WASHINGTON, February 19, 2010 ? Agriculture Secretary Tom Vilsack today announced the funding of 47 projects designed to protect public health by improving water quality and public sanitation services in 19 states. The projects, funded through the American Recovery and Reinvestment Act, are expected to provide construction jobs and create infrastructure needed to support community growth.

"These investments in water and wastewater infrastructure will deliver safe drinking water and protect the quality of our environment," Vilsack said. "A safe, reliable water supply is vital to economic growth and development. Through these projects, we are helping to achieve the Obama Administration's economic recovery goals to rebuild and revitalize the nation's infrastructure."

For example, the state of Kansas will build eight projects including one in the city of Muscotah. The community has been selected to receive a loan of $240,000 and a grant of $506,000 to construct a new 65,000-gallon elevated water storage tank and install new water lines. Muscotah water system improvements will reduce waterline breakages, meet the state water pressure requirements, and provide community residents with safe, dependable drinking water supplies.

The Fort Smith Water and Sewer District in Montana has been selected to receive a $1,368,000 loan and $2,322,000 grant to construct a new well and well house, connect two systems to a main line, install new fire hydrants and water meters, and construct a 100,000-gallon water storage tank. These system improvements will boost community water pressure.

The loan and grant funding announced today totals $128.1 million. To date, USDA has announced $2.2 billion in Recovery Act funds for water and environmental projects. The Recovery Act was signed into law by President Obama one year ago.

The funding announced today is being administered by USDA Rural Development's Water and Environmental Program which provides loans and grants to ensure that the necessary investments are made in water and wastewater infrastructure to deliver safe drinking water and protect the environment in rural areas.

Funding of individual recipients is contingent upon their meeting the terms of the loan or grant agreement. Below is a list of award recipients in the Midwest:

Illinois

• Village of Marissa: $1,380,000 loan; $815,000 grant; water system improvements

• FMC Water Company: $700,000 loan; water system improvements

Indiana

• Mexico Community Regional Sewer District: $1,506,000 loan; $4,449,000 grant; wastewater system improvements

• Town of Osgood: $2,370,000 loan; $778,000 grant; water system improvements

Iowa

• Southern Iowa Rural Water Association (SIRWA): $538,000 loan; $1,256,000 grant; wastewater system improvements

• Southern Iowa Rural Water Association (SIRWA): $181,000 loan; $402,000 grant; wastewater system improvements

Kansas

• City of Burlingame: $890,000 loan; wastewater system improvements

• City of Muscotah: $240,000 loan; $506,000 grant; water system improvements

• City of Olpe: $355,000 loan; $570,000 grant; water system improvements

• Osage County Rural Water District No. 6: $395,000 loan; water system improvements

• City of Parker: $390,400 loan; wastewater system improvements

• City of Smolan: $598,000 loan; wastewater system improvements

• City of Weir: $237,000 loan; storm drain system improvements

• City of Woodston: $342,000 loan; $484,000 grant; water system improvements

Minnesota

• City of Maple Lake: $1,314,000 loan; $604,000 grant; wastewater and water system improvements

Missouri

• Vernon County Public Water Supply District #7: $272,000 loan; $68,050 grant; water system improvements

South Dakota

• City of Sisseton: $616,000 loan; water system improvements

Wisconsin

• Village of Clyman: $2,317,000 loan; $1,727,000 grant; construction of a new Wastewater Treatment Facility (WWTF)

• Village of Winneconne: $3,659,000 loan; $916,000 grant; wastewater treatment plant improvements

• City of Mauston: $782,000 loan; $208,000 grant; water system improvements

• City of Mauston: $694,000 loan; $204,000 grant; wastewater system improvements

• Country Estates Sanitary District: $1,456,000 loan; $3,120,000 grant; wastewater system improvements

President Obama signed The American Recovery and Reinvestment Act of 2009 into law on Feb. 17, 2009. It is designed to jumpstart the nation's economy, create or save millions of jobs, and put a down payment on addressing long-neglected challenges so our country can thrive in the 21st century. The Act includes measures to modernize our nation's infrastructure, enhance energy independence, expand educational opportunities, preserve and improve affordable health care, provide tax relief, and protect those in greatest need.

