FDA demands dosage cuts for some sleep meds | Medicare cost growth remains low | CMS AMP rule could be finalized in Aug.
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January 11, 2013
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FDA demands dosage cuts for some sleep meds
The FDA is ordering makers of brand-name and generic sedative-hypnotic drugs, or insomnia treatments with active ingredient zolpidem, to reduce dosages for women. Studies find that high levels of the drugs remain in the bloodstream, which can raise the risk of car accidents by affecting coordination and alertness. Dosages for regular products should be lowered from 10 milligrams to 5 milligrams, while dosages for extended-release formulations should be reduced from 12.5 milligrams to 6.25 milligrams. The Wall Street Journal (tiered subscription model)/Dow Jones Newswires (1/10), The Seattle Times/The Associated Press (1/11)
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Legislative & Regulatory News
Medicare cost growth remains low
Growth in Medicare costs is historically low, according to a report from HHS, rising 0.4 percentage points per senior last year. Federal officials credited provisions in the Affordable Care Act, and other agencies say reductions in payments to insurers and providers will hold down cost increases for several years, but Republicans argue the measures mean doctors will eventually stop serving Medicare patients. The Hill/Healthwatch blog (1/10)
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CMS AMP rule could be finalized in Aug.
The CMS rule on average drug manufacturer price is due to be finalized in August. It could lead to lower Medicaid pharmacy reimbursements in states that now overpay for generic drugs, Adam Fein writes. The proposed AMP rule is related to an Affordable Care Act provision instructing CMS to develop a new formula for determining the maximum pharmacy dispensing fees that a state Medicaid agency can reimburse. Drug Channels (1/10)
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PBM Industry News
Drug Industry Spotlight
Advocates criticize drugmaker for increase in price of HIV drug
The AIDS Healthcare Foundation criticized Gilead Sciences for raising the price on its HIV drug Atripla, which combines efavirenz, emtricitabine and tenofovir. Analysts say the drug's wholesale acquisition cost recently rose 6.9%, while emtricitabine rose 5.5% and tenofovir rose 6.0%. PharmaTimes (U.K.) (1/11)
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Nonmedical use of Rx pain relievers varies between states
An estimated 4.6% of people nationwide aged 12 and older engaged in nonmedical use of prescription pain relievers between 2010 and 2011, according to a report from the Substance Abuse and Mental Health Services Administration. Oregon recorded the highest rate of nonmedical use of pain medications, while Iowa had the lowest rate, researchers said. DoctorsLounge.com/HealthDay News (1/10)
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