Is your medication FDA approved?

You may be surprised to learn that there are prescription drugs on the market today that are not approved by the Food and Drug Administration (FDA). In fact, the FDA estimates that there are several thousand products available that are not proven to be safe and/or effective. Many of these drugs came onto the market in some form prior to the 1938 and 1962 laws that established the process for drug approval in the U.S. That process, which remains in effect today, requires pharmaceutical manufacturers to put drugs through a series of tests (animal studies through large scale human trials) designed to determine the safety and effectiveness of the drug in question. The data from these tests is submitted for review by a panel of experts at the FDA.

FDA approval is required before drugs can be marketed in the United States. Often drug companies will claim that a drug is "grandfathered" and doesn't require approval. The FDA believes, and several lawsuits have agreed, that it's unlikely that any drug on the market today can be legally sold without formal FDA approval.

Over the past several years, there have been dozens of deaths linked to the use of unapproved drugs. Because of this, the FDA has begun taking stronger action against these illegally marketed medications with the intent of removing all from the market.

Providence encourages you to find out if your medications are FDA approved. You can do this by going to the FDA-sponsored online resources that list approved drugs. (A drugs absence on the list indicates it isn't approved.) For example, drugs@fda is a reference maintained by the FDA's computer systems. The information this resource provides is current, accurate and contains the vast majority of FDA-approved drugs. (To access this page on the FDA Web site, you'll need to remove everything -- including "http://" -- so that the only item listed in your browser field is drugs@fda. NOTE: Certain (biologic) medications such as vaccines and blood products may not be referenced on this site).

Other resourceful sites include www.fda.gov and www.accessdata.fda.gov/scripts/cder/drugsatfda/. Both sites allow you to search by drug name or active ingredient, or browse by the first letter of the drug name.

It's important to note that medications must be FDA-approved to be eligible for benefit payment under your Providence Health Plan prescription drug plan. Your prescription drug coverage is designed to provide a wide selection of safe and effective medications to treat all covered conditions. Our formularies provide you with a list of these options. Members and providers can feel confident that choosing drugs on our formulary have been proven safe and effective, and are covered under the benefit.

If you're taking a drug that is not FDA-approved, talk with your doctor or other medical provider to determine if there's a formulary alternative that will work for you. If your provider and you determine that an unapproved drug is the only option for you, it's up to you whether or not you want to continue taking that drug; however, it will not be covered under your pharmacy benefit.

You can learn more by visiting www.fda.gov/cder/drug/unapproved_drugs/consumer.htm#consumer or by contacting Providence Pharmacy Services at 503-574-7400 or 1-877-216-3644.

If you have questions about how to use the site, or if you are unable to find your medication and need help in determining if it is FDA approved, feel free to talk with your provider or pharmacist, or contact Providence Pharmacy Services at the number listed above.