WASHINGTON (Reuters) – Government health regulators in 2003 told the pharmacy now at the center of a deadly meningitis outbreak that its drug compounding activities did not constitute a manufacturing operation that would merit strict federal safety standards, a congressional report said on Monday.

The report by the Republican staff of a U.S. House of Representatives committee, said the Food and Drug Administration and Massachusetts state officials decided to leave oversight of the New England Compounding Center to a state pharmacy board, despite evidence of health problems linked to two drugs in 2002.

WASHINGTON (Reuters) – The Obama administration gave states extra time to work toward setting up new health insurance exchanges on Friday, three days after President Barack Obama’s re-election ensured the survival of his healthcare reform law.

The move is seen as a concession to dozens of states that delayed compliance with the Patient Protection and Affordable Care Act until after the November 6 election. Republican governors in some states had hoped to see a victory for the party’s presidential challenger Mitt Romney, who had vowed to repeal the law.

WASHINGTON, Nov 9 (Reuters) – The Obama administration gave
states extra time to work toward setting up new health insurance
exchanges on Friday, three days after President Barack Obama’s
re-election ensured the survival of his healthcare reform law.

The move is seen as a concession to dozens of states that
delayed compliance with the Patient Protection and Affordable
Care Act until after the Nov. 6 election. Republican governors
in some states had hoped to see a victory for the party’s
presidential challenger Mitt Romney, who had vowed to repeal the
law.

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.

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.

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.”

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.

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.

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.

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.