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Tuesday, Jun 2 2015

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'Cures Bill' Boosts NIH Funding, But Advocates Worry About Long-Term Impact

In other news, some senators express concerns about the unintended consequences of the Food and Drug Administration's compounding guidelines.

A $10 billion boost for the National Institutes of Health in a package expected on the House floor this month is widely supported as a way to spur medical cures, but some health advocates fear it could actually depress agency funding over the long run. The so-called 21st Century Cures legislation (HR 6), which the Energy and Commerce Committee endorsed 51-0 before recess, provides $2 billion in annual mandatory funding from fiscal 2016 to fiscal 2020 for an NIH Innovation Fund. The language restricts how the money can be spent and requires that it 鈥渂e used to supplement, not supplant the funds otherwise allocated by the National Institutes of Health for biomedical research.鈥 (Attias, 6/1)

In a bid to tighten regulation of compounding pharmacies, the FDA issued draft guidelines this year that, among other things, would place restrictions on the amount of time that some drugs can be used by patients. Specifically, the agency would not permit a biologic medicine to be used more than five days after it has been repackaged by a compounder, but only if a study confirms the drug is protected. (Silverman, 6/1)

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