Mobile Edition
Print
Get the Mag
Weekly UpdatesFDA has requested a 19% budget increase for fiscal year 2010 (Oct. 1, 2009 through Sept. 30, 2010), which would yield a $3.2 billion budget aimed primarily at food safety, but also with millions for drug, device and biologic safety and GMP compliance.
More than $160 million will fund an initiative to improve pharmaceutical safety. Proposed increases also cover new user fees, which support generic drug review, inspections and reinspections.
"The resources in this initiative will allow FDA to measurably improve the safety of medical products: human drugs, vaccines, blood and other biological products, medical devices, animal drugs and medicated feed," FDA stated in its budget request. "The investments in this initiative will increase FDA's capacity to effectively monitor the safety of medical products. Moreover, these investments will provide better information about the safety profile of medical products at earlier stages of development."
The FY 2010 budget contains a program level increase of $130.6 million for the human drugs program, $34.2 million for biologics and $41.8 million for the Center for Devices and Radiological Health (CDRH).
As part of its plan to ensure drug safety in FY 2010, FDA said it would identify Internet sites that expose consumers to drug fraud. "This effort will improve FDA's ability to conduct enforcement against those who sell and promote fraudulently marketed products," the request stated.
FDA has allocated $25,848,000 for a Reinspection User Fee that requires agency-inspected facilities to cover reinspections costs and associated follow-up work. FDA will impose the user fee upon reinspection when companies fail to meet GMPs.
The budget will also support research activities at CDRH, including device review and safety, technology evaluation, domestic and international standards development and new guidances. In addition, CDRH will advance nanotechnology and genomics research and development and validation of new clinical trial methods for assessing imaging devices and pursue efforts to assess the design and structure of electronic medical devices and software.
To better ensure medical device safety, field office staff will be thoroughly trained to conduct device inspections and audits of inspection reports. New staff will provide technical assistance during domestic and foreign device inspections. FDA will also boost its support of inspection teams and work with biological manufacturers to establish reliable quality systems focused on product safety and quality. The agency said it would "strengthen the safety of the supply chain for medical devices by employing a global medical device nomenclature to improve postmarket surveillance and facilitate our ability to share and analyze adverse event reports with other regulators."
The Office of Regulatory Affairs plans to ramp up inspections for medical device programs. Its goals include an increase of 41 domestic Quality Systems-GMP medical device inspections above the FY 2010 levels and an increase of 41 Quality Systems-GMP foreign medical device inspections above the FY 2010 levels before 2013.
According to the FY 2010 Congressional Justification, FDA will increase risk-based compliance by "inspecting the highest priority registered manufacturers of biological products. The highest priority firms will be those whose operations are determined to be the highest risk, new product types in need of an inspectional history to evaluate and stratify risk, and emergency response situations."
According to the FY 2010 Online Performance Appendix, FDA had met or exceeded 97% of its performance goals in FY 2008 and met and or exceeded 98% of its performance goals for the previous two years:
"In FY 2008, CDER met its target of acting upon at least 50% of the identified priority post-market safety issues within an established timeframe. During the first year of this new process, CDER focused its efforts on increasing its staff resources for tracking, managing, and monitoring post-market safety issues. CDER conducted a pilot for prioritizing post-market safety issues, developing action plans and timelines for those issues, and monitoring and managing progress toward those plans."
The agency also inspected 534 high-risk foreign and domestic drug manufacturers, exceeding its FY 2008 goal of 500.
The Pharmaceutical Research & Manufacturers of America (PhRMA) responded favorably to the proposed budget increase, saying the extra funding will go far in securing safe drugs and help provide lower-cost medication for consumers.
"PhRMA applauds the President's request to increase funding for the Food and Drug Administration (FDA)," said Billy Tauzin, President and CEO of the drug industry trade group. "A fully funded FDA is important not only to assure the safety of our nation's food supply, as the President notes, but also to help ensure the safety and efficacy of cutting-edge medical innovations that all Americans seek. The cure for cancer that we're all working toward will make its way to patients only after a careful review by FDA's leading scientists."
Generic Pharmaceutical Assn. President and CEO Kathleen Jaeger agreed:
"Given this extraordinary savings, it is critical that our government invest in increasing access to safe, effective and affordable generic medicines. With the President rightfully looking for programs that work and save money, adequately funding FDA's Office of Generic Drugs (OGD) is definitely the place to start. A very modest investment in OGD clearly reaps extraordinary dividends for consumers and the health care system."
By Carrie Nathans
Managing Editor
FEED