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Nov 7, 2012

Obama win clears health law hurdle, challenges remain

WASHINGTON, Nov 7 (Reuters) – President Barack Obama’s
re-election eliminates the possibility of a wholesale repeal of
his signature healthcare reform law, but leaves questions about
how many of the changes will be implemented as the national
focus shifts to tackling the U.S. debt and deficit.

The 2010 Patient Protection and Affordable Care Act, the
biggest overhaul of the $2.8 trillion U.S. healthcare system
since the 1960s, aims to extend health coverage to more than 30
million uninsured Americans beginning in January 2014.

Nov 7, 2012

Obama win clears healthcare reform hurdle, challenges remain

WASHINGTON (Reuters) – President Barack Obama’s re-election victory eliminates the possibility of a wholesale repeal for his healthcare reform law, but still leaves questions about how much of his signature domestic policy achievement will be implemented as the national political focus shifts to the debt and deficit.

The 2010 Patient Protection and Affordable Care Act, which represents the biggest overhaul of the $2.8 trillion U.S. healthcare system since the 1960s, aims to extend health coverage to more than 30 million uninsured Americans beginning in January 2014.

Oct 29, 2012

U.S. regulator needs new authority over compounding pharmacies: report

WASHINGTON (Reuters) – The U.S. Food and Drug Administration’s power to regulate compounded drugs similar to those linked to a deadly meningitis outbreak is legally nonbinding and lacks the authority of stringent standards imposed on drug manufacturers, according to a congressional report released on Sunday.

The report, compiled by the staff of U.S. Representative Edward Markey, a Massachusetts Democrat, drew an immediate response from FDA Commissioner Margaret Hamburg, who said the agency is committed to working with Congress and others to garner “the authority we need to help prevent tragedies like this from happening again.”

Oct 26, 2012

FDA: Pharmacy co. in meningitis crisis saw contaminants

WASHINGTON, Oct 26 (Reuters) – The pharmacy company at the
center of a deadly meningitis outbreak knew of contamination at
its Framingham, Mass., facility as early as January but has no
record of acting to safeguard the drugs prepared there, U.S.
health officials said on Friday.

A report by the Food and Drug Administration showed that
internal monitoring at the New England Compounding Center had
repeatedly detected bacterial and mold contaminations in the
months before the first suspect shipments of injectable steroid
treatments left the production site in May.

Oct 23, 2012

Health officials knew of problem steroids in 2002: U.S. House panel

WASHINGTON (Reuters) – U.S. and Massachusetts state health regulators were aware in 2002 that steroid treatments from the pharmacy at the center of a deadly meningitis outbreak could cause adverse patient reactions, congressional investigators said on Monday.

The U.S. House of Representatives Energy and Commerce Committee said complaints about preservative-free methylprednisolone acetate were partly responsible for joint state and federal inspections of the New England Compounding Center’s (NECC) Framingham, Massachusetts facility in 2002 and 2003.

Oct 22, 2012

U.S. probes deaths for links to Monster energy drink

NEW YORK/WASHINGTON (Reuters) – The Food and Drug Administration said on Monday that it was investigating reports of five deaths that may be associated with Monster Beverage Corp’s namesake energy drink, and the company’s shares fell more than 14 percent.

Monster is also being sued by the family of a 14-year-old Maryland girl with a heart condition who died after drinking two cans of its Monster energy drink in a 24-hour period.

Oct 18, 2012

U.S. FDA panel backs Sanofi, Isis drug for rare disorder

WASHINGTON (Reuters) – A U.S. Food and Drug Administration panel of outside experts recommended the Sanofi SA and Isis Pharmaceutical Inc drug, Kynamro, for treatment of a rare genetic disorder that causes unusually high cholesterol and life-threatening cardiovascular disease.

In a 9-6 vote on Thursday, the FDA advisory committee concluded that company-provided research showed the 200 milligram injection to be safe and effective enough for the one in 1 million Americans who have homozygous familial hypercholesterolemia, or HoFH, and are already on a cholesterol treatment regimen that includes lipid-lowering medication.

Oct 18, 2012

Meningitis deaths rise, FDA faces new questions

WASHINGTON/BOSTON (Reuters) – The death toll from a meningitis outbreak linked to contaminated steroids jumped to 19 on Wednesday, while U.S. lawmakers pressed federal health regulators to explain what they knew about the pharmacy that produced the drugs.

The Centers for Disease Control and Prevention said four more deaths had been confirmed in the last 24 hours, including two in Tennessee, the state hardest hit with eight deaths since the infections were discovered in late September.

Oct 17, 2012

U.S. meningitis deaths rise, FDA faces new questions

WASHINGTON/BOSTON, Oct 17 (Reuters) – The death toll from a
U.S. meningitis outbreak linked to contaminated steroids jumped
to 19 on Wednesday, while U.S. lawmakers pressed federal health
regulators to explain what they knew about the pharmacy that
produced the drugs.

The Centers for Disease Control and Prevention said four
more deaths had been confirmed in the last 24 hours, including
two in Tennessee, the state hardest hit with eight deaths since
the infections were discovered in late September.

Oct 17, 2012

Meningitis deaths rise to 19 as probe of firm intensifies

BOSTON/WASHINGTON (Reuters) – The number of deaths from a meningitis outbreak linked to contaminated steroid medications rose to 19 on Wednesday, just hours after federal agents raided the offices of the company at the center of the scandal and took away documents.

The Centers for Disease Control said states had confirmed four more deaths in the last 24 hours as the national outbreak grew.

    • About David

      "David Morgan has covered news from Wall Street and Fleet Street to the White House, the Pentagon and Congress, including politics, macroeconomics, military affairs, corporate finance, U.S. intelligence, national security and the international markets. He has also reported from Atlanta on the rise of American conservatism, civil rights, homegrown terrorism and the Olympics, and helped chronicle the Sept. 11 attacks and their aftermath from Philadelphia, New York and Washington."
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