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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.

Dec 18, 2012

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.

Dec 15, 2012

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.

Dec 13, 2012

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.

Dec 07, 2012

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.

Dec 04, 2012

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.

Nov 09, 2012

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.

Sep 21, 2012

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.

Jul 05, 2012

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.

May 01, 2012

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.

Apr 25, 2012

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.

Dec 12, 2011

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.

Nov 16, 2011

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.

Jun 20, 2011

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.

Jun 20, 2011

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.

May 18, 2011

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.

May 10, 2011

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.

Apr 25, 2011

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.

Mar 30, 2011

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.

Mar 15, 2011

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.

Feb 19, 2011

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.

Jan 29, 2011

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.

Jan 28, 2011

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.

Sep 22, 2010

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.

Apr 07, 2009

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.

Sep 04, 2008

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.

Aug 27, 2008

McCain Cites 'Strong Evidence' of Link Between Vaccines and Autism

WASHINGTON -- Sen. John McCain, the presumptive Republican candidate for president, has given credibility to "strong evidence" of a link between autism and thimerosal in childhood vaccines. He cited "divided scientific opinion" on the matter.

Mar 05, 2008

Presidential Frontrunners Play it Close to the Vest on Healthcare

WASHINGTON -- If the devil is in the details, the strengths and weaknesses of the healthcare positions of the major presidential candidates of both parties are only beginning to emerge.

Feb 08, 2008

'Second-Tier' Republicans Sound Off on Health Care

WASHINGTON -- As dark-horse candidates often leave footprints on the political trail, three Republicans vying for the presidential nomination may have an impact on the health care debate.

Dec 06, 2007