FDA Sees Rebound in Approval of Innovative Drugs in 2003

January 22, 2004

FDA Sees Rebound in Approval of Innovative Drugs in 2003

The Food and Drug Administration today announced improved results over last year on overall drugs and biologics approvals for calendar year 2003, and decreases in the time it took the Agency to review and approve most applications.

A highlight of this success was the approval of 21 New Molecular Entities (NMEs) with active ingredients never before marketed in the United States. This number of NME approvals is up from the calendar year 2002 total of 17. Priority approvals, approvals for priority products of special medical importance, increased from 2002 as well: There were 14 priority NDAs and 9 priority NMEs, compared to 11 and 7 in 2002, respectively.

The Agency’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) approved 466 new and generic drugs and biological products, many of which represent significant therapeutic advances. In particular, the Agency saw a significant increase in the number of approvals on NMEs, which typically represent the most novel new drugs.

"FDA is making new treatments available more quickly," said HHS Secretary Tommy G. Thompson, "And I expect FDA’s new innovation initiatives announced in early 2003 will lead to even faster approvals of safe and affordable medical treatments in the coming years."

Through a series of special new initiatives now being implemented, plus a continued dedication to timely and complete reviews of every application, FDA is committing to reach a goal of reducing the average total FDA time for review before marketing approval by 30 days for priority applications and two months for standard applications for the first half of the approval cohort for applications submitted in FY 2005-07 and beyond. This correlates to a 10% reduction or better.

The FDA already works hard to keep review times short, as prescribed under PDUFA. Under new initiatives the Agency is undertaking, FDA will be working to decrease the number of applications requiring multiple review cycles. The improvements in application quality needed to reduce the number of review cycles will be addressed through initiatives to improve the quality and frequency of FDA-industry interactions during drug development and during the first cycle of review. If sponsors take advantage of these programs and fulfill their obligation to file better applications, the result will be not just shorter time to approval, but a more efficient use of both company and agency resources.

Encouraging Innovation in Drug Development for the Coming Years

In 2003, the Food and Drug Administration announced several new initiatives to help encourage innovation in medical product development and speed access for all Americans to safe and affordable new medicines. The Agency anticipates that these initiatives will help build on this year’s encouraging results and allow FDA to meet its ambitious goals for faster therapeutic development.

Accelerating development of new medical products

In January 2003, FDA launched a broad new agency-wide initiative to speed development of innovative medical technologies. FDA is committed to reducing total review time for new drugs and biologics across the board by approximately 10.5% through this initiative. Such reductions in review time for drugs and biologics, as well as for new devices, will place much needed treatments in the hands of patients faster, thus help treat and prevent diseases and improve overall health.

The first element of this innovation initiative involves a reduction of multiple cycle reviews. FDA is undertaking a root cause analysis for product approvals that require more than one review cycle and many months of additional development time. Based on the results of this assessment, the Agency will take actions to prevent avoidable cycling. New pilot programs are also underway which include earlier communication with product manufacturers. Evidence shows that upfront, focused communication with product developers about FDA standards can often help the developers get the application right the first time around.

The second element of the innovation initiative involves the implementation of a "quality systems" approach to medical product reviews. Best management practices are being identified and implemented internally for FDA’s scientific review processes. Additionally, new peer review programs, coupled with more empirical data, will allow drug and other scientific reviewers to exchange ideas and use each others’ experience to learn about best practices.

Third, FDA is working collaboratively with the National Cancer Institute and other government agencies, academic researchers, health care providers and patients to address key clinical and scientific issues and to clarify regulatory pathways for targeted disease areas and new technologies. Through joint workshops and conferences, FDA is working to provide clarity to product innovators in these critical medical areas, thereby improving the efficiency and anticipated quality of submitted applications. FDA has issued specific new guidances on these issues including guidance on investigational new drug (IND) exemptions for studies of lawfully marketed cancer drug or biological products; guidance on integrating pharmacogenomic testing into the drug development processes; and draft guidance for reviewers of human somatic cell therapy INDs. FDA and NCI also announced a new system for receiving INDs electronically to help foster better and faster innovation in oncology.