Understanding FDA Priority Review Vouchers: Acquisition and Applications

FDA Priority Review Vouchers (PRVs) have become valuable assets in the pharmaceutical industry, offering a shortcut through the regulatory process for certain drugs. In this article, I explain what FDA PRV vouchers are, how they can be obtained, and their applications.

What is an FDA PRV Voucher? A Priority Review Voucher (PRV) is a certificate issued by the U.S. Food and Drug Administration (FDA) that grants the holder the privilege of a priority review for a drug application. In essence, it accelerates the FDA's assessment of the drug's safety and efficacy. (See my prior blog post on what Priority Reviews are and their benefits for expedited FDA reviews).

How to Obtain an FDA PRV Voucher:

1. Developing a Qualified Drug: To be eligible for a PRV, a pharmaceutical company must develop a qualified drug, which typically targets a neglected tropical disease or rare pediatric disease. Alternatively, it can focus on specific medical countermeasures against bioterrorism threats.

   
   

2. FDA Designation: The FDA must grant a specific designation to the drug, confirming its eligibility for a PRV. This designation is often referred to as a "priority review voucher-eligible tropical disease" (PRV-ETD) or "priority review voucher-eligible rare pediatric disease" (PRV-RPD).

   
   

3. Drug Approval: Once the drug receives FDA approval for its intended use, the pharmaceutical company is awarded the PRV. It's important to note that not all drugs meeting the criteria will receive a PRV, as the FDA has limited the number of vouchers issued.

What Are FDA PRV Vouchers Used For? FDA PRV vouchers serve as incentives in the pharmaceutical industry for several reasons:

1. Expedited Review: The primary purpose of a PRV is to expedite the FDA review process for another drug developed by the same company or sold to another company. This can significantly reduce the time it takes for a new drug to reach the market.

   
   

   This is an important point to clarify. The PRV is for a future review of another drug, not a priority review of the drug for which the PRV was received upon approval. Hence, as the name "voucher" implies, the PRV gives the holder the right for Priority Review of their drug, even if that drug is not for a tropical or rare pediatric disease. Therefore, the PRV is valuable to any company that holds it, hence, companies that are awarded a PRV may choose to sell the PRV to another company that desires a Priority Review.

   
   

2. Profit Potential: Pharmaceutical companies can use PRVs strategically to enhance the profitability of their products. By shortening the time to market, companies can begin generating revenue from their drugs sooner.

   
   

3. Attracting Investment: PRVs can also be sold or transferred to other companies, often at substantial prices. This can attract investment and additional funding for research and development. Some PRVs have sold for over $100 million US dollars.

   
   

4. Advancing Neglected Diseases: PRVs encourage the development of drugs for neglected and rare diseases that may not otherwise receive sufficient attention due to their limited commercial potential.

In summary, FDA Priority Review Vouchers are coveted assets in the pharmaceutical industry, incentivizing companies to develop drugs for rare tropical or pediatric diseases that otherwise would not be attractive for development due to small market sizes and poor returns on investment. Obtaining a PRV involves developing a qualified drug and receiving FDA designation. These vouchers can be used to accelerate the review of another drug, enhance profitability, attract investment, and advance treatments for neglected diseases. As a result, FDA PRVs have become valuable tools for pharmaceutical companies seeking to bring innovative medicines to market.