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Loebsack Statement on the President’s Speech in Newton PDF Print E-mail
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Written by Joe Hand   
Tuesday, 29 May 2012 15:05

Washington, D.C. – Congressman Dave Loebsack released the following statement today after the President spoke at TPI Composites in Newton about the need to extend the Production Tax Credit (PTC) for wind energy and a greater investment in clean energy, including renewable fuels.  Loebsack attended the President’s speech in Newton this afternoon.

 

“I am pleased the President visited TPI in Newton today to highlight the importance of extending the Production Tax Credit for wind energy, which has played such a vital role in bringing back manufacturing jobs to the area.  I have been pushing for some time to get Congress to act on extending the PTC and am pleased the President has committed to working on this issue.  We cannot afford to let the PTC expire at the end of the year.”

 

During the President’s visit, Loebsack presented him with a letter that discusses his commitment to extending the PTC and also highlights Iowa’s renewable fuel industry and the need to extend the biodiesel tax credit that expired at the end of 2011.

 

“Iowa is currently the largest renewable fuel producing state in the country.  This industry has created thousands of good-paying jobs in Iowa communities and here in Newton,” wrote Loebsack.  “Unfortunately, Congress allowed the biodiesel tax credit to expire for the second time at the end of 2011. Iowa has more than a dozen biodiesel production plants so a reauthorization of the biodiesel production tax credit would provide Iowa’s economy with a much needed boost, support good jobs for Iowans, and help reduce our dependence on foreign oil."

 

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FDA bill -- whistleblower protections and clinical trial transparency added PDF Print E-mail
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Written by Grassley Press   
Tuesday, 29 May 2012 15:02

Grassley:  FDA legislation now better protects whistleblowers, charts path to posting of clinical trials.

Senate proposal also targets counterfeit drugs and requires electronic import records

 

WASHINGTON – Senators late yesterday agreed to add two provisions sponsored by Senator Chuck Grassley to legislation that will renew user fee agreements that fund the Food and Drug Administration.

 

The first addition is a whistleblower reform he authored based on congressional oversight of the FDA.  The second is a plan to see that clinical trial results are posted when the National Institutes of Health issues regulations, as it was called upon to do in a law enacted five years ago.

 

Grassley said more should be done to protect FDA whistleblowers, but the part of his reform proposal that’s now been made part of the Senate FDA bill would expand protections for uniformed employees of the Public Health Service.  Earlier this year, Grassley was contacted by FDA whistleblowers after they were negatively targeted by FDA officials for communicating with his office about concerns regarding the FDA.  The FDA read messages on the employees’ personal email accounts to learn about the communication.

 

“The situation was egregious for a number of reasons, including the fact that the FDA went after an employee who wasn’t covered by the Whistleblower Protection Act,” Grassley said.  “Whistleblowers identify fraud, waste and abuse, often when no one else will, and risk their professional careers to do so.  Those inside the federal government should feel comfortable expressing opinions both inside agencies and to those of us in Congress.”

 

Grassley’s proposal to push the National Institutes of Health to publish regulations on clinical trials as was required in the reauthorization of user fees five years ago will require a study by the Government Accountability Office two years after the regulations are final in order to make certain the posting of clinical trial results occurs as intended.

 

“The goal is to give patients, researchers and health care professionals access to valuable information that could help to build understanding of the efficacy and safety of drugs and medical devices,” Grassley said.

 

Grassley’s clinical trials provisions are supported by the Union of Concerned Scientists, the Consumer Federation of America, U.S. PIRG, Public Citizen, and NRC for Women & Families.

 

Separately, the overall FDA bill, the Prescription Drug User Fee Act, contains legislation authored by Grassley and Senator Patrick Leahy to increase penalties for counterfeiting drug products.  It also contains legislative language that will heighten the scrutiny of imported drugs through electronic records.  This language comes from legislation Grassley previously co-authored with the late Senator Ted Kennedy.

 

Grassley also offered an amendment to the FDA bill with Senator Kohl and Senator Blumenthal to try to combat excessive use of antipsychotics in nursing homes.  “Our effort would empower nursing home residents and their loved ones in decision-making about what drugs are prescribed for them,” he said.

 

Otherwise, Grassley said he had hoped the 2012 reauthorization of the Prescription Drug User Fee Act would give the FDA its own subpoena authority so that it no longer would need to navigate a cumbersome process at the Department of Justice.  He said the FDA also should be given the FDA authority to destroy unsafe products that are refused admission to the United States.

 

In response to consumers, the drug industry and the FDA, Congress first enacted the Prescription Drug User Fee Act in 1992 to try to speed up the drug approval process.  The fees raise supplement federal appropriations instead of replacing them.

