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.

WASHINGTON – A federal grand jury in Anchorage, Alaska, has indicted Thomas T. Anderson, a current elected member of the Alaska State House of Representatives, on charges of extortion, conspiracy, bribery, and money laundering, Assistant Attorney General Alice S. Fisher of the Criminal Division announced today.

The seven-count indictment returned on Dec. 6, 2006, charges Anderson with two counts of extortion, one count of bribery, one count of conspiracy, and three counts of money laundering in connection with the use of a sham corporation to hide the identity of the bribery payments. The indictment further alleges that Anderson solicited and received money from an FBI confidential source in exchange for Anderson’s agreement to perform official acts to further a business interest represented by the confidential source.

The indictment also alleges that from July 2004 to March 2005, Representative Anderson, along with an individual identified as “Lobbyist A,” solicited and received $26,000 in payments from an FBI confidential source, in exchange for Anderson’s agreement to take official acts as a member of the Alaska State Legislature. According to the indictment, Anderson and Lobbyist A participated in the creation of a sham corporation to conceal the existence and true origin of the payments, and used the sham corporation to funnel a portion of the $26,000 to Anderson.

According to the indictment, the FBI confidential source was a consultant for a private corrections company located outside the state of Alaska, and Anderson and Lobbyist A initiated contact with the FBI confidential source in order to solicit bribery payments. The FBI confidential source, however, never communicated those solicitations or any other information to the corrections company due to the undercover nature of the operation. The corrections company was not implicated in the corrupt activities that are alleged in the indictment.

If convicted, Anderson faces a maximum penalty of 20 years and a $250,000 fine on the extortion counts; a maximum penalty of 20 years and a $500,000 fine on each of the money laundering counts; a maximum penalty of 10 years and a $250,000 fine on the bribery count; and a maximum penalty of five years and a $250,000 fine on the conspiracy count.

An indictment is merely an accusation and defendants are presumed innocent until proven guilty at trial beyond a reasonable doubt.

This case is being prosecuted by Trial Attorneys Nicholas A. Marsh and Edward P. Sullivan of the Public Integrity Section, which is headed by Acting Chief Edward C. Nucci, as well as Assistant U.S. Attorneys Joseph W. Bottini and James A. Goeke from the District of Alaska. The case is being investigated by Special Agents of the FBI.

US District Judge Thomas F. Hogan seemed skeptical of giving Rumsfeld immunity from the allegations, but also acknowledged that allowing the civil lawsuit to proceed would be unprecedented. He promised to rule quickly in the case. Rumsfeld resigned  from his position last month pending the confirmation of his successor. His resignation was quickly followed by the filing of a war crimes complaint against him under Germany's universal jurisdiction laws.