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The Supreme Court said on Friday that it would decide whether generic drug companies could be sued under state law over allegations they failed to provide adequate label warnings about potential side effects.
The nation’s highest court will consider whether federal law preempted such lawsuits because the drug had been approved by the Food and Drug Administration (FDA).
The high court agreed to hear appeals by Teva Pharmaceutical Industries Ltd, Mylan Inc’s UDL Laboratories and Actavis Inc, based in Reykjavik, Iceland.
The Supreme Court decided a related issue in 2009 when it ruled FDA drug regulations do not protect pharmaceutical companies from being sued under state law over drug labeling, a case involving Pfizer Inc’s Wyeth unit and its antinausea drug Phenergan.
The justices are expected to hear arguments in the generic drug cases in March or April, with a decision likely by the end of June.
In one case, a U.S. appeals court ruled that Actavis could face claims by a woman who said it should have warned her to risks of metoclopramide, a drug that treats symptoms such as heartburn, nausea and vomiting. The drug’s name brand is Reglan.
Julie Demahy sued Actavis under Louisiana law, claiming she developed a neurological disorder after the company failed to alert her to literature about the risks of using metoclopramide and failed to change the drug’s label.
In another case, a woman, Gladys Mensing, sued the three generic drug makers in federal court in Minnesota after allegedly developing a severe neurological movement disorder after taking generic versions of Reglan. A U.S. appeals court ruled her lawsuit could go forward.
The Obama administration supported the two women and said the appeals court in their cases correctly ruled their claims were not categorically preempted.
(Reporting by James Vicini)
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Taxing sodas and other sweetened drinks would result in only minimal weight loss, although the revenues generated could be used to promote obesity control programs, new research suggests.
Adding to a spate of recent studies examining the impact of soda taxes on obesity, researchers from Duke-National University of Singapore (NUS) Graduate Medical School looked at the impact of 20 percent and 40 percent taxes on sales of carbonated and non-carbonated beverages, which also included sports and fruit drinks, among different income groups.
Because these taxes would simply cause many consumers to switch to other calorie-laden drinks, however, even a 40 percent tax would cut only 12.5 daily calories out of the average diet and result in a 1.3 pound weight loss per person per year, researchers said.
A 20 percent tax would equate to a daily 6.9 calorie intake reduction, adding up to no more than 0.7 pounds lost per person per year, according to the statistical model developed by the researchers.
“The taxes proposed as a remedy are largely on the grounds of preventing obesity, and we wanted to see if this would hold true,” said study author Eric Finkelstein, an associate professor of health services at Duke-NUS. “It’s certainly a salient issue. I assumed the effects would be modest in weight loss, and they were.”
“I believe that any single measure aimed at reducing weight is going to be small,” Finkelstein added. “But combined with other measures, it’s going to add up. If higher taxes get people to lose weight, then good.”
As part of a growing movement to treat unhealthy foods as vices such as tobacco and liquor, several states in recent years have pushed to extend sales taxes to the purchase of soda and other sweetened beverages, which, like other groceries, are usually exempt from state sales taxes.
Other motions have seemed to target the poor, such as New York City Mayor Michael Bloomberg’s proposal earlier this year to ban sugared drinks from groceries that could be purchased by residents on food stamps.
Finkelstein’s study, reported online Dec. 13 in the Archives of Internal Medicine, showed that high soda taxes wouldn’t impact weight among consumers in the highest and lowest income groups. Using in-home scanners that tracked households’ store-bought food and beverage purchases over the course of a year, the data included information on the cost and number of items purchased by brand and UPC code among different population groups.
Researchers estimated that a 20 percent soda tax would generate about $1.5 billion in annual revenue in the United States, while a 40 percent tax would generate about $2.5 billion. The average household cost would be $28.
Finkelstein explained that wealthier households seemed impervious to the tax because they can afford to pay it, while poorer income groups weren’t as affected because they tend to buy lower-priced generic products or buy in bulk.
“It’s largely very cheap calories for them,” he said, adding that store brands such as Wal-Mart cola also contain more calories than the name-brand Coke.
