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A major thrust of FDA's activities last year was to strengthen the protection of patients by (1) modernizing the science that supports the medical product safety system throughout the products' entire life cycle; (2) improving the flow of medical product-associated information that enables rapid and accurate detection and assessment of risks to patients; and (3) improving the agency operations and management to ensure the implementation of processes supporting these changes. The new advances included the following:
New drug and biologics information format: FDA issued the first complete revision in 25 years of the format of the so-called package insert. The new rule, "Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products," serves to provide prescribers and patients with clear, concise and easy-to-read drug and biologics information, and thereby help reduce the incidence of medication errors. Research has shown that prioritizing warnings about a product's side effect can reduce the approximately 300,000 preventable adverse events that occur in American hospitals each year.
Protection from unapproved drugs: FDA stepped up its efforts to encourage companies to submit to the agency applications for unapproved medications whose marketing predates the laws requiring FDA's approval for all new drugs. These drugs are often included in pharmaceutical reference works and are prescribed by health care professionals who are unaware that these products lack FDA's approval. Although fewer than 2% of all prescribed drugs fall in this category, FDA wants to ensure that they meet modern standards for safety, effectiveness, quality and labeling. FDA restated its policy of focusing on products that present potential safety risks, lack effectiveness, and constitute a health fraud. The first enforcement targets under this policy are prescription drugs containing the antihistamine carboxamine. This ingredient has never been studied for pediatric use, and yet is prescribed for children under 2 years of age.
Clinical Trial Regulations and Bioresearch Monitoring: FDA launched the Human Subject Protection and Bioresearch Monitoring Initiative designed to strengthen the agency's oversight and protection of patients in clinical trials, and ensure the integrity of the resulting data. The series of new policies and guidances to be generated toward these ends will cover animal and human testing all FDA-regulated products, including devices, foods , human drugs, biological products and veterinary medicine.
Required drug pedigrees: FDA began full implementation of regulations requiring drug distributors to provide documentation of the chain of custody -- so-called "pedigree" -- of drug products throughout the distribution system. The requirement, which significantly fortifies the existing barriers against counterfeit products, is intended to encourage the use of electronic track and trace technology such as radio-frequency identification (RFID), and to create an electronic pedigree for tracking the drugs' movement through the supply chain. FDA also announced that its enforcement of the regulation will focus first on products most susceptible to counterfeiting and diversion
Prevention of device-associated adverse events: FDA set clear goals for prompt identification and analysis of adverse events related to the use of medical devices. As part of this initiative, FDA is strengthening the requirements for industry-sponsored studies of marketed devices; improving the agency's targeted surveillance to identify adverse events; enhancing its risk-based approach to inspections of manufacturing sites; improving its communication of risk-benefit information; and increasing the use of automated information systems. FDA also sought information on how a unique identifier system for medical devices could be implemented to reduce medical errors, facilitate device recalls, and improve medical device adverse event reporting.
Reducing hospital bed entrapment: FDA published guidance designed to reduce potentially dangerous patient entrapment in hospital beds that can occur when a patient's limb or body becomes caught between parts of the bed, such as in the space between the mattress and the side rail. The guidelines identify special issues associated with hospital bed systems and provide design recommendations for manufacturers of new hospital beds and suggestions for health care facilities on ways to assess the risk of entrapment in existing beds.
Review of clinical emergency research: FDA launched an examination of clinical research carried out in situations when patients, their family or their legal representatives are unable to provide informed consent to an experimental treatment. The purpose of the initiative is to ensure that this research maintains human subjects' protection and is conducted in a way that can yield scientifically validated solutions to benefit patients with such life-threatening medical conditions as head trauma, cardiac arrest, or stroke.
Strengthened advisory system: FDA announced several steps to make its advisory committee process more transparent and effective in providing state-of-the-art, independent scientific advice on complex issues involved in the approval of regulated products. To promote public confidence in the integrity of the advisory committee system and ensure the agency is able to recruit for it the best available experts, FDA announced it will revise guidances addressing conflict of interest waivers and their disclosure to the public, and disseminate more information about advisory committee schedules.
Human cell and tissue safety: FDA took necessary steps against two tissue recovery establishments that were not complying with the law. The agency also formed an interdisciplinary Human Tissue Task Force, and charged it with fully evaluating the new tissue regulations and determining whether additional steps are needed to enhance tissue safety.
