- The Washington Times - Monday, July 28, 2008

GAO

Report hits drugs over ‘off-label’ usage

When a state trooper pulls over a speeding motorist, the officer usually writes out a ticket on the spot.

When federal regulators catch a drug company peddling prescription medications for an unapproved use, it takes them an average of seven months to issue a warning, according to a draft report by congressional investigators. It typically takes four more months for the company to fix the problem.

The report from the Government Accountability Office delves into a gray area of medical practice and federal oversight: the use of medications to treat conditions other than the ones the drugs were approved for, a practice known as “off-label” prescribing.

What makes the practice so difficult to get a handle on is a web of seemingly contradictory laws and regulations.

Drug companies are forbidden to promote medications for uses that have not been validated by the Food and Drug Administration on evidence from clinical trials. Doctors, however, can use their own independent judgment in prescribing medicines. Also, under guidance proposed by the FDA this year, drug companies could distribute to doctors scientific articles that suggest new and unapproved uses for medications.

The situation has raised concerns for Sen. Charles E. Grassley, Iowa Republican, who requested the investigation.

HOUSING

McCain calls Wall Street ‘villain’

Sen. John McCain, Arizona Republican, put the blame on Wall Street for the home mortgage credit crisis that has roiled financial markets around the world.

“Wall Street is the villain in the things that happened in the subprime lending crisis and other areas where investigations and possible prosecution is going on,” Mr. McCain said during a taped appearance on ABC’s “This Week” program.

Mr. McCain, his party’s presumptive presidential nominee, said he supports the housing bill passed by Congress to stem foreclosures and aid Fannie Mae and Freddie Mac, the largest U.S. mortgage-finance companies, even though it may cost taxpayers as much as $25 billion.

He said the risk of the mortgage companies’ failure outweigh the potential cost. He also said Fannie and Freddie should be barred from lobbying Congress and their executives’ compensation should be reduced.

“We should eliminate the pay and bonuses that these people rake in,” Mr. McCain said

SENATE

Dodd to speed up housing-bill work

U.S. housing and banking regulators have been summoned to Capitol Hill this week in a bid to speed enactment of sweeping housing legislation lawmakers passed this weekend, Sen. Christopher J. Dodd said.

Mr. Dodd, Connecticut Democrat, said he is “terribly disappointed” by remarks he attributed to Housing and Urban Development Secretary Steve Preston that it would take as long as a year to implement regulations to provide help for almost 400,000 homeowners at risk of foreclosure.

A HUD spokesman said Mr. Preston didn’t make the comment Mr. Dodd mentioned.

“We wrote this legislation specifically to bypass the normal rulemaking process,” Mr. Dodd, chairman of the Senate banking committee, said at a press conference Saturday after the 72-13 vote in a rare Saturday Senate session.

Mr. Dodd said he has asked to meet with the leaders of HUD, the Federal Reserve, the Federal Deposit Insurance Corp. and Treasury Department in his Washington office Tuesday “to tell me why they can’t begin immediately to get this bill working.”

WHITE HOUSE

Bush thanks Hill for AIDS legislation

President Bush said Saturday he’s eager to sign legislation that triples money to fight AIDS and other diseases around the world - an initiative that has won him praise from some of his harshest critics.

In a rare case of cooperation between the White House and the Democrat-controlled Congress, lawmakers voted last week to significantly increase U.S. assistance to fight AIDS, malaria and tuberculosis around the world. It gave renewed life to a program credited with saving and prolonging millions of lives in Africa alone.

The 303-115 vote in the House on Thursday sent the five-year, $48 billion plan to the president.

“I thank members of Congress from both sides of the aisle for working with my administration to pass this important bill, and I will be honored to sign it into law next week,” Mr. Bush said in his weekly radio address.

POLITICS

Governor hopefuls argue in Delaware

Delaware’s two Democratic candidates for governor are sparring over campaign ads and financing.

State Treasurer Jack Markell is calling on Lt. Gov. John Carney’s campaign to return money the state Democratic Party used to buy radio ads supporting Mr. Carney. Markell campaign officials say the money should be used to campaign against Republicans, not fellow Democrats.

The Carney campaign, meanwhile, is calling on Mr. Markell to return money he received during his campaign for the state treasurer’s office. Mr. Markell transferred about $875,000 from that campaign to his gubernatorial campaign after he announced his bid for governor.

Mr. Markell faces Mr. Carney in the Democratic primary Sept. 9.

ARMY

Goals set to cut carbon ‘bootprint’

What if cutting greenhouse emissions could also save the lives of soldiers in Iraq, where fuel-laden convoys make them targets? The U.S. Army says it is happening now in a push to reduce its carbon “bootprint.”

From forward areas like Iraq and Afghanistan to training ranges in the United States, the Army has been working to limit its use of fossil fuels and make its operations more environmentally sustainable.

The goal is to bring Army emissions of climate-warming carbon dioxide down by 30 percent by 2015, said Tad Davis, deputy assistant secretary for environment, safety and occupational health.

“What I’m interested in doing is finding out what the greenhouse-gas emissions, this carbon bootprint, are for the Army in two to three years at the latest,” Mr. Davis said. “We want to emit less that do that, hand in hand with reducing energy consumption from fossil fuels.”

The Army has pushed for environmental sustainability at all of its bases, starting with the giant Fort Bragg in North Carolina in 2001, Mr. Davis said.

MEDICARE

Rankings planned for nursing homes

The Centers for Medicare & Medicaid Services is creating a ranking system for the nation’s nursing homes to help consumers judge the quality of care provided when they are choosing a facility for themselves or their loved ones.

The agency, which is part of the U.S. Department of Health and Human Services, says it is creating a five-star system that will evaluate the levels of patient satisfaction, medical care and cost, among other things, at every nursing home that takes Medicare funds.

The ratings are expected to be published in December.

From wire dispatches and staff reports

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