The Drug Approval Process is More Daunting Than You Think
The research to product pipeline in drug development takes decades and costs billions. Learn how this process protects (and hinders) the consumer.
When you pick up a prescription at the pharmacy, do you know how it got there?
It wasn’t just a matter of loading it onto a truck. Someone had to come up with the idea for the drug, and it was probably decades before it was available at CVS.
It’s a long and complicated process to develop and market even the simplest drug, and like anything that involves regulatory approval, there are some major controversies attached to it. Here, I’ll give you a brief overview of how bringing a drug to market works, and why people criticize the process.
Although the majority of drugs are developed by pharmaceutical companies, research will often start at a nonprofit or academic organization. The express goal of their research may not focus on a specific disease or condition, but may produce knowledge of a method or mechanism that is useful to drug development.
A good example of this is CRISPR. Jennifer Doudna and Emmanuelle Charpentier did not deliberately set out to develop a world-changing gene editing technique and win a Nobel prize in chemistry. Nevertheless, they developed CRISPR, and now gene-editing treatments are being developed globally. In fact, a CRISPR-based treatment of sickle cell disease was recently approved by the Food and Drug Administration (FDA).
After a certain point, however, research tends to transition to the corporate world. Because academic labs are not focused on making a profit, they have more freedom in the direction they take with their research. However, they often lack the funding and resources to fully develop a drug or treatment. At this point, pharmaceutical or biotech companies will license an academically-developed method, like CRISPR, or build off of research previously published by an academic or for-profit lab.
This process takes time. A drug can spend more than a decade in research and development, and that’s not counting the years dedicated to the research its development was built on. Beyond that, there’s no guarantee of success. If a drug is proven to be toxic five years into the process, it’s done for. Companies can’t bring a dangerous drug to market (and rightly so), and so they’re only going to invest time and energy into good ones.
Once a company has a good drug candidate, they have to complete two tasks: apply for a patent and apply for regulatory approval. It’s worth noting that these two tasks happen completely independently of each other. As far as the FDA is concerned, the patent office does not exist, and vice versa. However, in the interest of protecting its rights to the product, a company generally starts the patent process before beginning regulatory approval.
It takes an average of 22 months for a patent to be approved. Costs vary, but it will cost at least tens of thousands of dollars for the application. Then costs increase when you factor in lawyers fees and litigation costs. Afterward, the patent is only valid for 20 years from the date the patent application was filed. Once those 20 years end, generic drug brands can enter the market and produce the drug as well, generally selling it to consumers at a much cheaper price, although companies can sometimes finesse the system to extend their patent rights.
The patent process is controversial to most people, although for different reasons. Opponents of the United States’ system argue that it’s often misused, pushing off generic competition for years at a time at the expense of the consumer.
Companies will develop ‘patent thickets,’ covering their product in multiple different patents to extend their exclusivity. In order to produce the drug, a generic brand would have to challenge each patent, an expensive and time-consuming process. Because of the lack of competition prompted by patent thickets, drug companies can continue to sell their drugs to consumers at a higher price. Name-brand drugs are a billion dollar industry in the U.S. and can set their prices at will because consumers don’t have any other choice.
On the flip side, the patent process, while needing some reforms, is entirely necessary for innovation. The cost to bring a drug to market is absurdly high – often costing upward of $1 billion – and patents serve to justify this cost. When companies know they will reap the benefits of their innovation for 20 years, they’re more likely to pursue higher risk projects. In this case, patents protect innovation, benefiting the consumer, who gains access to drugs that might not have been developed otherwise.
There are benefits for the consumer in the regulatory approval process, although it’s also expensive and time consuming (see my latest article on regulatory systems and biotechnology for more information). In order to be approved by the FDA, a drug has to go through preclinical and clinical testing. Preclinical is dedicated to testing drug toxicity in cell cultures and animal models. If it’s proven to be safe under those conditions, then the company will proceed to clinical testing, where the treatment is tested on humans in a series of phases intended to limit the risk to the patients undergoing the experimental treatment.
Similar to other expenses, the testing trials will increase the cost of the drug once it hits the market. Despite this, it’s worth the cost to defend the consumer. None of us want to go back to the pre-FDA days where parents could give their children Mrs. Winslow’s Soothing Syrup to help them sleep– unknowingly giving them dangerous amounts of morphine and alcohol.
In short, the idea to implementation pipeline is a long one that needs some changes, but it is dedicated to protecting the average consumer, and we should remember that next time we pick up a prescription at the pharmacy.
Best,
Grace for the Don’t Count Us Out Yet Team
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