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Senate debate on the FDA user fees bill PDF Print E-mail
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Written by Grassley Press   
Tuesday, 29 May 2012 13:50

Mr. President, today we will be considering a vital piece of legislation that not only includes all four user fee agreements, but also includes policy proposals to improve the Food and Drug Administration’s (FDA) review and approval of medical products, particularly in the pharmaceutical supply chain.

 

In 2008, Senator Kennedy and I introduced the Drug and Device Accountability Act.   This legislation was largely in response to the extensive oversight I conducted of the FDA.  During these investigations, I identified serious problems at the FDA that included:

•           Severe weaknesses in the inspection process;

•           Delays of informing the public of emerging safety problems; and

•           Lack of enforcement authority

 

Based on these findings, our legislation included provisions to ensure the safety of drugs, including foreign manufactured drugs:

•           It would have expanded FDA's authority to inspect foreign manufacturers and importers on a risk-based schedule;

•           It would have required all manufacturers to register with the agency so we can properly identify the number of manufacturers and where they are located. This would have ensured that when a crisis occurs we can quickly locate the questionable facility; and

•           It would have increased civil and criminal penalties with respect to violations.

 

Unfortunately, we never had an opportunity to debate this legislation let alone cast a vote on it.  However, roughly a year ago, Senators Harkin and Enzi forged a bi-partisan working group to address these challenges.

 

The group has worked tirelessly to produce a bi-partisan bill that modernizes FDA’s authority to ensure that drug products coming into the United States are safe for American patients.

 

This bill incorporates many provisions introduced in the Drug and Device Accountability Act Senator Kennedy and I introduced.

•           It increases penalties for knowingly and intentionally counterfeiting drug products; and

•           It requires electronic submission of certain key information by a drug importer as a condition to grant entry.

 

I would like to have seen additional enforcement tools included in the legislation.  For example, granting FDA the authority to destroy unsafe products that are refused admission into the United States would enhance FDA’s ability to protect the public from tainted products.

 

Likewise, granting FDA subpoena authority would bring FDA up to par with all other federal agencies’ enforcement authorities.  Currently, FDA lacks subpoena authority and as such must go through the Department of Justice, which is time consuming and burdensome.

 

Ultimately, this legislation is a needed step in the right direction toward securing our supply chain.

 

This legislation did not address a top priority of mine, ensuring whistleblowers have adequate protections.

 

Four months ago my office learned of the abusive treatment by the FDA on whistleblowers due to protected communications with Congress, more specifically, with my office.   Once the agency learned of the communication, it began actively monitoring and observing employees personal email accounts for two years until the agency was able to have the employee fired.

 

Regrettably, I was not shocked to learn that FDA was mistreating whistleblowers within its agency, as it has done so on more than one occasion in the past.

 

What makes this example different and worse is that FDA intentionally went after an employee because it knew that employee was not covered by the Whistleblower Protection Act (WPA).  The employee in question was a member of the Public Health Service Commissioned Corps and because of a decision from the Court of Federal Claims, these employees, along with other members of the uniformed services, are not covered by federal employee whistleblower protections.

 

In 2009, the Court of Federal Claims held in Verbeck v. United States, that an officer in the Public Health Service’s commissioned corps is a member of the uniformed service and as such, is not covered under the civilian Whistleblower Protection Act (WPA) or the Military Whistleblower Protection Act.  This same logic extends to the commissioned corps of the National Oceanic and Atmospheric Administration.  So, under this precedent, the officers of both the PHS and NOAA currently have no whistleblower protections under federal law.

 

This is particularly problematic when you consider that PHS and NOAA officers can be detailed to agencies like the FDA or CDC.  There, they work side-by-side with civilian employees doing critical work to review and approve drugs, oversee medical devices, and even work on infectious diseases.  However, unlike their civilian colleagues sitting next to them, if these employees uncover wrongdoing, waste, fraud or abuse, they can be retaliated against by the agency and have no recourse for it.  This is wrong and needs to be fixed.

 

Whistleblowers point out fraud, waste and abuse when no one else will, and they do so while risking their professional careers.  Whistleblowers have played a critical role in exposing government failures and retaliation against whistleblowers should never be tolerated.

