The FDA has finally issued draft guidance on the minimum requirements that it thinks companies need to fulfill to get drug-eluting stents approved. Apparently it's not just approvals that the agency is dragging its feet on.
The crux of the new requirements is that most of the safety data will need to extend out two years before the agency will approve the tiny mesh devices used to hold open arteries. Then, post-marketing studies will be required to follow patients for at least five years. The agency is worried about reports from 2006 that the drug-eluting stents cause more blood clots than their bare metal brethren.
The guidance won't affect the three medical-device makers that currently have drug-eluting stents on the market: Johnson & Johnson (NYSE: JNJ ) , Boston Scientific (NYSE: BSX ) , and recent addition Medtronic (NYSE: MDT ) . It shouldn't even affect the approval of Abbott Laboratories' (NYSE: ABT ) Xience, since it should hear back from the FDA before the 120 days of public comments are up.
Instead, the new guidance would affect newcomers like XTENT (Nasdaq: XTNT ) that might try to get stents approved in the U.S. They also would affect development of next-generation stents by the current players.
If the new requirements go into effect, it will kind of be a wash for the current stent makers. There will be extra clinical-trial costs involved with getting next-generation stents approved, but the requirements should widen their moats. The rising research and development costs will mean that me-too stents that don't offer a substantial additional benefit will probably get cut in development.
A scaling back of competition is certainly welcome news for an industry that's been hurting for a few years.