Becoming Accessible in U.S.

Since 1938, Federal law requires that a drug go through the FDA approval process before being administered in the United States. [1] But first, what is a “drug” anyway?

According to the FDA, “a drug is defined as:  [2]

  • A substance recognized by an official pharmacopoeia or formulary.
  • A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
  • A substance (other than food) intended to affect the structure or any function of the body.
  • A substance intended for use as a component of a medicine but not a device or a competent, part or accessory of a device.

Biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing processes (chemical process versus biological process).”

While seeking patients can certainly travel outside of the United States to receive treatment, our goal is to help make desirable treatments more accessible and affordable nationally. Therefore, it would be in our best interest that such drugs complete the FDA approval process, not only making them available locally, but also making it more likely that our insurance will cover its cost.

What must one do to achieve FDA approval for a new drug?  [3]

  1. Gather favorable data from laboratory studies
  2. Obtain a sponsor to take the responsibility for and initiate a clinical investigation
  3. Submit an Investigative New Drug (“IDN”) application to the FDA’s Center for Drug Evaluation and Research (“CDER”); application must contain:
    1. Animal Pharmacology and Toxicology studies
    2. Manufacturing Information
    3. Clinical Protocols and Investigative Information
  4. Begin clinical trials, registering results with ClinicalTrials.gov [4]
  5. Submit a New Drug Application (“NDA”) if sponsor determines that the drug shows evidence of being safe and effective; application requires documentation of the drug’s “whole story,” including what happened from inception through clinical trials, and its ingredients, effects, and packaging, among other things.

What is the average cost to develop a drug and complete the FDA approval process?

As you can see in the chart below, it may cost well over $5 million just for the reviewing process of the drug applications.

Standard Costs (in thousands of dollars) for Components of the Process for the Review of Human Drug Applications [5]

FY 2014 - FY 2024

The expense exponentially increases when considering all costs that go into the development of a drug and gaining market approval. The Tufts Center for the Study of Drug Development (“CSDD”) reports that the total cost is approximately $2.6 billion, increasing 145% over the CSDD’s estimate in 2003. [6]


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