Orphan drugs (OD) are medications that are used to treat very rare medical conditions. Diseases that are diagnosed in extremely few patients can be life-threatening.
These drugs are used in the prevention, diagnosis, and treatment of rare diseases and can be extremely expensive. As the diseases are uncommon, there’s isn’t a lot of incentive for pharmaceutical companies to manufacture these medications.
With few patients needing these drugs, the manufacturers can barely cover the cost of producing these drugs. That’s why these drugs are expensive.
Here, we’ll discuss more orphan drugs.
Which Diseases Are Classified As Rare?
Medical conditions that affect fewer than 200, 000 people, in the US, is known as a rare disease.
Generally, these diseases are quite serious and can be life-threatening if not treated promptly. Currently, there are almost seven thousand rare diseases.
Who Gives Medications the “Orphan Drug” Status?
The FDA Office of Orphan Products Development is the organization that supports and approves the treatment options for rare medical conditions.
They are also the organization responsible for giving medication their orphan drug status.
Which Medicines Can Qualify For The Orphan Drug Designation?
These two conditions need to be fulfilled for medicine to qualify as an orphan drug.
The Manufacturing of the Medication Is Very Costly
If not qualified as an orphan drug, the manufacturing and development of these medicines would be very expensive.
Without the orphan drug status, the pharmaceutical company or manufacturer doesn’t expect to recover the cost of developing the medication from the sales. So, any such medicine would need the status to be used in treatment.
The Medicine is a Treatment Route for a Rare Disease
The medicine that’s being developed will only be used for people with a rare disease that affect fewer than 200,000 people in the United States.
The manufacturer intends to develop this medicine for a very small group of people, which have serious medical conditions. In this case, the medication will earn the designation of orphan drugs.
Get Prescription Assistance for Orphan Drugs
The Rx Helper is a patient prescription assistance program for the uninsured that can help you get the necessary medical treatment. Once you pay the monthly service fee, we can get you the medicine for little to no cost. To find out more, you can contact us or visit our website.