Before enactment of the Federal Food, Drug and Cosmetic Act of 1938, drugs could be marketed in the United States as long as a drug's label did not present false information regarding the drug's strength and purity. The Federal Food, Drug and Cosmetic Act first established the requirement that a manufacturer has to prove the safety of a drug before the manufacturer could market it in the United States.

In accordance with that statute, drugs marketed before the passage of the Federal Food, Drug and Cosmetic Act were "grand fathered" so that manufacturers, if they do not change the representations on the drugs' labels, were allowed to continue to market them unless evidence was developed to indicate that they were not safe (referred to as pre-38 drugs). However, once a manufacturer changed the representation on a pre-38 drug's label, that drug was considered by the Food and Drug Administration to be a "new drug" and the manufacturer was required to prove that the drug was safe for its intended use.

In 1962, the Federal Food, Drug and Cosmetic Act was amended to require that drugs sold in the United States be regulated more closely. Under the provisions of the Drugs Amendments of 1962 (Public Law 87-781), all new drugs must be shown by adequate studies to be both safe and effective before they can be marketed. This legislation also applied retroactively to all drugs approved as safe from 1938 to 1962 (referred to as pre-62 drugs). These pre-62 drugs were permitted to remain on the market while evidence of their effectiveness was reviewed. The program established under which the Federal Drug Administration (FDA) would review the effectiveness of drugs approved between 1938 and 1962 was named the Drug Efficacy Study Implementation (DESI) program.

If the DESI review indicates a lack of substantial evidence of a drug's effectiveness for all of its labeled indications, the FDA will publish a Notice of Opportunity for a hearing (NOOH) in the Federal Register concerning its proposal to withdraw approval of the drug for marketing. At that time, a manufacturer of that drug or identical, related or similar (IRS) drugs has the opportunity to request a hearing and provide FDA with documentation of the effectiveness of the drug product before a final determination is made. Drugs for which a NOOH has been published are referred to as less-than-effective (LTE) drugs. The IRS counterpart of a LTE drug is also considered as LTE.

In accordance with Section 1903(i)(5) of the Social Security Act, federal funds participation (FFP) is not available for LTE/IRS drugs for which a NOOH is issued for all labeled indications. This means that State Medicaid programs paying for LTE/IRS drugs must do so entirely with state funds.

Each calendar quarter, the Centers for Medicare & Medicaid Services publishes a list of LTE/IRS drugs which has been reviewed for accuracy by the FDA. This list is available in the downloads section below.

Downloads
List of LTE/IRS Drugs [PDF, 46KB]
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Page Last Modified: 12/17/2008 11:20:09 AM
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