PHARMACY

Many angered by House’s inability to override SCHIP veto

BY Allison Cerra

WASHINGTON The House of Representatives’ inability to override the President’s veto of the State Children’s Health Insurance Program has many in government and healthcare angry and disappointed, according to Associated Press and Business Wire reports.

The Democratic-controlled House failed to override President Bush’s veto of the politically popular children’s health bill, and the White House instantly called for compromise talks on a replacement.

In response to the failure, U.S. Senator Barack Obama said Thursday that “Washington’s failure shows a callousness of priorities that is offensive to the ideals we hold as Americans”, and if he becomes president, he would sign a universal health care bill into law that will cover every American.

Obama, the Illinois Senator who is one of the key players in the U.S. presidential race for 2008, was responsible for expanded health care in his state for 150,000 children and their parents.

Politicians are not the only ones who are outraged. The California Primary Care Association, which represents over 700 community clinics and health centers in California, issued a statement Friday that chastises the upholding of the veto, citing that the failure to pass the budget will cause the state “to bear the weight of caring for thousands more of our state’s uninsured children.”

“As California’s safety net providers, we believe that all children should be covered by health insurance, and this bill would have allowed our state to move one step closer toward achieving that goal,” said Carmela Castellano-Garcia, president and chief executive officer of CPCA.

At a cost of $35 billion over five years, the vetoed measure would have added nearly 4 million uninsured children to the insurance program. It provides coverage for those who are not poor enough to qualify for Medicaid, but whose families cannot afford private health care.

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PHARMACY

FDA approves label changes for Accutane and its generics

BY Drew Buono

The Food and Drug Administration has approved label changes to Roche’s acne medication Accutane and its generic isotretinoin, manufactured by Barr Laboratories, Genpharm/Mylan Pharmaceuticals and Ranbaxy Laboratories.

The label changes were made to improve the management of the iPledge pregnancy risk management program. Pregnant women are not allowed to take the medication due to risk of birth defects.

Roche, who proposed the changes, said they are intended to enhance the flexibility of the iPledge program, reduce interruptions in treatment and reduce the burden on patients, prescribers and pharmacies, thereby making the program more consistent with the way prescribers function.

The changes are planned to go into effect on Dec. 2.

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FDA approves Ixempra for breast cancer

BY Drew Buono

WASHINGTON The Food and Drug Administration has approved Bristol-Myers Squibb’s Ixempra monotherapy for the treatment of patients with metastatic or locally advanced breast cancer whose tumors are resistant or refractory to anthracyclines, taxanes and capecitabine.

The FDA has also granted approval of Ixempra in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to an anthracycline and a taxane or whose cancer is taxane-resistant and for whom further anthracycline therapy is contraindicated.

BMS anticipates Ixempra will be available soon.

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