The pharmaceutical industry boasts the most patents of any industry. However, pharmaceutical companies face many challenges trying to get a drug or medical device to market. For some, the FDA process proves to be the greatest challenge for a product or company.
The drug approval process is a long and arduous one that takes years and much capital to ensure a safe and efficient drug. However, all drug companies know what is involved to make this happen. The difficult part is making sure that they follow the process appropriately. For instance, they must ensure that they meet clinical trial deadlines. When they miss deadlines, it costs them money because they are keeping their product from the market longer. Furthermore, they must conduct the trial correctly and follow protocol to avoid the risk of repeating a trial. Repeating a trial can be just as costly as a clinical trial delay. All drugs go through three phases of clinical trials. Various phases can take years to complete. Therefore, a delay or a repeat can be detrimental while a competitor gets to market first.
The FDA also places limits on drug labeling. Therefore, companies must consider the best way to market their products. The FDA label guidelines restrict the value products could create if companies were allowed to market products for a variety of indications. Therefore, companies must be creative and determine the best avenue to retain value when marketing their products.
While the process and guidelines are arduous, consumers and companies alike rely on the FDA’s recommendations to ensure effective and safe products. No guarantee exists for any company in the drug approval process. If a drug simply has no value proposition in the market, meaning it has no benefit above and beyond other drugs already on the market, then the product brings no value. However, following the FDA process and guidelines precisely can eliminate inadvertent loss in value.