The Long, Costly Journey of a Drug

The Long, Costly Journey of a Drug

Despite the pandemic, some things never change. That includes the growing demand for healthcare and pharmaceuticals.

According to Fitch, this industry’s outlook in 2021 will be stable even with the pressing threat of a slow economic recovery, recession, and less control on prices. For those with brilliant scientific minds, getting into the field is a lucrative idea.

Creating pharmaceutical drugs, though, come with plenty of questions, particularly for new entrepreneurs. How long does it take? Will the FDA approve it right away? How much does it cost?

The Complicated Process

According to the Food and Drug Administration (FDA), drug development goes through four phases:

• Research and development
• Preclinical stage
• Clinical trials
• FDA approval or review
• FDA monitoring

While it sounds short, overall, the journey of medication takes an astonishing 10 years from research to marketing or launching. The majority of that revolves around clinical trials, which can last between 6 and 7 years.

Why are clinical trials long? The studies aim to answer at least two critical questions about the drug: Is it safe, and is it effective?

Clinical trials also involve a growing number of participants in each phase, all of which should meet the drug developer, researcher, and/or sponsor criteria. Usually, the earlier studies, particularly phase 1, include few recruits. As the trials move forward, the team needs to look for thousands of volunteers.

Other factors that can affect the trial include:

• FDA approval – It can take at least a month for the agency to review the application for a clinical trial. On rare occasions, it might order a cessation of the investigation or a clinical hold. It usually happens when the FDA believes the trial will place the volunteers or the researchers at significant risks, the researchers are not qualified to conduct the trial, or the application doesn’t provide enough information.
• Cost – Clinical trials are not cheap. On average, the company spends over $45,000 per patient. The higher the phase is, the costlier it gets. Fortunately, many independent researchers can now outsource some analyses and tests to labs like Pion. Expenses become more manageable.
• Drug improvement – Conducting the trials in phases allows investigators to adjust the medications depending on the initial results. This way, by the time these therapeutics become available in the market, they are deemed safe and efficient.
• Number of volunteers – As many as 80% of clinical trials experience delays due to lack of volunteers. Besides healthcare facilities, companies can reach out to organizations that promote trials or link to patients.

medicine tablets on a table

Pleasing the FDA

Before drugs reach the target market, they go through the FDA approval process, which is another waiting period.

According to Drug Watch, it takes about 10 months for the agency to review medication. However, it can apply for a priority review if the investigators believe that the drug offers a breakthrough in managing or treating a disease.

It can also grant emergency use authorizations (EUAs) if it addresses a public health emergency. A good example is the COVID-19 vaccine.

If the drug qualifies as over the counter (OTC), it can skip an FDA pre-approval and avoid further review by the administration as long as it meets the OTC monograph’s criteria.

Also called a recipe book or a rule book, it contains a list of active ingredients or formulations, dosing, and labeling deemed safe and effective for an OTC drug.

Otherwise, companies that want their therapeutics in the market fast can pay a fee to the FDA to hasten the process under the 1992 Prescription Drug User Fee Act (PDUFA).

To create a medication, companies need to be willing to spend time and money on it. But with the rising demand and its ability to help society, these efforts can be worth it.

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