Health reform is at a key juncture: What will happen in the Senate? President Trump may soon unveil a drug-pricing plan, and major FDA reforms are moving through Congress.

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A leaked draft of an alleged White House executive order on drug prices calls for value-based contracts, lower Medicare beneficiary out-of-pocket costs, drug rebate reforms, restricted hospital drug discounts, faster FDA approvals and higher prices in other countries.

Pfizer announced Thursday (June 22) that FDA has rejected its epoetin alfa biosimilar due to good manufacturing practice violations, despite an advisory committee recommending approval last month.

Democrats would likely use the Supreme Court ruling against mandatory Medicaid expansion to fight federal Medicaid funding caps, a former Senate Republican staffer said, but legal scholars doubt that suit would be a good precedent to use against the caps should the GOP health reform legislation be enacted.

CHICAGO -- A representative from pharmaceutical company Sarepta -- manufacturer of the controversial Duchenne muscular dystrophy drug Exondys 51 -- touted FDA's use of regulatory flexibility to approve Exondys 51, saying the approach has been frequently used for oncology drugs and could be a boon for the rare disease space.

A draft document obtained by Inside Health Policy sets out expected performance goals for an over-the-counter monograph user fee program (OMUFA) under which FDA would see improved review timelines and more efficient review capacity by year four of the program.

The Consumer Healthcare Products Association (CHPA), Pew Charitable Trusts and American Academy of Pediatrics along with four other health-focused groups recently penned a letter to Sens. Johnny Isakson (R-GA) and Bob Casey (D-PA) showing support for the senators' revised draft of their bill intended to reform FDA's over-the-counter (OTC) drug monograph system.

Recently unveiled over-the-counter (OTC) monograph legislation is all the more important to reducing the monograph backlog given that FDA's fiscal 2018 budget justification maintains fiscal 2017 funding levels for the agency's OTC review processes, the Pew Charitable Trusts recently recently told Inside Health Policy.