 

For this reason, I offered an amendment that expands whistleblower protections for uniformed employees of the Public Health Service.  It corrects the anomaly pointed out by the Court of Federal Claims and ensures that Officers in the Public Health Service have some baseline whistleblower protections.  It expressly includes the commissioned corps of the PHS within the protections of the Military Whistleblower Protection Act.  This is consistent with the structure of the commissioned corps functioning like a military organization and matches the fact that these officers receive military like benefits and retirement.

 

Unfortunately, this amendment, which I was able to get into this legislation, only covers employees of the Public Health Service.  It does not address the commissioned corps of NOAA because of other senators’ concerns that it is not related to the underlying bill.   I hope that we can address this remaining gap in whistleblower protections in the near future so that all employees of the federal government are covered.

 

All federal employees should feel comfortable expressing their opinion, both inside the Agency and to Congress.   The inclusion of this language will ensure those opinions receive appropriate protections.

 

I want to take this opportunity to express my appreciation for Senators Harkin and Enzi and their commitment and efforts over the years to reform and improve the FDA.

 

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Kids Help Create Program to End Bullying PDF Print E-mail
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Written by Ginny Grimsley   
Wednesday, 23 May 2012 12:20
‘I Choose’ Starter Kits Available Free to Schools And Communities

A new youth-driven campaign aims to end bullying where it begins: with kids and the choices they make.

“I Choose” (www.WhatDoYouChoose.org), available free to schools and communities, asks children and teens to adopt and embrace one of five words representing powerful social concepts: friendship, kindness, respect, compassion, love. In teacher-guided discussions, they analyze the meaning of their word and then strive to use it in daily interactions. When confronted with a choice involving peer relationships, they’re asked to choose their word to put into action.

A Lance Armstrong “Livestrong”-style bracelet imprinted with “I choose (their word)” serves as both a reminder and a message to others.

“‘I Choose’ was developed with the help of the youth community at Yoursphere.com (kids-only social networking site). We asked who they thought could end bullying and 98 percent of respondents said ‘kids can,’ ” says Mary Kay Hoal, the website’s founder and president. “When we asked about the choices they thought would be effective in helping them end bullying, they chose these five.”

The education initiative is the first for Yoursphere’s non-profit arm, The Yoursphere Media Foundation and Coalition for Internet Safety Education and Reform (FCISER).

“Bullying is a global issue and cyber-bullying is at an all-time high,” says Hoal, an Internet safety expert. “Unfortunately, a lack of funding and awareness has left many schools and communities without a solid bullying education program.”

School and community representatives can apply for a free Anti-Bullying Challenge Starter Kit at WhatDoYouChoose.org. They’ll receive an information packet, poster (“Bullying is a choice”) and the “I Choose” bracelets.

“After the initial implementation of the challenge, we tell teachers and youth group leaders to periodically follow up with their students to analyze the impact that the program is having in their life at school and at home”, Hoal says. “Have the students noticed a shift in the school or classroom culture? Did they stand up for someone they normally wouldn't have? This follow-through can be very empowering because it not only reinforces the fact that their choices matter, but it proves to the students that they can have a real impact."

The need is made painfully clear at the whatdoyouchoose website, where students can share stories and videos about their own experiences with bullying.

Maddie, 15, remembers bullies starting to leave nasty notes in her locker and binder when she was in seventh grade. They called her “fat,”“ugly,”“worthless.” It got worse the following year, she writes.

“I started to believe them. … So I stopped eating, not completely but to the point where I would eat so little a day, I was very very light-headed and sick by the end of the school day. …I started wearing more makeup than I already was wearing and I was just a mess,” she writes.

“To try to forget about the hurt and pain those people caused me, I turned to cutting myself. Not a good idea. I never told my parents because they were in the middle of getting divorced.”

Maddie’s doing better now, she writes, but the experience taught her how intensely painful and isolating life is for the victims of bullies.

Adults and children who’ve already chosen their words also have a place to share on the site. Nine-year-old Gladys chose kindness.

“I choose Kindness because it’s like Love. Love shows up when Kindness comes around. So Kindness is like niceness and Love merged together,” she writes.

