It seems like every day, we hear news of hopeful scientific discoveries that could one day cure a specific disease or diversify the treatment options available to certain types of suffering patients. But then we don’t hear any updates for years, if we hear any updates at all. The number of new drugs and new medical treatments introduced each year is staggeringly small—which is troubling, considering the rise of superbugs and the arms-race like need to develop new antibiotics to fight against them.
There’s no shortage of scientists and pharmaceutical specialists passionate about discovering new treatment options, nor is there some massive obstacle to scientific discovery. Instead, new drugs and treatments often get stopped at the approval stage—in the United States, that usually means at the Food and Drug Administration (FDA).
So why is it so hard for new drugs to be approved?
First and foremost, we have to acknowledge that some medical products end up having side effects and unintended consequences for the people using them. This occurs even in FDA-approved medications, so it’s something we need to be extra cautious in attempting to prevent. For example, Valsartan (Diovan) was once a popular medication used to treat high blood pressure and congestive heart failure (CHF). Last year, the FDA recalled the medication after it was revealed to be linked to cancer.
It’s incredibly difficult to predict what types of dangers exist for a given medication or treatment, especially because it might take months to years of consistent use for these side effects to be evident. However, regulatory agencies want to reduce the chances of these side effects slipping through as much as possible, so they demand many long-term experiments before they approve any new medical products.
Regulatory Processes and “Red Tape”
The FDA is also frequently blamed for being overly bureaucratic, and having too many approval processes that delay the approval process, at minimal benefit to the end consumer. Without having full transparent access to the organization, it’s hard to say for sure. Some of these processes are clearly designed not to arbitrarily delay the approval process, but to ensure consumer safety. At the same time, it seems a given that some of these approval stages may be overly redundant or time-consuming.
FDA critics have suggested working on a compromise that would allow the FDA to retain some degree of regulatory control while also opening a backdoor to innovation, which pharmaceutical companies could use to develop and approve products faster.
Lack of Developmental Resources
Sometimes, the problem lies with a lack of resources for developing the drug beyond the initial stages of discovery. To support a drug or treatment, researchers need to evaluate the drug under many different conditions, and under strict scrutiny. The entire process is labor-intensive, time-consuming, and most importantly, expensive. If the people or organization responsible for developing the drug doesn’t have access to the resources they need, they won’t be able to pursue development any further.
If the drug at any point looks questionable, funding and effort could be cut immediately. This is especially true for treatments that arise for problems that don’t yet exist; for example, if a scientist discovers a potential cure for many types of unknown viruses, but it doesn’t apply to any pressing patient needs, it would be much harder to follow the normal course of development.
Difficulty With Experimentation
Following procedures for experimentation with a new drug or product can also be difficult. Traditionally, a product must go through a series of trials in labs, with animals, and finally with an increasing number of people. These experiments often take years, and can be extremely difficult to organize, even with experience in the field.
Fortunately, the FDA is taking action in this area with its “compassionate use” policy. Basically, if a patient is suffering from an immediately life-threatening condition or a serious disease, they may be given an exemption to try an investigational medical product.
Finally, there are some drugs that simply don’t turn out the way their developers or discoverers hoped. While the initial discovery seems like a massive breakthrough, the follow-up research just doesn’t play that out; they may realize that the drug is prohibitively expensive to develop, or that there’s some logistical hurdle preventing it from getting made the way they need.
While it might be easy to blame the FDA for burdensome regulations or processes that slow down the path of innovation, the reality is much more complex. The FDA does make it hard to get new drugs approved, but there are also financial, logistical, and scientific barriers preventing new treatments from getting developed faster. Hopefully, as our knowledge grows, we’ll eventually find newer, faster paths to innovation.
Photo is Wikimedia Public Domain
Guest Author Bio
Jamie is a freelance writer who covers trends in business, technology, and health. She loves to go skiing, camping, and rock climbing with her family.
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