Allergan suing FDA over off-label policy

Allergan Inc., the maker of the Botox wrinkle treatment, challenged the government's ban on off-label drug marketing to doctors, saying it violates the company's right to freedom of speech.

The company contends in a lawsuit filed Thursday that it should be able to educate doctors about the risks and benefits of using treatments for unapproved uses.

Botox is approved for several uses by the Food and Drug Administration. In addition to its use as a wrinkle treatment, it is approved for eye muscle disorders and excessive underarm sweating. But physicians often use it for unapproved, or off-label, indications including muscle-spasm conditions.

While physicians can legally prescribe a drug for unapproved uses, companies are forbidden from marketing the product, especially to physicians, for any use not sanctioned by the FDA.

A call to the FDA for comment on Friday was not immediately returned. The lawsuit was filed in U.S. District Court for the District of Columbia against the U.S. government and the FDA.

The catalyst for the lawsuit is a requirement that the company provide new risk information education to physicians on Botox as a therapeutic treatment.

"Our reason for seeking action now relates to the fact that we have recently been required by FDA to initiate a REMS (Risk and Mitigation) program for Botox to ensure that physicians are equipped to evaluate the risks and benefits of treatment," Allergan spokeswoman Caroline Van Hove said in a statement.

Drug developers often walk a tight line with off-label drug practices and getting caught on the wrong side can be expensive. New York-based Pfizer Inc. paid a $2.3 billion settlement last month over allegations it marketed drugs for off-label use.

Part of the logic behind the FDA rule is this: the agency has reviewed detailed clinical trial data, spanning years, before approving a drug's use for a specific purpose. That same level of scientific, controlled review has not gone into unapproved uses.

In a statement Thursday, Allergan said some of Botox's off-label uses are medically accepted and commonly prescribed.

"Once a drug is approved, physicians may exercise their informed medical judgment to prescribe the drug for any use, including off-label uses," the company said, estimating that about 20 percent of Botox use is off-label.

The ban on off-label marketing to doctors is particularly difficult for Allergan, the company said, since the FDA has required safety updates to Botox's label.

In April, health officials warned doctors and patients about potentially deadly risks of using Botox and similar drugs for unapproved uses to treat certain types of muscle spasms. The drugs carried risks of rare botulism symptoms, particularly when given to children to help relax uncontrollable muscle movements.

In general, the new labeling urges physicians to tell patients about the risks of botulin-based drugs and to seek medical care if they develop any symptoms.

"To ensure that physicians are equipped to treat patients as safely and successfully as possible, Allergan believes it is important to proactively provide comprehensive information to physicians about these off-label uses, such as dosing guidelines, patient selection criteria and proper injection technique," the company said. "Without judicial relief, Allergan is unable to engage in a truthful and relevant information exchange with the medical community for fear of prosecution."

The Irvine, Calif., company stressed that the lawsuit doesn't challenge the government's ability to prohibit pharmaceutical companies from lying or distributing misleading information. Rather, the company said, it seeks to permit Allergan to proactively provide the medical community with truthful, important information about common off-label uses of Botox.

Allergan is represented in its lawsuit by Paul D. Clement, a partner at King & Spalding LLP in Washington, D.C., and formerly the Solicitor General of the United States.

Allergan shares fell $1.58, or 2.8 percent, to $54.37 in morning trading Friday.

Stocks dip as September jobs report disappoints

U.S. stocks fell Friday after the government reported that more jobs were lost in September than had been expected.

Major indexes were off their lows by midmorning as investors looked for bargains after four straight days of losses.

The day's news continued a drumbeat of bad indicators for the economy, especially the still-struggling job market. The Labor Department reported that employers cut 263,000 jobs last month, up from 201,000 in August and worse than the 180,000 losses economists were expecting. The unemployment rate rose to 9.8 percent, in line with forecasts.

Unemployment has been one of the market's biggest concerns throughout the recession because lost jobs mean trouble for nearly every part of the economy, from consumers defaulting on loans, cutting back their spending and getting forced into foreclosure on their homes. Most economists expect the rate to surpass 10 percent by early next year.

A surprise decline in factory orders Friday was also troubling investors. The Commerce Department said factory orders fell 0.8 percent in August following a 1.4 percent gain in July. Analysts had been expecting a 0.7 percent increase.

The decline in stocks was more moderate than the previous day's big drop, when the Dow tumbled more than 200 points after a disappointing report on manufacturing activity dealt another blow to optimism that had been emerging about a recovery in the industrial sector.

