Payers struggle to keep up with high rate of FDA drug approvals
The FDA approve these kind drugs faster than the common ones, the orphan drugs. Rather than being approved by clinical trial, the drug is monitored under the surrogate endpoint clinical, meaning the drugs will only require a minimum way to show it efficacy. Orphan drugs are the types of drugs that won't guaranteed for 100% cure, since the drugs are still in the beta stage, it only serves for the purpose of treating rare-disease that non-cure has been found. The FDA approve the surrogate endpoint clinical trial for these type of drugs (orphans drugs), it says that the clinical testing is more of a observing and researching for clues and evidences to understand more of the unsolved diseases. In a sense its more like a animal testing with no control, but in here its using the lives of real human to test it.
Something the FDA mentions to public about the drugs:
People should be aware and be more informative of these types of drugs.
People with rare disease should do more research about their disease and also research about the content ingredients found in these pills.
Well, from my perspective view I think FDA should put a label where it allow the users to scan and access to the information about the drugs, informing them about orphan drugs, the pros and cons, and also letting the public be more aware of these types of medicine out there.
No comments:
Post a Comment