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How Does the FDA Determine if a Drug is Safe?

On Behalf of | Oct 26, 2021 | Uncategorized

Have you ever wondered how the medicines you use end up on the shelf of a drug store?

Pharmaceuticals go through a long and complex process to be deemed safe by the Food and Drug Administration (FDA) before they can be prescribed or purchased over-the-counter. Unfortunately, unsafe pharmaceutical products have made it through the testing process and are released into the market, causing harm to the people who take them. It is important that we understand the process that drugs and other pharmaceuticals go through to be deemed safe for consumption, as any deviations from this process could result in an unsafe medication. Here, the pharmaceutical liability attorneys at Peter Angelos Law explain the drug approval process and provide insight into what legal action can be taken if you are impacted by an unsafe medication.

Preliminary Development of Pharmaceuticals

To begin the process, the scientist or company attempting to develop the new medication must submit an Investigational New Drug Application (IND). This allows a pharmaceutical company to begin any clinical trials as well as grants them legal permission to ship the experimental drug across state lines before marketing has been approved. Almost all drugs and pharmaceuticals have been tested on animals before they are able to submit an IND.

INDs can be divided into three categories, depending on what the pharmaceutical company’s goals are for the clinical trials. Pre-clinical testing INDs allow for animal pharmacology and toxicology studies to determine if the drug is safe to begin clinical trials in humans. Manufacturing information INDs are used to ensure that a company can adequately produce and supply consistent batches of the drug assuming that it gets approved for use. These require the pharmaceutical company to provide information such as drug composition, proposed manufacturer, stability of the drug as well as the controls used for manufacturing the drug. The final type of IND is an investigator information IND, which is used to assess whether those running the clinical trials are qualified enough to do so.

Much work has to go into a proposed drug before a pharmaceutical company can even apply for an IND. Often, months of work and collaboration with the FDA has already been completed before the IND application process even begins.

The IND application is then reviewed by a local institutional review board (IRB). The IRB is made up of a panel of scientists and non-scientists who work in hospitals and research institutions that oversee clinical research. The IRB can either reject or approve the proposed clinical trial protocols which include details such as the type of people who may participate in the clinical trial, the schedule of tests and procedures, the medication and dosages to be studied, the length of the study, the study’s objectives, and other pertinent details.

Clinical Trials for New Pharmaceuticals

Once an IND is granted, the pharmaceutical company may begin their clinical trials. The first step to this process is Phase I testing, which emphasizes drug safety. These clinical trials are typically conducted using healthy volunteers, and the goal is to determine what the drugs’ most frequent side effects are. Those running the trials also gather important data on how quickly the drug is metabolized and excreted. Phase I tests typically have between 20 to 80 subjects.

If Phase I studies do not reveal any unacceptable levels of toxicity, the drug may move on to Phase II testing. Phase II testing closely examines the effectiveness of a drug. In addition, it aims to discover if the drug works the same in individuals who have other health conditions. For controlled trials, two subject groups are used: those who receive the drug and those who receive a different treatment, typically an inactive substance, a placebo, or a different drug. The scientists running the trials examine the drug’s effectiveness by comparing the data collected from the two groups. Phase II tests can range in size from a few dozen subjects to nearly 300 subjects.

After the data from Phase II tests are compiled, the FDA and the sponsor of the proposed pharmaceutical will meet to come to an agreement on how large studies in Phase III need to be. This is one of the most pivotal agreements the FDA and the pharmaceutical company will make prior to the launch of a new drug, as the details of the Phase III testing will directly impact how a drug can be marketed.

Phase III testing will help to gather more information about the safety and the effectiveness of the new drug, and study the drug on a much larger scale than either previous clinical trials. Phase III will look at different populations and different dosages, as well as look at how the drug works when interacting with other medications. The amount of subjects in Phase III testing is much larger, usually ranging from several hundred subjects to nearly 3,000 subjects.

After all three required clinical trials are completed, additional testing may be conducted. Postmarket requirement and commitment studies can be voluntarily completed by the pharmaceutical company or an additional requirement from the FDA. These studies are used to gain more insight into a drug’s safety, efficacy, or optimal use. Sometimes, these studies reveal that a drug is more effective at treating a different condition than its intended purpose.

