Wednesday, March 7, 2012

WASHINGTON - The Senate Tuesday night unanimously approved a bill authored by U.S. Senators Patrick Leahy (D-Vt.) and Chuck Grassley (R-Iowa) to increase penalties for trafficking counterfeit drugs.  The legislation responds to recommendations made by the U.S. Intellectual Property Enforcement Coordinator and the administration's Counterfeit Pharmaceutical Inter-agency Working Group.


The Counterfeit Drug Penalty Enhancement Act will increase penalties for the trafficking of counterfeit drugs to reflect the severity of the crime and the harm to the public.  While it is currently illegal to introduce counterfeit drugs into interstate commerce, the penalties are no different than those for the trafficking of other products, such as electronics or clothing.  The Counterfeit Drug Penalty Enhancement Act will target violators that knowingly manufacture, sell or traffic counterfeit medicines to the United States.


"We cannot allow the counterfeiting of life-saving medicine to be just one more low-risk venture from which international organized criminals can profit," said Leahy.  "While we should not expect that enactment of this or any legislation will completely deter the serious problem of counterfeit medication entering the American supply chain, it is an important step in the fight.  I urge the House of Representatives to act quickly on this legislation."


"Worldwide counterfeit medicines are a multi-billion dollar industry, and growing at an alarming pace, especially over the internet.  These medicines pose a serious threat to the health and safety of unsuspecting Americans," Grassley said.  "The House should act as quickly as possible to ensure that counterfeit drug traffickers are punished accordingly for putting people's lives at risk with this serious crime.  "


The legislation is cosponsored by Senators Michael Bennet (D-Colo.), Richard Blumenthal (D-Conn.), Sheldon Whitehouse (D-R.I.), Dianne Feinstein (D-Calif.), Jon Kyl (R-Ariz.), Christopher Coons (D-Del.), Amy Klobuchar (D-Minn.), and Robert Casey (D-Pa.).  Companion legislation in the House of Representatives was introduced last year by Representatives Patrick Meehan (R-Pa.) and Linda Sánchez (D-Calif.).


It has been reported that counterfeit drugs result in 100,000 fatalities globally each year, and account for an estimated $75 billion in annual revenue for criminal enterprises.


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Request Comes in Wake of Investigation into Monitoring of Communications Between "FDA Nine" Whistleblowers and Congress


Agency may have intercepted passwords to personal accounts to search those accounts, which would be illegal


(WASHINGTON)–Senator Chuck Grassley (R-Iowa) and Rep. Darrell Issa (R-Calif.) have requested that the Obama Administration conduct a complete assessment of federal agency guidelines for the monitoring of employee's personal email accounts.  Grassley and Issa are conducting investigations into Food and Drug Administration (FDA) actions against nine employees who were whistleblowers to Congress about inappropriate actions they witnessed inside the agency.


In a letter to Office of Management and Budget (OMB) Acting Director Jeffrey D. Zients, Grassley and Issa noted that the "FDA may have intercepted passwords to the personal email accounts of its employees for the purpose of logging in to search for archived messages to and from Congress and the Office of Special Counsel." Although the FDA admitted monitoring the accounts, it also obtained confidential email between the whistleblowers and Congress sent prior to the time that the monitoring allegedly occurred, which raises questions about how the FDA obtained the prior emails.


"The FDA specifically targeted these employees for monitoring after they contacted the Presidential transition team and Congress to blow the whistle.  Therefore, the FDA's purpose for conducting surveillance was unlawful, because retaliation against individuals who engaged in protected forms of whistleblowing is illegal," Grassley and Issa added.


Grassley and Issa wrote to Zients saying that their investigation of FDA's surveillance of whistleblowers had given rise to a broader question about the policies and practices for electronic surveillance at all federal agencies.  They asked OMB to address a series of questions regarding parameters for such searches.


A complete copy of the letter and a full list of questions is here.


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Sen. Chuck Grassley today made the following comment on the Taiwanese government announcement that Taiwan plans to set an allowance level for U.S. beef that contains the feed additive ractopamine but not set a similar level for U.S. pork.  Ractopamine has been approved by the Food and Drug Administration and is used by many U.S. beef and pork producers as a feed additive.

