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FDA's Unlikely Defenders

 
• By Michael McCaughan

The primacy of FDA-approved labeling has an unlikely advocate. The Washington Legal Foundation is joining the EPO coverage dispute to tell CMS not to step into FDA’s turf.

Oncologists are definitely not happy about the Centers for Medicare & Medicaid Services’ proposed coverage restrictions for erythropoietin therapies. The agency received more than 1,800 comments on its draft policy, most from oncologists—and virtually all opposed to the changes. (See "Living in a Bipolar World," in this issue Also see "Living in a Bipolar World: Implications of the EPO Safety Debate (Part 1) " - Pink Sheet, 1 July, 2007..)

CMS’ policy is "dangerous," "poorly thought out," "deeply flawed," "too restrictive," "an injustice to patients," and "radical," the oncologists think....

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Cuban: Drugmakers Are More Afraid of PBMs Than Trump

 
• By Leslie Small

The billionaire investor said during a recent conference that brand drug manufacturers want to work with his Cost Plus Drug Co., but are afraid the PBMs will retaliate.

Faster HTA Reviews & Pricing Reform Could Help Fix Canada’s Drug Access Woes

 
• By Eliza Slawther

Canadian politicians must “move quickly” to introduce policies that will speed up access to medicines, such as by broadening criteria for the temporary reimbursement of medicines, the Canadian Chamber of Commerce says.

Most Favored Nation Pricing: Trump Ups Pressure On Voluntary Action, Clarifies Demands

 
• By Sarah Karlin-Smith

The new 60-day deadline for striking a deal with the drug industry underscores the challenges the Administration may be having in developing non-voluntary policies to achieve MFN pricing in the US.

340B Rebate Model Gets HRSA Endorsement; Pilot Program Limited To Medicare Negotiated Drugs

 
• By Cathy Kelly

Pilot is harbinger of greater transparency in the 340B program. But rebates may only be denied by manufacturers for overlap with Medicare negotiated prices, not for issues like diversion that have driven recent lawsuits.

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Japan Gives Global-First Recommendations To Taisho’s Vornorexant, Santen’s Sepetaprost

 
• By Lisa Takagi

Japan gives world-first approval recommendations to two domestically originated drugs, for insomnia and glaucoma/ocular hypertension.

August Brings Fresh Faces And Tough Calls To US FDA User Fee Calendar

 
• By Bridget Silverman

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Court Allows MSN Marketing Of Entresto Generic, But More Legal Issues Pending

 
• By Dean Rudge

Novartis failed to stop MSN from launching a generic Entresto and saw an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.