“It’s also like Friendship. If you’re kind, people want to be your friend, right? … It’s also like Respect. … If you’re showing Respect, that is a sign of Kindness. And last, it’s Compassion. If you’re helping others, isn’t that showing Kindness? Friendship, Respect, Love, and Compassion, ALL started with Kindness.”

It’s that kind of critical thinking that helps children remember they have a choice – and that with their choices they have the power to change people, Hoal says.

“‘I Choose’ is an important reminder to children that their choices do matter,” Hoal says. “We want them to stop, think and remember.”

About Mary Kay Hoal

Mary Kay Hoal is a nationally recognized Internet safety expert who provides technology tools and tips for parents at www.YoursphereForParents.com. She’s the founder and president of www.Yoursphere.com, a social network site for ages up to 17 and social media outlet for youth-oriented organizations. Yoursphere Media Foundation and Coalition for Internet Safety Education and Reform is the website’s charity arm. The ‘I Choose’ Anti-Bullying Challenge is its first education initiative.

 
Finding Heaven at Home PDF Print E-mail
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Written by Ginny Grimsley   
Wednesday, 23 May 2012 11:00
Biblical Scholar Offers Tips for Believers & Non-Believers

Americans believe in heaven -- since 1997, the numbers have fluctuated from 72 to 80 percent, according to Gallup polls.

But what is heaven and what does it look like?

“Too often the popular idea of heaven is a place where you’ll have nothing to do but tell a jealous God how good he is over and over for all eternity—and that wouldn’t be much better than hell,” says Charlie Webster, former senior engineer for NASA, Bible scholar and author of Revitalizing Christianity (www.NewCenturyMinistries.com).

“That’s not Jesus’ picture of heaven,” he says.

Heaven will be a place with exciting challenges against a background of caring love from everyone and to everyone.

“But you don’t have to wait ‘til you die to experience some of the most important benefits of heaven,” Webster says. “Anyone can create a real foretaste of heaven wherever they are. And you don’t even have to believe in God to experience part of this—though it certainly works better if you let God help you.”

“Caring about and helping with the needs and pains of others brings real joy,” Webster says.

It’s the same thing Jesus said two millennia ago: When you focus on yourself, you are the only one interested in helping you, he says.

“Even in places of worship, most folks are asking, ‘What can God do for me?’ instead of ‘What could I do to make this world the caring place God wants it to be?’”

Here are three ways Webster says anybody, regardless of creed, can get a taste of heaven here on Earth:

• Forgiveness: When you forgive a hurt or transgression, there’s a great sense of relief—a weight has been lifted. Animosity eats at the bearer. But how to forgive? It takes both faith and sympathy — “faith that if the transgression needs to be punished, it will be, and sympathy because you can’t know what caused someone to anger you,” Webster says. “Take a road-rage scenario—some speeding motorist almost kills you. Your immediate reaction is anger. But do you know the reasons behind his risky driving? Maybe it’s just that he thinks everybody should get out of his way. God will deal with that. But maybe he’s responding to a genuine emergency that you might have handled the same way. If you turn the matter over to God, you can arrive home stress-free. Better yet, offer a prayer for the offender. Whatever the cause, he needs prayer.

• Helping Others: Rather than stressing over time, money and travel logistics for a vacation focused on pampering yourself, Charlie suggests helping others in the form of a mission trip –- an all-around win. Volunteers often see a new part of the world; but more importantly they come home with wonderful new friends and the knowledge that they’ve made the world a better place. And you can usually find a trip that’s already planned and priced at reduced rates. When your mission vacation is over, you’ll truly be recharged and refreshed and you’ll have memories you could never get on a vacation focused on yourself.

• Having a Marriage that Works: By far the best marriages are the ones in which couples have asked themselves “how can I make his/her life better” rather than saying “I want him/her because he/she satisfies my needs.” Such marriages almost never end in divorce, Webster says. “Even couples who never go through a ceremony can experience this. God never demanded a ceremony—he demands the unselfish love that he knows will bring us true joy.”

