Sen. Chuck Grassley, ranking member of the Committee on Finance, today made the following comment on a letter from President Obama to congressional leaders on health insurance reform legislation. The President cited Grassley's concern about Medicaid access.  Grassley attended the President's health care summit last week.

"The flawed Medicaid policy in the Senate bill is a disgrace for everyone who needs access to health care because it gives 15 million people a false promise by putting them in Medicaid where they'll face challenges finding providers who will see them.  There's no question Medicaid won't be able to provide adequate access.  It's good if the White House has figured that out.  The question becomes whether the President is willing to cut spending in the bill to guarantee the poorest people adequate access to care."

March is Colon Cancer Awareness Month and gastroenterologists  and other healthcare professionals from around the Quad Cities are joining forces to spread the word about how to prevent colon cancer.  This coalition, Colon Cancer Free QCA, includes physicians and their staff members from The Center for Digestive Health, Digestive Disease Center, Eastern Iowa Gastroenterology, PLC, Gastroenterology Consultants, S.C., Gastroenterology Associates, P.C., Gastrointestinal Clinic of the Quad Cities, Regional Surgicenter, Genesis Medical Center and Trinity Medial Center.

"We felt this partnership was necessary, because despite the fact that colon cancer is the second deadliest form of cancer, it is also the most preventable," said Dr. Erling Larson III of Gastroenterology Associates, P.C. and The Center for Digestive Health.  The disease affects men and women equally and colonoscopies are the most effective prevention method.

"Colon cancer is the second most common cancer killer," expressed Dr. Rao Movva, medical director at Gastroenterology Consultants, S.C.  "However, if the cancer is detected early, your chance at survival is about 90 percent."  People with an average risk for colon cancer should be tested at age 50.  However, screenings should begin at age 40 if you have a family history of colon cancer. Dr. Sreenivas Chintalapani of Digestive Disease Center states, "Colon cancer also does not discriminate.  It crosses all social economic lines."

Colon Cancer Free QCA will be running public service announcements throughout the month of March and will end the month with an event on Saturday, March 27 at the Radisson Hotel in Davenport.  This event will include entertainment from Comedy Sportz, along with a few local colon cancer survivors who will tell their story.  Admission to this event is just $35.00 and all proceeds will go to Gilda's Club of The Quad Cities.  Please make your reservation today at


Go ahead and enjoy Lemonades Girl Scout Cookies being sold by Girl Scouts of Eastern Iowa & Western Illinois. They're totally safe to eat.

The lemon-flavored cookies being sold locally are not affected by reports of returns being requested by another baker of Girl Scout Cookies.

Lemonades are manufactured by ABC Bakers. Cookies of various lot numbers being requested to be returned are made by Little Brownie Bakers, another approved Girl Scout Cookies baker. Little Brownie Bakers' Lemon Chalet Cremes have been affected by an oil rancidity issue, that while renders an issue with the smell of the product, it remains safe to be consumed.

ABC Bakers regularly tests their cookies and have not noticed similar problems nor do they expect similar issues with any of the products that they manufacture for Girl Scouts of Eastern Iowa & Western Illinois. None of the products being produced by ABC Bakers are involved with the recent problems experienced by Little Brownie Bakers.

For more information, call the GSEIWI office at 309.283.2359.


MADISON, Wis. - Feb 25, 2010 - Whooping cough is becoming more common in infants - and a big part of the solution is for women to get a booster vaccination before they become pregnant or right after they give birth.

Also known as pertussis, whooping cough is a contagious bacterial disease of the upper respiratory system. It can lead to uncontrollable coughing and breathing difficulties and can cause permanent disability and even death in infants.

Dr. Jim Conway, an infectious disease specialist and associate professor of pediatrics at the University of Wisconsin School of Medicine and Public Health, says that, until they can be vaccinated, infants are totally dependent on the antibodies they get from their mother during pregnancy.

"The baby's primary protection for the first couple of months of life is what they get from mom," Conway says. "So, it is important for moms to get vaccinated, so they can give some immunity to the baby."

But Conway says this rule doesn't apply only to the mother.

"Anyone who has contact with infants should also receive the vaccination so that they don't expose the infant," he says.  "The mother is one part of it, and should receive vaccine either before pregnancy or immediately after delivering.  In addition, all family members should get it."

