US REGROW Act has chance of passing postpresidential election, risks cell therapy business paradigm, patient safety – experts

09 Sep 2016

The proposed US REGROW bill that has elicited concern from many cell therapy developers is unlikely to pass in Congress’s current session, but has success potential postelection, said political consultants. Cell therapy experts said despite the REGROW bill’s well-meaning aim of faster patient access to therapies, if passed it will harm development across the cell therapy industry and risk patient safety.

The legislation, introduced in the House as H.R. 4762 and in the Senate as S.2689 in identical language, would allow makers of cell therapies earlier market access by bypassing some clinical trials. The International Society for Cellular Therapy (ISCT), which represents companies involved in cell therapy such as Pfizer (NYSE:PFE), Celgene (NASDAQ:CELG) and Mesoblast (ASX:MSB), issued a statement on 18 August calling for changes to the legislation. The Alliance for Regenerative Medicine (ARM), which represents firms such as GlaxoSmithKline (LON:GSK), Biogen (NASDAQ:BIIB) and UniQure (NASDAQ:QURE), has also publicly stated it doesn’t support the act.

Both bills were introduced in March by Republicans with bipartisan support. It has gained renewed interest as Congress nears the end of its current session before the presidential election. The bills would allow a form of conditional approval for cell therapies, allowing them to be marketed without undergoing Phase III trials, or in the case of cell therapies which double as medical devices -- such as scaffolds for cells to grow on -- after in vitro studies, said a cell therapy consultant. The bills state the therapy maker would have to apply for full approval within five years via the usual regulatory pathway for biologics.

Three Washington, DC-based healthcare consultants, and Michael Werner, executive director, ARM, said REGROW is highly unlikely to be read and voted on in Congress’s current session as some patient groups had advocated, given the session lasts just three more weeks. One consultant added stem cell therapies – one of several therapies affected by REGROW – are perceived as too closely associated with the abortion controversy in the US, and so these bills will be too contentious to pass in the run-up to a hotly contested presidential election in November.

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