FDA continued to make major strides in implementing its Critical Path Initiative, a cooperative program that seeks to bring safe and effective medical products to patients faster and at lower cost by making their development more predictable and efficient. The agency advanced this top-priority project by:
Releasing Critical Path Opportunities List: FDA set forth 76 research projects, most of which are focused on the creation of smarter tools for an early evaluation of candidate medical products for their suitability for further development. The Opportunities List, the central component of the Critical Path blueprint, invites scientists in the academia, government agencies and industry to cooperate in finding answers to unresolved issues in six broad topic areas: development of biomarkers; clinical trial designs; bioinformatics; manufacturing; public health needs; and pediatrics. By the end of 2006, almost one-half of the listed projects were in progress.
Advancing Critical Path research: FDA advanced research involving the two most important predictive instruments -- reliable biomarkers and focused clinical trials -- through the following actions:
Spurring medical device development : To help provide patients with new medical devices, FDA launched a significant initiative to encourage early consultations between FDA and industry. The goal of the initiative is to promote scientific innovation in product development; focus device research on the latest science; modernize FDA's review processes; and facilitate a least burdensome approach to clinical trials. As part of this effort, FDA issued draft guidance on the use of Bayesian statistical methods in designing more efficient clinical trials by using safety and/or effectiveness data on earlier developed medical devices.
In 2006, FDA continued its emphasis on promoting the introduction and use of new technologies and processes to advance the agency's public health mission. In addition to facilitating medical product development and improving medical product safety, FDA last year initiated the following significant projects:
Automation of drug registration and listing: FDA proposed a rule to make managing drug information more efficient and effective by automating the process by which drug firms register themselves and list their products with the agency. The proposal, which is part of a broader federal effort, would make electronically accessible information about the more than 120,000 drug products marketed in the United States. The data, which include ingredients, dosage forms, strengths, and labeling and manufacturer information, will help the agency to rapidly respond to drug emergencies such as recalls and drug shortages.
Prevention of pandemic influenza: FDA initiated numerous steps to advance the development, production and integrity of vaccines to combat pandemic influenza, and to speed up the diagnosis of this serious disease. Most significant were several guidances for vaccine manufacturers, two of which describe how to bring new vaccines on the market more quickly by following the existing regulatory pathways. Another guidance outlines the best practices for manufacturing cell-based viral vaccine using current and emerging science, and for facilitating the development and availability of vaccines including those addressing emerging and pandemic threats. FDA also cleared a new lab test to diagnose H5 strains of influenza and approved two antiviral drugs for prevention of influenza. In addition, FDA prohibited off label use in chickens, turkeys, and ducks of two classes of human anti-influenza drugs to help preserve the effectiveness of these products in humans.
Better protection of food security: FDA collaborated with the National Association of State Departments of Agriculture, the Food Safety and Inspection Service of the United States Department of Agriculture, and the Department of Homeland Security in developing a model food emergency response plan. The template is designed to guide the States in the development of individual or collective plans to respond to food-related emergencies caused, or threatened to be caused, by accidental or deliberate contamination of food.
Creation of Nanotechnology Task Force: FDA charged a group of its senior scientists, policy makers and managers with assessing regulatory approaches to facilitate continued development of innovative, safe and effective FDA-regulated products that use nanotechnology materials. The Nanotechnology Task Force will identify and recommend how to address existing knowledge and policy gaps in order to enable the agency to evaluate possible health effects of these products. The agency also will continue to address product-specific nanotechnology-related issues on an ongoing basis.
Advancement of federal e-health program: FDA adopted medical vocabulary called Systematized Nomenclature of Medicine as the standard computerized system for electronic coding of important items in the Highlights section of prescription drug labeling. The adoption advances the federal effort to facilitate electronic health records for all Americans, and will make easier and more efficient access and sharing of clinical health and treatment information by health care professionals.
Research on computer-aided diagnosis: FDA scientists investigated the potential differences in clinical performance when a radiologist reading mammograms uses computer-aided diagnosis (CAD) concurrently, compared with using the CAD aid as a second reader. The study demonstrated that the use of a particular CAD on simulated breast masses leads to improved sensitivity over reading without CAD, and that concurrent reading outperformed CAD when used as a second reader. This research is an important step in understanding how to best regulate the newer CAD devices.
Minor Species Drug Indexing: FDA proposed a rule for "indexing," a new process designed to encourage the development of safe and effective drugs for non-food minor species of animals, including zoo animals, aquarium fish and small pets such as guinea pigs. At present, the manufacturer's cost of FDA's full approval process is typically greater than the potential market for a minor species drug, and as a result few of these drugs are developed. Under the proposed rule, which is authorized by Congress , the safety and effectiveness of such minor species drugs could be assessed more economically by panels of outside experts. Following their listing by FDA on a proposed "Legally-Marketed Unapproved New Animal Drug Index", the products could be widely used.