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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.