"I'm encouraged that the Taiwanese government may allow some U.S. beef that contains traces of ractopamine into Taiwan, but the announcement falls far short of resolving this issue.  The Taiwanese government has not set any allowable level of this additive for U.S. pork imports.  As I've said before, Taiwan must treat U.S. agricultural products fairly, in accordance with scientific evidence, and in keeping with its trade obligations, if it expects to maintain its status as a strong economic partner with the United States.  There is no scientific reason for Taiwan to set residual levels of a certain additive for beef but not pork.  I hope Taiwan's announcement was just a first step in the right direction toward more removal of the trade barriers hurting U.S. farmers."

Grassley, Enzi, Hatch, Pitts Seek Details of Discount Drug Program


WASHINGTON - Sen. Chuck Grassley, Sen. Michael Enzi, Sen. Orrin Hatch,  and Rep. Joe Pitts today asked a wide range of stakeholders for a detailed accounting of how they operate the 340B program, a discount drug program that's meant to supply federally funded grantees and other safety net health care providers but whose exploding growth raises questions about program integrity.


A June 2011 Health and Human Services Inspector General report raised questions of program integrity without proper federal oversight of taxpayer dollars.  Likewise, a report from the Government Accountability Office issued in September 2011 said federal oversight of the program is "inadequate" to ensure that covered entities and manufacturers are in compliance with program requirements.


"With the reliance on self-policing among participating manufacturers and covered entities and the increase in the number of new settings in which the program is offered, the risk of improper purchases or diversion of 340B drugs has significantly increased," the members wrote.  "The problems identified by the GAO as it relates to the oversight responsibilities of each party and the expansion of the program need resolution."


Grassley, Enzi, Hatch, and Pitts wrote to the Pharmaceutical Research and Manufacturers of America; the Biotechnology Industry Organization; Apexus, Inc.; and the Safety Net Hospitals for Pharmaceutical Access.  The legislators said that with so many stakeholders involved in the program, everyone must work together to ensure the program is serving the intended beneficiaries.


The members' three letters are available here, here and here.



WASHINGTON - U.S. Senators Chuck Grassley, R-Iowa, and Herb Kohl, D-Wis., today released a report urging the Centers for Medicare and Medicaid Services (CMS) to improve oversight of the new system being created to monitor the quality standards in nursing homes.

The Government Accountability Office (GAO) report, entitled, "Nursing Home Quality: CMS Should Improve Efforts to Monitor Implementation of the Quality Indicator Survey," urges CMS to improve efforts to monitor implementation of the Quality Indicator Survey (QIS) for nursing homes.  The full report can be found here.

CMS started moving toward the QIS process in 2005 after reports indicated a need for improvements in the traditional survey process.  But the agency has decided to temporarily suspend implementation until a number of concerns raised by states and regional CMS offices have been resolved.

"The report shows CMS doesn't do enough to monitor and facilitate states' implementation progress," Grassley said.  "After six years of implementation, 26 states had trained or started training surveyors to use the system, but uncertainty about progress by these states led CMS to suspend implementation for the rest of the country.  If CMS were better tracking state implementation from the beginning, the agency could have identified these problems earlier and helped the states that are struggling."

"There's an obvious need for a clear, consistent and efficient system for monitoring nursing home quality," Kohl said. "QIS has the right goals in mind, and has the potential to make a positive difference in the consistency and accuracy of state survey work across the country -- but implementation needs to be done well, and the agency's goals need to be realized sooner rather than later."

Grassley and Kohl have worked together on nursing home quality for many years.  Most recently, their bill, the Nursing Home Transparency and Improvement Act of 2009, was passed into law.  Through the Senate Special Committee on Aging, the senators have pressed the federal government and states to improve the quality of nursing home care through more rigorous inspections and better information about inspection results for consumers through the federal Nursing Home Compare database.  Kohl is chairman of the Aging Committee.  Grassley is former chairman.  A landmark GAO report from 1998 was the subject of Aging Committee hearings Grassley convened.  The hearings exposed serious quality of care problems in nursing homes, exacerbated in part by highly predictable annual inspections and few citations for serious deficiencies.  After the hearings and at the urging of the Aging Committee, the Clinton Administration took steps to improve the inspection process.  Grassley and Kohl have urged continued attention and refinements.