A spate of bad economic news this week has led to even more doubts that the 50 percent surge in stocks over the past six months can be sustained. After coming within 82 points of the 10,000 level last week, the Dow has pulled back about 4.5 percent.

"Pullbacks are going to constantly be used as opportunities to get into the market," said Hank Smith, chief investment officer of equity at Haverford Investments in Radnor, Pa.

In late morning trading, the Dow fell 29.55, or 0.3 percent, to 9,479.73, after earlier falling as much as 79 points. The Standard & Poor's 500 index fell 3.43, or 0.3 percent, to 1,026.42, and the Nasdaq composite index fell 2.85, or 0.1 percent, to 2,054.63.

About 3 stocks fell for every one that rose on the New York Stock Exchange, where volume came to 456.3 million shares, compared with 358 million at the same time on Thursday.

In other trading, the Russell 2000 index of smaller companies lost 3.66, or 0.6 percent, to 580.09.

Government bonds reversed early gains and moved lower. The yield on the benchmark 10-year Treasury note rose to 3.20 percent from a five-month low of 3.18 percent late Thursday. Yields on bonds move opposite to their prices.

The dollar was mixed against other currencies. Gold prices rose.

In corporate news, struggling small business lender CIT Group Inc. said late Thursday it launched a debt restructuring program it hopes will trim at least $5.7 billion from its balance sheet. CIT is asking bondholders to approve a prepackaged reorganization plan in case it is forced to file for bankruptcy protection.

Letterman creates brilliant hour of TV from woes

It was business as usual for David Letterman and CBS' "Late Show." The band played. The host, dapper as always in a well-tailored suit, recited his monologue; some jokes hit, some missed.

Then Letterman proceeded to take viewers, and television, on an extraordinary journey that was part confessional, part entertainment and wholly, if jarringly, hypnotic.

The medium has come close to moments like this before — Hugh Grant's prostitute mea culpa on "Tonight" is the familiar example of recent years — but never achieved the merger of farce and drama that Letterman finessed.

"I'm glad you folks are here tonight," he told his "Late Show" New York studio audience Thursday. "I'm glad you're in such a pleasant mood, because I have a little story that I would like to tell you and the home viewers as well."

"Do you feel like a story?" Letterman asked amiably, as if making sure a child was ready for a cozy bedtime tale.

The audience got much more than that from a man acknowledged to be a master of the art of broadcasting.

By turns raffish, somber, self-effacing, blunt and coyly, comically manipulative, Letterman wove a mystery tale of his own behavior and that of a CBS' "48 Hours" employee arrested in an alleged multimillion-dollar extortion plot against him.

Letterman took his time — 10 minutes, a TV eternity these days for one topic — to slowly reel in viewers.

President Richard Nixon's famed "Checkers" speech, so old-school in its clumsy sentiment as he fought to remain on the GOP ticket as vice president, had nothing on this.

Even the 21st-century pipelines that allow the famous to control their message, whether Twitter or Facebook or you name it, looked like amateur hour.

Opening his tale, the 62-year-old Letterman said it all started with a letter and package left in his car.

"I know that you do some terrible, terrible things and that I can prove you do some terrible things," the letter warned, with proof enclosed, he recounted.

The audience, expecting the comedy that's reliably delivered by Uncle Dave, played along. They laughed.

They laughed about the man who allegedly threatened to put this "terrible stuff" about Letterman's life in a screenplay and a book. They laughed when he recalled the district attorney's office telling him, "Hellooo, this is blackmail."

The first break in the levity came when Letterman finally disclosed how much allegedly was demanded for silence, a princely $2 million. Real money, even for a well-paid late-night host.

"Oooooh," breathed a respectful studio audience.

Letterman started to edge away from the light and into darkness. He feared being harmed, he said.

"I want to reiterate how terrifying this is," he said, almost plaintively, a private man forced to bare his soul. "I'm motivated by nothing but guilt. I'm a towering mass of Lutheran Midwestern guilt."

The audience, sensing its cue, applauded.

He had them on the hook, ready to deliver the big plot twist that would wow them — or turn them against him. Viewers knew there was something "creepy" that Letterman had done, because he kept saying that was part of the goods someone had on him. Letterman, a careful wordsmith, repeated "creepy" enough to make sure it stuck.

Even a devoted fan could easily summon the specter of the most awful transgressions. Then Letterman dropped his bombshell: There were allegations that he had sex with women who worked for him.

Finally cowed by an unvarnished, unfunny remark, by the suggestion of improper behavior, the nasty whiff of sexual harassment in the workplace, the studio audience murmured uneasily.

Letterman made his final, brilliant move. He was honest.

