When a new pharmaceutical is invented, several steps need to be taken in order for it to be brought to the market. Effectively marketing is an essential process, which is preceded by primarily drug development and drug manufacturing. It is very important to find just the right chemicals that will be able to pass all the testing, as well as get approved by FDA. Only after these phases are behind, a successful marketing campaign is possible.
Usually, newly emerging drugs are represented by either a totally new chemical substance or are a result of molecular engineering manipulations of already existing substances. But it does not make any difference, how the substance was discovered, as the developers are still obliged to perform tests according to FDA guidelines to ensure the drug is safe and effective. Such tests can be divided into two phases according to their location.
The first phase involves in vitro testing when the chemical analysis is carried out. The second phase is done on animals, unusually rats, and is termed in vivo testing. During this phase, any adverse effects, such as addictiveness, toxicity, and oncogenicity are being tested and evaluated. This testing phase also includes such attributes as a therapeutic index, which determines the margin between a therapeutic and a toxic dose (Turley, 2003).
Only after the animal trials are over, the drug developer can advance to the next stage, which is human testing. However, in order to conduct human trials, FDA permission is strictly required. Human testing consists of three phases. During phase 1 such aspects, as safe dosage, optimal dosage, and side effects of a medication are determined. For this purpose up to 100 healthy individuals can be involved. Phase 1 also gives insight into drug absorption, metabolism, and excretion.
The next phase determines the therapeutic effect of the drug on humans. For this phase, the actual patients who suffer from a disease that the drug is for are used.
The final third phase works involve a much greater cohort of individuals who suffer from the disease, in fact, the drug is administered in exactly the same manner it would be administered, once passed all the tests, except with the use of placebos. During this phase comparison with other similar medications is made, and double-blind studies are performed to ensure effectiveness.
The human trials are rather a lengthy process with phase 1 lasting for an average of 18 months, phase 2 – 24 months, and phase 3 being the longest – 42 months (Goozner, 2004). According to the FDA guidelines, it is important to evaluate how a drug works in both men and women. After all the testing is complete, FDA it is up to FDA to decide on approval or denial of a new medication. FDA makes evaluations and assumptions based on supplied documentation of the trial’s results. After examining all the possible risks and benefits, it makes the final decision. However positive verdicts are made in only about 20% of the cases. After approval was made, it is too late to change anything concerning labeling, manufacturing, ingredients, packaging, or dosage.
After a company was granted approval from FDA, it is protected by a 17-year patent. However a part of this time is lost to testing and approval, therefore it is sometimes allowed to get back up to 5 years on this patent. After the 17-year patent is over, other companies can manufacture the drug under a different name, hence it is necessary to have a successful marketing campaign so that the label would gain enough popularity and the physicians would keep prescribing it even after other makes of the same drug would be available in the future.
In order for the drug to be successful on the market an effective advertising campaign is required. It is known that directly advertised medications have a 40% annual sales growth rate, whereas those not advertised are limited by 13% (Angell & Relman, 2002). Drug companies are claiming that their spending on each drug reaches $500 million, however, some analysts believe that this number is closer to $100 million. But it does not matter, as this number is still extremely high, and it is most likely that pharmaceutical companies are trying to compensate the costs of research and development.
References
Angell, M., & Relman, A. S. (2002). Patents, Profits & American Medicine: Conflicts of Interest in the Testing & Marketing of New Drugs. Daedalus, 131(2), 102+.
Goozner, M. (2004). The $800 Million Pill: The Truth behind the Cost of New Drugs. Berkeley, CA: University of California Press.
Turley, Susan. (2003). Understanding Pharmacology for Health Professionals. Third Edition. Pearson Education.