 

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Governor Pat Quinn Statement on SB1849 House Vote PDF Print E-mail
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Written by Leslie Wertheimer   
Tuesday, 29 May 2012 14:02

SPRINGFIELD – May 23, 2012. Governor Pat Quinn today issued the following statement regarding the House’s passage of SB 1849.

 

“It’s ironic that on the very day that U.S. Attorney Patrick Fitzgerald announced his resignation, the Illinois House would pass a gambling bill that continues to have major ethical shortcomings.

 

“This new bill falls well short of the ethics standards I proposed in my framework last October. Most importantly, it does not include a ban on campaign contributions as lawmakers in other states have done to keep corruption out of the gambling industry and out of Illinois. Massachusetts, New Jersey, Pennsylvania, Louisiana and bordering states like Iowa, Michigan and Indiana have all approved such bans.

 

"It does not provide the Illinois Gaming Board with sufficient time to make critical licensing and regulatory decisions. This bill also does not provide adequate oversight of the procurement process. It does not ensure clear oversight of the proposed Chicago casino.

 

“As long as I’m governor, I will not support a gambling bill that falls well short of protecting the people of Illinois. It is clear that this gaming bill still needs significant improvement.

 

"Finally, Illinois cannot gamble its way out of our fiscal challenges. I urge the members of the Illinois House and Senate to pay close attention to the most pressing issues that we must address by next Thursday, May 31 –pension reform and Medicaid restructuring."

 

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Is The Bible The Ultimate Financial Guide? PDF Print E-mail
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Written by Ginny Grimsley   
Tuesday, 29 May 2012 14:01

Financial how-to books come and go – they’re published by the hundreds every year. But Peter Grandich, dubbed “The Wall Street Whiz Kid” by Good Morning America’s Steve Crowley, says the one he relies on has been around for nearly 2,000 years.

“I get my financial guidance from the Bible,” says Grandich, author of Confessions of a Wall Street Whiz Kid (www.confessionsofawallstreetwhizkid.com). “Money and possessions are the second most referenced topic in the Bible – money is mentioned more than 800 times – and the message is clear: Nowhere in Scripture is debt viewed in a positive way.”

Grandich, who says his years as a highly successful Wall Street stockbroker left him spiritually depleted and clinically depressed, says the Bible is an excellent financial adviser, whether or not you’re religious.

“The writers of the Bible anticipated the problems we would have with money and possessions; there are more than 2,000 references,” he says. “Our whole culture now is built on the premise that we have to have more money and more stuff to feel happy and secure. Public storage is the poster child for what’s wrong with America. We have too much stuff because we’ve bought into the myth fabricated by Wall Street and Madison Avenue that more stuff equals more happiness.”  He adds, “That’s the total opposite of the truth, and the opposite of what it says in The Bible.”

What’s Grandich’s No. 1 most important biblical rule of finance? “God owns everything. You may have bought that house, but He gave you the money to buy it, so it’s His.”

Some other lessons from the ultimate financial guide?

• Do put money aside for investing: “One of the most revealing parables is Jesus’ story about a wealthy master who left three servants in charge of his financial affairs when he went away on a long journey,” Grandich says. “When he returned, two of the servants had multiplied the coins for which they were responsible. The third buried his to keep it safe.” That last servant ended up out on his ear. The story is a lesson: We must invest our money – and invest wisely.

• Debt’s not prohibited, but it should be avoided: The Bible clearly warns that the borrower will be a servant to the lender, but it also instructs us to lend money. That suggests that there are times when it’s OK to borrow, but it should not become a way of life. The Bible also instructs us to repay what we’ve borrowed.

• The more you make, the more you should give: This is a hard one for people caught up in buying bigger and better things, but there are numerous references to charitable giving. The Bible says that it’s quite all right to buy the bigger house – but the more you make and spend on yourself, the more you need to give to others. That doesn’t include tithing, another very clear demand: God expects you to give 10 percent of your wealth to your place of worship.

• Don’t focus on acquiring possessions: There are many, many warnings that accumulating stuff is dangerous. Material things are fleeting and they’ll do you no good in the long run. What you put your effort into, that’s where your heart will be, Grandich says.

About Peter Grandich

Peter Grandich became renowned in the financial industry when he predicted market crashes and rebounds in The Grandich Letter, a newsletter he created in 1984. It’s currently a blog featuring his commentary on the world’s economies and financial markets as well as social and political topics. Grandich is co-founder, with former New York Giants player Lee Rouson, of Trinity Financial Sports & Entertainment Management Co., a firm that specializes in offering guidance from a Christian perspective to professional athletes and celebrities.

 
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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