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What Does It Mean If My Medication Is Not FDA-Approved?

Updated on March 29, 2017
BYPharmD profile image

Brandon is a community pharmacist in Minnesota. He received his Doctorate of Pharmacy from the University of Minnesota.

Picture this

You've gone to see your doctor and received a prescription. You take that prescription to your pharmacist and are told that your insurance does not cover it because the drug does not have FDA approval. You may be told that it's a "DESI" drug.

You might wonder what it means that the medication doesn't have FDA approval. Has the government not approved this drug? Is it illegal? Or dangerous? You might ask why your doctor prescribed a drug that isn't approved... and you might also wonder, what is a DESI drug, anyway?

Good questions!

The drug-approval process is complicated—and it has a complicated history. First and foremost, know that nearly all prescription and over-the-counter (OTC) drugs do have FDA approval and are safe to use if you follow the labeling.

But that's not the whole story. You may have experienced a situation like the one outlined above, or perhaps you've heard about someone who has. Let's dive in to the history of FDA regulation and approval, the current situation with certain drugs, and the deal with certain insurance plans.

The role of the FDA

The FDA (Food and Drug Administration) is a United States federal agency that regulates, among other things, prescription and OTC medications. This agency was founded in 1906, and since then have worked to protect the integrity of the U.S. drug supply.

One of the key oversights the FDA provides for medications is their approval process. Any company that wants to market any drug product in the United States must first receive FDA approval to do so. At least, that's how it works today.

Historically, the FDA has not always mandated safety and quality review before drugs can be sold. Drugs that have been sold since before approval was necessary have been received Grandfathered status, meaning they can continue to be marketed and used. However, around 2011 the FDA decided to crack down on on these "unapproved" drugs.

Furthermore, insurance companies are deciding more and more to not cover drugs that do not have full FDA approval, citing that they aren't required to. And that's a hard stance to argue against.

To better understand how these situations came to be, let's look at a very general history of the FDA's drug approval process.

1906

The wild west

Before 1906, no federal agency regulated drugs. Think of any product one might call a drug, and then imagine that there is no guarantee that that product is safe whatsoever. It could be poison. It could kill you. There's not even any guarantee that it is what the seller says it is. Cold remedy? Could be water. Pain medication? Might just be a sugar pill. Or, again, it could be poison. And if it turned out that it was just water, or sugar, or poison there was nowhere you could go to file a complaint or report a problem. Think about that.

The Wiley Act

In 1906, the United States government pass the Pure Food and Drugs Act and The Wiley Act.

Together, these actions essentially created the FDA and gave them the authority to test food and drugs sold in the United States if they so chose to. They also encouraged drug makers to place accurate labeling on their products. But they didn't require it.

Still, nothing had to be submitted to the FDA before a drug entered the market, and there was no requirement for drugs to be safe and no requirement for them to do what they said they did.

1938

The Federal Food, Drug, and Cosmetic Act

Finally, in 1938, the FDA required manufacturers to submit proof that any new drug product was safe for human use.

Now, drugs couldn't just be sold, they had to first be approved. This approval was only for safety to insure that United States citizens were safe when they used FDA approved drugs.

This act also required the labeling on drugs to be adequate for safe use. This meant that the average person would be able to read the label and understand how to safely use the drug.

1962

The Kefauver-Harris Amendments

This act created the rules we have around today.

It required that all manufacturers submit proof that their drug is both safe, and also effective. Meaning that the clinical trials show that the drug will treat, cure, or prevent the disease it's approved for. It can't just be snake oil.

The act also established rules for those drug studies to make sure they produced quality results. It also created Good Manufacturing Practices that ensured drug product was safe and reliable and gave control of drug advertising to the FDA.

Very importantly, it also required a retrospective review of any drug approved since 1938 (the date that drugs had to be proven safe before being sold). This was a review of effect, and was designed to make sure that all drugs that had every received FDA approval were approved to be both safe and effective.

This retrospective review was called The Drug Efficacy Study Implementation (DESI). A DESI drug is one that never completed this review, or did not pass the review.

So what does all of this history have to do with me and my prescription?

DESI drugs and insurance

Insurance companies use a wide variety of tools to keep drug costs down.

