New Pharmaceuticals and Their Journey to the Market
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When pharmaceutical companies take on an experimental drug there is a lot of time and money they have to allow for them to maybe make it to market. It’s reported that only 5 in 5,000 drugs that head into preclinical testing even make it to human testing. (Drug approvals - from invention to market, n.d.) A study of the cost has shown that the cost of developing a drug that obtains market approval is $2.6 billion with another $312 million for post-approval development for a life cycle cost of $2.9 billion. (Mullin, Chemical, & News, n.d.)
It all begins in preclinical tests, where the pharmaceutical company perform studies before they test on humans. In vitro testing first, where the future drug is tested in a laboratory and after that in vivo tests, where they test on animals. These tests take 3 ½ years. (Drug approvals - from invention to market, n.d. ). The in vivo tests study and record side effects, adverse effects, addictions, cancerous tumors, or fetal deformities. (Turley, 2014)
After the animal studies are through, the drug company requests permission for human testing from the FDA by submitting an Investigational New Drug (IND) application. The IND shows information from the animal studies that the drug shouldn’t pose a risk to humans and the chemical structure of the compound along with how it is manufactured. If the IND is approved by the FDA, the drug company may begin sending the drug to clinical sites for human testing.
The next three phases are the clinical trials. In phase I, 10 – 100 people who volunteered are used to study and evaluate the safe dose range and the side effects which helps them determine a final, correct dose and the whole process takes about 1 ½ years. (Turley, 2014) During phase II they open the scope up volunteer wise and take on 50 – 100 volunteers. These patients have the disease the drug will actually treat and this part is done to see the extent of the drug’s therapeutic effect. This phase takes usually 2 years. In phase III of the clinical trials even more volunteers are used, several hundred to several thousand, and they all possess the disease for which the drug is intended. Also, double-blind studies, where some receive a placebo and others do not, are performed and neither the patient nor the physician-investigators knows who is who. Phase III testing will usually last 3 years. (Turley, 2014)
Next, the drug company sends all the documentation on the drug to the FDA in a New Drug Application (NDA) where they then wait for a final decision of approval or denial. It is the FDAs responsibility to evaluate new drugs based on the company’s findings of the risks and benefits of the drug. This process usually takes about 2 ½ years. (Drug approvals - from invention to market, n.d. ). In conclusion, what I’ve learned is that it is a long journey for a new drug to reach the market, in which takes a lot of people to achieve. All totaled up, it’s around a 12 year journey that costs $2.9 billion for the pharmaceutical company to even think about doing in the first place. Also, the FDA plays a vital role in taking on the responsibility for the safety and effectiveness of all the drugs and I’m a lot more thankful for them as well.

References

Drug approvals - from invention to market. Retrieved January 26, 2016, from http://www.medicinenet.com/script/main/art.asp?articlekey=9877

Turley, S. M. (2014-12-01). Understanding Pharmacology for Health Professionals, 5th Edition. [VitalSource Bookshelf Online]. Retrieved 27 January 2016, from https://devry.vitalsource.com/#/books/9781323059272/

Mullin, R., Chemical, & News, E. Cost to develop new pharmaceutical drug now exceeds $2.5B. Retrieved January 27, 2016, from http://www.scientificamerican.com/article/cost-to-develop-new-pharmaceutical-drug-now-exceeds-2-5b/