On June 17, the Food and Drug Administration announced a new national priority voucher plan whose aim is to reduce drug review times to one to two months from the current average of 10 to 12 months. Chrissy Buteas, president and chief executive officer of the HealthCare Institute of New Jersey, in a statement June 19, said, “Anything that can shorten a review period without compromising safety and efficacy means patients will benefit from new discoveries even sooner.”
In the program’s first year, the FDA plans to give a limited number of vouchers to companies “aligned with U.S. national priorities,” it said. The FDA commissioner will use specific criteria to make the vouchers available to companies that are aligned with the national health priorities of addressing a health crisis in the U.S.; delivering more innovative cures for the American people; addressing unmet public health needs; and increasing domestic drug manufacturing as a national security issue.
FDA Commissioner Marty Makary said, “Using a common-sense approach, the national priority review program will allow companies to submit the lion’s share of the drug application before a clinical trial is complete so that we can reduce inefficiencies. The ultimate goal is to bring more cures and meaningful treatments to the American public.”
The FDA said vouchers can be directed by the agency toward a specific experimental drug of a company or be granted to a company as an undesignated voucher, allowing a company to use the voucher for a new drug at the company’s discretion and consistent with the program’s objectives.
The new voucher process brings together experts from FDA offices for a team-based review instead of using the standard review system of a drug application being sent to numerous FDA offices.
“Researching and discovering a new treatment or cure can take a decade or longer and cost billions of dollars,” said Buteas. “The most important priority is to ensure a product is safe and effective for patients. Researchers, clinicians and government regulatory agencies work collaboratively to review all available data – from lab bench to clinical trials to post-market reviews – to confirm product safety and efficacy. Our companies will continue to partner with FDA and other stakeholders to deliver our life-saving treatments and cures to patients as quickly and as safely as possible.”