Dr. Greg DeMuri, also an infectious-disease specialist and associate professor at UW, says there have been greater efforts to get new moms immunized.

"Many women who have given birth have not had a pertussis booster since kindergarten," he says. "Some hospitals are implementing vaccination programs on their labor and delivery units."

The booster vaccine not only protects against whooping cough, but also against tetanus and diphtheria. Infants get their first immunizations in three doses, beginning at two months of age. After that first series, children should receive shots between 15 and 18 months; four to six years; and when they reach age 11 or 12.

Immunizations don't end at childhood, and adults should check with their physicians during routine visits and annual physicals to see if they are due for booster shots to guard against tetanus, an infection often connected to puncture wounds from rusty nails, fish hooks, or open wounds infected by dirt. If left untreated, tetanus may cause muscle contractions and other complications requiring hospitalization.

"Tetanus is a soil microbe, so as long as there is soil, there will be tetanus, and people will be at risk of tetanus contaminating a wound," says DeMuri. "It's completely preventable by vaccination. Adolescents and adults should receive regular boosters every 10 years."

Conway says about 30 to 40 cases are diagnosed annually, and most of them are in the western part of the country and involve people over 40 years old.

"They stop paying attention to their health, think they are super human and don't need the vaccine," he says. "Also, it's not routine practice to administer these vaccines in other countries, and some immigrants may not be protected. Older adults who get tetanus usually survive, but it's an unpleasant condition in which all of your muscles are spasmodic."

Conway says people who get puncture wounds or infected lacerations should get a shot as soon as possible if they are not sure of their vaccination history. However, a product called tetanus immunoglobulin can be given to patients who wait too long and put themselves at greater risk.

"If someone stepped on a nail three or four days ago, and they haven't had a tetanus booster for more than 10 years, tetanus immunoglobulin can provide instant immunity and the antibodies needed to fight off tetanus," he says.



WASHINGTON, Feb. 24, 2010 - USDA officials today highlighted one of its newest web-based mapping tool, Your Food Environment Atlas, which will enable researchers, policy makers, and the public to find information on a range of factors that affect access to healthy, affordable food, and will allow users to map the data by county. The map will provide highly detailed information on local food environments and health outcomes, including grocery store access and disease and obesity prevalence.

The demonstration of the new mapping tool follows First Lady Michelle Obama's launch of the Let's Move! campaign, a high-priority initiative to address childhood obesity within a generation. The food environment atlas will help to jump-start a national discussion on childhood nutrition, health, and well-being. The Food Environment Atlas is at Learn more about the Let's Move! campaign by visiting

"The First Lady has set an aggressive goal of solving childhood obesity within a generation because this epidemic is keeping our children from reaching their potential, and we're going to need new tools, greater collaboration, and new partnerships to address this crisis," said Agriculture Secretary Tom Vilsack. "As we continue working to improve the nutrition of our kids, this new food atlas will be an important tool to help decision makers become more aware of local challenges that impact the overall health and nutrition of the American people in their local communities."

Factors such as food prices, household income, and proximity and access to grocery stores in a community are among the potential determinants of balanced, healthy diets. These "food environment" factors interact to influence food choices and diet quality, and also reflect the outcome in terms of residents' well-being.

The Food Environment Atlas, developed by the USDA's Economic Research Service, assembles information on three broad categories of food environment indicators:
  • Food Choices-Indicators of the community's access to and acquisition of healthy, affordable food. Examples are access and proximity to a grocery store; number of food stores and restaurants; expenditures on fast foods; food and nutrition assistance program participation; quantities of foods eaten; food prices; food taxes; and availability of local foods.
  • Health and Well-Being-Indicators of the community's success in maintaining healthy diets. Examples are food insecurity; diabetes and obesity rates; and physical activity levels.
  • Community characteristics-Indicators of community characteristics that might influence the food environment. Examples are demographic composition; income and poverty; population loss; urban versus rural location; natural amenities; and recreation and fitness centers.
The online Atlas currently contains 90 indicators of the food environment and is available to the public. Most of the data are at the county level. A user can select an indicator - for example, the prevalence of obesity - and create a map showing how obesity levels vary across the United States or across a state. Atlas users can identify counties with a combination of indicators - for example, those with persistent child poverty as well as high numbers of residents with poor access to grocery stores.  The Atlas also allows users to get data on any and all of the county-level indicators for a particular county.
In addition to USDA's Economic Research Service, a number of government agencies contributed to the data in the Food Environment Atlas. The National Institutes of Health provided indicators on physical activity and recreation centers; USDA's Agricultural Marketing Service provided indicators on farmers' markets; USDA's Food and Nutrition Service provided information on State-level food and nutrition assistance program participation rates; and the National Farm-to-School Network provided statistics on farm-to-school programs. The Centers for Disease Control and Prevention contributed the statistics on obesity and diabetes.