“In the end heaven is really more about relationships than where you are,” Webster says. “It’s not fluffy clouds, scratchy robes, and awkward wings. The heaven Jesus taught about is an active life in an environment of unselfish caring — the kind of environment that builds strong bonds.”

“If you accept that the after-life taught by Jesus is real, then doing this in your daily life prepares you for an eternity of ever-greater joy. It’s a life of unselfish caring that brings the kind of joy that will make heaven, heaven.”

About Charlie Webster

As an engineer, Charlie Webster headed NASA projects for several years; as a Bible scholar, he has taught biblical studies at the college level. Webster has a son and daughter, and was widowed in 1999. He has been happily remarried since 2000.

 
Celebrating the Life of Katie Beckett of Cedar Rapids PDF Print E-mail
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Written by Grassley Press   
Wednesday, 23 May 2012 10:58

Floor Statement of U.S. Senator Chuck Grassley

Celebrating the Life of Katie Beckett

Tuesday, May 22, 2012

Mr. President, I come to the floor today to celebrate the life of Katie Beckett.  Never has the word “inspiration” been used more appropriately in describing someone, and today, I am grateful to be able to recognize the inspirational life of Katie Beckett.

Mary Katherine “Katie” Beckett was born in Cedar Rapids, Iowa on March 9, 1978.  Five months after she was born, Katie contracted viral encephalitis followed by grand mal seizures.  The encephalitis caused damage to her central nervous system and her respiratory system, and she was attached to a ventilator.  She would be almost two years old before she could breathe on her own.

Under Medicaid law of the time, Katie could only receive care through Medicaid if she remained in the hospital even though she was able to receive care at home.  Iowa Congressman Tom Tauke heard of Katie’s situation and realized that it made no sense to keep a child in the hospital who could be at home with her family.  He worked to convince the Administration that the system should be changed to allow states to provide Medicaid to children receiving care in their homes.

Ultimately, President Reagan took up Katie’s cause intervening so that Katie could receive treatment at home and still be covered under Medicaid.  This change in policy became known as “Katie Beckett waivers” and, to date, more than a half million disabled children have been able to receive care in their homes with their families rather than being forced into hospitals and institutions.

But Katie’s story doesn’t end there.  As Katie grew up, as she battled to establish her own place in society as a young American with disabilities, she realized she had an opportunity to serve others who faced similar challenges.  In her own words, this is from a piece Katie wrote in 2002 titled “Whatever happened to Katie Beckett?”

“I started my advocacy career at age ten.  It was not my choice but rather a path chosen for me. It was not until I was twelve or thirteen that I realized the important work I was able to do because I was who I was and how much this work helped other kids.”

Katie graduated with a degree in English from Mount Mercy College in Cedar Rapids.  She lived in the community.  She wanted to be a teacher and write novels for young people.  She was fiercely independent, sometimes to the consternation of her mother, Julie.  She was quick witted and funny and loved a good cup of coffee.  She lived her life as a tireless advocate for the disabled.  She testified before Congress several times and was a contributing voice on numerous groups dedicated to disability policy.  When we took up policy proposals like the Family Opportunity Act and Money Follows the Person, we wanted Katie’s perspective, and we depended on her advocacy in the community to get those laws passed.

Katie was the living embodiment of a person with disabilities participating and contributing in society.  Mr. President, on Friday, May 18, Katie went home to be with the Lord.

She leaves behind thousands of lives touched by her presence.  A light may go out, but a light lives on in those of us fortunate to have known Katie Beckett.  We remain inspired to work every day to create opportunities for the disabled to participate and contribute and live the life of service and dedication that Katie did.  Katie remains an inspiration.


 
Should you DIY or hire a pro? PDF Print E-mail
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Written by Morgan Zenner   
Wednesday, 23 May 2012 10:30

NARI offers advice on deciding how to tackle projects during Home Improvement Month.

 

Des Plaines, Illinois, May 22, 2012— As May, National Home Improvement Month, winds down, the National Association of the Remodeling Industry (NARI) shares advice with homeowners before they tackle their spring projects: namely, whether to do-it-yourself (DIY) or hire a professional during the busy remodeling season.