Review of New Drug Clinical Trials & New Drug Applications

Once all required and voluntary testing is completed, a pharmaceutical company can formally ask the FDA to consider approving the new drug for marketing. The pharmaceutical company submits a New Drug Application (NDA), which includes a compilation of all data collected from both animal and human trials, information about how the drug behaves in the body, and a detailed process of how the drug is manufactured.

Once the NDA is submitted, the FDA has 60 days to decide whether or not to review it. The FDA may refuse to review an application if it feels it is incomplete. For instance, if required studies are missing or if the FDA feels that the studies are not comprehensive, they may reject the application. The FDA does have requirements for how quickly they review NDAs and how many they review. According to their website, the FDA acts “in accordance with the Prescription Drug User Fee Act (PDUFA) [and] the FDA’s Center for Drug Evaluation and Research (CDER) expects to review and act on at least 90% of NDAs for standard drugs no later than 10 months after the applications are received”. The review goal for priority drugs is six months.

In the drug approval process, it is typically the clinical trials that take the longest, sometimes many years. The FDA tries to emphasize speed in the review process so that safe and effective drugs can go to market as quickly as possible.

Filing the New Drug Application

If an NDA is approved, it is filed and an FDA review team is assigned to closely evaluate the research on the drug’s safety and effectiveness. This review team is made up of a variety of different professionals, including medical doctors, chemists, statisticians, microbiologists, pharmacologists and other experts to get a comprehensive analysis of the drug. The team is not looking to see if there are no side effects to the drug, as all medications have some side effects. Rather, they will deem the drug “safe” if the benefits of the drug outweigh the known risks.

Reviewal of Drug Labeling & Production Facilities

After the panel completes their analysis of the research, the FDA moves on to reviewing the professional labeling of the drug. The FDA has extensive requirements for labeling, including prescribing information, medication guides, instructions for use, patient information, and the labeling of the physical container the drug will be sold in. This is a critical point in the reviewal process, as it deals with the materials that will be provided to consumers regarding proper use of the drug. It is essential that the appropriate information be communicated clearly and accurately.

In addition to taking a close look at the labeling, the FDA will inspect the facilities in which the drug will be manufactured as a part of the approval process. The facility must meet all appropriate standards before production can begin.

Approval of New Drugs

If a drug passes all inspections and the review team feels that the drug is safe, the pharmaceutical company is granted the NDA and they are able to begin marketing the drug.

In some instances, pharmaceuticals can have an accelerated approval process. This is common for those drugs that are for serious and life-threatening illnesses that currently lack satisfactory treatments. In an accelerated approval, the NDA is approved before the measures of effectiveness that would typically be required for approval are available. Instead, the trial will utilize surrogate endpoints to evaluate a drug’s effectiveness. Surrogate endpoints are laboratory findings that may not be a direct measurement of how a patient feels, functions, or survive, but are statistically likely to predict benefit.

Pharmaceutical Liability & the New Drug Approval Process

Although the new drug approval process is lengthy and requires extensive research, unsafe pharmaceutical products are put into the market far too often. Some critics feel that large pharmaceutical companies pressure the FDA to approve drugs too quickly, interpreting data to skew results. Sometimes, further studies reveal that there is a potential link between taking a drug and developing a particular health problem. In other instances, previously unknown drug interactions may come to light after a drug is put onto the market. Regardless of the reason, it is important that consumers who were harmed by an unsafe drug are able to seek justice for any harm done.

Consult With The Experienced Pharmaceutical Liability Lawyers at Peter Angelos Law

When we take a medication that has been approved by the FDA, we trust that the rigorous approval process will ensure that the drug is truly safe for our consumption. However, many unsafe medications slip through the cracks and can end up on the market, causing harm to consumers. If you or someone you love has suffered health complications or death as a result of an unsafe drug, the team at Peter Angelos Law stands by you. While financial compensation cannot reverse the harm done from unsafe medications, it can offer financial relief and allow you to seek justice from large pharmaceutical companies. Contact our office today or fill out the form below to share more about your case.