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Judge Refuses To Throw Out HRSA's New 340B Orphan Drug Rule; Says PhRMA 'Is Free To File' New Lawsuit

A federal District Court judge Wednesday (Aug. 27) rejected PhRMA's request that it throw out the Health Resources and Services Administration's new interpretive rule on 340B orphan drug exclusions, which is substantively identical to a rule the court vacated in May, but said the drug industry is free to file another lawsuit on the new rule.

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CMS plans to again take the sunshine and health reform law's Open Payments system offline, announcing Thursday (Aug. 28) that the system will be unavailable due to scheduled maintenance for two days over the next two weeks, and two more days will be added to the end of the review and dispute process.

The National Institutes of Health -- following an expedited sign off from FDA -- next week will start testing in humans a vaccine intended to prevent the Ebola virus, NIH said Thursday (Aug. 28).

CMS does not plan to waive restrictions on telemedicine services for accountable care organizations in the Medicare Shared Savings Program, an agency spokesman says, but it would consider doing so for pioneer ACOs separately participating in a demonstration.

FDA's generic drug office laid out firm guidelines about the kinds of drug development questions it will accept and from whom -- saying in guidance released this week that controlled correspondence will be limited to entities directly involved in drug development, and that correspondence related to citizen petitions and pending regulations will not be answered ahead of official FDA action.

The Grocery Manufacturers Association is launching an initiative aimed at revamping safety assessments of food ingredients -- an overhaul that FDA and industry have been under pressure to undertake by consumer advocates.

Beneficiary advocates are stepping up efforts to get immigrants and other Americans to respond to HHS' request for documentation by Sept. 5 to avoid potentially losing coverage purchased through the federal marketplace.

An emerging court battle over the generic drug Precedex, if successful, could arm branded drug companies with a way to block generic drug competition by preventing label carve outs with Orange Book patent listings, industry attorneys said.

The United Compounding Network, which was launched last month to negotiate with payers and pharmacy benefit managers on reimbursement for compounded drugs, named its key leaders, including a former high-level manager from Express Scripts, a PBM which has drawn the ire of compounders for recently restricting its coverage of such products.