July 26, 2012
Additional funding for FDA to improve food and medical product safety including establishing unique device identifiers
HHS Secretary Leavitt announced yesterday that the Administration is amending its budget request for fiscal year (FY) 2009 to include an
additional $275 million for the U.S. Food and Drug Administration (FDA). 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 FY 2009 to $404.7 million – a 17.8% boost in
funding from FY 2008. The program Protecting America’s Food Supply will get $125 million. The increase allows FDA to intensify actions to
implement FDA’s Food Protection Plan. Announced on November 6, 2007, the Food Protection Plan is an integrated, risk-based strategy to
help ensure the safety of domestic and imported food and feed. The $125 million increase adds to the $42.2 million increase proposed for
food protection in the budget announced in February 2008.
The increase in food protection activities will allow FDA to reduce threats to the food supply, expand FDA’s international presence, and
increase technical assistance to help ensure that foreign and domestic food facilities comply with food safety standards. FDA will also be
able to improve the risk-based approach it uses to conduct more targeted import exams and foreign and domestic inspections of food
manufacturing, processing, and packaging facilities. FDA will pursue additional research on ways to prevent intentional and unintentional
contamination, deploy screening technologies to identify microbial and chemical contamination, and respond more quickly to contain
outbreaks of food-borne illness. Finally, FDA will conduct at least 1,000 more foreign inspections of food and medical product facilities and
an additional 1,000 domestic inspections with funds in the budget amendment.
The increase of $100 million for the FDA’s medical product programs will strengthen FDA’s 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 increase for medical product programs
will allow the FDA to respond to this trend.
FDA will more aggressively conduct active safety surveillance to identify early signs of adverse events linked to medical products. FDA will
also implement new requirements under the FDA Amendments Act of 2007 related to clinical trials, pediatric drugs and devices, postmarket
study commitments, and the labeling and safe use of drugs. FDA will also establish unique device identifiers to track devices, facilitate device
recalls, and support inventory management during disasters and the response to terrorism events. Finally, FDA will conduct more import
exams and foreign and domestic inspections of medical product manufacturers.
The budget amendment also proposes increases to strengthen 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 will also improve laboratories and other facilities that are essential to carrying out FDA’s mission and invest in science training,
professional development, and fellowship programs to strengthen and modernize the FDA workforce. The program increases listed above
include $65 million to modernize FDA’s information technology infrastructure.
Additional information at http://www.fda.gov/bbs/topics/NEWS/2008/NEW01849.html
Red Cross is fined for blood violations
Federal regulators said yesterday that they have fined the American Red Cross $1.7 million for continued failures to adequately manage the
nation's blood supply. The Red Cross, a charity based in the District that administers nearly half the U.S. blood supply, washed six units of
red blood cells using the wrong saline solution, according to a review by the Food and Drug Administration.
The blood cells, which measure about six pints, were transfused to three patients in 2006 and last year at chapters in the Northeast and
Southeast. Red Cross executives said that the violations did not endanger patients and that no adverse effects have been reported.
The fine is the latest levied against the Red Cross under an agreement with federal regulators to eliminate chronic problems with blood
safety. Since 1993, the charity has been under a court-supervised consent decree about its blood collection procedures. A 2003 agreement
made the charity subject to federal fines for violations.
In February, the Red Cross was fined $4.6 million after an FDA review found 113 instances in which the charity retrieved "unsuitable blood
components," according to federal documents. That could mean using an ineligible donor, failing to conduct proper testing or shipping the
blood at an improper temperature.
The Red Cross has been fined more than $21 million for safety lapses over the past five years but said it has implemented new measures. In
the latest incident, the six units of red blood cells were washed in a "hypertonic saline" instead of a "sterile normal saline," the federal
Chris Hrouda, the Red Cross's executive vice president for biomedical services, said it was "done out of protocol" but posed no danger.
"These were perfectly acceptable units of blood," he said. "They were fully tested and distributable units." (Washington Post) See the original
Suppliers fight plan to cut Medicare's equipment costs
Medicare shells out $1,825 for the same home hospital bed that anyone can buy online for $754, according to government data. It pays
$4,023 for a power wheelchair that retails for $2,174. Outraged over such disparities, Congress in 2003 required the federal health insurance
program for the elderly to phase out its outdated fee schedule in favor of a competitive bidding system that would bring its durable medical
equipment costs more in line with market prices.