 

According to a consumer poll from NARI.org, the largest determining factor for deciding to DIY or hire a professional was cost, at 40 percent. Thirty percent of respondents placed project type and know-how as the second most important factor, and level of difficulty was close behind at 25 percent. Safety and length of time required to complete the project were last, with 2 and 3 percent respectively.

 

“Some of the biggest homeowner misconceptions are related to the three largest considerations: cost, difficulty and know-how,” says NARI National President Dean Herriges, MCR, CKBR, Urban Herriges & Sons Inc., based in Mukwonago, Wis. “Many believe that if they do-it-yourself, the cost will be greatly reduced. And most people also believe that the learning curve for home improvement is lower than it actually is.”

 

In reality, the home improvement process—though varied across project type—can be very costly and involved for anyone, not to mention a beginner. That’s why it’s important to weigh all considerations before you begin work to prevent a DIY disaster.

 

“There are a few basic questions that homeowners must consider before they start; otherwise, they will find themselves paying a professional even more money to fix multiple issues or, even worse, injured,” Herriges says.

 

The most important considerations for homeowners have to do with physical ability, skills, time and understanding of what needs to be.

 

“Oftentimes, people underestimate height and physical limitations like lifting or controlling heavy objects, or whether the job requires more than one person,” Herriges says. “When people attempt things that are beyond their ability, they open themselves up to injury.”

 

Herriges says that homeowners should have basic skills when it comes to using tools or knowing which tools are necessary, measuring, installing and following product manufacturer instructions.

 

He also says that homeowners should plan the process from beginning to end to ensure they have time to complete. “If you’re working on a bathroom, you need to map out a good time for you to be without a bathroom and how long those critical steps will take so you know when you will have a bathroom again,” he says.

 

And then homeowners should consider the costs. Permits, materials, time and costs associated with correcting mistakes must be factored into the total cost. “If you are doing the project yourself for financial reasons, you need to consider what it would take to correct mistakes that cause damage,” Herriges says. “Fixing a project is usually more expensive than hiring a professional to do the project the first time through, so it’s wise for homeowners to know what they are getting into and if the risk is worthwhile.”

 

Most homeowners can handle routine maintenance projects and cosmetic touch-ups, but it’s recommended they consult with qualified professionals for larger remodeling jobs and major changes to the home’s structure. Visit the NARI Website to access a DIY quiz, designed to help you decide whether you are going to need to hire a professional.

 

If you find out that you do need to hire a professional, hiring someone who is qualified and competent to do the work is just as important as preventing a DIY disaster. “You want to select someone that is certified or has professional experience working in the home improvement industry,” Herriges says.

 

As of April 22, 2010, the U.S. Environmental Protection Agency passed new regulations to address a lead safety concern in homes built before 1978. The Renovation, Repair and Painting (RRP) rule is designed to train professional remodelers how to minimize lead dust in the home to reduce exposure to children under 6 years and pregnant women. Remodel-ready homeowners should make themselves aware of lead-safe practices in their homes during a remodel, either by a professional or as a do-it-yourself practitioner, to keep their families safe. Please learn more at www.nari.org/leadsafety.

 

NARI is a good source for homeowners seeking to hire a professional remodeling contractor because members are full-time, dedicated remodelers who follow a strict code of ethics that observes high standards of honesty, integrity and responsibility.

 

Visit the NARI.org site to get tips on how to hire a remodeling professional and to search for NARI members in your area.

 

NARI members represent a select group from the approximately 800,000 companies and individuals in the U.S. identifying themselves as professional remodelers.

 

NARI is a professional association whose members voluntarily subscribe to a strict code of ethics.  Consumers may wish to search www.nariremodelers.com to find a qualified professional who is a member of NARI. For the latest information on green remodeling, visit www.GreenRemodeling.org. Click here to see an online version of this press release.

 

# # #

About NARI: The National Association of the Remodeling Industry (NARI) is the only trade association dedicated solely to the remodeling industry.  The Association, which represents 7,000 member companies nationwide—comprised of 63,000 remodeling contractors— is “The Voice of the Remodeling Industry.”™ To learn more about membership, visit www.NARI.org or contact national headquarters, based in Des Plaines, Ill., at (847) 298-9200.

 
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