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Critical Reports

In two reports released this week, the US Government Accountability Office criticizes the Food and Drug Administration, saying that the agency's plans aren't adequate to keep up with scientific advances, Stat News reports.

In one report, the GAO says FDA hasn't set measurable goals for gauging its progress in advancing regulatory science. The report notes that the agency has strategic planning documents to guide its work, but that those documents don't include targets or time frames for achieving its goals. It also says the agency needs a way to track funding across its regulatory science priority areas.

At the same time, in its other report, the GAO notes flaws in FDA's strategic integrated management plan, saying that it doesn't cut across all three of FDA's centers that oversee medical products.

Republican senators are pointing toward these reports to encourage their colleagues to take up the 21st Century Cures Act, Stat News reports. The House of Representatives has already passed its version of the bill.

"These reports demonstrate the need for Congress to pass smart laws and then conduct rigorous oversight to ensure that an agency tasked with safeguarding the health of Americans isn't falling behind," Senator Lamar Alexander (R-Tenn.) says in a statement.

Critics of the bill argue that it would weaken FDA standards for drug and device approval, Stat News notes.

To get things moving, Alexander has parceled the legislation into parts, but funding for FDA and the National Institutes of Health remains an unresolved issue.

The Scan

Hormone-Based Gene Therapy to Sterilize Domestic Cat

A new paper in Nature Communication suggests that gene therapy could be a safer alternative to spaying domestic cats.

Active Lifestyle Linked to Type 2 Diabetes Prevention in People at High Genetic Risk

A study in the British Journal of Sports Medicine shows that an active lifestyle goes a long way in type 2 diabetes prevention.

Beneficial, Harmful Effects of Introgression Between Wild and Domesticated European Grapes

A paper in PNAS shows that European wild grapevines were an important resource for improving the flavor of cultivated wine grapes.

Genetic Ancestry of South America's Indigenous Mapuche Traced

Researchers in Current Biology analyzed genome-wide data from more than five dozen Mapuche individuals to better understand their genetic history.