PHARMACY

Ala. GOP representative proposes stopgap bill to fund FDA

BY Alaric DeArment

NEW YORK — A Republican congressman from Alabama has proposed a stopgap bill that would fund the Food and Drug Administration through the middle of December or until the government shutdown ends, though it is unlikely to pass in the Senate.

Last week, Rep. Robert Aderholt proposed the joint resolution, designed to ensure that the agency continues to receive funding until Dec. 15 or until the shutdown ends. However, Senate majority leader Harry Reid has said he will oppose such short-term funding bills. The federal government has remained shut down since Oct. 1, when Congress and the White House failed to reach an agreement on a fiscal year 2014 budget; Republicans in Congress have insisted that any budget agreement be tied to a delay or defunding of the Patient Protection and Affordable Care Act.

As part of its contingency staffing plan announced at the beginning of this month for the shutdown, the Department of Health and Human Services said the FDA would continue "limited" activities related to user-fee funded programs — such as reviews of generic drug applications — and such vital activities as consumer protection and high-risk recalls.

 

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Study finds rise in medical, prescription spending amid recession

BY Alaric DeArment

WASHINGTON — Consumers paid more for prescriptions as the country’s economy recovered from the recession, according to a new study.

According to the study, conducted by researchers at the Health Care Cost Institute and published in this month’s issue of the journal Health Affairs, per-person spending on prescriptions rose by 3.3% between 2007 and 2011. The study was based on analysis of spending by 40 million people for each year studied, using data provided by health insurers Aetna, Humana and UnitedHealthcare.

Overall, spending per person on prescriptions and medical care rose by 4.9%, faster than the economy. The amount that consumers paid out of pocket for prescription drugs and devices remained the same during the study period as insurers covered a larger portion of prescription costs.

"Overall, spending growth may have slowed down after the recession, but consumers, employers and insurers have had different experiences," lead study author and HCCI research director Carolina Herrera said. "After the recession, consumers didn’t see their out-of-pocket medical spending groth slow, but medical spending growth for employers and health plans did slow."

 

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FDA approves Pfizer drug for hot flashes

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for hot flashes and the prevention of osteoporosis, the agency said.

The FDA announced the approval of Duavee (conjugated estrogens; bazedoxifene), made by Pfizer. The drug is for women who suffer from moderate to severe hot flashes associated with menopause, and is also designed to prevent osteoporosis after menopause.

The drug is the first approved by the agency that combines estrogen with an estrogen agonist or antagonist, in this case bazedoxifene, which is designed to reduce the risk of excessive growth of the lining of the uterus, also known as endometrial hyperplasia, which can occur from estrogen. The drug is only meant for postmenopausal women who still have a uterus.

 

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