WASHINGTON - Senator Chuck Grassley is asking Wellmark for information about its plan to increase health insurance rates.

In a letter sent today, Grassley requested an accounting of the factors considered, including any independent actuarial analysis, data about reserves, and documentation of the insurer's effort, announced in 2007, to make itself a true nonprofit.

"I'm asking because Iowa consumers deserve to know, and as the health care debate in Washington continues, insurance rate increases are a major issue. The health reform legislation passed last year would not drive costs down.  In fact, health reform bills passed by the House and Senate would cause premiums to go up even more than they already would have gone up, according to the Congressional Budget Office," Grassley said.

The text of Grassley's letter to Wellmark is here.


February 23, 2010

Mr. John Forsyth

Chairman and Chief Executive Officer

Wellmark Blue Cross and Blue Shield

636 Grand Ave

Des Moines, IA 50309-2565

Dear Mr. Forsyth:

As the senior senator from Iowa and Ranking Member of the Senate Committee on Finance, I am writing regarding Wellmark Blue Cross and Blue Shield's plan to increase health insurance premiums by as much as 22 percent on April 1, 2010.  At a time of record unemployment rates and sluggish wage growth, I'm concerned that a rate increase of this magnitude could force some Iowans to drop health insurance entirely.  This would not only have a negative impact on the health of Iowa citizens, but could also place a greater financial burden on providers that will be forced to deliver more uncompensated care.

Recent reports have stated that Wellmark Blue Cross and Blue Shield plans to raise premiums by an average of 18 percent for approximately 80,000 of its 1.8 million customers.  This is almost twice as much as last year's 9.3 percent increase.  Moreover, some 44,000 Wellmark beneficiaries will see rate increases as high as 22 percent.  I'm particularly concerned about the level of these increases since the Centers for Medicare and Medicaid Services' Office of the Actuary recently reported that health care spending increased by a much lower rate of 5.7 percent in 2009.  I understand that the individual and small group health insurance markets face unique challenges regarding adverse selection and that the recent economic downturn has likely exacerbated these challenges.  However, I also believe Iowans deserve a clear explanation for why premiums are increasing at a much faster rate than national health care spending.

As Ranking Member of the Senate Committee on Finance, I take my oversight responsibilities very seriously and I have always believed that greater transparency allows consumers to make better choices.  Accordingly, in an effort to obtain more information about Wellmark's plan to increase health insurance rates on April 1, 2010, I ask that you respond to the following questions and requests by no later than March 8, 2010.  In responding, please repeat the question followed by the appropriate response.

1.   What factors were taken into consideration when coming up with the health insurance rates for 2010?

2.   Were the 2010 rates reviewed by any independent actuarial firms before being presented to the Iowa Insurance Division? If so, please provide a copy of this independent analysis and any supporting documentation.

3.   Please provide a report on Wellmark's average Medical Loss Ratio in its individual and small group products for each of the last five years along with a description and explanation of the factors involved.

4.   Please provide a report on the amount held in reserves for each year for the past five years along with an explanation of how Wellmark Blue Cross and Blue Shield's reserves compare to any minimum levels required by the Iowa Insurance Division, and whether Wellmark utilized any reserves to mitigate rate increases for 2010 or for any year within the five year period.

5.   In 2007, Wellmark announced its goal to be a pure non-profit and reduce profits to 0 percent. Please provide copies of Wellmark's Form 1120, U.S. Corporation Income Tax Return, for the past five years. Please also provide copies of all studies and reports used to determine compensation for the officers listed on Schedule E of Form 1120.

Thank you for your attention to this important matter.  While there are strong differences of opinion on how to improve the U.S. health care system, there is widespread agreement that health care spending levels are unsustainable.  Your answers to the questions listed above will not only be informative for Iowa consumers, but will also be helpful as Congress considers potential policy solutions.


