The Wall Street Journal reports that the FDA will review its clearance of ReGen Biologics' Menaflex device. The Journal previously alleged that ReGen had undue influence on the regulatory process, making campaign donations to politicians who lobbied for the device's clearance and selecting its own panel members.
This news follows a letter from acting FDA Commissioner Joshua Sharfstein to the Senate Finance Committee suggesting the regulatory process may have been "compromised." The House Energy and Commerce Committee determined separately that the Menaflex decision was in need of review. The House noted in their letter (and the Journal noted previously) that certain FDA scientists who opposed the device were excluded from the final decision process, and no formal vote was ever conducted.
This action appears to be more of a procedural review of the clearance process rather than a scientific review of the device, though it's unclear at this point whether the inquiry will escalate. These events do help to illustrate the effects of mounting pressure from both Congress and the public to ensure the safety and effectiveness of devices as well as echo calls for transparency and reflect heightened scrutiny on the orthopedic industry.
