Seeking to boost competition in the pharmaceutical industry, the House passed a bill that would close a loophole in a law that was meant to encourage development of rare disease drugs, but that had inadvertently precluded availability of lower-cost versions of medicines.
The legislation was proposed last year after a company complained that it was unable to win approval from the Food and Drug Administration to sell an opioid addiction treatment because of a stipulation in the Orphan Drug Act. The provision offers what critics have called a loophole that allowed some drug manufacturers to unfairly monopolize a market, causing consumers to pay higher prices.
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