Dr. Stephen Cook, an assistant professor of pediatrics at Golisano Children’s Hospital at the University of Rochester Medical Center (URMC), said the study is valuable because it echoes the results of others similar to it.
“It’s good to see an amount of replication in the findings,” said Cook, also an assistant professor of URMC’s Center for Community Health. “It brings up an important point of how we should address obesity, as a disease or a public health threat.”
Despite the modest weight loss resulting from the soda taxes, both Finkelstein and Cook support such a measure as one of many possible ways to attack obesity, which affects one-third of Americans.
As for the revenue generated, it can also tackle obesity if it’s funneled toward weight-control programs and not other government initiatives, Cook said.
“The other side of the taxing coin is what we do with the money,” Cook said. “We need to take the revenue and use it for interventional programs instead of it being used as a money grab. I think it’s good when it’s properly done and the money is used for those strategies.”
Cook added that future measures could include taxing foods with added sugars as well as lowering the prices of healthy foods such as fruits, vegetables and skim milk.
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Pfizer Inc is voluntarily recalling its drug to treat a life-threatening lung condition and will end studies of the pill after it was linked to potentially deadly liver toxicity.
The European Medicines Agency on Friday said the modest-selling drug, used to treat pulmonary arterial hypertension, was withdrawn due to “new information on two cases of fatal liver injury.”
Pfizer spokesman Curtis Allen said the drug, called Thelin, which is not sold in the United States, was being recalled in Europe, Canada and Australia after being linked to a new liver problem “that occurs rarely and unpredictably in patients.”
“The decision was based on a review of emerging safety information and post-marketing reporting,” said Allen, referring to reports by doctors that have prescribed it.
Thelin and similar medicines already carry warnings of elevated liver enzymes, a marker for potential liver damage. But the new liver risk for Thelin now suggests its overall risks outweigh its potential benefit, Allen said.
Pfizer, the world’s biggest drugmaker, whose chief executive abruptly resigned on Sunday, scrapped U.S. trials of Thelin for pulmonary arterial hypertension. Such patients have elevated blood pressure in lung arteries and veins that cause shortness of breath and other symptoms, which can lead to heart failure and early death.
About 1,100 patients have taken Thelin since it was launched in Europe in 2006 and in Australia and Canada the following year.
Pfizer in 2008 paid $195 million for the company that developed the product, Encysive Pharmaceuticals, even though the U.S. Food and Drug Administration had repeatedly rejected the drug for lack of efficacy.
Pfizer had been counting on the U.S. trials to ultimately prove Thelin’s worth. It is the latest in a long string of setbacks for Pfizer, whose labs have not generated any big-selling drugs for more than a decade.
“It’s another ding in their pipeline, though expectations for it (Thelin) had been fairly low,” said Damien Conover, an analyst at Morningstar. “Had it been approved in the United States and didn’t have the safety side effect, you could have seen it just breaking into blockbuster sales at peak.”
Conover said investors are more focused on Pfizer’s so-called JAK inhibitor, an oral treatment for rheumatoid arthritis, and its ALK inhibitor for a subset of patients with lung cancer. Both drugs, if successful in trials, could generate peak annual sales of more than $2 billion, he said.
Pfizer shares were up 1.3 percent to $16.98 in afternoon trade on the New York Stock Exchange. The stock has fallen nearly 18 percent from a 52-week high of $20.36 in January.
Thelin garnered sales of $44 million in the first nine months of 2010, making it a small product for Pfizer.
It competes with Tracleer, a drug made by Actelion Ltd that had sales of $1.4 billion in 2009. Thelin also competes with Letairis, made by Gilead Sciences Inc, which produced 2009 sales of $184 million.
Thelin, Tracleer and Letairis all block fragments of endothelin, a protein that causes blood vessels to tighten up.
Deutsche Bank analyst Richard Parkes said on Friday the new liver problem appears to be specific to Thelin.
