Why do some drugs cost so much? What is the government doing to make sure these drugs are safe? What’s the process of getting a drug approved in the United States?

Theses are valid questions, and Jay Harold will attempt to show why some drugs cost so much in this post. Let’s start with the government agency responsible for approving drugs in the United States.

The Food and Drug Administration¹ (FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.

The process of how drugs are developed is long and complicated. The FDA’s Center for Drug Evaluation and Research² (CDER) job is to ensure that drugs marketed in this country are safe and effective. For a detailed summary of the drug approval process, click on this link.

The costs associated with the drug approval process is considerable. Millions of dollars are often spent on the testing of a drug treating a common disease. The costs are much higher for drugs that treat rare diseases. A novel drug is innovative new products that never before have been used in clinical practice. Here’s what the FDA says about novel drugs.

Why are drugs so expensive?

Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. With its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat, FDA provides scientific and regulatory advice needed to bring new therapies to market.

The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public. For this reason, CDER supports innovation and plays an essential role in helping to advance new drug development.

Each year, CDER approves a broad range of new drugs and biological products. Some of these products are innovative new products that never before have been used in clinical practice. Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace.

Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product; these products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but nonetheless, contain active moieties that are closely related to active moieties in products that have previously been approved by FDA. For example, CDER classifies biological products submitted in an application under section 351(a) of the Public Health Service Act as NMEs for purposes of FDA review, regardless of whether the Agency previously has approved a related active moiety in a different product. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act.

Below is a list of the Novel Drug approvals for 2016.  For more detailed information, click on the underlined word or go to Medlineplus³.

A novel drug was approved to treat women with a certain type of ovarian cancer in 2016.

* This information is currently accurate. In rare instances, it may be necessary for FDA to change a drug’s new molecular entity (NME) designation or the status of its application as a novel new biologics license application (BLA).  For instance, new information may become available which could lead to a reconsideration of the original designation or status.  If changes must be made to a drug’s designation or the status of an application as a novel BLA, the Agency intends to communicate the nature of, and the reason for, any revisions as appropriate.

Novel drugs approved in 2016 ranged from treatments of partial onset seizures, dry eye disease, and recurrent prostate cancer. Unfortunately, this quote applies to novel drugs:

“The best things in life are free. The second best things are very, very expensive.”― Coco Chanel

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Bibliography

1. https://www.fda.gov/default.htm
2. https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/
3. https://medlineplus.gov/
4. https://vsearch.nlm.nih.gov/vivisimo/cgi-bin/query-meta?v%3Aproject=medlineplus&v%3Asources=medlineplus-bundle&query=Clostridium+difficile