In recent months we’ve talked about Lyrica being the first drug ever to receive FDA approval for the treatment of fibromyalgia. We’ve also speculated on whether Cymbalta will become the second medication to receive this designation. It was after my recent SharePost “Cymbalta Hits a Bump in Its Road to FDA Approval” that one of our members asked a very good question: “What benefit does FDA approval of a drug for a specific diagnosis provide?”
What FDA Approval Does
- It ensures that before a drug is promoted as a treatment for a specific condition, it has undergone a rigorous series of clinical trials to prove its safety and efficacy.
- It allows the pharmaceutical companies to begin to recoup the enormous expenses of research and testing by permitting them to market the drug for the approved condition.
- It helps physicians know which medications they can safely prescribe for specific conditions. This is especially important for non-specialty doctors who can’t reasonably be expected to keep up with all the latest research on every illness that one of their patients might possibly have.
- It adds legitimacy and credibility to an illness like fibromyalgia that is still fighting for recognition and acceptance by some in the medical community.
- It does not ensure that every patient with the condition will benefit from taking the drug.
- It does not assure that some patients will not suffer adverse reactions (i.e. side effects) from taking the drug.
- It does not guarantee that insurance companies will pay for the medication.
The FDA and Clinical Trials
For a clinical trial to be considered successful, it’s not necessary for every subject taking the drug have positive results. You might be surprised to learn that it’s not even necessary for the majority of subjects to show improvement. What is necessary is that the difference between the percentage of positive results for subjects receiving the drug and the percentage of positive results for subjects receiving the placebo must be “statistically significant.” I can’t tell you what number is considered statistically significant; I’m not even sure there is a specific number or percentage. I do know sometimes the difference is a lot less than I would expect.
Medications and Insurance Companies
Unfortunately, FDA approval of a drug does not automatically mean that insurance companies will cover it. As a general rule, insurance companies can pretty much set their own policies about what they will and will not cover. I suspect that price has more to do with what they’ll pay for than does FDA approval. Newer drugs that have no generic counterpart are almost always extremely expensive and insurance companies often try to avoid paying for them whenever possible. Sometimes your doctor can appeal to your insurance company, demonstrating that other medications you’ve taken have not helped and explaining why it’s important for you to take a particular drug.
It’s also not unusual for insurance companies to use the lack of FDA approval as the reason they will not pay for certain off-label prescriptions. If this has happened to you, be sure to read “Migraine, Medications, and Insurance Companies” which describes an appeal technique that MyMigraineConnection expert Teri Robert has found to be successful.
Published On: November 21, 2007