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 was first adopted in 1992 under the Prescription Drug User Fee Act (PDUFA). Through PDUFA, the FDA created two detailed processes through which to approve drugs. These processes are Priority Review and Standard Review.

The FDA Priority Review Program is designated for drugs that have the potential to offer major advances in clinical treatment. The program also favors 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. Through the Standard Review Program, the FDA aims to review a drug in ten months. By expediting the approval process for these clinically significant drugs, patients can receive urgent treatment that may otherwise be unavailable.

FDA Priority Review Program Uses

The FDA Priority Review Program is designed to allocate additional attention and resources from the FDA. These novel treatments receive more attention because of their potential ability to provide significant medical advances as opposed to treatments that only provide minor improvement from existing treatments.

The FDA Priority Review Program may be used for drugs that:

• Eliminate or significantly reduce a drug reaction that limits treatment
• Show evidence of improved prevention, treatment, or diagnosis of a disease
• Enhance the willingness or ability of patients to take the drug as required and scheduled
• Show evidence of effectiveness and safety for a new subgroup, such as children

FDA Priority Review Program Controversy

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.

Safety Issues

Experts indicate that the FDA may be more likely to err 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.

Inadequate and Arbitrary Nature

Critics of the FDA Priority Review Program 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.

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.

PRVs are the subject of controversy and heated debate. 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.”