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FDA Panel Favors Nasacort OTC Switch

SILVER SPRING, Md. -- An FDA advisory committee voted Wednesday to make allergy nasal spray triamcinolone acetonide (Nasacort AQ) available without a prescription -- but some expressed concern about its use in children.

Wyeth Settles Rapamune Marketing Charge

WASHINGTON, D.C. -- Pfizer's Wyeth Pharmaceuticals unit will pay $490.9 million to resolve state and federal allegations that it marketed rapamycin (sirolimus, Rapamune) for unapproved indications.

FDA Panel Nixes Humira for Spinal Arthritis

SILVER SPRING, Md. -- An independent panel of FDA advisers overwhelmingly rejected AbbVie's bid to gain approval of Humira (adalimumab) for treatment of spinal arthritis.

Xarelto Gets a No for Stent Thrombosis

SILVER SPRING, Md. -- The FDA has rejected an application for a new indication allowing rivaroxaban (Xarelto) to be used to reduce the risk of stent thrombosis in patients with acute coronary syndrome.

Public Citizen's Wolfe Still Needling FDA

Sidney Wolfe, MD, founder of Public Citizen's Health Research Group, sat down this week with 51成人动漫 in his Washington office to discuss his 40 years of work as a leading voice in consumer health advocacy.

Medicare to Pay for More FDG-PET Scans

WASHINGTON -- Up to three scans using 18F-fluorodeoxyglucose-enhanced positron emission tomography technology can be covered by Medicare for oncology treatment planning, the Centers for Medicare and Medicaid Services said.

CHIP Faces Uncertain Future

锘縒ASHINGTON -- The final implementation of the Affordable Care Act (ACA) could be bad news for re-authorization of the Children's Health Insurance Program (CHIP), a congressional staffer said.

Gun Control: Docs Told to Speak Up

WASHINGTON -- Physicians need to do a better job at promoting the data that supports stronger gun-control laws, experts here said.

FDA Lowers Age for OTC Plan B

WASHINGTON -- The FDA has approved over-the-counter sale of the emergency contraceptive Plan B One-Step to women and girls as young as 15.

FDA Splits on Safety of Endo's Aveed for Low-T

SILVER SPRING, Md. -- An FDA advisory committee was split Thursday on the safety of an injectable form of testosterone replacement, but voted overwhelmingly against a proposed risk mitigation plan.

More Docs Joining Forces in ACOs

SAN FRANCISCO -- The number of physician-led accountable care organizations (ACOs) has recently surpassed the number led by hospitals, becoming the largest backers of the payment and delivery model, an analysis showed.

Docs May See Pay Delay Under ACA Exchanges

SAN FRANCISCO -- A provision in the Affordable Care Act (ACA) states that insurance companies will not process claims on patients who haven't paid their premiums in 3 months, leaving doctors on the hook to recoup payment directly from the patients.

Docs' Charting Falls Short of ICD-10 Demands

SAN FRANCISCO -- Nearly 65% of clinical documentation doesn't contain enough information for coders to use for billing under the upcoming ICD-10 coding system, a survey of patient charts found.

Judge OKs $762 Million Deal in Aranesp Case

A federal judge approved a $762 million settlement Wednesday in a case involving Amgen's off-label promotion of darbepoetin alfa (Aranesp), an anemia drug.

Amgen Agrees to Pay $762 Million in Aranesp Case

The biotech drug giant Amgen pled guilty Monday to promoting its blockbuster anemia drug darbepoetin alfa (Aranesp) for off-label dosing regimens, agreeing to pay $762 million in fines.

Pfizer Will Pay $55 Million in Off-Label Case

Pfizer subsidiary Wyeth has agreed to pay $55 million plus interest to settle allegations it promoted off-label use of the acid reflux drug pantoprazole (Protonix), the company and government officials announced.

No Need for Skin Preps to Be Sterile, FDA Told

WASHINGTON -- Requiring that antiseptic skin preparation products be sterile is unnecessary and wouldn't lead to a dramatic drop in infections, speakers told the FDA Wednesday.

FDA Panel Gives Thumbs Down to Opioid

SILVER SPRING, Md. -- An FDA advisory committee voted 11-2 on Friday against recommending approval of a single-entity hydrocodone product, raising questions about its abuse potential.

High-Dose Zofran Pulled From Market

WASHINGTON -- The 32-mg dose of the anti-nausea drug ondansetron (Zofran) has been pulled from the market because of concerns about cardiac problems, the FDA announced Tuesday.

FDA Panel Wary on Making Bladder Control Drug OTC

WASHINGTON -- An FDA advisory panel on Friday voted against recommending making oxybutynin transdermal patch (Oxytrol) available over-the-counter for overactive bladder in women.

