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2004 FDA Accomplishments

In 2004, the U.S. Food and Drug Administration (FDA) once again played a vital role in protecting and advancing public health in the United States. By creating innovative initiatives and improving existing performances, the FDA accomplished many goals that enhanced the lives of Americans. Some highlights of FDA’s accomplishments last year include:

• Introduced new initiatives to combat critical health threats such as obesity, counterfeit drugs and medical errors;
• Approved a substantially greater number of products, including an unprecedented number of generic drugs;
• Strengthened the security of the nation’s food supply against potential bioterrorism attacks;
• Strengthened food safety through major initiatives and actions; and
• Streamlined paperwork process to reduce errors, reform outdated practices, and enhance new product innovation.

NEW FDA INITATIVES

In 2004, FDA launched many comprehensive new initiatives to better protect American consumers. All details of FDA initiatives can be found on the FDA website at www.fda.gov. Here are highlights of some of these initiatives:

Drug Safety – In November, FDA's Acting Commissioner Crawford authorized a series of measures to further strengthen the safety of FDA-approved drugs. In addition to publishing guidances on the management of the risks of drugs and biological products, the initiative calls for (1) an in-depth study by the Institute of Medicine (IOM) of the effectiveness of the system in place that protects the safety of marketed drugs; (2) a program for ensuring that the opinions of the agency's scientific reviewers are formally incorporated into decision-making processes, (3) a search for a nationally recognized drug safety expert to fill the currently vacant position of director of the Office of Drug Safety; and (4) workshops and advisory committee meetings to discuss complex drug safety and risk management issues. http://www.fda.gov/bbs/topics/news/2004/NEW01131.html

Counterfeit Drugs Task Force Report – This final report focused on securing America’s drug supply from counterfeiting. It recommends Radio Frequency Identification Technology (RFIT) to track drug shipments as they move through the domestic supply chain. The FDA report also led many manufacturers to announce their intent to adopt RFIT as well. http://www.hhs.gov/news/press/2004pres/20040218.html

“Calories Count” - Obesity Working Group – As part of the Department of Health and Human Services’ initiative to combat the growing epidemic of obesity in the United States, this FDA report emphasized the importance of balancing caloric intake and expenditure, with recommendations including strengthening the food label to increase the prominence of calorie information and address serving size issues, partnering with others on education efforts, and participating in a national policy dialogue on obesity and away-from-home foods. http://www.fda.gov/bbs/topics/news/2004/hhs_031204.html

Critical Path Initiative – This initiative focused on both identifying and finding solutions to the challenge of developing new medical breakthrough technologies. The report calls for a vigorous collaborative research effort to create a new generation of medical products. http://www.fda.gov/bbs/topics/news/2004/NEW01035.html

Current Good Manufacturing Practices (cGMPs) – This initiative is designed to modernize the rules under which FDA regulated products are manufactured. Together with the Critical Path Initiative, the cGMP overhaul is designed to improve and ensure product quality, development of innovative technologies, reduce cost in development and manufacturing of pharmaceuticals. http://www.fda.gov/bbs/topics/news/2004/NEW01120.html

“Good Tissues Practice” Rule – FDA published the last of three major final rules defining comprehensive protections for patients treated with new technologies involving the use of human cells, tissues, and cellular and tissue based products. The GTP rule, in combination with the donor eligibility and establishment registration final rules, is designed to ensure that the recovery, processing, storing, labeling, packaging, and distribution of these products are performed in a way that prevents the introduction, transmission, and spread of communicable diseases. http://www.fda.gov/bbs/topics/news/2004/NEW01137.html

NEW DRUGS

Last year FDA’s Center for Drug Evaluation and Research (CDER) met or exceeded the performance from the prior year in its drug approval process both for New Drug Applications (NDAs) and Biologic Licensing Applications (BLAs) and for New Molecular Entities (NMEs). See the following tables for a comparison of CY 2004 to previous years’ performance for “priority” and “standard” reviews. Applications for drugs similar to those already marketed are designated “standard”, while “priority” applications represent drugs with the potential for significant advances over existing treatments. NME approvals (From Table 2) represent a subset of overall CDER Approval Times (from Table 1)

Table 1 CDER Approval Times for Priority and Standard NDAs and BLAs

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Table 2 CDER Approval Times for Priority and Standard NMEs and New BLAs

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Significant new products approved by CDER last year included:

• Apokyn (apomorphine hydrochloride) for the treatment of patients with advanced Parkinson's disease;
• Avastin (bevacizumab) for metastatic cancer of the colon or rectum;
• Clorar (clofarabine) for use in children with lymphoblastic leukemia;
• Pentetate Zinc Trisodium and Pentetate Calcium Trisodium injections for the treatment of internal contamination with plutonium;
• Campral (acamprosate calcium) for the treatment of alcohol dependence;
• Prialt (ziconotide) for the management of chronic pain.
• Kepivance (palifermin) for easing severe oral mucositis in patients undergoing chemotherapy for certain types of cancer;
• Macugen (pegaptanib sodium) for the treatment of macular degeneration; and
• Tarceva (erlotinib) for the treatment of metastatic non small-cell lung cancer.

