Saturday, September 14, 2013

Morning Break: Compounding Pharmacy Issues and More

Attention continues to surround compounding pharmacies' product sterility as more pharmacies that used Front Range Laboratories to provide product-sterility testing have issued recalls, as fallout from FDA inspections showing deficiencies in Front Range's procedures. The latest victim: Leiter's Compounding Pharmacy in San Jose, Calif.

Meanwhile, Congress continue to work the issue of regulating compounding pharmacies as lawmakers in the House of Representatives filed a bill Thursday that clarifies the FDA's authority over large-scale compounders.

Not to be outdone Thursday on the health-legislation front, Rep. Leonard Lance (R-N.J.) filed a bill that promotes the development of treatments for rare and chronic diseases.

Kaiser Health News reports that the White House kicked off Out2Enroll, a drive to enroll lesbian, gay, bisexual, and transgender community in Obamacare.

What's the White House's strategy for deterring last-minute attempts at Obamacare derailment by Republicans? "Don't blink," Politico reports.

Requirements to achieve "meaningful use" incentives for electronic health records should be relaxed to allow providers to apply technologies to their individual practices, the American College of Physicians wrote Thursday. Also, a guest blog on the organization's website says people shouldn't blame the American Medical Association's Relative Value Scale Update Committee -- commonly called the RUC -- for misaligned payment incentives.

The beauty of comedy is its proximity to truth, as this satire on physicians "dumping" patients off to clear their weekend exemplifies.

Drugmaker Sanofi withdrew its marketing application to the FDA for its diabetes drug lixisenatide over concerns of compromised "integrity" of an ongoing study.

The FDA rejected Delcath Systems' Melblez system for delivering melphalan in patients with ocular melanoma metastatic to the liver. An advisory committee earlier this year had unanimously voted against approval. Delcath also sacked its president and CEO.

Drugmaker GlaxoSmithKline lost its bid to extend patent coverage for its fish oil pill Lovaza, saying in a statement that it is unaware of any FDA-approved generic.

The FDA blogs how it intends to assess the potential health risk from long-term exposure to arsenic in rice and rice-based foods.

And finally, Pennsylvania may be the 27th state to accept Medicaid expansion as Gov. Tom Corbett (R) reportedly said Thursday he would sign authorization.

http://www.medpagetoday.com/PrimaryCare/GeneralPrimaryCare/41582

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