NEW YORK – U.S. Deputy Attorney General Paul J. McNulty announced today during a speech at a meeting of the Lawyers for Civil Justice in New York that the Department of Justice is revising its corporate charging guidelines for federal prosecutors throughout the country.

The new guidance revises the Thompson Memorandum, which was issued in January 2003 by then-Deputy Attorney General Larry D. Thompson and titled the “Principles of Federal Prosecution of Business Organizations.” The memo provides useful guidance to prosecutors in the field through nine factors to use when deciding whether to charge a corporation with criminal offenses.

The guidance continues to require consideration of the factors from the Thompson memo but adds new restrictions for prosecutors seeking privileged information from companies. Specifically, it creates new approval requirements that federal prosecutors must comply with before they can request waivers of attorney-client privilege and work product protections from corporations in criminal investigations.

“Our efforts to investigate and prosecute corporate fraud in the past five years through the President’s corporate initiative have been tremendously successful,” said Deputy Attorney General Paul J, McNulty. “With this new guidance, we want to encourage corporations to prevent corruption through self-policing and continue to punish wrongdoers through cooperation with law enforcement.”

The new guidance requires that prosecutors must first establish a legitimate need for privileged information, and that they must then seek approval before they can request it. When federal prosecutors seek privileged attorney-client communications or legal advice from a company, the U.S. Attorney must obtain written approval from the Deputy Attorney General. When prosecutors seek privileged factual information from a company, such as facts uncovered in a company’s internal investigation of corporate misconduct, prosecutors must seek the approval of their U.S. Attorney. The U.S. Attorney must then consult with the Assistant Attorney General of the Criminal Division before approving these requests.

The guidance cautions prosecutors that attorney-client communications should be sought only in rare circumstances. If a corporation chooses not to provide attorney-client communications after the government makes the request, prosecutors are directed not to consider that declination against the corporation in their charging decisions. Prosecutors are told to request factual information first and make sure they can establish a legitimate need to go further before requesting a waiver of privilege to obtain attorney-client communication or legal advice.

The new memorandum also instructs prosecutors that they cannot consider a corporation’s advancement of attorneys’ fees to employees when making a charging decision. A rare exception is created for those extraordinary instances where the advancement of fees, combined with other significant facts, shows that it was intended to impede the government’s investigation. In those limited circumstances, fee advancement may be considered only if it is authorized by the Deputy Attorney General.

The changes announced today by Deputy Attorney General McNulty were made after careful review and numerous meetings with those in the business and legal communities who raised concerns about the Department’s guidance.

“We will safeguard every tool prosecutors need to fight fraud and continue our aggressive efforts in rooting out corruption in our financial markets to protect the interests of the investing public,” said Deputy Attorney General McNulty. “The Department supports the sanctity of attorney-client privilege. We encourage full and frank communication between corporate employees and their lawyers. With this new guidance, I will personally approve all future requests for attorney-client communications.”

South Korean authorities expressed support Monday, for the scheduled resumption of talks on North Korea's nuclear weapons.

South Korean Foreign Ministry Spokesman Choo Kyu-ho said Seoul welcomes the news that the six-party talks will resume next Monday, December 18, in Beijing.

China, Russia, the United States, Japan and South Korea have tried for three years to convince the North through diplomacy to give up its nuclear programs in exchange for political and financial benefits.

Soon after it signed a pledge in September last year, agreeing in principle to give up its nuclear weapons, North Korea boycotted further talks in protest at U.S. financial measures targeting North Korean business interests.

The United States says those measures, which had the effect of restricting North Korea's access to the international banking system, were law enforcement measures needed to protect U.S. interests from North Korean money laundering and counterfeiting.

North Korea has said resolving the financial issue must be one of the goals of the six-party talks.

Ryoo Kihl-Jae, dean of Kyungnam University's School of North Korean Studies in South Korea, says the North's test of a nuclear device in October may have given China and the United States fresh impetus to cooperate on convincing the North to negotiate.

He says China is likely to pressure the North not to miss this opportunity to get what it wants from the United States.

On Monday, North Korea repeated a demand it has made before, that Japan be left out of the six-party talks. An editorial in Pyongyang's official Rodong Sinmun newspaper labelled Japan as "a state of the United States" which would only distract the talks with side issues.

Japan, which maintains a hard line on the North Korean nuclear issue, demands that Pyongyang do more to address its abductions of Japanese nationals in the late 1970's and early 1980's.

The Food and Drug Administration (FDA) today proposed significant regulatory changes to make experimental drugs more widely and easily available to seriously ill patients with no other treatment options and to clarify the circumstances and the costs for which a manufacturer can charge for an experimental drug.

Under the proposed rule, expanded access for experimental drugs would be available to individual patients, small patient groups, and larger populations under a treatment plan when there is no satisfactory alternative therapy to diagnose, monitor or treat the disease or condition.

"This proposed reform is carefully designed to balance several objectives," said Dr. Andrew C. von Eschenbach, Acting FDA Commissioner. "One goal is to enable many more patients who lack satisfactory alternatives to have access to unapproved medicines, while balancing the need for safeguarding the individual patient. Another equally important goal is to ensure the continued integrity of the scientific process that brings safe and effective drugs to the market."

