The Challenge of Developing New Medicines

When you have a cold, you might go to the pharmacy to purchase some over-the-counter (OTC) cold medicine. Others may need medicines to lessen the impact of allergies or help a headache disappear.

And others will have prescription medicines recommended by their doctors to treat serious or chronic illnesses or conditions, among other needs.

These medications are available due to decades (and in some cases, centuries!) of medical research. The process to review a medical condition, identify a potential solution, test, and ultimately, end up with an FDA-approved medication is a long and arduous task. It’s so difficult…

Less than 12% of medicines that enter clinical testing will be approved by the FDA.


The average cost to develop a new medicine has increased to $2.6 billion.

The medicines that aren’t approved, and the research done to create them, help inform further research and iterations of the drug until the proper medication is created and approved.

Pharmaceutical Research Takes Time

As our understanding of the biology, causes and complications of many diseases evolves, we’re able to develop medications that are more targeted and more successful at treating various illnesses and conditions. It’s an exciting time for medical research, but this research requires a lot of time and effort in order to be successful.

Medicines aren’t developed quickly – it can take years to create a medication ready for testing, and then many further years of clinical analysis and testing. Only then will the FDA assess whether or not the medication is both safe and effective – at which point it can begin to be made available to the general population.

Pharmaceutical Research Is Complex – And Evolving

The ways in which new medicines are discovered and tested are continuously changing. Various groups must work together, including patient advocacy groups, academic and government researchers, the FDA and biopharmaceutical companies. Their combined efforts must follow regulations with regard to research and testing, while constantly using the latest technology and the most up-to-date medical research to help their studies proceed efficiently, safely and with the best opportunity for success.

Below, you’ll find a video that explains the challenges associated with developing treatments and cures for the thousands of diseases, illnesses and ailments afflicting people worldwide.

Patient Volunteers Are Critical

Recruiting patients for studies can be extremely difficult, but these patients are necessary. A tremendous amount of research occurs to make a medication ready for patients to test, but these researchers have to test these new medicines on volunteers before they can bring a medication to the public.

If you’re interested in participating in a clinical trial, talk to your doctor, or research opportunities online through websites such as National Institutes of Health: Clinical Center;; National Cancer Institute and CenterWatch. Speak to your doctor before ever agreeing to participate in a clinical trial.

Pharmaceutical Discoveries Are Occurring Right Now

A record 45 new drugs were approved in 2015, marking the highest number of drugs approved in a single year in nearly 20 years (learn more about this in the FDA’s Center for Drug Evaluation and Research’s Novel New Drugs Summary).

And biopharmaceutical companies are on track to introduce even more in 2016, seeking ever better ways to treat and cure conditions affecting people of all ages, ethnicities, lifestyles and health diagnoses.

The process to develop these medicines is long and complex, but every treatment – and every happier patient – is worth the wait.