Friday, March 2, 2012


During his weekly video address, Senator Chuck Grassley discusses the need to increase production of domestic energy to help lower gas prices and create jobs.  Along with other senators, he's urging President Obama to examine his policies that contribute to higher gas prices, including restricting access to federal lands and permitting delays, regulatory threats to refiners, and his Keystone XL pipeline decision.



Click here for audio.


Here is text of the address:


Along with other senators, I wrote to President Obama this week asking him to examine his policies that contribute to rising gas prices -- such as:

  • restricting access to federal lands and permitting delays,
  • regulatory threats to refiners,
  • and his Keystone XL pipeline decision.


A lot of factors impact the price of oil - including OPEC decisions and Mideast turmoil -- but the Obama Administration has made things worse.  By limiting domestic energy production, we have less supply and higher prices.


Last year, consumers spent a greater percentage of household income on gasoline than any other year since 1981.

  • Paying $4 or more for gas acts like a hidden tax on individuals and families.
  • Rising energy prices also get in the way of job creation by raising costs of doing business for employers.


Americans need a comprehensive approach that:

  • ramps up domestic production of traditional energy,
  • allows the expansion of alternative and renewable energy sources,
  • and encourages conservation.


Greater domestic energy production would increase supply and help to lower prices, and it would create American jobs.




WASHINGTON - Sen. Chuck Grassley of Iowa has asked each state for information to help determine whether the states and the federal government are conducting enough oversight of their rate-setting for Medicaid managed care plans.


"In light of the billions of dollars already spent on Medicaid, including managed care, and the planned expansion of Medicaid, it's important to look at whether states are setting their managed care payment rates appropriately and in keeping with federal law," Grassley said. "If the payment rates are out of whack, and scrutiny is lacking, Medicaid money could be ill-spent to the detriment of vulnerable beneficiaries and the taxpayers.  The risk could be especially high when Medicaid provider payment rates are boosted to match higher Medicare rates for two years as Medicaid is expanded under the new federal health care law."


Grassley's inquiry comes after the Government Accountability Office in 2010 found inconsistent scrutiny from the federal government of state rate-setting in this area.  GAO cited two states - Tennessee and Nebraska - as examples of those that received inadequate oversight from the federal Centers for Medicare and Medicaid Services.  Now, the state of Minnesota and its contractor non-profit health plans are drawing scrutiny in the state for what some analysts consider high operating margins. States are required to set rates for Medicaid managed care that are actuarially sound, but it's unclear if the requirement is clearly defined or enforced.


Grassley wrote in his letter to each state, citing the GAO report, "In the 18 months since that report was issued, I have seen nothing to convince me CMS or the states have improved in their ability to confirm that managed care entities are appropriately and correctly reimbursed for the services provided. If an entity is paid too little, the access to and quality of care provided to beneficiaries is jeopardized.  If an entity is paid too much, scarce Medicaid resources are diverted away from providing services to beneficiaries."


Grassley's letter includes questions such as whether states have an independent audit requirement for managed care entities and if so, whether the audit entails certain elements; for a list of all managed care entities operating in the state and an accounting of audit occurrences and results; the state's definition of allowable medical costs under the managed care contracts; and whether states have received any guidance from CMS or sought guidance from CMS on Medicaid managed care rate-setting.


The federal government will spend nearly $4.5 trillion on Medicaid over the next decade.  That's only the federal share.  State governments spend additional, significant amounts of money on Medicaid.  "Every dollar that's spent improperly doesn't help a Medicaid beneficiary," Grassley said.  "Getting a handle on managed care payment rates is necessary for the program's bottom line."


The new federal health care law boosts federal Medicaid payments to primary care physicians for two years, from Jan. 1, 2013, to Dec. 31, 2014.  For that period, the doctors will receive Medicare payment rates, which are higher than Medicaid payment rates.  At the same time, Medicaid programs and providers will cover more patients, as required under the health care law.


