Drug Development and Regulatory Interactions, Article Review Example

Drug development is a long process due to the many regulatory requirements that a drug is subjected to at each stage of review. Ultimately, this often indicates that a drug that has been developed and tested in the laboratory for several years may not reach the final phase of clinical trials for several years, and will then require validation and FDA approval before it could be legally placed on the market. This process makes drug development a risky and expensive investment, as many of the drugs that show promise during preliminary studies are never approved for human use. Therefore, pharmaceutical companies and academic institutions often partner up in order to save funds during this process, which allows more money to be invested in drug development if it is discovered that the promising drugs cannot be approved for a particular use. This strenuous process also causes researchers to determine if there are alternate uses for the drugs they develop, as finding new applications for it is a money saving venture.

While many researchers and industry members think of the typical drug approval process as containing three phases of human trials, it is important to recognize the wealth of work that went into the drug development before the initiation of clinical studies. The pre-clinical stage of research tests many of the important questions that researchers have of the drug, and may include many important pharmacokinetic and pharmacodynamic studies using animal models. Like the clinical stage of research, there is a certain order to the pre-clinical stage, as animal regulatory agencies will not allow drug studies to be conducted on higher animals without some basic evidence that it will be effective. Therefore, many of the drugs that are eventually used in humans are tested utilizing basic chemistry experiments and cultures of human cells. It may take many years to complete these experiments before a research team could provide sufficient evidence that will enable them to test the drug in humans.

An additional concern of researchers is that, even after a lot of money and effort is spend testing a drug in humans, it is possible that it may be removed from the market. Even after a drug is approved for use by the FDA, researchers continue to collect data about it to determine its more long-term effects. It is often impossible to determine the full extent of side effects during a clinical trial, because these often need to only last a few years for the pre-clinical results to be validated. If these trials last longer than the minimum, it is possible that our scientific knowledge of the drug and the disorder that it is intended to treat will change significantly before it is able to provide any benefit to the target population. Therefore, it is important for researchers to speed up the clinical trials, or it is difficult to argue that the drug will contribute to scientific progress in a timely manner.

Ultimately, the drug development and regulatory process works in such a manner that the pharmaceutical industry and the regulatory agencies must work together for a drug to be released on the market. However, true cooperation rarely occurs between the two. A very small percentage of drugs are released on the market, even if they show promise for a small portion of the population. It is important to find ways for there to be more agreement on what can and cannot be released to the public, especially in situations in which there are few options for terminally ill patients, such as those with certain forms of cancer. Many of these individuals would prefer to try experimental drugs over not taking any medication, as taking no action will certainly not promote their recovery, while taking drugs with some potential of efficacy may help.

When evaluating the extent of research that goes into the drug discovery stage, it is surprising that federal agencies are not convinced with the potential of these drugs. While it is certainly necessary to test these drugs in humans to confirm that they work similarly in the target population as they do in isolation and for laboratory animals, the drug development process is very detailed and ordered. Most of the time, the information gained from this development is very valuable, and contributes to a greater understanding of how a drug works in addition to potential applications it could have. Furthermore, these studies give us an understanding about the level of toxicity that the drug could have based on our metabolism, and also provide us information concerning the drug’s mechanism of action. While some variables can be missed during this evaluation phase, scientists are careful to minimize this. Therefore, clinical trials should simply be confirmatory studies of these preliminary results, but this is unfortunately not the case.

Once a research team decides to pursue a drug, they often conduct a series of pre-clinical testing that includes dosing information based on weight, chemical analysis, binding studies, and toxicology tests. These are many of the same tests that are repeated in humans during clinical trials, and for many drugs, these tests results are similar. It is important to emphasize that the researchers must be accurate in calculating the dosage for humans based on the understanding of dosage for laboratory animals and accurately understand the relationship between animal toxicity and human toxicity. However, if this is done correctly, there shouldn’t be many unknown variables by the time that the clinical trial begins.

A major problem that occurs in these early pre-clinical laboratory experiments is that researchers often use a small number of animals and high doses of medication in order to determine the most detrimental effects that would occur as a consequence of the drug. This is somewhat helpful because it does provide us information about extreme situations, and it will be useful to look out for these extreme reaction during a clinical trial so that we can make decisions about withdrawing patients from a study. However, it would be beneficial to the field as a whole if we were to mimic the three phases of the clinical trials in animals before bringing the study to humans. In order to be sure that we are gaining statistically significant results, it is not sufficient to complete a mock phase I clinical trial with mice, as the population size is too small. Rather, we should complete a large scale trial to determine how the side effects of the medication varies over a large group.

While researchers who develop new pharmaceuticals are primarily concerned with the FDA and related regulatory agencies that approve these drugs for human testing and use, it is essential to emphasize that drug development progress is also inhibited by animal review boards. At each phase of the study, regardless of whether it is pre-clinical or clinical, the researchers must demonstrate that their work is ethical and shows promise for contributing to a greater cause. Ultimately, it appears that a lot of time in the research process goes into simply confirming that the work is ethical. While this is not a negative aspect, it is important to consider that approval from review agencies takes a long period of time. Therefore, even agreeable studies are often not started in a timely manner to ensure that compliance is met. This process is made even lengthier when a simple mistake in the application is made and it must be revised and resubmitted. Often, these mistakes have no impact on the ethicality of the study, which is what makes this process a hindrance.

One of the highest potentials for a delay before research could start is when the IND is submitted to the FDA for approval. Even if the IND is submitted correctly, approval means that the research team must wait for 30 days before they can continue with their plans. The time that researchers must wait for similar approval varies across the world and can last up to 8 months in some instances. Therefore, it is difficult to initiate many international clinical trials in the interest of saving time.

In conclusion, the drug development and approval process is very time consuming, and the regulatory process may actually hinder the ability of many individuals to receive lifesaving drugs. While it is necessary to ensure that these studies are ethical and that there is a rationalization for the drug, it would be beneficial to expedite the regulatory process so that effective drugs can be approved and put on the market more rapidly. This information is relevant to what is going on in the drug industry today because it describes the lengthy process that all researchers must undertake to develop drugs for a variety of illnesses. Overall, it could take a drug more than 15 years from initial development to be approved by regulatory agencies after a series of clinical trials. This is detrimental because it discourages many academic institutions to participate in drug development because of the funds that this length of investment requires. In many cases, it is important to emphasize that an approved drug can later be removed from the market at the request of the FDA. Therefore, there is a very small likelihood that research institutions will receive a return on their investment, which causes them to abandon the research of many potential drugs. As a consequence, this system does not favor the sick who would benefit from the drugs that have already been developed, it favors whatever will make money. Since drug development is a rigorous, time consuming, and expensive process, researchers tend to develop only those that will make them the most money if it were to be successful. It is important for us to reconsider the manner in which we are developing and approving drugs across the world. The real purpose of drug development is to cure human disease, and we have not been able to effectively accomplish this using our current system. Improvements must be made.