FDA Priority Review Program

The FDA Priority Review Program is in place to expedite the approval of therapeutically important drugs. Through the program, these drugs are given priority in the FDA’s queue of new drugs and biologics that request approval. The FDA Priority Review Program is designated for drugs that have the potential to offer major advances in clinical treatment and new treatments where no adequate treatment currently exists. The FDA Priority Review Program sets a goal to complete a drug’s review process in six months instead of the Standard Review which takes ten months. By expediting the approval process for these clinically significant drugs, patients can receive urgent treatment that may otherwise be unavailable.

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What Is the FDA Priority Review Program?

The FDA’s approval program is fit into two designations – Standard Review and Priority Review. When a drug or medical device gets Priority Review designation, that means the FDA’s goal will be to review that application within the next 6 months after its submission (compared to the typical 10 months that’s associated with the Standard Review designation). 

The FDA decides on the designation for each application, but applicants can request priority review as described in the Guidance for Industry Expedited Programs for Serious Conditions. 

What Does the Priority Review Designation Mean?

When a drug or device receives Priority Review designation, overall attention and resources will be directed to said drug or device to evaluate the drug’s or device’s benefits and uses. The ultimate goal is to find that the drug or device creates significant improvement in the safety or effectiveness of a treatment, diagnosis, or prevention of serious conditions. 

Additionally, the designation of a drug as “Priority” does not alter the scientific and medical standard for approval or the quality of the evidence necessary. 

What Classifies as a Significant Improvement?

Significant improvement, as classified by the FDA, can be demonstrated by: 

  • Evidence of increased effectiveness in treatment, prevention, or diagnosis of the condition; 
  • Elimination or substantial reduction of a treatment-limiting drug reaction; 
  • Documented enhancement of patient compliance that is expected to lead to an improvement in serious outcomes; or 
  • Evidence of safety and effectiveness in a new subpopulation. 

What Are the Negatives of the Priority Review Program?

Controversy exists over the FDA Priority Review Program. However, issues with the program are different in nature than those created by the FDA Accelerated Approval Program or Fast Track program. Unlike these other programs, the FDA Priority Review Program does not omit efficacy or safety studies. It also does not require the FDA to provide approval within a certain amount of time. However, because this review program shortens the approval period, it may not include enough time to observe long-term results.

How Does Priority Review Affect Public Safety?

Experts indicate that the FDA may be more prone to error if it feels pressure to meet deadlines faster under the FDA Priority Review Program. A 2008 report showed that a higher rate of post-marketing safety issues existed in new molecular entities that were approved in the two months prior to the first review deadlines. These safety issues were increased in comparison to drugs that were approved at other times.

Critics of the FDA Priority Review Program also argue that the decreased review time is inadequate to truly gauge long-term results. Some allege that the shortened review time may prove harmful to a drug’s long-term efficacy and standing. Additionally, the designation of “priority” is also questioned. Many argue that the decision to assign priority to a drug is arbitrary.

What Is the Priority Review Voucher Program?

The FDA offers Priority Review Vouchers (PRVs) as an incentive for companies to invest in new vaccines and drugs to treat neglected tropical diseases (NTDs). Tropical diseases include tuberculosis, malaria, cholera, African sleeping sickness, and similar conditions. Any company that obtains FDA approval for an NTD treatment will receive a transferable Priority Review Voucher. This PRV can be used for priority review of any drug of the company’s choosing. Furthermore, the manufacturer has the ability to sell the voucher on the open market.

What Is the Negative Impact of the Priority Review Voucher Program?

In a 2016 report, FDA officials showed their opposition to the renewal of the pediatric PRV program, expressing concern that the program interfered with the FDA’s ability to actually prioritize drugs with high clinical importance. They also noted the adverse impact of the workload that the voucher program created. 

Many argue that PRVs are obscure and unethical. In 2008, the New England Journal of Medicine published a perspective discussing the trouble with Priority Review Vouchers. The journal stated that PRVs present “an inefficient and potentially dangerous way of encouraging research into tropical diseases.”