Charles E. Grassley

Ranking Member


WASHINGTON - Senator Max Baucus, Chairman of the Committee on Finance, and Senator Chuck Grassley, Ranking Member, today released a committee report based on a two-year inquiry of the diabetes drug Avandia. The senators also asked the Food and Drug Administration to describe what steps the agency has taken to protect patients in an ongoing Avandia clinical trial, and why the study is allowed to continue, given that the FDA itself estimated that the drug caused approximately 83,000 excess heart attacks between 1999 and 2007.  In 2008, FDA officials called the clinical trial, as then-designed, "unethical and exploitative" of patients.

"There's a real problem when FDA's office that reviews drugs that are on the market is an unequal player in drug safety efforts," Grassley said.  "It doesn't make any sense to have these experts, who study drugs after they have been on the market for several years, under the thumb of the officials who approved the drug in the first place and have a natural interest in defending that decision.  The Avandia case may be the most alarming example of the problem with this set-up.  Both the FDA and Congress need to take every step possible to establish independence for post-market surveillance. The Institute of Medicine has made recommendations.  It's a matter of sound science and public safety."

"Americans have a right to know there are serious health risks associated with Avandia and GlaxoSmithKline had a responsibility to tell them.  Patients trust drug companies with their health and their lives and GlaxoSmithKline abused that trust," Baucus said.  "We will continue watching closely and working with the FDA to make sure patients and doctors are aware of the risks associated with Avandia and all drugs so they can make safe and informed decisions when choosing their medicines."

The committee report explores when the Avandia manufacturer, GlaxoSmithKline, became aware of heart attack risks associated with the drug, whether the company sufficiently warned patients and the FDA of the dangers, and steps the company apparently took to create doubt regarding negative findings about the drug.

The report was developed over the last two years by committee investigators who reviewed more than 250,000 pages of documents provided by GlaxoSmithKline, the FDA, and several research institutes.  Committee investigators also conducted numerous interviews and phone calls with GlaxoSmithKline, the FDA and anonymous whistleblowers.  The report can be found at

Baucus and Grassley directed the report over concerns that Avandia and other high-profile drugs such as Vioxx put public safety at risk because the FDA has been too cozy with drug makers and has been regularly outmaneuvered by companies that have a financial interest in downplaying or under-exploring potential safety risks.  In 2007, Congress enacted legislation giving the FDA some new tools to better protect patients from harm caused by drugs that are brought to market without sufficient safety oversight or consumer warnings. However, the legislation did not fix a fundamental problem at the FDA -- the imbalance between the office responsible for monitoring the safety of drugs after approval and the office that puts drugs on the market in the first place.

The FDA has overlooked or overridden safety concerns cited by its own officials, as appears to be the case with the ongoing Avandia study.  The text of the Baucus-Grassley letter to the FDA on the Avandia study follows here.  The letter with attachments is at

February 18, 2010

The Honorable Margaret A. Hamburg, MD, Commissioner

U.S. Food and Drug Administration

White Oak Building 1

10903 New Hampshire Avenue

Silver Spring, MD 20993

Dear Commissioner Hamburg:

As senior members of the United States Senate and Chairman and Ranking Member of the Committee on Finance (Committee), we have a duty under the Constitution to conduct oversight into the actions of executive branch agencies, including the Food and Drug Administration (FDA).  In this capacity, we must ensure that FDA properly fulfill their mission to advance the public's welfare, safeguard the nation's drug supply, and protect patients participating in clinical trials.

We recently released a report raising concerns about Avandia, a diabetes drug made by GlaxoSmithKline (GSK).  We began this inquiry after the New England Journal of Medicine published a study in May 2007 warning of the possible cardiovascular risk of Avandia.

Our report was based on a review of hundreds of thousands of pages of internal GSK documents and concluded:

The totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public. Based on this knowledge, GSK had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner. Instead, GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug ACTOS (pioglitazone) might reduce cardiovascular risk.

