A Medical Device Daily

The FDA should be getting some extra cash in its FY09 budget.

HHS Secretary Mike Leavitt said that the administration is amending its budget request for FY09 to include an additional $275 million for the agency. He called on Congress to act quickly on this budget amendment and pending administration legislative proposals to strengthen FDA.

The increase brings the administration's total proposed increase in FDA's budget for FY09 to $404.7 million a 17.8% boost in funding from FY08.

The action supports the fundamental change in strategy currently underway at FDA to adapt to the demands of the rapidly growing and changing global economy. These funds are expected to expedite implementation of the strategy outlined in the Action Plan for Import Safety and the complementary Food Protection Plan, both released in November 2007.

"Last year we outlined important changes in how this nation deals with imports. We are moving from an intervention strategy where we stand at the border and try to catch things that are unsafe to an integrated strategy of prevention with verification. We are rolling the borders back and seeking to build safety and quality into products at every step of the way before they reach American consumers," Leavitt said. "Combined with crucial legislative proposals, this increase will allow FDA to continue to transform its regulatory strategies to meet the challenges of the evolving global marketplace. I urge Congress to act quickly to give FDA the authority and funding it needs to enhance the safety of our food and medical products."

The extra funds will allow the agency to conduct at least 1,000 more foreign inspections of food and medical product facilities and an additional 1,000 domestic inspections. The budget amendment is also expected to help FDA establish a presence in five countries or regions and implement other measures to ensure greater foreign compliance with FDA standards. Another initiative aims to expedite entry for goods bearing certification by trusted parties. The extra funds also will help the agency modernize its information technology infrastructure.

Congress has not yet granted some new authorities requested for federal agencies in the Action Plan for Import Safety, including: a request to authorize FDA to accredit "highly qualified" third parties to evaluate compliance with FDA requirements; a request authorizing the agency to require certification of designated high-risk products as an additional condition of importation; a request giving authority to refuse admission of imports from a firm who delayed, limited, or denied FDA access to its facilities; and a request that would allow FDA to issue a mandatory recall of food products when voluntary recalls are not effective.

"FDA's mission to protect and promote the health of the America public will be greatly aided by these additional funds to implement our strategic plan," said Andrew von Eschenbach, MD, FDA commissioner. "FDA has already embarked on an ambitious program to transform the Agency. This added funding will ensure that FDA can move ahead with these proposals more rapidly."

The budget amendment proposes increasing FDA's program for safer drugs, devices, and biologics by about $100 million.

The agency said the increase of $100 million for its medical product programs will strengthen its ability to ensure the safety and effectiveness of medical products, from product development and pre-approval testing, through approval, and post-approval safety surveillance. FDA faces growing challenges from the globalization of medical product development and manufacturing, the agency noted. The increase for medical product programs will allow the FDA to respond to this trend.

The budget amendment also proposes $50 million to increase FDA's capacity to support product safety and development in areas of emerging science such as nanotechnology, cell and gene therapies, robotics, genomics, advanced manufacturing, and the critical path initiative. FDA said it will also improve laboratories and other facilities that are essential to carrying out its mission and invest in science training, professional development, and fellowship programs to strengthen and modernize the FDA workforce.

SHIPs slated to get additional $15M

The Centers for Medicare & Medicaid Services said that an additional $15 million will be distributed to State Health Insurance Assistance Programs (SHIPs) to help people with Medicare get more information about their health care choices.

The $15 million is the second of three installments of SHIP funding in 2008 and will be distributed in June. CMS will distribute over $50 million to the nation's SHIPs in 2008; of that, $36 million was distributed on April 1 and an additional $1.5 million will be distributed in performance-based awards to SHIPs in September. This funding represents a $20 million increase in SHIP funding over FY07.

"State health insurance assistance programs fill an important role in providing information and support to people with Medicare where they live," said CMS Acting Administrator Kerry Weems. "In addition to answering beneficiaries' questions about Medicare, this year's funding should further the SHIPs' efforts to reach those people who are most likely eligible for extra help paying the costs of Medicare prescription drug coverage, and assist them in applying for extra help."

SHIPs are state-based programs that use community-based networks to provide Medicare beneficiaries with local, personalized assistance on a wide variety of Medicare and health insurance topics. A significant accomplishment of the SHIPs has been their success in helping to educate many of the nation's 44 million Medicare beneficiaries about Medicare as well as their prescription drug coverage options so that they can make a choice about their health care that best meets their needs.

CMS said it expects the SHIPs to use the increased 2008 funding to conduct community-based programs targeted at reaching more beneficiaries who are unable to access other sources of information such as the CMS online tools at www.medicare.gov.

SHIPs will continue their outreach and assistance to currently and newly eligible Medicare beneficiaries and their caregivers, as well as reaching out to beneficiaries with limited incomes who may be eligible for the extra help with prescription drug costs.

CMS said it would continue to support the SHIPs in 54 states and territories with training and technical assistance. This will help to ensure that the community networks remain fully capable of accessing and using all of CMS' regional office resources, as well as the online tools at www.medicare.gov to provide assistance to beneficiaries.