MedPage Today Washington Watch

FDA Issues Draft Guidance for Biosimilar Products

Thu, 09 Feb 2012 17:03:47 -0400

(MedPage Today) -- Manufacturers of "biosimilars," or generic biologic drugs, should consider using a "stepwise" approach to demonstrate their product's similarity to something already on the market, the FDA said in draft guidance issued Thursday.

Pain Patch Rejected for HIV Neuropathy

Thu, 09 Feb 2012 16:58:02 -0400

(MedPage Today) -- SILVER SPRING, Md. -- By a vote of 12-0, an FDA advisory panel said a capsaicin skin patch did not relieve neuropathic pain from HIV.

Panel Nixes AML Indication for Dacogen

Thu, 09 Feb 2012 16:27:04 -0400

WASHINGTON (MedPage Today) -- An FDA advisory committee voted 10-3, with one abstention, against expanding the indication for decitabine (Dacogen) for use in elderly acute myelogenous leukemia (AML) patients.

FDA: HCV Drug Interferes With HIV Meds

Thu, 09 Feb 2012 15:15:09 -0400

WASHINGTON (MedPage Today) -- A new drug for hepatitis C can reduce the effectiveness of some HIV medications if they are taken together and vice versa, the FDA is warning.

CMS Site to Track Central Line Infections

Thu, 09 Feb 2012 09:00:00 -0400

(MedPage Today) -- A government website that publishes data on hospital outcomes such as mortality and readmission rates will now include information on central line infections, officials said.

Panel: Hospitals Should Consider Mandatory Flu Shots

Wed, 08 Feb 2012 18:53:34 -0400

WASHINGTON (MedPage Today) -- If hospitals and clinics can't get 90% of their employees to get an annual flu shot, they should "strongly consider" making the vaccine mandatory, a federal vaccines panel has voted.

FDA Panel Turns Down Bone Drug in Prostate Ca

Wed, 08 Feb 2012 15:24:29 -0400

WASHINGTON (MedPage Today) -- An FDA panel has voted 12-1 against expanding the indication for Amgen's denosumab (Xgeva) to prevent the spread of prostate cancer to the bones in men with a high-risk form of the disease.

FDA Staff Says Decitabine No Help in AML

Wed, 08 Feb 2012 13:40:56 -0400

WASHINGTON (MedPage Today) -- Decitabine (Dacogen), a hypomethylating agent, does not appear to improve mortality in older patients with acute myelogenous leukemia, FDA reviewers concluded.

All Sides Agree: Tax Law Doesn't Apply to ACA

Tue, 07 Feb 2012 16:43:20 -0400

WASHINGTON (MedPage Today) -- The Obama administration and plaintiffs suing the federal government over the Affordable Care Act at least see eye-to-eye on one thing: A federal tax law shouldn't bar the Supreme Court from ruling on case.

Study Quantifies Families Without Health Insurance

Tue, 07 Feb 2012 13:28:58 -0400

WASHINGTON (MedPage Today) -- More than half of poor families and a third of middle-income families had no health insurance during the preceding year, according to a new survey by the Commonwealth Fund.

Benefit of Bone Drug in Prostate Cancer in Doubt

Tue, 07 Feb 2012 09:00:00 -0400

WASHINGTON (MedPage Today) -- FDA reviewers have questioned whether expanding the indication for Amgen's denosumab (Xgeva) to prevent the spread of prostate cancer to the bones would provide much added benefit.

Washington Watch: SGR Action Starts Up Again

Sat, 04 Feb 2012 18:01:44 -0400

WASHINGTON (MedPage Today) -- This week in Washington marked the resumption of a congressional committee tasked with fixing the problem with the sustainable growth rate (SGR) formula for Medicare physician reimbursement.

Memo Reveals Obama Thinking on Malpractice

Fri, 03 Feb 2012 13:54:33 -0400

WASHINGTON (MedPage Today) -- A memo from two White House aides to President Obama reveals the administration's thinking on medical malpractice reform and its role in passage of the Affordable Care Act.

Enrollment Up, Premiums Down in Medicare Advantage Plans

Wed, 01 Feb 2012 19:19:05 -0400

WASHINGTON (MedPage Today) -- Enrollment in Medicare Advantage plans has risen by 10% in the past year and premiums have dropped by 7%, despite billions of dollars in reimbursement cuts to the program, HHS officials announced Wednesday.

Docs Urge Feds to Regulate 'Toxic' Sugar

Wed, 01 Feb 2012 17:25:33 -0400

(MedPage Today) -- Added sugars are as much a threat to public health as alcohol and tobacco, and should be regulated in a similar fashion, some researchers suggest.

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