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Today, Congressman Bob Latta (R-Bowling Green) issued the following statement after the House of Representatives agreed to amendments to S. 3187, the Food and Drug Administration Safety and Innovation Act. 

The House and Senate have been working on bipartisan legislation to reauthorize the user fee programs for prescription drugs and medical devices, as well as establish user fee programs for generic drugs and biosimilars, and reform Food and Drug Administration (FDA) programs.  This legislation was passed out of the House Committee on Energy & Commerce, of which Congressman Latta is a member.  

Latta collaborated with colleagues to insert language in the bill that assists hospital systems in coping with drug shortages by allowing them to repackage those drugs into smaller doses.  The House language details specific parameters on drug repackaging and provides an immediate solution for hospitals and health systems struggling to manage drug shortages in the near term, while still allowing the Food and Drug Administration (FDA) to issue guidance.  Latta worked with health systems across the country on this language, including systems in Northwest Ohio.

"Mercy appreciates Congressman Latta's leadership on an issue that will benefit Mercy patients and all residents in Northwest Ohio by enhancing continuity of care through the reduction of interruptions of essential prescription medications," said Andrea R. Price, Mercy President and Chief Executive Officer.  

This language will allow hospitals within a health system to manage drug shortages in a timely and efficient way.  Current law does not allow for a hospital to repackage a drug for use in another hospital within their system.

"We applaud Congressman Latta’s action in the re-packaging fight and for looking for a true compromise, said Steven Mickus,” President of Healthcare Operations and Chief Operating Officer, at Catholic Health Partners."The FDA legislation that this is included in should serve as a model for more bipartisan action, and we are proud that our Congressman was in the thick of this debate fighting for us," he added.

“I worked with my colleagues on a bipartisan agreement for this repackaging language,” Latta said.  “This will help to ensure that patients across Ohio receive the drugs they need during a drug shortage.”  

The bill is anticipated to be agreed upon by the Senate, and it will then go to the President.