GENERIC DRUGS

CDER last year approved in record time an unprecedented number of generic drugs, which are up to 70 percent cheaper than their trade-name counterparts. In 2004, CDER approved 474 generic drugs in the median approval time of 15.7 months. This record performance was made possible by additions to the review staff and by making the review process more efficient. The increase in approvals came partly as a result of an upsurge in submissions (635 in 2004 compared to 479 in 2003 and 392 in 2002). In addition, the Office of Generic Drugs worked with the generic industry to encourage them to submit more complete applications which will facilitate getting generic products onto the market faster. The following table shows a comparison of CY 2004 progress to previous years’ performance:

Table 3: Generic Drug Approvals

Significant new generics approvals in 2004 included:

• Fluconazole (several dosage forms), an antifungal agent;
• Benazepril hydrochloride, used to treat high blood pressure;
• Ciprofloxacin for antibiotic use, particularly as an anthrax agent;
• Ribavirin, a drug used in combination with interferon alpha 2-A for several indications, including the treatment of chronic hepatitis C; and
• Metformin Hydrochloride (extended release tablets) which is used to treat type II diabetes mellitus.

NEW BIOLOGICAL LICENSES

The Center for Biologics Evaluation and Research (CBER) continues to ensure the safety of the nation’s blood supply and the safety and efficacy of counter-terrorism and other vaccines and anti-toxins, as well as cutting edge technologies such as somatic cell and gene therapies. CBER also continues to approve new biological licenses as well as biological license supplements.

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Significant CBER approvals in 2004 included:

• Rhophylac (Rho(D) Immune Globulin Intravenous) for antepartum and postpartum immunization of Rho(D) negative women;
• Octagam (Immune Globulin Intravenous) for the treatment of several immune deficiencies;
• Three OraSure OraQuick Rapid Tests for the detection of antibodies to HIV-1/2, HIV-1 and HIV- 2; and
• Uni-Gold Recombigen HIV-1, a single-use rapid test for the detection of antibodies to HIV-1 in plasma, serum, and whole blood.

NEW DEVICES

The Center for Devices and Radiological Health (CDRH) also had a significant year. CDRH approved 52 new devices that use new technologies and cleared 3365 devices that used existing technologies. Significant CDRH approved products included:

• Phillips HeartStart Home OTC Defibrillator, the first automatic external defibrillator for use without a prescription;
• ImageChecker CT CAD Software System, a new technology to help radiologists analyze computed tomography images of the chest;
• ExAblate 200 System, a non-invasive device that uses magnetic resonance image-guided focused ultrasound to destroy non-cancerous uterine fibroids; and
• pediatric DeBakey VAD, the first miniaturized heart pump approved for children between 5 and 16 years old who need temporary mechanical blood circulation while awaiting a heart transplant.

CDRH also cleared for marketing several important new in-vitro devices, including:

• AmpliChip Cytochrome P450 Genotyping Test, a DNA microarray test that provides unique genetic information to help in selecting a patient's medications and optimizing the dose;
• NeoGram Amino Acids and Acylcarnitine Tandem Mass Spectrometry Kit, the first blood test cleared for screening infants for certain inherited diseases; and
• QuickELISA Anthrax-Pa Kit, the first rapid serum antibody test used for detecting antibodies triggered by infection with anthrax.

Other important devices cleared for marketing included:

• CellSearch Epithelial Cell Kit/CellSpotter Analyzer for monitoring the effectiveness of cancer treatment; and
• Ventana Medical Systems' Pathway Anti-c-KIT (9.7) Primary Antibody, the first immunohistochemical marker used to help in treatment selection for patients with a rare gastrointestinal cancer.

PROTECTING THE NATION’S FOOD SUPPLY AND ENHANCING PUBLIC HEALTH

The FDA's Center for Food Safety and Nutrition (CFSAN) last year completed the implementation of major new regulations designed to protect the public against potentially contaminated imported food. These regulations, which require the registration of all food facilities with products on the U.S. market, prior notices of their imports, and administrative detention for suspect shipments, were issued to implement the Public Health Security and Bioterrorism Preparedness Act of 2002.

As part of the agency's counter-terrorism program, CFSAN also:

• conducted vulnerability assessments and identified preventive measures for certain foods;
• completed or made additional progress on identified research projects in support of food defense;
• completed a nation-wide test of federal and state capability for analyzing foods for biological and chemical agents of concern; and
• collaborated with other federal, state, and local agencies, and with tradeassociations and industry, in preparing the food and agriculture sector for protecting the safety and security of the food supply.

CFSAN also issued regulations or proposed regulations and a consumer advisory that will significantly benefit public health. The Center in 2004

• published a Bovine Spongiform Encephalopathy (BSE) regulation prohibiting the use of some cattle material, such as eyes, brains, and spinal cord, from use in foods and cosmetics. The prohibited cattle material is the cattle material most likely to contain the BSE agent. Consumption of products contaminated with this agent is the likely cause of a fatal human disease in people called Creuzfeldt-Jacob disease. CFSAN’s regulation is consistent with a USDA regulation prohibiting certain cattle materials from use as human food.
• published a proposed regulation that would require on-farm egg safety measures to prevent the contamination of shell eggs with Salmonella Enteriditis (SE) during egg production and thereby produce a health benefit by reducing human illness from SE in eggs by 50 percent.
• issued a joint advisory in March with EPA entitled, “What you need to know about mercury in fish and shellfish”. The advisory contains three recommendations for women and young children to reduce their exposure to harmful effects of mercury while eating fish or shellfish. FDA has embarked on an aggressive outreach campaign to disseminate this new joint advisory.

Overall, FDA’s performance in 2004 demonstrated its steadfast commitment to advancing America’s public health.

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