The Food and Drug Administration
has finalized a guidance (PDF)
that will help drug
and biologics manufacturers bring products that treat unmet needs to the market faster than the usual approval pathways currently make possible.
“For those drugs that qualify, participating in one of these expedited programs can reduce the time and possibly the cost of developing new therapies that can save lives,” Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, said in a statement. “That's a win for drug innovation and for patients.”
The guidance describes four expedited programs at the agency and the criteria a medical product needs to meet to use them. These include fast-track designation, breakthrough therapy designation, accelerated approval, and priority review designation. A draft version of the guidance, which received comments from major companies like Merck & Co., Novartis and Pfizer, was released last summer.
Nearly half of the 27 novel drugs approved by FDA last year took advantage of at least one of these expedited drug development and review approaches with review times as short as 4½ months compared with the year or more assessment period other drugs go through, according to the agency.
The release of the final guidance comes nearly three months after the FDA alerted drugmakers
to change labeling on drugs approved through the accelerated approval pathway so doctors and patients know such approvals could subsequently be revoked.
Approval granted through one of these programs can be revoked in instances in which a trial required to verify the predicted clinical benefit of the product fails to do so; other criteria for revocation include when evidence comes to light the product is not shown to be safe or effective and when a manufacturer fails to conduct any required post-approval trial of the drug or disseminates false or misleading promotional materials relating to the product. Follow Virgil Dickson on Twitter: @MHvdickson