More information about USDA's Recovery Act efforts is available at www.usda.gov/recovery. More information about the Federal government's efforts on the Recovery Act is available at www.recovery.gov.

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WASHINGTON --- Senator Chuck Grassley is asking the Food and Drug Administration for an update on the implementation of new guidelines for medical device makers on when they need to file new information with the agency and seek clearance for the marketing and use of modified devices under the 510(k) system, the agency's less stringent process for reviewing most medical devices.

Grassley said that his inquiry today follows up on questions he asked more than a year ago, after a ring used in heart-valve repair was being implanted in patients even though the device hadn't been cleared for this purpose by the FDA.  The FDA subsequently told Grassley that its current policy was inadequate and that an update was underway.  Grassley also asked a number of questions today about the FDA's requirements for manufacturers to report changes made to FDA-approved devices.

"My questions are aimed at establishing greater transparency and accountability for doctors and their patients," Grassley said.  "People have a right to know exactly what the FDA has approved, or not, in making decisions about their health care.  For this to happen, the FDA's policies need to be effective in establishing an accurate public record about the FDA-approval status of any particular product."

The text of the letter sent today from Grassley to the FDA Commissioner follows here.

February 16, 2010

The Honorable Margaret A. Hamburg

Commissioner

U.S. Food and Drug Administration

10903 New Hampshire Ave.

Silver Spring, MD 20993

Dear Commissioner Hamburg:

The United States Senate Committee on Finance (Committee) has jurisdiction over, among other things, the Medicare and Medicaid programs.  As Ranking Member of the Committee, I have a responsibility to the more than 100 million Americans who receive health care coverage under these programs to oversee their proper administration and ensure that taxpayer dollars are appropriately spent on safe and effective drugs and devices.

I appreciate your response of September 30, 2009, to my questions regarding the Food and Drug Administration's (FDA or Agency) guidance to manufacturers on when a modification to a device requires the filing of a new 510(k).  Over a year ago, I wrote to the FDA regarding serious allegations that an annuloplasty ring used in heart valve repair was being implanted in patients even though the device was allegedly not cleared for marketing by the FDA.  The FDA concluded that the company had made the wrong decision when it marketed the product without first seeking clearance from the Agency.  That device, the Myxo dETlogix Annuloplasty Ring (dETlogix ring), has since been cleared by the FDA, but as I stated in my letter to the FDA last April, the fact remains that for more than two years, patients at Northwestern Memorial Hospital were being implanted with the device before a 510(k) was submitted to the Agency.

I also wrote to Northwestern Memorial Healthcare and Northwestern University in September regarding the same allegations and asked them whether or not they obtain assurances or confirmation from a device manufacturer that a device is FDA-approved before it is used in their facilities. Attached are their responses for your consideration.  Northwestern Memorial Healthcare stated in its response that Edwards Lifesciences assured Dr. McCarthy that it was taking the steps necessary for FDA approval.  It also stated that, "the health care provider relies on the manufacturer to provide timely and accurate information regarding the regulatory status of the device."  However, in this case, the manufacturer followed FDA's guidance and made the wrong decision regarding its device.

In your September response, you stated that FDA believes its current policy on when a modification to a device requires a new 510(k) submission is not sufficiently clear and is revising the guidance document.  I agree that the guidance document needs to be revised so that we can prevent similar events from occurring in the future.  However, it has been more than four months since I received your response and the new guidance has yet to be released.  Accordingly, I would appreciate you advising me immediately on the status of FDA's revisions to the Agency's guidance entitled, "Deciding When to Submit a 510(k) for a Change to an Existing Device."

