A study by the Center for Responsive Politics in April found that Senators Robert Menendez and Frank Lautenberg and Congressmen Steve Rothman and Frank Pollone, Jr. wrote letters to the FDA requesting approval for the device despite a recommendation from FDA scientists against approval.
Executives of ReGen, based in Hackensack, N.J., paid more than $26,000 to the New Jersey lawmakers or their campaigns, the Examiner reported.
In total, the Examiner said, ReGen spent close to $500,000 to aggressively lobby Washington for approval of the device.
During the FDA’s review of the approval, ReGen said it will continue marketing Menaflex and training surgeons to use it.
Read the Washington Examiner’s report on FDA approval of Medaflex’s ReGen.
At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 18–20 in Chicago, spine surgeons, orthopedic leaders and ASC executives will come together to explore minimally invasive techniques, ASC growth strategies and innovations shaping the future of outpatient spine care. Apply for complimentary registration now.
