An expedited review track as well as studies on regulations and manufacturing are being considered as possible solutions to national shortages of certain drugs.
The House Energy and Commerce health subcommittee held an April 18 hearing on draft language addressing drugs in short supply. Lawmakers are seeking to add the provisions to the reauthorization of the Prescription Drug User Fee Act. The act, which expires this year, sets fees for Food and Drug Administration reviews of drug approval applications. The law sets performance goals for drug reviews while raising hundreds of millions of dollars from manufacturers seeking approval of their products.
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