Three decades ago, Congress set up a system to encourage drug companies to develop treatments for rare diseases. The law has worked, but at a high cost.

Drugmakers have brought almost 450 orphan drugs to market and collected rich incentives by doing so. But nearly a third of the medicines aren't new or were repurposed many times for financial gain.

Sweeping legislation that would reshape how the Food and Drug Administration reviews new products and bolster National Institutes of Health funding is moving closer to becoming law. What's at stake?

More than 1,455 lobbyists weighed in on the 21st Century Cures Act in this congressional cycle. Only one health bill since 2011 has garnered more attention.

About 27 percent of Food and Drug Administration reviewers who approved hematology-oncology drugs from 2001 through 2010 left to work for the industry they previously regulated, an analysis found.

Four years after user fees were imposed to speed up the review of generic drug applications by the Food and Drug Administration, more than 4,000 generics remain in limbo.