A very common practice is to only pay for drugs when they are being used for their FDA approved medical conditions. Your doctor, of course, can prescribe any drug for any reason, and that reason may not be one the FDA has reviewed the drug for. This is fairly common, actually, since the FDA only approves drugs for medical conditions that a manufacturer has submitted an application for. In the case of older drugs, no manufacturer wants to pay the application fee for what might be a very small return on investment.

Recently, it seems that insurance companies have decided that since DESI drugs do not technically have FDA approval for any medical condition, they will not pay for them regardless of what they are being used to treat.

It is important to say that not all insurances companies are making this decision, and not all that do will cut coverage for the same drugs. It is always case by case. But, there is a current trend that more and more insurance companies are paying for fewer and fewer DESI drugs.

DESI drugs today

Today, most drugs have been thoroughly approved by the FDA. Any drug that was made after 1962 has certainly gone through FDA approval. However, drugs first marketed before 1938 and certain drugs first marketed between 1938 and 1962 may not have ever received full FDA approval.

For example, any drug first made before 1938 was exempt from FDA approval. If that drug has been on the market and is unchanged ever since, then it technically does not have FDA approval. More commonly, if a drug was made between 1938 and 1962, then it was supposed to be retrospectively reviewed as a DESI drug. In certain cases, that review was never done. That is where most of the unapproved FDA drugs come from, and that is whey they are referred to as DESI drugs.

DESI drugs make up a very small portion of the available drug products. However, if you find yourself in need of one of these drugs, you may have a hard time getting it. In some cases, the FDA has pulled them from the market entirely. In other cases, they are still around, but your insurance may not cover it.

Famous DESI drugs

Starting in 2007, isometheptene and other ergotamine medications were pulled from the market by the FDA because they were DESI drugs that had never been retrospectively reviewed for safety and efficacy. Many patients who suffered from migraine medications relied on these medications for symptom control. Ask them, and they could tell you that the medication worked just fine. And they were commonly used, so the risks were common knowledge to doctors and other health care practitioners who used them for their patients. All the same, no manufacturer offered up evidence to prove their safety and efficacy so they were pulled from the market, leaving patients scrambling for other, often inferior, options for migraine pain control.

Another drug mostly pulled from the market was antipyrine. It was an ear drop used to treat ear pain associated with infection or other inflammatory problems. I say "mostly pulled from the market" because every once in a while there is a manufacturer that is still making it despite FDA warnings not to. This highlights the complicated approval process and how the FDA can take action, but it's hard to universally enforce.

Some DESI drugs

Drug
Usual use
Donatal
IBSm enterocolitis
Analpram
Hemorrhoids
Isometheptene
Migraine headache
Iodoquinol
Antifungal and antibacterial
Est Estrogens and Methyltestosterone
Postmenopausal symptoms
Phenazopyridine
Urinary tract pain
Pramoxine
Topical pain
Antipyrine
Ear pain
This list is not exhaustive. Note that some drugs on this list may be available in different forms, or through certain manufacturers that have received FDA approval. This list was made to be as accurate as possible, but there may be individual excep

Looking up more information

A full, comprehensive list of DESI drugs is hard to come by. There does not seem to be a official FDA list available.

You can search drug approval status case-by-case at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm

You can also use the FDA Orange Book to search for therapeutic equivalence and approval status.

Lastly, you can use DailyMed (https://dailymed.nlm.nih.gov/dailymed/) to search for approval status and review clinical information about any drug.

What can you do if you are in this situation?

If you happen to find yourself needing a DESI drug, there are a couple of options.

If the drug is simply not available, such as if it was pulled from the market, then you're going to have to find an alternative. Before doing that, check with a few pharmacies in the area to see if any of them still have access to the medication. Different pharmacies use different wholesalers, and one might be able to get a small supply. If the drug truly is off the market entirely, talk to your pharmacist and your physician to see what alternatives there are.

If the drug is available, but your insurance does not cover it because of it's DESI status, the first step is to call your insurance and see if there is any sort of exception they can make. You could have your doctor call on your behalf and explain the medical necessity of the DESI drug. If nothing else, the insurance company may offer some assistance. But, if the insurance won't budge, then you could again talk with your pharmacist and physician to see if there are alternatives.

Disclaimer

The information provided on this page is intended for general educational and informational use only. It is not specific, personalized healthcare advice for you. For healthcare advice regarding your particular situation, talk to members of your healthcare team.

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