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FDA-TRACK monitors accountability, transparency; supports Open Government Initiative

The U.S. Food and Drug Administration launched an innovative performance management system designed to advance the President’s commitment to transparency, public participation, and collaboration in the work of government.

The system, called FDA-TRACK, will monitor more than 100 FDA program offices through data from key performance measures established each year. That data will be gathered monthly, analyzed and presented each quarter to FDA senior leadership. Importantly, the public will be able to track this data and the agency’s progress through the FDA-TRACK website.

“FDA-TRACK will bring the operations of this historically opaque Agency into the daylight and help us be even more responsive as we work to protect the public health,” said FDA Commissioner Margaret Hamburg, M.D.

FDA-TRACK is designed to be informative, encourage accountability among the people who work at the FDA, and make that work more transparent. It gives managers and employees a new way to measure their effectiveness in meeting goals to protect the public health and provides a way for the public to monitor agency activities.

Adapted from several successful state and local performance management models, FDA-TRACK hopes to set the standard for open government at the federal level. The system monitors performance indicators in four categories:

Common Measures – Agency-wide measures applicable to each of more than 100 program offices and may focus on the agency’s most recent priorities.

Example: Increase the total number of employees who are trained in the Incident Command System, which helps the agency respond to emergencies.

Key Center Director Measures – Center-specific measures that are applicable to each Center and are central to the Center’s priorities and strategic goals.

Example: Increase the FDA’s technical guidance by increasing the number of technical publications drafted, which enables the Center to better prepare industry and consumers.

Program Measures – Program office-specific measures that are applicable to the office and reflect work important to the public and to the FDA’s mission.

Example: Monitor the percentage of 510(k) decisions meeting the 90-day Medical Device User Fee Act goal during a specific time period.

Key Projects – Program office-specific projects that are applicable to the office and important to the mission and objectives of the office. Performance for Key Projects is measured through achievement of the stated milestones within the project’s plan.

The FDA’s Center for Devices and Radiological Health (CDRH or the Center) has released two preliminary reports for the public to comment on recommending concrete steps we could take to advance three key objectives of a balanced public health approach: fostering medical device innovation, enhancing regulatory predictability, and improving patient safety.

These reports address issues of great importance to the Center, the industry we regulate, and the public we serve. Together, they represent a blueprint for smarter medical device oversight, with the tools CDRH needs to drive innovation and help bring the best technologies to patients.

CDRH’s responsibility is two‐fold: to protect and promote the public health. We use our oversight to keep patients from harm, and we foster the development of safe and effective new products. The recommendations in today’s reports represent significant opportunities to increase our effectiveness in carrying out both parts of our mission. By increasing the predictability, reliability, and efficiency of our regulatory pathways, we can help provide better treatments and diagnostics to patients more quickly, stimulate investment in and development of promising new technologies to meet critical public health needs, and increase the global market position of U.S. medical devices.

The actions proposed in these reports would complement two major steps CDRH is already taking, in collaboration with others in the federal government, to foster medical device innovation. We have established a new interagency Council on Medical Device Innovation, whose aim is to identify unmet public health needs and facilitate the development or redesign of devices to address those needs.1 In addition, FDA recently signed an information‐sharing Memorandum of Understanding with the Centers for Medicare and Medicaid Services (CMS), which will allow us to better coordinate the work of our two agencies.2 These efforts have the potential to dramatically streamline the process of bringing new safe and effective medical technologies to patients.

The reports were developed by two internal committees I established in September 2009: the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making. I convened these groups to address critical challenges facing the Center and our external constituencies.

The premarket notification (510(k)) medical device review program is intended to meet two important goals: making available to consumers devices that are safe and effective, and fostering innovation in the medical device industry. In recent years, however, concerns have been raised both within and outside of FDA about whether the current 510(k) program optimally achieves these goals. Some have argued that the 510(k) process allows devices to enter the market without sufficient evidence of safety and effectiveness. Others have argued that a lack of predictability, consistency, and transparency in the process is hindering device development. I charged the 510(k) Working Group to evaluate the 510(k) program and explore actions CDRH could take to enhance our 510(k) decision making.

Focusing on Chemical Identifiers Contained in the Drugs

A Drug Anti Counterfeiting Guidance was recently released by the FDA. This initiative plays a major part in addressing the manufacture and duplication of drug products by counterfeiters. Drug counterfeiting is a serious concern and The Food and Drug Administration is working vigorously to reduce the likely hood of incidences where individuals are in contact with harmful or unapproved chemicals and ingredients in pharmaceuticals.

Recognized by their unique characteristics, physical chemical identifiers (PCIDs) play a determining role in the identification of counterfeit drugs, and in the verification of the substance’s authenticity. PCID’s are typically distributed in such low dosages as to not interact with the drugs active ingredients.

The Drug Anti Counterfeiting Guidance suggests the administration of lower levels of PCIDs to support product authenticity and verification.

The FDA recently released that they are approving labeling for the use of a “Plan B emergency-contraceptive pill” which will allow usage for women above the age of 16. According to the FDA, there will also be a single use product available the “Plan B One-Step”, which will be available to women over 16 as well.

The recent change was ordered by a federal court in response to laws enacted during the Bush administration requiring the age limit to be lowered to permit the sales to women under the age of 18. The Plan B Contraceptive Pill was approved for women 18 and over by the Food Drug Administration in 2006. Though supported by medical experts in 2004, the FDA’s previously rejected the application to allow the drug to be sold without a prescription.

FDA Guidance for Salmonella Species Pistachio Products

The FDA released the guidance for industry regarding measures to address the risks of contamination in foods containing pistachio ingredients … More info on the FDA Food Guidance is available at the FDA …

FDA Warning video on acetaminophen containing drugs is now available on CBSNews The video contains footage of Dr Jennifer Ashton explaining an FDA proposal to Dave Price about lowering acetaminophen doses and to add drug labeling warnings to help reduce the possiblity of poisoning and fatalities from acetaminophen overdoses.

Three FDA advisory committees are currently discussing remedies to reduce the likelihood of liver damage from Acetaminophen usage … More information is available on the FDA page, Acetaminophen Liver Injury FAQ’s …

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