The new system, scheduled to begin in 10 metropolitan areas July 1, relies on bids by accredited suppliers to determine who can sell to
Medicare beneficiaries. It promises to cut prices by an average of 26 percent, saving the government about $125 million over the next year,
according to the Centers for Medicare and Medicaid Services. Taking it nationwide eventually would generate annual savings of $1 billion,
But, an intensive industry lobbying campaign on Capitol Hill threatens to derail the new bidding system weeks before its start. Suppliers
contend that the changes will sever longstanding ties between Medicare beneficiaries and many of the businesses they depend on for
oxygen, diabetic supplies, walkers, power wheelchairs and scooters. The new system has unfairly disqualified some suppliers, accepted bids
from others with little experience and will lead to declining quality and service, they argue.
The industry's arguments are gaining traction in Congress. Only about 4 million households will be affected by the program's first phase, but
all lawmakers count Medicare beneficiaries among their constituents. A lot of money is at stake: Medicare spends about $8.5 billion annually
on durable medical equipment.
Rep. Pete Stark (D-Calif.), chairman of the Ways and Means subcommittee on health, said he plans to introduce legislation as soon as this
week to delay the program by 18 months. But his cooperation comes at a price: The industry must agree to cuts in current fees equivalent to
the projected savings of the bidding program.
"I don't mind the fee schedule if we set the fees right," Stark said in an interview. "But when I can go on eBay and buy stuff for a third of what
Medicare is paying for it, then I know something is wrong. . . . There's money to be saved there, but I don't know that you have to put people
out of business to do it."
Officials with the American Association for Homecare, a trade association that has contributed $138,490 to members of Congress since
2002, said many suppliers favor temporary fee cuts over the possibility of being excluded from the program. Most derive as much as half
their revenue from Medicare, officials say.
The program allows oxygen and oxygen-equipment suppliers who were not low bidders to keep servicing their Medicare customers -- but
only at the new, lower price, he said. Similarly, wheelchair suppliers can still provide repairs and service on chairs they've sold, he said. For
the first time, suppliers of equipment must be accredited and meet standards for quality and financial health.
Walter Gorski, vice president of government affairs for the Homecare Association, said many beneficiaries will lose, too. "If Congress wants
to create the Amazon.com model of DME [durable medical equipment], then competitive bidding may be the direction they want to go in,"
Gorski said. "What is lost many times is . . . it's more than just an equipment-based benefit." (Washington Post) See the complete story
Salmonella scare holds the tomato
The tomato is quickly disappearing, albeit temporarily, from many restaurants and grocery stores due to a major salmonella outbreak that
has sickened at least 145 people, the latest in a series of disease flare-ups in the U.S. food chain.
Oak Brook-based McDonald's confirmed Monday that it has pulled tomatoes from its sandwiches, though the company hasn't detected
salmonella bacteria in any of its tomato supplies. Other restaurant chains such as Burger King and Taco Bell have taken the same
precaution, as have grocery stores, including Chicago's leading supermarkets, Jewel and Dominick's.
Since mid-April, people in 16 states have been infected with a rare strain of bacteria known as Salmonella Saintpaul, which has been linked
to several kinds of raw tomatoes, the Centers for Disease Control and Prevention reported. The bulk of the cases have been in Texas and
New Mexico, and 23 of them have required hospitalization.
The FDA on Saturday said consumers should not eat raw red round tomatoes, as well as raw red Roma and plum tomatoes. The agency
advised restaurants and grocery stores not to offer those types of tomatoes for sale.
The salmonella outbreak is the latest of several in the tomato industry, but it appears to be the first where the FDA has publicly advised food
companies to avoid selling the product. McDonald's, for instance, didn't banish tomatoes during salmonella scares earlier this decade. But
after the FDA weighed in last week, tomatoes disappeared from the company's premium chicken sandwiches and Big N' Tasty burgers.
Other food companies reacting included Chipotle, which pulled tomato salsa from its menu. The FDA says raw tomatoes are often used in
fresh salsa, pico de gallo and guacamole. However, raw cherry tomatoes and grape tomatoes don't present a problem, the FDA says. So
McDonald's, for example, will continue to serve grape tomatoes in its premium salads.
The FDA hasn't traced the origin of the Salmonella Saintpaul outbreak, but a New Mexico Department of Health official told the Albuquerque
Journal last week that preliminary information points to Mexico as the source. From a growing-season perspective, that would make sense,
some tomato safety experts say. It's still relatively early in the tomato-growing season in a good part of the U.S.
Statistically, the frequency of salmonella tainting tomatoes is low, said Trevor Suslow, a researcher at the University of California at Davis
and a specialist in fresh-produce safety. But since the tomato is such a popular item, the chances are greater that salmonella scares will be
associated with it, he said.
