The Process Of Developing New Drugs

Pharmaceutical research is an incredibly complex field. There is a constant stream of new conditions and illnesses that need to be addressed, with extensive government regulation and the constant pressure of doctors, patients, and funders to get the product completed and onto the market quickly.

Amid all that activity, the process of actually developing these drugs is very difficult. It can take many years to take a product from theory to the market, and the entire system is expensive and complex. To give you an idea of why these products don’t appear quite as quickly as TV commercials would suggest, let’s look at just a fragment of the process.

The Facilities

Research facilities are among some of the most scientifically-advanced places on earth. Inside them are endless arrays of complex instruments that cost thousands of dollars. The people operating those instruments are highly educated and very skilled. And the materials they are working with–the test pharmaceuticals, the biological samples, and all the related substances–are incredibly sensitive to the environment, critical to the research, and absolutely irreplaceable.

In the years-long process of developing a new drug, a product may move through multiple facilities. This could be due to the massive size of clinical trials, the need for added equipment, or just because the old facility became obsolete. During this transition time, the research must be carefully protected. The need to carefully preserve these important materials cannot be overstated, so they must be kept in biological storage and properly handled during any type of transit.

The Products

Sometimes the creation of an effective product is just the beginning. Researchers may have achieved exactly what they had hoped to do, but they are only scratching the surface of getting that product patient-ready.

More important than anything, the product must be stable. It may work if administered immediately after manufacture, but will it still be effective after being transported to a pharmacy, held on a shelf until a prescription comes in, and stored at the patient’s home until he or she takes the very last pill? If the product cannot withstand that type of use, it is not practical for patients and will have to be adjusted.

The product must also be consistent. With so many variables associated with the action of a drug inside the body, researchers cannot assume that an improvement in a patient’s condition is definitely due to the drug. They must be able to replicate the active properties in that product again and again.

The Approval

We often shudder at regulation, but the fact of the matter is that it saves lives. There is no more important characteristic of a pharmaceutical product than its safety for human use. If it fails to meet that standard, nothing else matters.

In the United States, that standard is assessed by both the Food & Drug Administration (FDA), a government agency that reviews safety; and by United States Pharmacopeia (USP), which is a private agency that reviews purity and quality.

For both agencies, the process is meticulous and often time-consuming. The frustration of ailing patients and their anxious doctors is almost palpable when these products are in the FDA’s hands, but despite that urgency, the system must run its course properly. Only when the government allows it can prescriptions be issued to the general public.

Because we rarely see all the steps involved in creating a new pharmaceutical, it can be easy to miss just how complicated it is. The reality is that there are countless working hours behind every product that hits the market, and the process of building these products from concept to the pharmacy shelf is a long and difficult one.

Author: Robin Gupta