Proposed budget gets mixed reviews

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The White House's proposed budget for fiscal year 2015—which starts in October—has arrived.

What counts as a winning proposition depends partly on expectations: as noted by Modern Healthcare, the
White House is looking to up the outlay for the FDA by 1%, for a total sum of $2.6 billion. (The Washington Post has a quick visual of agencies that gain and lose money in the proposed budget.)

“Given that the FDA regulates about 25 cents of every dollar of the gross domestic product, it does not have enough money to fulfill its public health mission,” Kasey Thompson of the American Society of Health-System Pharmacists told Modern Healthcare.

While the FDA is charged with approval and oversight of drugs, drug manufacturing, drug compounders and food safety, among other matters, the budget is also cutting into other parts of the drug industry.

Lobbying group PhRMA said in a statement that it is against a budget proposal that would remove certain drug class protections on the Medicare Part D formulary. The Centers for Medicare and Medicaid Services argues that the change will lower prices, but PhRMA writes the proposed change “pushes, yet again, previously rejected proposals that would hurt, not bolster the program.”

The group is also against a proposal to ban or restrict patent settlements, aka “pay-for-delay” arrangements that keep generics off the market.

The White House made this same proposal for the FY 2014 budget. FDA Law Blog wrote at the time that the FY 2014 push said these limits would save taxpayers over $14 billion between 2014 and 2023. PhRMA said in Tuesday's statement that this proposal creates an uncertain business environment for an industry that is comprised of “critical partners in achieving many of the healthcare and economic goals set by the president himself.”

Unsurprisingly, the Generic Pharmaceutical Association's reaction is a bit different. This interest group supports the proposed change to Medicare Part D.

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