A recent FDA report stated that staff scientists rejected ReGen’s application three times, citing concerns that patients might suffer adverse impacts or that the product would do little to help them heal from a torn meniscus.
Then, the report said, ReGen appealed to Andrew von Eschenbach, the FDA commissioner, and he ordered an expedited review by a panel of independent advisers and allowed ReGen input about the composition of the panel.
In December, the report said, Mr. von Eschenbach approved the company’s application without any explanation for overruling the judgment of his staff.
The FDA is leaving the product on the market while it conducts a fresh review to make sure it meets safety and efficacy standards.
Read the Washington Post’s report on the ReGen FDA application.
