Big Money Stem-Cell Therapy Push Raises Concerns

Brett Norman, POLITICO: April 29, 2016

A bill that would make it easier to bring stem-cell treatments to market is getting a major push from a GOP senator in a tough reelection fight, a deep-pocketed GOP donor and a centrist Washington think tank — and it’s raising alarm among federal regulators and some medical research experts who say the measure could put patients at harm.

The bill’s supporters say it will spur investment in a flourishing field of research and accelerate patients’ access to potential curesBut even some of the most high-profile advocates of stem cell treatments argue the bill would remove key regulatory safeguards for a promising, but largely unproven area of medical research.

Sen. Mark Kirk’s (R-Ill.) REGROW Act would allow companies to sell stem-cell therapies that have been shown to be safe but haven’t yet been proven to work — a lower standard that’s unprecedented for human treatments in the United States but has been recently adopted in Japan and Europe. […]

The bill instead would require a full traditional drug application demonstrating effectiveness after five years, or else FDA could revoke the approval. Companies would be required to monitor patients for side effects and FDA could pull a treatment off the market if any harmful consequences are detected along the way.

Some patient groups, academic centers and companies are supporting the bill, but it’s opposed by two of the largest advocacy organizations in the field: the Alliance for Regenerative Medicine and the International Society for Stem Cell Research.

“What we don’t need at this point are products that go onto the market under some conditional approval process that aren’t rigorously tested and could truly compromise the whole industry,” said ARM chairman Edward Lanphier, also the CEO of Sangamo BioSciences.

FDA declined to comment on the legislation, but lobbyists and Senate aides told POLTICO that senior agency officials expressed concern that the bill would undercut the longstanding standard that medical treatments be proven both safe and effective before they are allowed to be sold to the public. […]

Some patient advocates will fight it all the way. Diana Zuckerman, president of the National Center for Health Research, called the bill an effort to short-circuit the FDA’s “gold standard” for drug approvals that shows “a lack of understanding of the importance of well-designed research.”

“In recent years, Congress has been chipping away at that standard and REGROW is just the latest, and in some ways most egregious example of that,” Zuckerman said.

To see the full article, click here.