FDA criticized at hearing about compounding pharmacies | PCMA: How independent drugstores that compound drugs can be part of the patient safety solution | AMA backs ending pay-for-delay
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November 15, 2012
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FDA criticized at hearing about compounding pharmacies
The FDA needs new authority over drug compounders to avoid tragedies such as the fatal meningitis outbreak tied to contaminated custom-made drugs from the New England Compounding Center, FDA Commissioner Dr. Margaret Hamburg told members of a House Energy and Commerce subcommittee. However, several lawmakers sharply criticized the FDA, and committee Chairman Fred Upton, R-Mich., faulted the agency for not following up after finding problems years ago. The Hill/Healthwatch blog (11/14), The Washington Post (tiered subscription model) (11/14)
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Legislative & Regulatory News
AMA backs ending pay-for-delay
The American Medical Association issued a statement in support of banning deals between brand-name and generic-drug-makers to delay generics' market entry. "Pay for delay keeps quality, low-cost generic drugs out of the marketplace and unnecessarily drives up costs for patients," according to board member Patrice Harris in an AMA statement. Pharmalot/Pharma blog (11/14)
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Republican governors ask for more time on exchange decisions
The federal government has not given governors the information they need to determine whether to operate health insurance exchanges or allow HHS to do it for them, the current and incoming chairmen of the Republican Governors Association said. Los Angeles Times (tiered subscription model)/Politics Now blog (11/14)
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Drug Industry Spotlight
Medication adherence lowers death risk in schizophrenia patients
Researchers looking at data on more than 2,100 adult patients with schizophrenia found that those who were at least 90% compliant with their antipsychotic treatment regimen were 25% less likely to die than those with compliance below 10%. Among patients on high daily doses of first-generation antipsychotics, however, risk of death was 88% greater. The study appeared online in the journal Schizophrenia Bulletin. U.S. News & World Report/HealthDay News (11/14)
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SmartQuote
Keep your fears to yourself but share your courage with others."
-- Robert Louis Stevenson,
Scottish novelist, poet and essayist
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PCMA is the national association representing America's pharmacy benefit managers (PBMs), which administer prescription drug plans for more than 216 million Americans with health coverage provided through Fortune 500 employers, health insurance plans, labor unions, and Medicare Part D. PCMA is dedicated to enhancing the proven tools and techniques pioneered by PBMs that generate savings and access for consumers and payors.

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