Generic Drug Reviews Take A Hit In FDA 2007 Budget Request

FDA is reducing the percentage of generic drug applications for which it aims to shorten review time.

The agency is seeking to "decrease the average FDA time to approval or tentative approval for the fastest 25% of original generic drugs applications by 0.5 months," according to the revised targets included in FDA's 2007 budget request, which was released Feb. 6.

The original FY 2006 goal was to "decrease the average FDA time to approval or tentative approval for the fastest 70% of original generic drug applications by 0.5 months."

The numeric goal is intended to be a measurement of how FDA is improving "the efficiency and effectiveness of the generic drug review program to ensure safer and more effective generic drug products are available for Americans."

FDA said that it adjusted the review measure due to the "strategic redeployment of resources to highest priority areas."

Additionally, the agency will make reductions in generic drugs research contracts and information processing modernization for the generic drugs program.

Resources being redeployed from the Office of Generic Drugs will go to, among other areas, the Critical Path initiative, drug safety, and pandemic preparedness.

The Generic Pharmaceutical Association expressed "extreme disappointment" over the funding level for the Office of Generic Drugs.

"OGD is flat-funded at best, even though its workload has increased by a staggering 36%....This is the third fiscal year in a row that OGD's budget has been flat-funded," GPhA said.

According to FDA, operations and salaries for the office were funded at $28.3 mil. in fiscal 2006 and would be increased to $29.1 mil. in fiscal 2007 under the request.

The agency hired 12 new people for the office in 2005 and plans to hire more in 2006; however, FDA could not provide hiring projections for 2007.

The agency is expecting a growing number of abbreviated new drug application actions over the next two years.

Compared to the 1,496 ANDA actions in fiscal 2005, FDA anticipates 1,553 ANDA actions in fiscal 2006 and 1,612 ANDA action in fiscal 2007.

The agency is also anticipating an increase in the number of NDAs and BLAs over the next two years.

In 2005, FDA granted full approval to 361 ANDAs, an all-time record for the agency. According to the budget request, ANDA approval actions (both tentative and full approvals) are expected to drop to 450 in fiscal 2006 from 467 in fiscal 2005, with a jump back up to 470 in 2007.

The number of ANDA supplemental actions (labeling and manufacturing) is also expected to rise. Compared to the 4,566 in fiscal 2005, the agency expects to take 5,406 ANDA supplemental actions in fiscal 2006 and 5,610 in fiscal 2007.

Overall, FDA expects the median time from ANDA receipt to approval to steadily increase, from 16.3 months in fiscal 2004 and 2005 to 16.9 months in fiscal 2006 and 17.5 months in fiscal 2007.

GPhA deemed the increase in generic drug review time "outrageous," along with the revised percentage of generic applications for which the agency hopes to shorten review time.

The generic trade group argued that the agency's effort to "streamline" generic review will not solve the problems facing the industry, including the backlog of generic drug applications. There are about 850 generic drug applications pending at FDA, according to the agency.

"FDA fails to realize that over the years, OGD and the generic industry have worked successfully on collaborative efforts to streamline the approval process for generic drugs. And, we now have reached a saturation point on administrative efficiency," GPhA said.