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FDA Recaps Approvals in 2003, Expects Faster Approvals in the Future

ROCKVILLE, MD -- January 16, 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.”

“FDA is committed to using the latest science and all our available resources to get innovative, safe and effective medical technologies to more patients, and helping to reduce the costs of developing these products, while maintaining the Agency’s traditional high standards of consumer protection,” said FDA Commissioner Mark McClellan, MD, PhD. “In 2003, we have continued to meet or exceed our goals for reviewing applications for drugs and biologics, and in 2004, we intend to build on these successes through our innovation initiatives.”

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 at least a 10 percent reduction.

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.

Strong Drug and Biologics Approvals, Reductions in Review Time in 2003 In 2003 CDER approved 72 new drug applications (NDAs), compared with 78 in 2002 and 66 in 2001. Of these NDA approvals, 21 were NMEs, up from the calendar year 2002 total of 17. Priority approvals – approvals for priority products of special medical importance – increased to 14 priority NDAs and 9 priority NMEs in 2003, compared to 11 and 7, in 2002.

Median total approval time for CDER’s priority NDAs was 7.7 months, compared with 19.1 months for 2002. FDA has attributed the 2002 figure to the effect of a few applications with unusually long regulatory histories on the median time to approval: when only a small number of applications are approved, a few older applications can have a notable impact on the median. The median total approval time for standard NDAs was 15.4 months, also in line with the previous year (15.3 months).

Approval times for priority NMEs have also declined with the increase in approvals. In 2002, the median total approval time for priority NMEs was 16.3 months, which result from a few outlier applications with particularly long regulatory pathways. In 2003, this median total approval time was 6.7 months, which is in line with recent experience. The Agency experienced an increase in median approval time for standards NMEs to 23.1 months in 2003 from 15.9 months in 2002. Given the small pool of applicants, FDA similarly attributes this increase to statistical outliers and anticipates a return to more standard levels if applications increase in the future.

CBER also reported improvements in biologics approvals and review times over last year. The Center approved 22 Biological License Applications (BLAs) in 2003, one more than in 2002 and six more than in 2001. Five of these products (6 in 2002) were priority, and their median review time was 12.1 months (compared with 12.0 months in 2002). Median total approval times for user fee BLAs came down to 20 months, from 28 in 2002, and the median approval time for non-user Fee BLAs dropped to 9 months, from 13 in 2002. The overall median review time for BLA approvals in 2003 was 12.8 months, compared with 12.9 months in 2002 and 13.8 for 2001.

Priority approvals for 2003 included a number of significant medical innovations which bring high value for patients. CDER-approved priority NMEs included Fuzeon (enfuvirtide) injection for the treatment, in combination with other antiretroviral agents, of HIV-1 infection; Somavert (pegvisomant) injection for the treatment of acromegaly, an enlargement of the extremities of the skeleton; Emend (aprepitant) capsules for use in combination with other antiemetic agents for the prevention of nausea and vomiting in chemotherapy; Iressa (gefitinib) tablets for the treatment of non-small cell lung cancer; Velcade (bortezomib) injection for the treatment of multiple myeloma; Reyataz (atazanavir) capsules for combination treatment of HIV-1; and Cubicin (daptomycin) injection for the treatment of complicated skin and skin structure infections.

CDER-approved priority NDAs in 2003 included Pyridostigmine Bromide tablets for the prevention of poisoning by Soman, a potential agent of terrorism; Gleevec (imatinib mesylate) tablets for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia; and Rebetol (ribavirin) oral solution for use in combination therapy for chronic Hepatitis C.

CDER also approved 362 generic drugs in 2003, compared with 384 in 2002. New generic drugs introduced to the market in 2003 include Quinapril Hydrochloride tablets (equivalent of Accupril) for treatment of hypertension and heart failure; Ganciclovir capsules and injection (Cytovene) for the treatment and prevention of Cytomegalovirus Retinitis in AIDS and transplant patients; Paroxetine Hydrochloride tablets (Paxil-GSK) for the treatment of major depressive disorder; and Mupirocin ointment 2% (Bactroban, GSK) for impetigo, an infection of the skin.

CBER's priority approvals included Fabrazyme (agalsidase beta) for use in patients with Fabry disease to reduce GL-3 deposition in kidney cells; Aldurazyme (laronidase) for treatment of patients with Hurler, Hurler-Scheie and Scheie forms of Mucopolysaccharidosis I (MPS I); Bexxar (tositumomab and iodine I 131 tositumomab) for treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma; Zemaira (human alpha-1-proteinase inhibitor) for use in individuals with Alpha-1-Antitrypsin Deficiency and evidence of emphysema; FluMist (an influenza vaccine that is the first nasally administered vaccine to be marketed in the United States); and BabyBig (human botulism immune globulin intravenous) for treatment of infant botulism caused by type A or type B Clostridium botulinum.

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.

Increasing availability of low-cost generic drugs
When approved by the FDA, generic drugs are just as safe and effective as brand-name drugs, but they often cost 70 percent less. FDA has launched several major initiatives to improve patient access to generic drugs.

First, the Agency has introduced new regulations and systems to speed access to generic drugs when legitimate patents expire. In August 2003, a final rule went into effect limiting drug companies to only one 30-month “stay” of a generic drug’s entry into the market for resolution of a patent challenge. FDA has also introduced a new system of early communications with generic drug manufacturers who submit applications. FDA is also using new resources granted by Congress to review generic drug applications more quickly and to develop ways to expand the range of generic drugs available to consumers particularly by facilitating the development of generic versions of drugs that had previously been hard to characterize as “equivalent,” such as certain creams and inhaled drugs.

FDA has also begun new educational programs and partnerships to help consumers get accurate information about the availability of generic drugs. In addition, FDA has increased monitoring of generic drugs already on the market. All of these steps to improve access to generics are expected to save consumers more than $3 billion per year. Improved consumer education and generic drug science could also lead to billions in additional savings from greater consumer confidence and wider use of generic drugs.

Through these various new initiatives, FDA intends to continue to meet its strategic goals for drug and biologic approvals, and to further speed innovation in order to get safe, affordable and effective treatments in the hands of all Americans sooner than ever before.

Source: The Food and Drug Administration

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