In addition, it is my understanding that device manufacturers registered with the FDA must also list the devices that they make with the Agency.  According to FDA's website, registration information must be submitted each year between October 1 and December 31 even if no changes have occurred, and at that time listing information should be reviewed as well.  The website also states that a manufacturer can access the FDA Unified Registration and Listing System at any time to update changes to their registration and listing information as the changes occur.  Examples provided by the FDA include a change to a previously listed device or the introduction of another device into commercial distribution.  In light of the statements made on FDA's website please respond to the following questions:

1)         Would a manufacturer be required to update its device listings even if it changed only the name of an existing device?

2)         Would the manufacturer also be required to update its listings if it made a modification to a device that did not require submission of a new 510(k) but marketed that device under a different name?

3)         If the answer to either question is no, please explain why not.  Please also explain how patients and their doctors would obtain information about the status of a device other than from the manufacturer itself.

4)         FDA concluded that Edwards Lifesciences' dETlogix ring did require a new 510(k).  However, even if a new 510(k) had not been required, was the company required to list that device with the FDA?

Thank you for your attention to this important matter.  I would appreciate a response to the requests set forth in this letter by no later than March 2, 2010.

Sincerely,

Chuck Grassley

United States Senator

Ranking Member of the Committee on Finance

WASHINGTON --- Senator Chuck Grassley has asked the Food and Drug Administration about progress made to improve foreign drug inspection, following commitments made by the agency when Baxter International temporarily suspended production of its blood thinner heparin in 2008 because of adverse reactions.

"My letter today follows up on oversight I did at that time because requirements the FDA already had in place then were not met by the FDA, and the drug company itself didn't have a system to check the quality of upstream providers of the drug components.  In fact, pharmaceutical companies aren't required to have those checks in place," Grassley said.  "I will continue asking the FDA for information and working to hold the federal agency accountable in its work to protect the safety of the drugs in our medicine cabinets."

Since 2007, Grassley also has twice filed legislation to dramatically beef up the FDA's foreign inspection operation, including enhanced enforcement for quality and safety violations.  The legislation, which Grassley had introduced with the late Senator Kennedy, hasn't been passed by Congress.  China is one of the largest exporters of pharmaceutical products to the United States.  Following questions raised by Grassley and others in 2007 and 2008 about the inadequate foreign inspections, the FDA has opened an office in China to facilitate inspections.

Below is the text of the letter Grassley sent today to the FDA Commissioner.

February 16, 2010

The Honorable Margaret A. Hamburg

Commissioner

U.S. Food and Drug Administration

10903 New Hampshire Ave.
Silver Spring, MD 20993

Dear Commissioner Hamburg:

As Ranking Member of the United States Senate Committee on Finance (Committee), I have a special responsibility to the more than 100 million Americans who receive health care coverage under those programs to ensure that taxpayer and beneficiary dollars are appropriately spent on safe and effective drugs and devices.

In 2007 and 2008, I wrote a series of letters to the Food and Drug Administration (FDA/Agency) inquiring about the Agency's oversight of foreign-made drugs and active pharmaceutical ingredients (API).  I appreciate FDA's responses to my letters and look forward to the Agency's continued cooperation.

Almost two years ago, in February 2008, Baxter International (Baxter) had announced that it had temporarily suspended production of its blood thinner heparin because of increased reports of serious adverse events, in particular allergic reactions, associated with the use of its drug.  The company recalled its heparin sodium injection single-dose vials, the remainder of its multiple-dose vials, and the heparin flush products from the market.  Prior to the recall of its products, Baxter manufactured about 50 percent of the heparin used in the United States.  Thus, there were serious concerns about whether or not this country would have enough heparin to meet patient needs.