A copy of Grassley's letter to each state is available here.  The letters are identical.  The 2010 GAO report is available here.



Washington, D.C. - House Judiciary Committee Chairman Lamar Smith (R-Texas) and Senate Judiciary Committee Ranking Member Charles Grassley (R-Iowa) today sent a letter to Attorney General Eric Holder and Department of Homeland Security Secretary Janet Napolitano expressing concern about the Ninth U.S. Circuit Court of Appeals recent decision to put several deportation cases on hold in light of the administration's backdoor amnesty directives.  The letter urges both Attorney General Holder and Secretary Napolitano to make clear to the Court that the administration will enforce immigration laws, including the deportation of removable illegal and criminal immigrants who lose their cases in the federal court of appeals.


Below are excerpts from the letter.


"The Ninth Circuit's decision to put several deportation cases on hold is an overreach of judicial authority and shows the inherent danger in this administration's backdoor amnesty policies.  Instead of deciding these cases under the law of the land, the Ninth Circuit has asked the Obama administration whether it intends to grant the illegal immigrants amnesty under the prosecutorial discretion initiative announced last year.


"The orders appear to be the court's attempt to suspend its everyday review of immigration cases due to the administration's plans to close tens of thousands of cases for the 300,000 aliens who are in removal proceedings.  The Ninth Circuit has acted beyond the bounds of its judicial role and is inserting itself into an area - prosecutorial discretion - reserved solely to the executive branch.


"In responding to the Ninth Circuit's question, the administration will be required to reveal whether it intends to manipulate our legal system and waste taxpayer dollars, as part of it efforts to grant amnesty to illegal immigrants.  Your response to the Ninth Circuit's order must clearly and unequivocally indicate that the government will enforce the immigration laws, including promptly deporting all removable aliens who lose their cases in the federal courts of appeals.


"If the administration responds to the Ninth Circuit orders by indicating that the illegal and other removable aliens will be granted relief via amnesty, then it must explain to the American people what that answer means for the integrity of our legal system and why their tax dollars are being spent on prosecutions that the Obama administration has no intention of enforcing with deportation.


"We are seriously concerned that the Ninth Circuit's order ignores the rule of law and confounds constitutional principles, and we would like to know who how you plan to respond to the Court's actions."


To read the entire letter, please click here.



WASHINGTON – Applications for summer internships with Senator Chuck Grassley are due March 15.


Internships are available for college age Iowans in Grassley offices in Washington, D.C., Cedar Rapids, Council Bluffs, Davenport, Des Moines, Sioux City and Waterloo.  There are two sessions for 2012 summer internships.  The first is May 21 through July 3.  The second is July 5 through August 17.


Senate interns assist staff members with administrative, legislative and communications work, including that of Grassley's staff on the Senate Committee on the Judiciary, where he serves as Ranking Member.  A video about Grassley internships produced by last year's summer interns can be seen here.


Grassley said he encourages young Iowans who are interested in learning more about government to apply.  "Working in a congressional office is a good way for college students and new graduates to learn more about the legislative branch of the federal government, while gaining valuable work experience.  Internships in my offices are available to students in all areas of study," he said.


Application forms are available on Grassley's Senate website and in Grassley's offices in Iowa. Due to security-related delays in postal mail delivery to U.S. Senate office buildings, internship applications should be emailed to  For additional information, send messages to or call 202-224-3744.



Sen. Chuck Grassley of Iowa today made the following comment on the President's executive order creating a new Interagency Trade Enforcement Center within the office of the United States Trade Representative.

"When U.S. trading partners violate their obligations, the U.S. trade representative's office already should be taking the lead and working with other agencies to take action as needed.  I'm skeptical that a new Interagency Trade Enforcement Center is necessary to ramp up enforcement against trading partners who are playing fast and loose with trade rules.  There's nothing to stop the United States from bringing more cases now.  I plan to press the trade representative on the need for this new entity when he comes before the Senate Finance Committee soon.  If this new center gets up and running, there should be real results to back up the presidential pronouncement.  The pressure will be on the White House to deliver."