"My response to that is, yes, I have. I have had sex with women who work on this show," he said. Married since March to a girlfriend of many years, and the father of a son born in 2003, Letterman didn't say when the encounters occurred.

The comedian, who has mocked so many celebrities for such transgressions, suddenly was himself a target. But the audience was back on his side and erupting in applause and cheers.

Letterman moved gracefully into the role of victim.

He invoked his need to protect the women involved, his family and himself. He ended with — shades of Nixon — his hope that he can "protect his job."

"Thank you for letting me bend your ears," he said. Then, back to the business at hand with guest Woody Harrelson.

"Good to be here on this auspicious night," the actor said with a sly but good-natured smile. All was well with "Late Show" and its host.

But what happens when the TV bubble bursts and people take another look?

As local food gains, local planners face decisions

Chickens finally can roost legally in Bozeman, Mont.

And it's thanks largely to a group of food-minded locals calling itself the Community Led Urban Chicken movement — that's right, CLUC — that persuaded city officials to lift restrictions on the increasingly popular practice of keeping backyard birds for eggs or meat.

Such encounters between so-called locavores (people who strive to eat locally produced foods) and bureaucrats are increasingly common as more people try to bring a taste of the farm to the city.

As the popularity of eating local has moved from the high-end restaurant scene to the mainstream, local food has become a priority issue for more mayors, city planners and zoning officials who must make decisions about everything from chicken coops and farmers markets to more expansive policies designed to boost consumption of fresh food.

"All across the country, city officials are beginning to realize that the food system isn't merely like other businesses — office supplies or electronics," said Nevin Cohen, an assistant professor of urban studies at The New School in New York City. "Food is something different that affects cities in a different way. So there's a role for government in figuring out how to get the food system right for a city."

Local food is a tiny part of the overall U.S. food market, but it's growing fast as consumers become more discerning about the quality of their food and where it comes from. The market research firm Packaged Facts estimates demand for local food will grow to $7 billion in 2011, up from around $4 billion in 2002.

Americans' growing taste for local food is most apparent in the farmers markets sprouting up nationwide like corn stalks in summer. The 4,900 farmers markets counted by the U.S. Department of Agriculture is double the number tallied in 1996.

But even something as benign-sounding as a place for local farmers to sell lettuce and apples can pose zoning or planning issues. Markets need variances if they're to be set up in noncommercial areas. Impacts on the neighborhoods need to be considered: Are there enough parking spaces? Will unsold vegetables will be left to rot on the curb? Will it be too noisy?

"People think it's going to be a two-week process, and it ends up being a six-month process," said Rob Sentner, a member of the local planning commission and open space committee in Upper Milford, Pa., near Allentown.

Sentner said behind-the-scenes work for a market in Upper Milford included tweaking local regulations to define what a farmers market is and demonstrating that it met state health and agricultural standards.

It's not any easier in bigger cites. Los Angeles Councilwoman Jan Perry, who has helped land four farmers markets in her district, said it takes tenacity and working around logistical issues. She recently helped launch Los Angeles' Food Policy Task Force, which will take a more systemic approach to bringing local produce across the city.

Those kinds of citywide efforts, many aimed at fighting obesity among poor people, are becoming common. San Francisco Mayor Gavin Newsom in July issued the city's first comprehensive food policy, which places an emphasis on regional food. New York City's Planning Commission in September approved a proposal to offer tax incentives to land more grocery stores that devote shelf space to fresh produce, meats and dairy.

Kimberley Hodgson, manager of the American Planning Association's Planning and Community Health Research Center, said more municipalities are starting to consider plans that take into account whole regions — city and country — as they consider the entire food chain from production to disposal.

"This is the new trend because planners are realizing that there is such an urban-rural linkage to the food system," Hodgson said. "So to just focus on the city or county food system really ignores the other parts of the system."

This is not always simple. Local officials sometimes must balance the desire for fresh food with the nuisance factor. New York City officials asked to legalize bee keeping within the city limits this year were essentially being asked to favor urban beekeepers and local honey lovers over residents who fear getting stung.

Then there is the chicken issue. It's illegal in many cities because of the noise and the mess. But with more people agitating to raise chickens in their back yards, a lot of municipal officials are rethinking their laws.

"People came up and said, 'Hey we like the idea of knowing where our food comes from. We like the idea of having a sustainable food source in our back yard,'" said Brit Fontenot, assistant to the Bozeman city manager. "'Why can't we look at removing this restriction?'"