Romney Takes Daily Statin, Aspirin

WASHINGTON -- Republican presidential nominee Mitt Romney has hyperlipidemia and takes a statin and low-dose aspirin daily, according to a letter from his personal physician released Friday.

California Docs Sue Aetna Over Out-of-Network Denials

Several medical groups and more that 50 individual physicians in California are suing Aetna, claiming that the insurer often wrongly denies coverage for patients accessing out-of-network providers.

Lewin Group Founder Dies

Lawrence (Larry) Lewin, founder of the healthcare consulting firm The Lewin Group, has died at age 74, according to an announcement on the organization's website.

OIG: Avastin a Better Buy for Wet AMD

茂禄驴WASHINGTON -- The Centers for Medicare and Medicaid Services should establish a national payment policy for bevacizumab (Avastin) to treat wet age-related macular degeneration, a government report concluded.

FDA Panel Split Over Inhaled Antipsychotic

WASHINGTON -- An FDA advisory panel punted on the question of approval for an inhaled version of the antipsychotic drug loxapine (Adasuve) to treat agitation in bipolar and schizophrenic patients, despite the risk for respiratory side effects.

AMA Adopts Policies on Circumcision, Gun Safety

The American Medical Association (AMA) House of Delegates has adopted a number of new policies at its interim meeting, including policies on male circumcision, physician discussion of gun safety, and a new medical coding system that will go into effect in 2013.

AMA: House of Delegates Backs Individual Mandate

CHICAGO -- The American Medical Association's House of Delegates has reaffirmed its support of individual responsibility -- including a requirement that most U.S. residents buy health insurance -- as the foundation of universal coverage.

AMA: Delegates Sharply Divided on Individual Mandate

CHICAGO -- As the constitutionality of the individual mandate is debated in the nation's courts, the issue has emerged as a lightning rod in the American Medical Association's annual House of Delegates meeting here.

FDA Panel Recommends New Rules for Kids' Acetaminophen

SILVER SPRING, Md -- For the first time since they came on the market in the 1950s, children's liquid medicines containing acetaminophen would carry dosing instructions for children younger than 2, if the FDA follows the unanimous recommendation of a federal panel.

Primary Care Still Hard to Get in Massachusetts

WASHINGTON -- More than half of primary care practices in Massachusetts are not accepting new patients, and wait times for many new patients continue to lengthen five years after the state passed its landmark healthcare reform law.

Rx Data-Mining Case Reaches Supreme Court

WASHINGTON -- The U.S. Supreme Court will hear arguments Tuesday in a case involving a state law that restricts pharmaceutical companies' use of physician prescribing records.

AAPM: 'Focused Factories' on Healthcare Horizon

WASHINGTON -- The next big thing in healthcare won't be large, all-purpose healthcare organizations -- it will be 'focused factories' for treating specific problems, a Harvard economist says.

Medicare Paid Millions for Viagra

WASHINGTON -- Despite a rule that bars Medicare reimbursement for erectile dysfunction treatment, the Centers for Medicare and Medicaid Services (CMS) paid out $3.1 million for the drugs in 2007 and 2008, a new government report found.

Standards Issued for Healthcare Interpreter Services

All U.S. healthcare organizations must be able to talk with patients about their care in a language they can understand, according to new Joint Commission standards.

More Vets Approved for Agent Orange Claims

WASHINGTON -- Veterans who served in Korea from 1968 through 1971 were probably exposed to Agent Orange, which makes them eligible for treatment at VA medical centers, according to a ruling from the Department of Veterans Affairs.

FDA Panel: Keep ECT Devices as High Risk

GAITHERSBURG, Md. -- The FDA should continue to regulate electroconvulsive therapy (ECT) machines as high-risk devices for treating depression and most other conditions for which ECT is typically used, members of the agency's Neurological Devices Advisory Committee agreed.

Not Enough Evidence to Use BMP Off-Label, Panel Says

BALTIMORE -- A Medicare advisory committee has voted that there is not enough evidence to warrant off-label use of recombinant human bone morphogenetic protein, or BMP, for bone surgery.

FDA Panel Recommends Limited Use of Investigational Antipsychotic

SILVER SPRING, Md. -- An FDA advisory panel voted to recommend FDA approval for sertindole (Serdolect) to treat schizophrenia, but only for a subgroup of patients that the agency would have to define.

New Jersey Doctor-Delegate Sees Big Trouble in Universal Coverage

ST. PAUL, Minn. -- Ben Chouake, M.D., of Cliffside Park, N.J., an internist and emergency medicine specialist, is the son of holocaust survivors. He is a delegate for John McCain at the Republican National Convention here.

Hillary Clinton Touts Obama's Goal of Healthcare for All

DENVER -- Despite tortuous battles during the presidential primaries over the nuances of healthcare reform, Sen. Hillary Clinton was ringing in her support for Sen. Barack Obama's goals at the Democratic National Convention here.

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