"FDA hopes this proposal will increase awareness in the healthcare community of the range of options available for obtaining experimental drugs for seriously ill patients," added Dr. Janet Woodcock, FDA's Deputy Commissioner for Operations. "By clarifying and streamlining the processes, FDA also hopes to encourage companies to make such drugs available, and reduce barriers for healthcare practitioners in obtaining them."

FDA has allowed many types of access to experimental therapies since the 1970's. Some of the larger programs, including those under the treatment IND (Investigational New Drug) regulations, were successful in enabling tens of thousands of patients with HIV/AIDS, cancer and cardiovascular diseases to receive promising therapies before the products were approved for marketing. However, the existing regulations did not adequately describe the full range of programs available, explicitly recognizing only emergency use for individual patients and widespread treatment use access for large groups of patients. FDA believes it is important that its regulations clearly reflect the full range of treatment use programs available to ensure broad and equitable access to experimental drugs for treatment use. The regulations covering when it is appropriate to charge for an experimental drug need revisions because they fail to account for the full range of circumstances in which charging should be permissible and because they have proven difficult to interpret in practice, resulting in confusion over what costs could be recovered.

The proposed rules, which are open for comment for 90 days are described in detail at the following CDER web address: (http://www.fda.gov/cder/regulatory/applications/IND_PR.htm) The most significant proposals would:

(1) Modernize applicable regulations to include all circumstances under which access to experimental drugs is permitted, including:

• single patients in non-emergency and emergency settings;
• small groups of patients; and
• larger groups of patients under a treatment IND. To authorize these expanded access treatment uses, FDA generally must be satisfied that the patient's serious or immediately life-threatening disease or condition has no satisfactory approved therapy; that the potential benefit for the patient justifies the potential risks; and that providing the therapy will not interfere with the drug's development.

(2) Make experimental drugs more widely available in appropriate situations by establishing criteria that link the level of evidence needed to support the use of an experimental drug to the seriousness of the disease and the number of patients likely to be treated with the drug;

(3) Revise the current regulation regarding manufacturers' recovery of the costs of an experimental drug to:

• clarify that such charges are permissible in a clinical trial only to facilitate development of drugs that promise significant advantages over existing therapies, and might not otherwise be developed because of their high cost;
• clarify that allowing charging for treatment use of an experimental drug is intended to facilitate and encourage access to drugs that might not be made available for treatment use unless a manufacturer is able to recover its costs.

The proposal also would simplify the cost recovery calculation by making clear that charges for an experimental drug used in a clinical trial may include only direct costs associated with the drug's development, and that charges for experimental drugs for treatment use may also include administrative costs of making the drug available for intermediate
patient populations and under large scale treatment INDs.

House Republicans had initially planned to terminate the agency in October 2007 through through HR 5122, transferring its mandate to the State and Defense departments. Democrats in the House introduced new legislation last month authorizing the agency for an additional year. The measure passed the Senate on Wednesday, and the House approved it by voice vote during its last sitting of the year on Saturday. Rep. Ike Skelton (D-MO), who will take over as Chairman of the House Armed Services Committee in January, has already suggested that he will expand the scope of SIGIR in the new year.

Former Chilean dictator General Augusto Pinochet has died, according to an announcement from a military hospital in Santiago. Pinochet, 91, suffered a major heart attack.

In recent years Chilean authorities have made multiple efforts to bring the ex-dictator to justice for dozens of human rights violations he is accused of committing during his military rule from 1973 to 1990.

Pinochet suffered from mild dementia, strokes, arthritis and other ailments that made his fitness to stand trial questionable. He enjoyed general immunity from prosecution under the 1980 Chilean Constitution, but was incrementally stripped of that immunity in light of charges brought against him.

Two weeks ago, a judge ordered he be placed under house arrest in connection with the executions of two of former President Salvador Allende's bodyguards during the so-called Caravan of Death that followed the 1973 coup in which Pinochet seized power; the house arrest order was lifted earlier this week for his recuperation. Last month, on the occasion of his birthday, Pinochet publicly assumed full political responsibility for the actions of his former regime.

WASHINGTON - The Justice Department announced that on Dec. 9, 2006, it will monitor the congressional runoff election in New Orleans, La., to ensure compliance with the Voting Rights Act.

The Department monitors will watch and record activities during voting hours at polling locations in the city. A Civil Rights Division attorney will coordinate the federal activities and maintain contact with local election officials.

Each year, the Justice Department deploys hundreds of federal observers from the Office of Personnel Management, as well as departmental staff, to monitor elections across the country. In 2004, a record 1,463 federal observers and 533 Department personnel were sent to monitor 163 elections in 105 jurisdictions in 29 states. This compares to the 640 federal observers and 103 Department personnel deployed in 2000. On Nov. 7, 2006, the Department deployed an unprecedented number of federal personnel to monitor the midterm election, sending more that 500 federal observers and more than 350 Justice Department personnel to 69 jurisdictions in 22 states "more than double the total sent on Election Day in 2002" the previous record for a midterm election.

The government alleged in the complaint filed in this case that Drake and Sorenson devised and operated a scheme that helped some members of the Santa Ynez Band of Chumash Indians claim bogus deductions on their federal income tax returns to offset income the members receive from the Band’s casino operations at the Chumash Casino Resort in Santa Ynez, Calif. The complaint also stated that each Band member received over $300,000 in casino distributions in 2004 and over $400,000 last year.

The injunction order requires Drake and Sorenson to mail a copy of the injunction to all customers who participated in the scheme and to any other persons to whom they sold a similar scheme in the past five years.