Earlier this year, in his first address to Congress, President Trump criticized the FDA’s drug approval process saying the length of time in which drugs need to be approved is “slow and burdensome.” In many cases, the FDA approval process is both long and expensive, which can drive retail prices up for consumers.
Many argue that this system prevents life-saving drugs from making it to market, or makes them cost-prohibitive, and favor reducing or eliminating FDA regulations altogether.
The other side of the argument is that the United States already has the fastest drug approval system in the world, having streamlined the process over several decades.
Let’s first consider the potential outcomes of deregulation as we examine whether it is the only means by which to quickly introduce new and affordable medications.
The Case for Deregulation
Currently, new drugs go through a six-step process to get to market, which can take as little as nine years or as long as 18 years to complete. The first step in the process is drug discovery and preclinical testing.
The pharmaceutical industry in the United States is known for its extensive research and development. But R&D comes at a price. According to the International Trade Administration, 15 to 20 percent of revenues are allotted to R&D. So clearly R&D plays a role in the cost of our drugs, but it isn’t the whole story.
Once the discovery has yielded compounds for testing, manufacturers conduct preclinical research. Together that discovery/pre-clinical step can take anywhere from three to six years.
In the second step, IND submission, the FDA’s new drug division decides if a drug can be approved for testing on humans. Once a drug is approved for clinical testing, this is when more time and costs are added.
In steps three through five, aka Phase 1-3 clinical trials, the drug sponsor (pharmaceutical company) is conducting extensive testing to assure safety and effectiveness of the drug. Collectively this set of steps can take anywhere from six to 11 years.
The sixth and final step is the FDA approval. This step can typically take as little as six months or as long as two years. That sounds reasonable, right? After all, there are truckloads of data that the FDA needs to analyze in order to complete the approval.
That begs the question: are clinical trial phases so time consuming because of some potentially unnecessary regulatory requirements?
Given the costs and resources needed to bring new drugs to market, some fear the rate at which new and innovative drugs can be introduced will decline. Thus, by eliminating some of the requirements, pharmaceutical companies would be able to introduce new drugs at a faster rate.
The Risks of Deregulation
But, removing regulations all together can be detrimental to patient safety. Under the current FDA drug approval system, pre-clinical and clinical trials help expose the risks a patient assumes by taking a drug.
Introducing a drug to the market without the necessary research could expose patients to adverse events from harmful effects that could have been predicted.
So, there’s a real risk that new drugs that fail to undergo the regulatory approval process would be poorly understood and consequently could do more harm than good. This would in effect, negate any of the potential benefits of deregulation.
The only real solution seems to be the industry and regulators working together to further streamline the process and remove the stifling bottlenecks and requirements in the process.
Getting to Market Under the Current System
While the debate on how best to speed up the drug approval process endures, many companies are keeping an eye on the present by focusing on ways to streamline under the current process.
One simple way to do this is to transition from manual to automated processes. Amazingly, many companies—start-ups and Fortune 500s alike—utilize disjointed systems like paper, email, fax, and spreadsheets to manage products throughout their lifecycle. This isn’t just inefficient, it can also be risky as it increases the odds of losing critical information along the way.
Transitioning to an automated, fully-digital quality system ensures that everyone is working from the same playbook. This helps to eliminate redundant processes that prolong the approval process, or lead to lost information that can delay approvals or get drugs pulled from the market.
When clinical drug development practices are integrated with other key systems and quality procedures, companies can progress faster and work more collaboratively with their partners and the FDA to get approvals, while ensuring the safety of the public throughout the drug’s lifecycle.
About the Author
Joe Goodman is the Director of Solutions Consulting at Sparta Systems. He has specialized in the fields of quality systems, regulatory compliance, and the implementation of enterprise software across the life sciences industry.