After several months of investigation, the FDA and the Centers for Disease Control and Prevention concluded that the adverse events were caused by heparin contaminated with oversulfated chondroitin sulfate.  According to the FDA, this contaminant was found in heparin API produced by Baxter's API supplier in China, Changzhou Scientific Protein Laboratories (SPL), as well as more than 10 other Chinese facilities in the heparin supply chain.  In addition, the Agency revealed that due to human error, the FDA had failed to conduct a pre-approval inspection of Changzhou SPL in accordance with its pre-approval inspections program to ensure compliance with current good manufacturing practices (CGMP).

Despite its own audits and inspections of the API supplier, Baxter did not discover that its heparin API supply was contaminated because the company did not have mechanisms in place to ensure that the upstream providers, such as the crude heparin processors and slaughterhouses, were providing quality product to Changzhou SPL.  Baxter and other heparin manufacturers, however, are not required to have such mechanisms in place.  FDA has stated that API and drug manufacturers "frequently audit suppliers of critical materials" but the audits are not a requirement of the CGMP regulations for finished pharmaceuticals.  Nonetheless, there was one heparin manufacturer, APP Pharmaceuticals, which had a traceable distribution system that did allow it to trace crude heparin from the API supplier to the workshops and pig farms.  That company was able to increase its heparin production capacity and take over as the major supplier for the U.S. market after Baxter's product recalls.

Investigation of the contamination of the U.S. heparin supply in 2008 highlighted the need to improve FDA's protection of the safety of products made in this country and abroad.  In fact, the FDA acknowledged at a press conference on April 21, 2008 that the heparin problem "illustrated the need for [the FDA] to focus on enhanced regulation and scrutiny of the whole supply chain for drugs, including all sources of materials, including the natural sources."  In the Agency's response to me, dated June 5, 2009, the FDA also stated that "Aside from a traceable distribution system, it is imperative that both the API and drug product manufacturer establish and implement procedures and controls to secure and assure the integrity of the supply and distribution chain."

In response to the heparin contamination, the FDA announced a number of efforts it was implementing to prevent similar incidents from occurring in the future, including the establishment of an FDA presence abroad by opening field offices in China, India and Latin America, as well as the pursuit of international agreements to augment its foreign inspection program.  The FDA also stated that the FDA and international regulators had agreed to hold an inspection summit in 2009 to apply the lessons learned from the heparin contamination.  In addition, the FDA stated in its letter to me that it is collaborating with several pharmaceutical associations "to establish more robust systems and procedures to qualify suppliers of pharmaceutical ingredients and assure the identity and purity of batches of incoming ingredients."

I am writing today to follow up on the status of FDA's initiatives to improve its foreign drug inspection program, in particular any efforts to prevent tainted final dosage forms and API from entering this country.  I would also appreciate a response to the following requests:

· A reporting of FDA's plans to ensure the safety and quality of drug products that are imported into this country, including efforts to improve surveillance, technology and testing capabilities, to harmonize regulatory standards and procedures, and to enhance the Agency's regulation of the whole supply chain of drugs.

· If FDA conducted its own assessment of how the Agency handled the heparin contamination, a copy of any report or memorandum generated from that assessment, including any recommendations and lessons learned.

· A status report on FDA's review of reports of adverse events occurring after heparin administration and the number of deaths and adverse events that have been determined to be epidemiologically associated with use of the contaminated product.  During the April 21, 2008 FDA press conference, the Agency stated that there were 81 deaths linked to the allergic reactions that may have been caused by contaminated heparin.  A month earlier, on March 5, 2008, the Agency stated that it had received 785 reports of adverse events.  FDA's webpage on adverse event reports and heparin, last updated July 1, 2009, shows that between January 1, 2007 through May 31, 2008 there were 146 reported deaths that included one or more allergic symptoms that is associated with use of the contaminated heparin.  The webpage, however, does not identify the total number of other adverse events reported to the FDA.

Thank you for your assistance on this important matter.  I would appreciate a response to the requests set forth in this letter by no later than March 2, 2010.

Sincerely,

Chuck Grassley

United States Senator

Ranking Member of the Committee on Finance