Obamacare's Solyndra? Oversight Panel Expands Co-Ops Probe, Renews Document Demand To HHS

Citing worries that "taxpayers will lose a significant amount of the money," House Committee on Oversight and Government Reform officials are significantly expanding their probe of the $2 billion Obamacare loan program to fund new health insurance co-operatives to compete with established private-sector firms in 24 states.

Committee Chairman Rep. Darrell Issa, R-Calif., requested a lengthy list of documents in a March 25, 2013, letter to officials with eight of the groups starting co-ops. Together, the eight have received more than $657 million in low-interest loans that must be repaid at a future date.

The requested documents include details of how they've spent the federal funds to date and copies of "all documents and communications" their employees have exchanged with Obama administration officials in the White House and the U.S. Department of Health and Human Services.

Also signing the letter were subcommittee Chairmen Rep. Jim Jordan, R-Ohio, and Rep. James Lankford, R-Okla.

The co-op program is overseen by the Center for Consumer Information and Insurance Oversight in HHS.

The eight new co-op groups under the committee's focus are CoOportunity Health of Iowa; Maine Community Health Options; Louisiana Health Cooperative; Illinois-based Land of Lincoln Health Inc.; Kentucky Health Cooperative; Evergreen Health Cooperative in Maryland; Montana Health Cooperative; and HealthyCT in Connecticut.

The committee previously contacted Hospitality Health, based in Nevada and FreeLancers Insurance Co., which is establishing co-ops in New York, New Jersey and Oregon, bringing the total of co-ops being reviewed to 13 of the 24 to be established. The 10 groups establishing the 13 new co-ops have received $1.06 billion in federal loans.

In a second March 25 letter, the oversight committee leaders sternly reminded HHS Secretary Kathleen Sebelius that it had yet to receive any of the documents about the Obamacare co-op program requested from her last October in a letter signed by Issa and Rep. Trey Gowdy, R-S.C., chairman of the oversight panel's Subcommittee on Health Care, the District of Columbia, Census and the National Archives.

A Feb. 12, 2013, response signed by Marilyn Tavenner, acting administrator of the Centers for Medicare and Medicaid Services, or CMS, "took nearly four months to prepare" but "failed to provide any of the information the committee requested."

"We remain concerned that taxpayers will lose a significant amount of the money awarded through the co-op program," Issa, Lankford and Jordan said in the letter to Sebelius.

"According to the Office of Management and Budget, taxpayer losses are projected at 43.2 percent for the loans given out through the co-op program," they said, noting that the "mean average taxpayer loss for other non-educational loans made as part of the federal government's Direct Loan Program is 8.3 percent."

Sebelius was given an April 8, 2013, deadline and was told that "if the department does not produce the requested documents by this time, we will be forced to consider use of the compulsory process."

The compulsory process would include issuing a congressional subpoena, which the Obama administration would then have to decide whether to comply with the committee's request or challenge it in federal court.

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U.S. FDA panel votes against approval of Noven's menopause drug

March 4 (Reuters) - A panel of advisors to the U.S. Food and Drug Administration recommended that the agency reject a drug for hot flashes associated with menopause made by Hisamitsu Pharmaceutical Co Inc's subsidiary Noven Pharmaceuticals Inc.

The panel voted 10-4 against approval, with the majority saying the drug's benefit was not sufficient to offset its risks. The panel was evenly divided over whether the drug was in any way effective.

(Reporting By Toni Clarke. Editing by Andre Grenon)

((toni.clarke@thomsonreuters.com)(617-856-4340)(Reuters

Messaging: toni.clarke.reuters.com@reuters.net))

Keywords: MENOPAUSE/NOVEN

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India panel proposes to regulate prices of patented medicines

By Kaustubh Kulkarni

MUMBAI, Feb 26 (Reuters) - An Indian government panel has proposed that prices of patented medicines be based on the country's per capita income, a move that would substantially reduce prices of costly drugs made by global pharmaceutical firms.

The proposal, which seeks the input of other government agencies as well as industry groups, could provoke the ire of Big Pharma, which has clashed with India over protection of intellectual property, price regulations for generic drugs, and compulsory licenses for costly medicines.

A panel formed under the ministry of chemicals and fertilizers has recommended setting up a committee to negotiate with drugmakers to fix prices of costly drugs used to treat deadly diseases such as cancer, HIV and hepatitis.

The proposal is the latest in a series of measures taken by India to make medicines more affordable for the country's 1.2 billion population.

"If we compare the per-capita income with the prices of patented medicines in countries like Australia or France, prices in India are comparatively high and hence, they need to be regulated," a senior ministry official told Reuters, declining to be identified because he was not authorised to speak with media.

Generic medicines account for more than 90 percent of India's $13 billion pharmaceuticals market. U.S.-based Abbott Laboratories has the largest share of the overall Indian drug market followed by India's Cipla .

The proposal, posted late on Monday on the ministry website, cites as an example the lung-cancer drug erlotinib HCL, sold by Roche Holding AG as Tarceva. In India, it costs 35,450 rupees ($660) for one month of 100 mg tablets, equivalent to 121,085 rupees in France and 121,650 rupees in Australia.

Based on per-capita gross national incomes, if the drug costs 35,450 rupees in India, its respective cost would be just 11,643 rupees in France and 10,309 rupees in Australia based on per capita income in the respective countries, the report said.

The Organization of Pharmaceutical Producers of India, which represents foreign drugmakers in India, did not reply to questions from Reuters.

