On December 13, a called the 21st Century Cures Act was signed by President Obama. It introduces changes on how the Food and Drug Administration approves drugs and medical devices, to speed up regulatory review and to bring medicines and devices to the market faster.
Both patient advocacy groups and the pharmaceutical industry supported the legislation. This bill was heavily lobbied by the pharmaceutical companies. With this bill, the ease and lowering the threshold on data which the FDA uses to make decisions will speed the approval of medicines.
Some say that by hastening the approval process, there may be consequences that will not become apparent until the law has been passed. They say that we may be sacrificing safety and efficacy of drugs and devices under this new system. Before the new system, obtaining approval from the FDA for a new drug is both time consuming and costly. It takes around 10 months for the FDA to review an application.
Research and development of a drug may take 10 years to complete. It takes hundreds of millions to develop new drugs and after that, regulatory approval from the Food and Drug Administration needs to be obtained in order for the companies to be able to sell their medicine.
For approval of devices, this is based on tiers. Class I devices such as enema kits are considered low risks and follow lighter regulation. Class II devices are those that require special control such as powered wheelchairs and class III are devices such as cardiac pacemakers. These devices goes through a very strict review process known as premarket approval. The process of bringing a medical device into the market may take from three to seven years.
Depending on the application, the FDA takes between 115 and 300 days to complete the review as reported in The Conversation. The new law will hasten the approval of drugs and medical devices by the FDA. Although this is seen as a good thing by both the pharmaceutical companies and patient advocacy groups, there are some who say that this may not be a totally good thing as reported by the STAT.
