A Diagnostics & Imaging Week

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 the 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 American 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.

Anesthesia monitor maker gets warning

Safer Sleep (Nashville, Tennessee) and FDA apparently went through quite a process in sorting out findings from the most recent inspection of the firm's plant, given that the inspection took place last November and that FDA finally inked a warning letter for that inspection May 27.

Perhaps more remarkable is the apparent state of disinformation exhibited by the company on the quality systems regulations (QSR). Although the company's web site touts the principal product, the SAFERsleep device, as "user friendly and field-proven in over 25,000 anesthetics," the warning letter pinned the company down on 10 fairly routine QSR violations.

According to FDA, the company was unable to provide any documentation "of validation of the embedded software in the ... device" and had not established procedures for corrective and preventive action. The warning letter also cited Safer Sleep for lack of procedures for quality audits, and said that the firm had not appointed a management representative for quality systems. FDA indicated that Safer Sleep "presented the investigator with a new, written quality policy prior to the close of the inspection," but that the company could not document that "the policy has been implemented."

Danny Gardner, Safer Sleep's president for U.S. operations, told diagnostics & Imaging Week that the company "is restructuring its quality program to be fully consistent with the FDA quality systems regulation."

PTO publishes fee schedule for FY09

The U.S. Patent and Trademark Office published an announcement in the Federal Register earlier this week on the fee schedule for patent applications for fiscal 2009. PTO will accept comments on the proposed fee schedule until July 3.

Using the Consumer Price Index as a fee adjustment, PTO proposes to charge a basic filing fee for a design application of $370 for a "non-small entity" and half that amount, or $185, for a small entity. The notice did not list the previous fees charged, but PTO said that the CPI measurement will be for the year ending September 30, 2008.

A filing for a patent that includes a search of patents in Japan or in Europe will cost the small entity $510 in FY09, and the big entities will pay twice that amount, or $1,020.

According to subsection 1.27 of chapter 37 of the Code of Federal Regulations, a small entity is defined as anyone "who has not assigned, granted, conveyed, or licensed, and is under no obligation under contract or law to assign, grant, convey, or license, any rights in the invention."