FDA's Accomplishments in 2005 Highlight BG Medicine's Role in Liver Toxicology Biomarker Study

In its recent report on accomplishments during this last year, the FDA highlighted their agreement in October of 2005 with Flagship portfolio company BG Medicine as an important example of their Critical Path initiative. You can read more about the project on its website.

Full text of the FDA's press release follows:

FDA's Accomplishments in 2005

March 29, 2006 -- In 2005, on the eve of its 100th anniversary, the Food and Drug Administration continued strengthening the performance of its core functions: ensuring the safety and effectiveness of drugs, biologics, and medical products; protecting the safety and security of 80 percent of the food supply; making certain that cosmetics and equipment that emits radiation do no harm; and ensuring the safety of animal drugs and feed. In addition, the agency took major steps to advance its forward-oriented agenda by implementing the FDA's strategic plan, a part of the Administration's blueprint for a healthier and more vigorous America.

During the year, all FDA's components -- Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM) and National Center for Toxicological Research (NCTR), ORA and various offices within the Office of the Commissioner -- achieved outstanding results. In addition, the agency continued to advance long-term strategic objectives.

Innovative Technology

The FDA made progress in implementing its Critical Path initiative, a pioneering project that seeks to apply the best available science to the medical product development process by creating novel tools -- such as proven biomarkers and simulation models -- for assessment of the safety and effectiveness of drugs and medical devices.

As part of this initiative, the FDA conducted a workshop with The Drug Information Association and The Biotechnology Industry Association to discuss ways of routinely using new imaging techniques in drug development. The agency also created a non-regulatory pathway for discussions with sponsors about certain issues involving submission and use of pharmacogenomic data; concluded an agreement with BG Medicine, a biotechnology research company, to collaborate on discovering signs of liver toxicity in the initial stages of drug development; and published a final guidance on the development of pharmacogenomic data that could help predict the optimum treatment for each individual patient. The agency issued a final guidance on Exploratory Investigational New Drugs, setting forth recommendations regarding preclinical and clinical issues as well as chemistry, manufacturing and controls issues that sponsors should consider when planning exploratory studies, including studies on closely related molecules, early in drug development.

Patient and Consumer Protection

The FDA launched several initiatives to reform and make more transparent the system that protects patients from adverse events associated with marketed drugs. The steps taken in 2005 included a contract with the Institute of Medicine to study the effectiveness of the U.S. drug safety system; the appointment of 31 top drug experts to a novel Drug Safety Oversight Board that oversees the management of important drug safety issues; and four contracts to improve FDA's access to databases that can help identify rare side effects of medicines. Other examples of patient and consumer safety-oriented projects included FDA's investigation of the mechanical strength of vertebrae following injections with bone glue, the most common treatment for compression fractures that affect a quarter of all women over the age of 50; and studies of the toxicity of acrylamide in food.

FDA made important contributions to the nation's preparedness for the potential influenza pandemic. The agency provided guidance to speed vaccine manufacturing and availability; sought to increase the number of vaccine manufacturers and their capacity; and addressed such needs as the creation of pandemic strain libraries, for use in vaccine manufacturing and development, and improved assays and testing.

CFSAN launched a new comprehensive bi-lingual food safety education program for pregnant women which focuses on prevention of food borne illness. This program, Food Safety for Moms-to-Be, highlights food borne illness risks that pregnant women and their babies are particularly vulnerable to, such as illnesses due to Listeria monocytogenes, methylmercury, and Toxoplasma.

FDA proposed to modify its animal feed regulations to prohibit from use in the food or feed of all animals certain high-risk cattle materials that can potentially carry and spread the agent of bovine spongiform encephalopathy (BSE or mad cow disease.) This proposed regulation builds on a series of previously established anti-BSE firewalls that include FDA’s 1997 ruminant feed ban regulation. The removal of high-risk materials from all animal feed, including pet food, will protect against the transmission of the agent of BSE that could occur through cross –contamination during feed manufacture and transport, or intentional or unintentional misfeeding of non-ruminant feed to cows on the farm.

Bioterrorism

To help protect the nation against bioterrorism, Congress has charged the FDA with helping to secure the food supply and encouraging the development and availability of counterterrorism medical products. As part of this program, the FDA last year strengthened the protection against the effects of inhaled anthrax by approving several generic versions of Cipro (ciprofloxacin). The agency also approved ThyroShield (potassium iodide oral solution) for use in radiation emergencies and developed draft guidance on studies of products to eliminate inhaled, absorbed, or ingested radioactive contaminants.

CFSAN, along with the U.S. Department of Agriculture (USDA), the Federal Bureau of Investigation (FBI), and the Department of Homeland Security, announced a new collaborative effort with states and private industry to protect the nation’s food supply from terrorist threats through the Strategic Partnership Program Agroterrorism (SPPA) Initiative. CFSAN has spearheaded this effort to identify sector-wide vulnerabilities, mitigation strategies and research needs to protect our nation’s food supply.

Over the past three years, FDA has continued to implement the provisions of the Bioterrorism Act of 2002 designed to prevent the importation of intentionally contaminated regulated products. Last year, the agency finalized registration requirements for food and animal feed companies that sell products in the U.S., and processed approximately 167,000 prior notifications each week of intended regulated imports. These notifications were used to review, evaluate and assess the inspections of imported foods.

Better Manufacturing Practices

Another major FDA priority in 2005 was to ensure the proper manufacture of medications by strengthening compliance with the recently overhauled pharmaceutical standards Good Manufacturing Practices (GMPs). An example of this emphasis has been the agency's close cooperation with the United Kingdom's Medicines and Health Products Regulatory Agency (MHRA) in ensuring the correction of sterility failures that had caused the MHRA to suspend the license for Chiron, a major producer of influenza vaccine for the United States.

Both FDA and MHRA provided extensive input on Chiron's remediation plan for the firm's facility in Liverpool, and repeatedly inspected its implementation. The joint efforts resulted in the release and delivery of the Fluvirin influenza vaccine to the United States for the 2005-2006 influenza season.

Modernizing FDA

In 2005, the consolidation of the FDA's widely dispersed facilities moved closed to reality with the completion of a new building for CDER on the agency's White Oak campus. Another significant achievement was the consolidation of administrative and IT services in all of FDA's locations, which improved administrative procedures and made possible nonstop IT helpdesk services. Working for a better future has been the key to the FDA's success story since the agency's founding in 1906. In 2006, this tradition is stronger than ever. During its centennial year, the agency will continue following its strategic plan by developing new tools and methods for speeding safe and effective medical products to patients, advancing medical and pharmaceutical sciences, and helping improve the public health and quality of life in the United States.

To help protect patients from medication errors, to better inform practitioners about the information they need to use products most safely, and to better enable the use of electronic labeling of drug and biologic products, FDA finalized its new rules governing the format and content of the required information (labeling) that must accompany drug and biologic products when they are marketed in the united states.

Recognizing that most of the food we eat and that many of the medical products we use are imported, FDA continued this year to foster special relationships with agencies with similar responsibilities in other key countries. These efforts have resulted in the completion of confidentiality and other agreements with these agencies in thirteen key countries around the world. Under these agreements, FDA is more quickly and efficiently able to share important information regarding product safety with and to leverage our scientific, human, and inspectional resources with those of these key countries. These efforts are primarily aimed at helping to protect and promote the health of the USA and these countries and to reduce the burden of duplicative regulation of common products through timely exchange of important knowledge, data, and expertise and by increasing the internal capacity of foreign agencies to help oversee products destined for the United States before they leave their country of production.