In 2007, the FDA asked GSK to perform a cardiovascular safety trial, called TIDE (Thiazolidinedione Intervention With Vitamin D Evaluation), to compare Avandia to other diabetes treatments such as ACTOS (piolglitazone).  According to, the TIDE trial is currently recruiting patients. [ATTACHMENT A]

In response to several document requests made to the FDA, we received and reviewed an analysis conducted by two FDA safety officials.  It is our understanding that this analysis, conducted in October 2008, reviewed all available studies comparing rosiglitazone (Avandia) to pioglitazone (ACTOS).  The analysis by these FDA officials raise some alarms.  For instance, they wrote:

[T]here is no evidence that rosiglitazone confers any unique health benefits over pioglitazone while there is strong evidence that rosiglitazone confers an increased risk of   [heart attacks] and heart failure compared to pioglitazone.  [ATTACHMENT B]

Even more alarming, they concluded that "any proposed head-to-head trial of rosiglitazone vs. pioglitazone would be unethical and exploitative."

Two days after releasing this analysis, one of these same safety officers reviewed the protocol for the TIDE trial. This safety officer wrote that because of cardiovascular concerns with Avandia "the safety of the study itself cannot be assured, and is not acceptable." [Attachment C]

After reading these documents, we would like to know what steps the FDA has taken to protect patients in the TIDE trial, and why this trial is allowed to continue.  We would also like to know if the Office for Human Research Protection (OHRP) was notified about the safety concerns of the TIDE trial identified by the FDA.  Further, we were alarmed to learn that the warnings from these safety officers do not appear to be addressed in the consent form that was handed out to patients that were enrolled in the study.  [Attachment D]

We look forward to hearing from you by no later than March 4, 2010.


Max Baucus, Chairman

Chuck Grassley, Ranking Member

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:


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

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


  • 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


  • 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


  • 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


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


  • 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


  • 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 More information about the Federal government's efforts on the Recovery Act is available at

# # #

State board votes 6-0 in favor of reclassifying marijuana for medical use and establishing a legislative task force to implement the change

CONTACT: Mike Meno, MPP assistant director of communications ............... 202-905-2030

DES MOINES, IOWA ? Today, the Iowa Board of Pharmacy voted 6-0 to recommend to state lawmakers that marijuana be reclassified as a Schedule II drug and that a state task force be established to study how a medical marijuana law could be implemented in Iowa. Marijuana is currently classified on the federal level as a Schedule I drug, alongside much more harmful substances such as heroin and LSD, as having no proven medical use and a high potential for abuse. Schedule II drugs have accepted medical uses for treatment.

The recommendation comes after the board held four hearings last year to receive public input on the issue. Dozens of doctors, patients, researchers, and advocates testified before the board, and nearly all comments were supportive of medical marijuana. The Iowa House and Senate are each considering bills that would protect from arrest chronically ill patients who use marijuana to alleviate their conditions, though the bills missed the funnel deadline and will not be enacted this year.

"This vote sends a clear message to Iowa lawmakers that they should, as soon as possible, pass legislation that would give chronically ill patients who could benefit from medical marijuana safe and legal access to their medicine," said Noah Mamber, a legislative analyst for the Marijuana Policy Project, who testified during the Board's hearings last year. "The recognition of marijuana as medicine in Iowa is a huge step. But for patients' lives to improve, the legislature must also provide protections from arrest, as 14 other states have already done."

"This is a great step forward for seriously ill Iowans who can benefit from medical marijuana," said state Sen. Tom Courtney (D-Burlington). "Several years ago, my wife passed away from cancer. Marinol pills gave her some relief, but it would have been so much better if she had had legal access to marijuana."

A Des Moines Register poll released yesterday found that 64% of Iowans support patients' use of medical marijuana with a doctor's recommendation. Fourteen other states, including most recently New Jersey and Michigan, have passed medical marijuana laws, and nearly a dozen others, including Illinois, Minnesota, and Wisconsin, are considering such legislation. In Iowa, the legislature is considering S.F. 293, sponsored by Sen. Joe Bolkcom, and H.F. 2179, sponsored by Rep. Mary Mascher.

With more than 29,000 members and 124,000 e-mail subscribers nationwide, the Marijuana Policy Project is the largest marijuana policy reform organization in the United States. MPP believes that the best way to minimize the harm associated with marijuana is to regulate marijuana in a manner similar to alcohol. For more information, please visit


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


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.


Chuck Grassley

United States Senator

Ranking Member of the Committee on Finance