FDA drug approvals jump in 2004
Drug risk-management guidances also finalized
The number of drugs approved by the FDA had a marked increase in 2004 from the number approved in 2003. Some of this increase, however, stems from the transfer of Biologic Licensing Applications (BLAs) for therapeutic products from the FDA’s Center for Biologics Evaluation and Research (CBER) to the agency’s Center for Drug Evaluation and Research (CDER).
CDER says it "met or exceeded the performance from the prior year in its drug approval process both for New Drug Applications (NDAs) and BLAs and for New Molecular Entities [NMEs]." In 2004, CDER approved 29 NDAs and BLAs under "priority review." Priority applications are for drugs with the potential for "significant advances over existing treatments," according to the CDER definition. In 2003, CDER approved 14 NDAs and BLAs under priority review.
Likewise, CDER approved 90 NDAs and BLAs in 2004 under "standard review," an increase from 2003’s total of 58. (The approval figure in 2003 was a decrease from the 67 NDAs and BLAs approved under standard review in 2002.) CDER defines standard review as the process for drugs that are similar to those already marketed.
Even with the increase in approvals, the median total approval time in months decreased under both priority and standard review. For instance, CDER had an approval time in 2004 for priority review of six months; in 2003, the number was 7.7 months. The median total approval time for standard review was 12.9 in 2004. In 2003, the number was 15.4 months.
The changes hold true for CDER’s approval for priority and standard NMEs and New BLAs as well. In 2004, CDER approved 21 NMEs and new BLAs under priority review; in 2003, CDER approved nine. CDER approved 15 NMEs and new BLAs under standard review in 2004. In 2002, CDER approved 12. CDER took a median total approval time of six months for these priority reviews in 2004, down from 6.7 in 2003. CDER, however, took longer to approve NMEs and new BLAs under standard review. The number of months increased from 23.1 in 2003 to 24.7.
The transfer of BLAs for therapeutic drugs from CBER to CDER accounts for some of the increase in number of approvals. But that’s not the whole story, says Christine S. Parker, an FDA public affairs specialist. "There are a number of factors that can come into play that impact the number of applications approved and the median review times. These include the number of applications submitted, the completeness of the applications (e.g., no major deficiencies that would stand in the way of first cycle approval), the mix of priority and standard applications submitted, competing workload within a review division, divisional staffing, responsiveness of the sponsor to requests for information or new analyses, etc."
Last year brought several significant approvals of new products, CDER says. They include:
- Apomorphine hydrochloride (Apokyn) for the treatment of patients with advanced Parkinson’s disease.
- Bevacizumab (Avastin) for metastatic cancer of the colon or rectum.
- Clofarabine (Clorar) for use in children with lymphoblastic leukemia.
- Pentetate zinc trisodium and pentetate calcium trisodium injections for the treatment of internal contamination with plutonium.
- Ziconotide (Prialt) for the management of chronic pain.
- Palifermin (Kepivance) for easing severe oral mucositis in patients undergoing chemotherapy for certain types of cancer.
- Pegaptanib sodium (Macugen) for the treatment of macular degeneration.
- Erlotinib (Tarceva) for the treatment of metastatic non-small cell lung cancer.
Looking to this year
Although the time to make a drug approval has decreased in most cases, some critics wish the FDA would take its time and more carefully weigh all information — both good and bad — before making a decision. One of the FDA’s most vocal critics has been one of its own employees, David J. Graham, MD, MPH, associate director for science at FDA’s Office of Drug Safety. Graham testified to a Senate committee last year about his perception that the FDA is not capable of protecting the health of the American public. He also made headlines across the country by telling reporters, "FDA has a system in place now that will guarantee that unsafe drugs will remain on the market."
Will this type of public scrutiny affect the number of drugs the FDA approves in 2005? No, says Parker. "FDA has not altered its standards for approval of new drugs. The number of applications approved this year, like all years, will be driven by the number of applications (or resubmitted applications) received, the quality of the applications, and the ability of sponsors to address outstanding deficiencies in a timely manner."
Risk-management guidances finalized
The FDA, however, did issue three final guidance documents to help develop new and improve current methods that assess and monitor the risks associated with drugs and biological products in clinical development and general use. These guidances are one of five initiatives announced by the FDA in November to strengthen its drug safety program.
The final guidances are titled "Premarketing Risk Assessment," "Development and Use of Risk Minimization Action Plans," and "Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment." These guidances address pre-market risk assessment and describe additional safety testing, monitoring, and interventions that may be helpful in selected circumstances; the development, implementation, and evaluation of risk-minimization action plans (called RiskMAPs); and pharmacovigilance practices and assessment of reported adverse events.
"Two of the three new risk guidances are expected to have an impact on improving the efficiency of the review process over time by improving the assessment of risk included in the development program and the application, and improving the planning to manage any risks during the early post-approval phase," Parker says. "The third risk guidance is related to surveillance of approved products, and is less likely to impact on the approval process."
For more information on these guidances, go to the following addresses:
- Premarketing Risk Assessment: www.fda.gov/cder/guidance/6357fnl.htm
- Development and Use of Risk Minimization Action Plans: www.fda.gov/cder/guidance/6358fnl.htm
- Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment: www.fda.gov/cder/guidance/6359OCC.htm.
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