Chapel Hill in North Carolina gave the OK to chicken keeping earlier this year, as did Buffalo, N.Y. The Iowa City Council is considering a backyard chicken ordinance, and officials in Washington — which in September opened a new farmers market just blocks from the White House — are considering easing restrictions on raising chickens within 50 feet of homes, which would allow more residents to raise the birds.

But officials in some other towns have balked. The Denver Suburb of Aurora, Colo., declined to allow it in June. Aurora Neighborhood Support Division manager Ron Moore said given factors like noise and sanitary concerns, city council member simply saw little reason to change the law.

In Bozeman, chicken keeping can officially commence on Oct. 29. CLUC organizer Alison Sweeney said she can't wait to move her chicks from a friend's house to within the city limits.

"I'm so excited," she said. "They're so precious."

Electric cars tax credit now eligible in Oklahoma

The Oklahoma Tax Commission on Thursday withdrew a rule that had blocked certain electrically powered vehicles from being eligible for a state tax credit.

It comes one week after an electric vehicle dealer sued the commission to block enforcement of the rule.

"They made a step in the right direction," said Roger Gaddis, owner of Ada Electric Cars, which sued the Tax Commission and its three commissioners to prevent enforcement of the rule.

Gaddis said the rule would prohibit buyers of his vehicles from claiming the electric car tax credit.

"They are going to make hundreds, if not thousands, of taxpayers in Oklahoma happy that they've taken the proper course of action and not tried to change the rules in the middle of the game," Gaddis said.

An existing state tax credit allows purchasers of electric vehicles to claim an income tax credit totaling 50 percent of the purchase price that can be spread over five years.

But the Tax Commission passed an emergency rule on Sept. 17 that excluded electric vehicles whose bodies are similar to a golf cart or go-cart instead of a traditional passenger automobile. Also excluded were vehicles designed and manufactured primarily for sporting or recreational purposes.

Commission spokeswoman Paula Ross said the purpose of the emergency rule was to clarify the standards for qualifying for the income tax credit. However, commissioners felt it had not achieved its purpose.

Ross said applications for the income tax credit will be reviewed according to guidelines that were in place before the rule was adopted.

Gaddis said the rule would have prohibited owners of the golf cart-like electric vehicles he sells from claiming the tax credit this year and in subsequent years, despite the vehicles exceeding federal highway standards for street-legal cars.

The vehicles, manufactured by Tomberlin, have been licensed with the Oklahoma Motor Vehicle Commission for more than three years and were engineered to be street-legal, low-speed vehicles, Gaddis said. The most popular model with no accessories sells for about $8,500, he said.

"We are extremely pleased that they have reversed course and put back in place what legislators intended," Gaddis said.

He said he will meet with his attorney before deciding whether to pursue the lawsuit, which was filed Sept. 23 in Garfield County District Court in Enid.

Entergy files plan to recover storm damage

Entergy Corp. is proposing the use of revenue bonds backed by surcharges on Louisiana customers' bills to pay for about $420 million in costs for restoring power following hurricanes Gustav and Ike last year, according to a regulatory filing.

Entergy Louisiana is asking the Louisiana Public Service Commission to recover $267.4 million in costs, plus another $200 million to replenish its storm reserve. Entergy Gulf States Louisiana wants $152.6 million and another $90 million for its storm reserve.

In its initial PSC filing in May, the two Entergy units said the reserve funds — established after hurricanes Katrina and Rita in 2005 — had kicked in $229.5 million to help with damage from Gustav and Ike.

If the full amount is approved by the PSC, Entergy Louisiana customers would see an increase of about $2.41 per 1,000 kilowatt hours, while Entergy Gulf States Louisiana customers would pay about $1.86 per 1,000 kilowatt hours, Entergy said.

By using bonds, Entergy Louisiana customers would save $49.5 million to $139.7 million, while Entergy Gulf States Louisiana customers would save $25.7 million to $88.5 million, Entergy said. Savings would depend upon interest rates when the bonds are placed.

Customers of the two Entergy units already are paying about $1 billion over 10 years as the result of Katrina and Rita. Those restorations also are being paid through revenue bonds. Under the law, power companies are entitled to recover any storm restoration costs determined by the PSC to have been incurred properly.

At the height of Gustav, which hit Sept. 1, 2008, there were 829,000 Entergy customers in Louisiana without power. At the height of Ike, which struck 13 days later, power had been cut to 141,378 customers.

If the PSC approves, the bonds would be issued by the Louisiana Public Facilities Authority and the proceeds loaned to a state entity known as the Louisiana Utilities Restoration Corp. Customer surcharges would go to the LURC to repay the bonds.

The use of such bonds have been used in other states for utilities to recover storm costs and reduce interest costs for customers.