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Nov 15, 2012

US lawmakers will act on meningitis outbreak -senator

WASHINGTON, Nov 15 (Reuters) – The Democratic chairman of a
congressional panel investigating a deadly fungal meningitis
outbreak linked to compounded steroids predicted on Thursday
that U.S. lawmakers would take actions to prevent a similar
public health disaster.

The lawmaker, Senator Tom Harkin of the Senate Health,
Education, Labor and Pensions Committee, predicted that his
panel would find a bipartisan solution that would protect small
drug compounders from regulations that could mean higher
compliance costs.

Nov 15, 2012

US drug industry resists more oversight despite meningitis outbreak

WASHINGTON, Nov 15 (Reuters) – U.S. states should remain the
primary regulators for compounding pharmacies, rather than the
U.S. Food and Drug Administration, despite a deadly fungal
meningitis outbreak that has killed 32 people since September,
an industry group said on Thursday.

The International Academy of Compounding Pharmacists,
headquartered in Missouri City, Texas, told a U.S. Senate
oversight panel that the meningitis outbreak raging across 19
states occurred because regulatory officials at both the state
and federal levels failed to take action under current laws.

Nov 15, 2012

U.S. Congress takes aim at FDA over meningitis outbreak

WASHINGTON/NEW YORK (Reuters) – U.S. Republican lawmakers accused federal health regulators on Wednesday of failing to prevent a deadly fungal meningitis outbreak by not acting much earlier to shut down the compounding pharmacy at the center of the crisis.

As Congress began debate on whether new laws are needed to help the U.S. Food and Drug Administration police the little-known drug compounding industry, Republicans in a committee hearing warned against the knee-jerk adoption of new regulation.

Nov 14, 2012

FDA chief asks for greater control over compounded drugs

WASHINGTON, Nov 14 (Reuters) – The top official at the U.S.
Food and Drug Administration has asked Congress to strengthen
federal authority over drug compounders that are not currently
subject to the stringent FDA safety and efficacy standards
imposed on drug manufacturers.

FDA Commissioner Margaret Hamburg, in written testimony to
an oversight panel in the House of Representatives, said the FDA
should be given clear authority to test compounded drugs and
inspect the records of “non-traditional” compounding pharmacies
that pertain to prescriptions, shipping and volume of
operations.

Nov 14, 2012

Meningitis victim’s widow urges U.S. action on drug compounding

WASHINGTON, Nov 14 (Reuters) – The widow of a Kentucky judge
who was among the first to die in a meningitis outbreak that has
killed 32 people in 19 states asked Congress on Wednesday to
crack down on drug compounders to prevent more needless tragedy.

“I would ask that you inquire how such a product became so
widely distributed. Why did so many medical providers purchase
this product from unregulated or poorly regulate sources?” Joyce
Lovelace asked in written testimony to an oversight panel in the
House of Representatives.

Nov 13, 2012

Meningitis outbreak spurs calls to strengthen FDA

WASHINGTON, Nov 13 (Reuters) – U.S. and state health
regulators called on Congress on Tuesday to s trengthen federal
oversight of compounding pharmacies as lawmakers prepared for
two days of hearings on a deadly fungal meningitis outbreak
linked to a compounded steroid.

But the main federal regulator, the U.S. Food and Drug
Administration, said in a statement to Reuters that it faces
legal restrictions in regulating drug compounders such as the
New England Compounding Center. The Massachusetts pharmacy was
at the center of the outbreak that has infected 438 people,
including 32 who have died, in 19 states.

Nov 13, 2012

U.S. FDA seeks stronger authority on eve of meningitis hearings

WASHINGTON, Nov 13 (Reuters) – The U.S. Food and Drug
Administration called for congressional action to strengthen the
agency’s authority over compounding pharmacies, as lawmakers
prepared for two days of hearings on a deadly fungal meningitis
outbreak linked to compounded steroids.

In a Tuesday statement issued to Reuters, the U.S. regulator
also acknowledged that it had agreed with Massachusetts state
officials in 2003 to designate the company now at the heart of
the outbreak as a compounding pharmacy exempt from the strict
safety standards FDA imposes on drug manufacturers.

Nov 13, 2012

Meningitis-linked U.S. firm not a drug maker in 2003 -report

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.

Nov 9, 2012

States given more time to work on health exchanges

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.

Nov 9, 2012

U.S. gives states more time to work on health exchanges

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.

    • 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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