Senator Urges FTC to Examine Link Between Drug Shortages, Pharma Consolidation
"Regardless of the cause, in order to provide patients with uninterrupted access to medicines it is important for all of us who provide life-saving medications to work collaboratively to minimize unexpected disruptions in the supply of vital medicines," Uhlendorf said.
Schulman said the AHA supports Senate bill (S.296) , which would strengthen FDA oversight of the nation's drug supply. The bill requires drug manufacturers to notify FDA at least six months in advance of a planned discontinuation or interruption to the drug supply, with penalties in place for noncompliance; requires the FDA to post on its Web site information about drug shortages and to distribute that information to providers and patients' advocacy groups so they can plan ahead; and requires FDA to develop criteria to identify drugs that are vulnerable to shortages, and plan for ways to mitigate or prevent the shortage.
Government action, however, may not be enough.
"It's going to be a combination of industry actions, regulatory change, and some legislative change," Schulman says. "I don't think FDA has the authority it needs to mitigate these issues."
Kohl, who has served four terms in the Senate, announced this month that he will not seek re-election next year.
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