The salmonella bacteria has a hard time growing on the tough, waxy skin of the tomato, but not so when the fruit is cut, whether accidentally
nicked in the field or chopped up, said Jerry Bartz, a plant pathologist and produce specialist at the University of Florida. When a tomato is
cut, salmonella microbes feed off the fruit's sap. In fact, the bacteria can be spread in the chopping process, as one bad tomato taints the
blade of a slicer, which in turn can taint more tomatoes, Bartz said. See the complete story www.chicagotribune.com/business/chi-tue-
Women who gain excessive weight during pregnancy have children who are more likely to be overweight
Children of mothers who gain more than the recommended amount of weight during pregnancy are more likely to be overweight at age
seven, say researchers from The Children's Hospital of Philadelphia and the University of Pennsylvania School of Medicine, in a study
published today in the American Journal of Clinical Nutrition. Children of mothers who are obese prior to pregnancy and gain excessive
weight are at the greatest risk for overweight.
"The earliest determinants of obesity may operate during intrauterine life, and gestational weight gain may influence the environment in the
womb in ways that can have long-term consequences on the risk of obesity in children," said study leader Brian Wrotniak, P.T., Ph.D., of The
Children's Hospital of Philadelphia and the University of Pennsylvania. "Adherence to pregnancy weight gain recommendations may be a
new and effective way to prevent childhood obesity, since currently almost half of U.S. women exceed these recommendations."
According to the Institute of Medicine (IOM), which makes recommendations for weight gain during pregnancy, the amount of weight women
should gain during pregnancy depends on the mother's weight status before pregnancy. Women at a healthy pre-pregnancy weight are
encouraged to gain 25 to 35 pounds, while women who are overweight should stay between 15 to 25 pounds. Women who are underweight
should gain more weight during pregnancy—between 28 and 40 pounds. Of the women studied by the researchers, 11 percent gained
excessive weight, 24 percent gained adequate weight and 65 percent gained insufficient weight.
Using the IOM guidelines, children whose mothers exceeded the recommended weight gain were 48 percent more likely to be overweight
than children whose mothers stayed within the recommended weight gain. The risk of overweight was similar for children born of women who
gained insufficient weight compared with mothers who gained appropriate weight during pregnancy.
Henry Medical Center saves 40 percent on orthopedic spend
Broadlane announced that Henry Medical Center in Stockbridge, Georgia will maintain its exclusive relationship with Broadlane. Henry
Medical Center will continue to access Broadlane’s unparalleled national GPO portfolio of consumable supplies, equipment, pharmaceuticals
and purchased services to help manage its approximate $30 million in annual spend.
Broadlane’s proprietary technology, including OnRamp (Broadlane’s client portal) and BroadLink (Broadlane’s e-commerce exchange), will
be utilized to streamline the purchasing processes. Henry Medical Center recently added clinical consulting to its list of Broadlane-provided
services. Specifically, Henry Medical Center implemented Broadlane’s Orthopedic Management Program to control orthopedic spend for
total joint implants which resulted in a 40 percent savings.
Broadlane’s orthopedic consulting team conducted an in-depth assessment of Henry Medical Center’s total joint program to provide a true
picture of the program’s profitability. An analysis of vendor market share and spend, hospital reimbursement and surgeon product
preferences allowed Henry Medical Center the opportunity to implement a savings program tailored to its needs. A detailed monitoring and
reporting tool was implemented to facilitate tracking of actual savings for the hospital.
Cardinal Health introduces combined medication, medical supply management system
Cardinal Health, has launched a new the Pyxis DuoStation system which allows clinicians to safely and accurately dispense both
medications and medical supplies from a single dispensing machine, increasing workflow efficiency and cost savings opportunities through
inventory reduction and increased charge capture.
The new automated dispensing system is built on the foundation of the Pyxis MedStation system and Pyxis SupplyStation system. The Pyxis
DuoStation system functions similarly to Cardinal Health’s existing dispensing technologies. Nurses use unique identifiers, like an employee
ID number and their fingerprint, to log onto the system. After log-in, a screen appears and the nurse selects a patient and sees a list of
medication orders that have already been verified by one of the hospital pharmacists. Additionally, the nurse can toggle to a medical supplies
screen and select the supplies needed to care for the patient.
In addition to the safety benefits of dispensing the right medications for the right patient, the system records the medications and supplies
used for each patient and then transfers the information to the hospital’s billing system. The system also generates reports that can be used
to help identify and prevent potential diversion, optimize medication and supply utilization and manage costs. The Pyxis DuoStation system
provides a scalable approach for non-automated hospitals, while offering larger acute care facilities a single point of access for medication
and supply dispensing.