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What common drugs are not FDA Approved?

The FDA (Food and Drug Administration) go through a thorough process to approve the medication for specific age ranges and uses. Unapproved prescription drugs pose a significantly increased risk to anyone who takes them as the FDA has not effectively reviewed them to ensure the medications:

  • Safety
  • Quality
  • Effectiveness

When the FDA has not thoroughly reviewed the medication, there is no way to identify if the drugs are effective for what they are being taken for or if they are even safe within the human body. Unapproved drugs will result in many patient injuries that will pose a life-threatening consequences to the individual.

The law requires FDA approval.

The US federal law requires all new drugs developed in the United States to be effective for their intended use and safe before any marketing materials go out. However, drugs are available within the USA despite not receiving the required FDA approval.

The FDA will permit the occasional unapproved prescription drugs t be marketed to the public if:

  • The is an insufficient supply of an FDA-approved drugs
  • The drug has become subject to an open drug efficacy study implementation program (DESI)
  • Medical and health care professionals heavily rely on the specific drug to treat an array of severe medication conditions in which there are no FDA-approved medications to treat the said condition

The law within the United States allows for specific unapproved prescription drugs to be lawfully marketed to the public if they meet the above criteria and are generally recognized as effective, safe or grandfathered. “Grandfathered” – Allowing an individual who has been stabilized on medication to continue taking it without meeting any authorization criteria.”

FDA drug approval process

Within the medical industry, if a pharmaceutical company seeking to gain FDA approval for a new drug, they must first complete a 5 step process; this can be seen to include thorough evidence of:

  • Discovery and concept
  • Preclinical research
  • Clinical research
  • FDA review
  • FDA post-market safety monitoring

After the test of the drug at hand, the pharmaceutical company must then send the FDA a new drug application known as an NDA, which must include the following:

  • All of the drug test results
  • All data gathered during the animal studies and human clinical trials
  • Manufacturing information demonstrates the company can effectively manufacture the drug
  • The companies proposed labels for the drugs, which include uses for which have been most effective, exactly how to use the drug and any possible risks that may occur

Search unapproved FDA drugs

Identifying what drugs have and have not been signed off and approved by the FDA should be a straightforward task; however, you may need to do some digging to find out what drugs have been approved and what drugs have. The following listed databases can help individuals identify what drugs have been approved by the FDA and which drugs should be taken with caution:

  • Orange book
    • The orange book is the common name for the database; the medical profession will refer to the publication as the Approved Drug Products with Therapeutic Equivalence Evaluations. It helps anyone interested in finding out what drugs are on the approved list based on their safety and effectiveness.
  • National Drug Code Directory (NCD)
    • The NCD continuously publishes data derived from information summited to the agency as part of the drug listing requirements, which will include information regarding drugs that are unapproved by the FDA.

Unapproved drug awareness

The medical field is continuously improving, working on new drug trials to cure all kinds of diseases; however, when it comes to certain severe diseases such as cancer, medical professionals sometimes opt to use medications that the FDA has not approved.

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