New Pharmaceutical Drugs to Market, Research Paper Example

Question: Describe the steps required to bring new drugs to market.

The process of bringing a new drug to market, is indeed a rather challenging one that may take as much as 18 years, thousand of man-hours of research, over 3000 patient volunteers, excess of $500 millions per company, and yet only one in 10, 0000 may succeed.

In order to get a product marketed successfully, the process has to start in the pre-clinical testing stage, where laboratory and animal testing are done, to ascertain whether the safety and biological activity meets the required industry standard, to permit future research and investment by the sponsoring company.

The job of the research scientists at this stage, is to find a promising agent, using the understanding of disease, pharmacology, computer science and chemistry. (Lipsky, Sharp, 2001). Clues can be found according to Lipsky and Sharp, when a disease process is broken down into components, and in some cases it may be found that an enzyme is a key component of the process, and these scientists may then work to find ways and means of inhibiting its actions and as a result produce a successful product for the drug market. (Lipsky, Sharp, 2001)

This process may take as much as three years, and if the requirements are met, an Investigational New Drug (IND) application is made to the Food and Drug Administration (FDA).

A successful application will advance the drug to the 1^st Clinical Evaluation Stage, where the drug pharmacological actions and safe dosage rates are determined, as scientists monitors how the product is absorbed, distributed, metabolized, and excreted. (Lipsky, Sharp, 2001)

According to Drugs.com, a total of 20 to 80 volunteer patients, who are suffering from the disease and for whom whose cures are being sought, are engaged in the experiment, to establish the drugs safety and profile, during a period approximately one year. (www.drugs.com, 09/13/10)

The drug is usually given at the low dosage level initially to protect the health of the volunteers, and then gradually increased afterwards, as more and more reaction information is generated.

Any drug that meets the stringent requirements of this level, is advance to the 2^nd Clinical Evaluation stage, where controlled studies are done on patient volunteers to assess its effectiveness.  According to Lipsky and Sharp, simultaneous studies using rats and humans are done to examine further safety of the drug. (Lipsky, Sharp, 2001)

This phase of the process covers a period of two years, and involves 100 to 300 volunteer patients according to Drugs.com and on successful completion it is passed to the 3^rd Clinical Evaluation stage, where testing is done on a greater number of patients, usually in the 1000 to 3000 range. (www.drugs.com, 09/13/10)

The patients are administered the drugs, under hospital and clinic conditions by qualified physicians, so that its efficacy and adverse reactions can be recorded and reported. The reports after a period of three years, are expected to match that of the previous clinical stage in terms of efficacy and low incidence adverse reactions, in order for the drug to move to the next stage.  In order to do so, the sponsoring company is then require to submit a New Drug Application (NDA) to the FDA. (www.drugs.com, 09/13/10)

On this application, which may have as much as 10,000 pages, information regarding the drug chemical composition and its manufacturing process, the pharmacology and toxicity of the compound, human pharmakinetics, the results of trials, and the proposed labeling is required, in order to meet the FDA approval. (Lipsky, Sharp, 2001)

The average total research and development cost for any new drugs during the late 1990’s according to Moran was $897m, a 200% increase on the cost for the1970’s. (Moran, M. 2003)  These increases the writer notes, came as a result of developmental cost associated with clinical test, which are different from what basic research requires.

He also says, that the number of subjects has increased since the 1970’s, with more procedures, more tests, and greater complexity in clinical trials. (Moran, M., 2003)

Approval or rejection of NDA by the FDA, usually take a period of 30 months, during which time it  may require further reports on cases of patient that has experienced adverse reactions and other clinical data. It will also independently make its own assessment of the performance of the drug, before making a final decision. (www.drugs.com, 09/13/10)

This phase is also called the Post Marketing, because medical practitioners are required to prescribe the drugs to patients, and report on its performance to the FDA, as well as the sponsor. (Lipsky, Sharp, 2001)

In some situations, where the drug being tested meets unmet needs, it may be placed on a fast track to save the lives on those facing death. The FDA under such condition may approved the application within six month, but require the sponsor to continually submit performance reports for further considerations and evaluations. (Lipsky, Sharp, 2001)

There is also the possibility that a drug may be subjected to a 4^th clinical phase, where the sponsor will try to assess its effect over a longer period, the effect of optimizing the dosages for marketing purposes, the reactions of pediatric patients, as well as the possibility that it could be used for additional purposes not yet identified. (Lipsky, Sharp, 2010)

The process of bringing drugs to the market, is therefore a costly and challenging exercise, with the Pharmaceutical industry investing approximately $12.6b annually, but it is vital to the medical field for the saving of thousands of lives. It is imperative therefore, that all concerned maintain excellent protocol in all aspects, so that lives may not be destroyed through selfishness, greed, impatience, poor scientific work, or a lack of social responsibility, at any phase of trials going forward.

Reference

New Drugs Approval Process, Drugs A-Z www.drugs.com/fda-approval-process.html, 09/13/10, web

Lipsky, M. S., Sharp, L.K., 08/01/2001, From Idea to Market: The Drugs Approval Process JABFP, vol.14 no.5, print

Moran, M., .08/01/2003, Cost of Bringing New Drugs to Market Rising Rapidly, Health Care Economics, www.pn.psychiatryonline.org/conny=tent/38/15/25.full, 09/13/10, p.1 web