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Before a new drug comes to market, it must go through a long process of
approval by the U.S. Food and Drug Administration (FDA). Today, federal law
requires prescription drugs to be shown to be both safe and effective under the
Kefauver Harris Amendment to the Food, Drug, and Cosmetic Act, which was passed
in 1962. During the approval process, the applicant (drug manufacturer) must
demonstrate that its manufacturing process can reliably produce products with
expected identity, strength, quality, and purity. Additionally, all labelling
must provide necessary information for health care professionals to understand
the product's risks and uses. However, these requirements were not always in
place.
The original Food and Drugs Act of 1906 prohibited the sale of misbranded or
adulterated drugs but did not require FDA approval. In 1938, manufacturers were
required to prove that the new drug was safe, but they were not required to
prove efficacy. Then, in 1962, Congress amended the law and required
manufacturers to show that their drugs were both safe and effective.
Conversely, there are some drugs (mostly older products) that, due to a
variety of historical reasons, have been marketed and used without FDA
approval. These may include:
- drugs available prior to the amended law requiring safety and
efficacy;
- a manufacturer combining two approved products into a combination product
without obtaining approval;
- a manufacturer marketing a currently approved product without obtaining
FDA approval.
Verifying drug status
The
Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
(Orange Book),
identifies FDA-approved drugs that have undergone the mandatory safety and
efficacy requirements of the Federal Food, Drug, and Cosmetic Act. If a
medication is not included in the Orange Book, it has not demonstrated
the requirements in accordance with this Act. Those drugs that entered the
market based solely on safety and/or drugs that were on the market prior to
1938 are not included in the Orange Book.
Many health care providers continue to unknowingly prescribe unapproved
drugs, usually because they are unaware of the non-FDA-approved status of the
drugs.
Effective January 1, 2016, Independence will no longer cover
non-FDA-approved drugs. The table below lists examples of non-FDA-approved
drugs, as well as some FDA-approved alternatives.
Non-FDA-approved drug
Alternative medications |
Alternative medications |
Sulfacetamide/sulfur (Avar®,
Avar-E®, Avar® LS) | Clindamycin/benzoyl
peroxide (Benzaclin®), benzoyl peroxide/erythromycin
(Benzamycin®) |
Lidocaine/menthol patches (RelyyT Patch®, Silvera Pain
Relief) | Lidocaine patch (Lidoderm®) |
Isometheptene/dichloralphenazone/APAP (Migragesic IDA) |
Sumatriptan (Imitrex®), butalbital/caffeine/APAP
(Fioricet®) |
Saliva substitute (NeutraSal®, Aquoral®,
Caphosol®) | Over-the-counter (OTC) saliva products
|
Estrogen, Ester/Me-testosterone (Covaryx®) |
Conjugated estrogens/medroxyprogesterone (Prempro®),
estradiol-norethindrone (Activella®), bazedoxifene/conjugated
estrogens (Duavee®) |
Omega-3/DHA/EPA/Fish oil (Vascazen®),
phyosterol/OM-3/DHA/EPA/FISH (Vayarol®) | Omega-3 acid
Ethyl Esters (Lovaza®) |
Choline Sal/Magnesium Salicylate (CHOLINE MAG TRISAL) | OTC
aspirin, OTC acetaminophen, prescription and OTC ibuprofen |
For more information
To learn more, read the following articles published on the FDA website:
You can send inquiries regarding FDA-approved and non-approved drugs to druginfo@fda.gov.
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