"If stringent price regulations are enforced then latest drugs will not be made available in India," said Ameet Hariani, managing partner at Hariani & Co, a Mumbai-based law firm that advises drugmakers and other companies.

($1 = 53.89 rupees)

(Editing by Tony Munroe and Louise Heavens)

((kaustubh.kulkarni@thomsonreuters.com)(+91 22 61807399)(Reuters Messaging: kaustubh.kulkarni.thomsonreuters.com@reuters.net))

Keywords: INDIA PHARMA/PRICES

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UPDATE 1-FDA advisory panel backs J&J diabetes drug approval

* FDA panel votes 10-5 in favor of canagliflozin approval

* Panel members would like longer-term follow-up on heart risk

* Drug is first in new class of treatments for Type 2 diabetes

(Updates with details from panel discussion)

Jan 10 (Reuters) - A panel of advisers to the U.S. Food and Drug Administration recommended the agency approve an experimental new treatment for diabetes developed by Johnson & Johnson, potentially making it the first drug of its type to be approved in the United States.

The FDA's Endocrinologic and Metabolic Drug Advisory Committee voted 10-5 on Thursday to recommend the agency approve the drug, canagliflozin, for Type 2 diabetes, saying that it proved effective at lowering blood sugar in patients with diabetes, though some panelists had lingering concerns about its potential to cause cardiovascular problems and recommended longer term follow-up.

Canagliflozin, which will be sold under the brand name Invokana, is a member of a new class of diabetes drugs known as sodium-glucose co-transporter-2 (SGLT2) inhibitors which lower blood sugar by blocking reabsorbtion of glucose by the kidney and increasing the excretion of glucose in urine.

In its discussion, the panel weighed the relative risks and benefits of canagliflozin, especially in relation to any potential it might have to increase the risk of heart attack or stroke.

A clinical trial of patients at especially high risk of cardiovascular disease showed that within the first 30 days, 13 patients taking canagliflozin suffered a major cardiovascular event compared with just one patient taking a placebo. After that the imbalance was reversed. The drug also caused a slight increase in unhealthy LDL cholesterol.

The majority of panelists felt the overall risk benefit profile was acceptable but that longer-term data will be needed to fully assess the impact on patients of the higher LDL levels. The y were unable to determine conclusively that the imbalance in cardiovascular events seen in the first 30 days was a statistical anomaly.

Diabetes is a condition that affects the body's ability to metabolize glucose and is often caused by obesity. Left untreated, the disease can cause nerve disease leading to amputation, as well as kidney disease and blindness. It affects roughly 26 million people in the United States.

The panel also weighed the relative benefit of the drug for patients with impaired kidney function -- a common feature of patients with diabetes. They concluded that since the drug is less effective in patients whose kidney function is damaged, the risks may well outweigh the benefits in those patients.

Jeff Jonas, an analyst with Gabelli & Co, who estimates the drug will generate at least a billion dollars in annual sales for J&J, said he believes the FDA will approve the drug.

"It clearly works, and the side effects were not a major issue. If a patient has impaired kidneys, I think the FDA will say no, don't use it."

Damien Conover, an analyst at Morningstar, believes the drug could generate peak annual sales of more than $2 billion.

The vote in favor of canagliflozin follows the agency's rejection last January of a similar drug made by Bristol-Myers Squibb Co and AstraZeneca Plc. That drug was subsequently approved in Europe, however, under the brand name Forxiga. European regulators concluded that concerns cited by the FDA about a potential increased risk of cancer or liver injury were addressed by warnings in the drug's product label.

A recent report by market research firm Decision Resources estimated that the market for Type 2 diabetes drugs will nearly double over the next decade, increasing from $26 billion in 2011 to nearly $50 billion in 2021 in the United States, Japan and the main markets of Europe.

The FDA is set to rule on whether to approve the drug by March 29th. The agency is not required to follow the advice of its advisory panel but typically does so.

(Reporting By Toni Clarke in Boston; additional reporting by Ransdell Pierson and Bill Berkrot in New York; editing by Carol Bishopric)

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Senate Panel Faults State Department And Pentagon In Benghazi Attack Report

A bipartisan Senate Homeland Security report to be released today has found that the State and Defense Departments share blame for the security failures that resulted in the death of 5 Americans after an attack on a U.S. diplomatic mission in Benghazi, Libya back in September.

An independent review earlier this month faulted the State Department for failing to adequately respond to security requests prior to the attacks and called for restoring diplomatic security funding Republicans previously cut. While State Department officials have previously accepted responsibility for inadequate security in Benghazi, the new Senate report expands blame to the Pentagon, the Hill reports:

The report also blames the Pentagon, finding that the Defense Department (DOD) had failed to place adequate resources in the region to respond “in the event of a crisis.”

“Although DOD attempted to quickly mobilize its resources, it did not have assets or personnel close enough to reach Benghazi in a timely fashion,” the report concludes.

The Senate report also criticizes the Obama administration’s mixed messages in the aftermath of the Benghazi assault, claiming the White House was “inconsistent” about whether it constituted a terror attack. The inconsistency “contributed to the confusion in the public discourse” about the attacks, wrote Sens. Joe Lieberman (I-CT) and Susan Collins (R-ME).

“We’re going to solve this,” President Obama said on NBC’s Meet the Press on Sunday. “We’re not going to pretend that this was not a problem. This was a huge problem. And we’re going to implement every single recommendation that’s been put forward.”

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