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The battle between vaccines and therapeutics: What is a priority review voucher and how does it affect disease strategy?
As the world faces challenges from various diseases, the speed of drug development is increasingly important. It is against this background that the U.S. Food and Drug Administration (FDA) Priority Review Voucher program came into being to speed up the review process of drugs that are expected to have a significant impact on disease treatment.
The Priority Review Voucher is an incentive designed to encourage pharmaceutical companies to develop treatments for diseases with limited profit potential.
According to FDA regulations, if a drug is determined to significantly improve safety or effectiveness, it can apply for priority review. These priority review vouchers focus on neglected tropical diseases, rare childhood diseases, and medical emergencies in response to terrorism.
The significance of priority review
In the United States, every drug marketed must go through a detailed FDA review process. Since the promotion of the Prescription Drug User Fee Act in 1992, FDA has established two review time limits: standard review and priority review. Priority review aims to complete the review within six months, compared to ★ten months★ for a standard review.
Applications for priority review status must be submitted by pharmaceutical manufacturers, and the FDA will decide whether to grant priority review status within 45 days after receiving the application.
Generation and expansion of voucher plans
The Priority Review Voucher Program was originally established in 2007 to target neglected tropical diseases. In 2012, the program expanded to include rare childhood diseases. In 2016, the scope of medical emergency measures was added.
The original intention of this program is to encourage pharmaceutical companies to develop treatments that have traditionally been less profitable, and to provide companies with funds to recoup research expenses through the sale of vouchers. The value of the certificate is also rising, and millions of transaction cases have appeared on the market.
The value and market of certificates
As of 2017, fourteen Priority Review Vouchers have been granted, including four for tropical diseases and ten for rare childhood diseases. The voucher is transferable and can be sold, creating additional economic value for drug developers.
The market value of priority review vouchers can range from $50 million to $350 million, prompting many companies to actively compete for this resource.
Impact of using priority review
Companies using the vouchers are required to pay an additional fee to ensure that FDA can recoup the costs of expedited review. In fiscal 2018, this expense was $2.8 million. Since then, the model for the use of priority review credentials has continued to evolve and is occasionally affected by policy changes.
Future Prospects and Challenges
Even though the priority review voucher brings rapid market entry time for new drug research and development, it still faces some criticisms, including that it may put pressure on FDA's resources or excessive market profit expectations, resulting in unnecessary market distortions.
Critics say that while priority review vouchers encourage innovation, they may fail to address issues of access to existing treatments.
Many experts and scholars are still discussing the overall utility of priority review vouchers. Some people believe that although the original intention of the policy is good, whether it can truly meet the emergency needs of global diseases requires further verification and adjustment.
As global health concerns continue to increase, what role will the future development of priority review vouchers and other similar programs play in drug development and disease management strategies?
