegedly prevents COVID-19 was distributed to the public without prior FDA approval. What’s even more baffling is that the drug known as Ivermectin is being used for veterinary purposes, particularly heartworm prevention for dogs and cats.
Permitted by FDA
Due to the rising number of COVID-19 cases and the fact that supplies against the pandemic are now running low, the Philippines’s FDA has recently allowed two private hospitals to use Ivermectin for treating the novel coronavirus. This is despite the fact that there are no enough studies yet on the effectiveness of the drug on humans.
“There are two hospitals na actually ‘yong nag-apply sa atin and have been given CSP (compassionate special permit),” said FDA Director-General Eric Domingo. The first hospital applied for the permit and was given approval last week, and just this morning, April 16, the second hospital was given the go signal.
This approval is contrary to the FDA’s earlier statement that warned the health sector and the public on purchasing Ivermectin to treat COVID-19. Hence it makes us wonder: What exactly is the CSP that allowed the two private hospitals to use Ivermectin in treating COVID-positive individuals?
Compassionate Special Permit
CSP, or expanded access, is a permit given by the FDA for investigational drugs and medications. It is only given when there is an ‘immediate life-threatening condition or serious disease or condition,’ and there are no other alternatives available.
The following are the conditions that a patient must satisfy:
- The patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.
- There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
- Patient enrollment in a clinical trial is not possible. (Read: How Effective is China’s Sinopharm COVID-19 Vaccine?)
- Potential patient benefit justifies the potential risks of treatment.
- Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
In the case of Ivermectin, it has been proven useful in animals when given orally or intravenously, but not in humans. Thus, human use has not yet been approved by the FDA which is why it is still considered an investigational medical product.