“In contrast, Actelion has generated a large database of safety, showing that liver enzyme elevations with Tracleer can be safely managed,” Parkes said in a research report.
Actelion shares rose 1.3 percent, as the recall of Thelin eliminated a rival to Tracleer.
Pfizer late last year bought U.S. rival Wyeth in hopes Wyeth’s drugs would bolster Pfizer’s aging array of medicines, including the $11 billion-a-year cholesterol fighter Lipitor, which faces U.S. generic competition in November 2011.
On Sunday, Pfizer CEO Jeffrey Kindler surprised Wall Street by announcing he would retire to “recharge his batteries.” He handed the company’s reins to Ian Read, head of Pfizer’s global drug business.
(Reporting by Ransdell Pierson and Toni Clarke; Editing by Steve Orlofsky. Tim Dobbyn and John Wallace)
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Johnson & Johnson, which has been beset with recalls of Tylenol and other consumer products over the past year, has recalled almost 5 million additional packages of Benadryl, Motrin and Rolaids because of manufacturing “insufficiencies.”
J&J said the recalls, like many of the earlier ones, involved products made at its plant in Fort Washington, Pennsylvania. The facility was closed earlier this year to fix quality-control lapses, including unsanitary conditions.
The latest actions involve 4 million packages of Children’s Benadryl Allergy Fastmelt Tablets in cherry and grape flavors. The allergy drug was distributed in the United States and other markets, a company spokeswoman said.
An estimated 800,000 bottles of Junior Strength Motrin Caplets, a painkiller, were recalled in the United States.
The Benadryl and Motrin recalls were initiated after a J&J review “revealed insufficiencies in the development of the manufacturing process,” J&J said.
The company spokeswoman declined to identify the specific manufacturing lapses. She said there was no indication that the products failed to meet quality standards.
In addition, about 71,000 packages of Rolaids antacid, in a cherry flavored extra-strength Softchews formulation, were recalled in the United States.
J&J said the Rolaids were made by a third party, and were recalled following consumer complaints about “an uncharacteristic consistency or texture, traced to crystallized sugar in the product.”
Unlike previous recalls, J&J did not issue press releases announcing the latest actions by its McNeil consumer healthcare division. It posted them on a company website.
“This is not a consumer-level recall; consumers do not have to take any action,” the spokeswoman said when asked why press releases were not issued.
She said all three new actions instead were “wholesale and retail level” recalls, which called instead on wholesalers and retail outlets to take action.
(Reporting by Ransdell Pierson in New York and Thyagaraju Adinarayan and S. John Tilak in Bangalore. Editing by Jon Loades-Carter and Robert MacMillan)
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Three pharmaceutical companies have agreed to pay 421 million dollars for reporting inflated drug prices to the US government, officials said Tuesday.
The Justice Department said that Abbott Laboratories, Roxane Laboratories, a US-based subsidiary of a German firm, and German drug maker Braun Medical Inc all agreed to pay the fines.
The three companies are accused of artificially inflating the prices of the drugs reimbursed by the federal government under the Medicare and Medicaid health care programs for elderly and low-income Americans.
Tony West, Assistant Attorney General for the Justice Department’s Civil Division, said the companies were guilty of “offering their customers one price and then falsely reporting a greatly inflated price to the lists the government uses when determining how much to pay for the drugs,” he said.
The fraud led to the government overpaying reimbursements by hundreds of millions of dollars, according to officials.
“Pharmaceutical companies created an incentive for the purchase of their drugs, since buyers could obtain government payment at the inflated price and pocket the difference,” said West.
Authorities said, however, that they have recovered the overcharges and more in its settlements with offending companies over the unlawful pricing schemes.
Since January 2009, officials said they have reclaimed more than nine billion dollars in cases alleging false claims — about half of those funds from fraud related to federal health care programs.
West said the price inflation scams are a drain on government coffers and hurt health programs intended for the sick and elderly.
“Taxpayer-funded kickback schemes like this not only cost federal health care programs millions of dollars, they threaten to undermine the integrity of the choices health care providers make for their patients,” he said.
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