This Biotech Company Has Spent Nearly 3 Years in FDA Limbo
The FDA says it can't license Regenative Lab's overseas sales today because it might change its regulations tomorrow. Now, the company is suing.
An American biotech company that specializes in human tissue therapy* has been waiting for nearly three years for the Food and Drug Administration to process an application to sell products overseas.
Now, it is asking a federal court to get involved—and giving the Trump administration a chance to fix a mess made by its predecessor.
Regenative Labs sued the FDA in federal district court on Thursday, alleging that the agency has "unlawfully withheld" a license the FDA awards to signal to foreign governments that products meet U.S. regulatory standards—a crucial step in being able to sell American-made medical tech in other countries.
There is no question that Florida-based Regenative Labs' products meet U.S. standards, as the company has been lawfully operating in the American market and registered with the FDA since 2020. Regenative Labs harvests tissue cells from donated umbilical cords to make jellies that the company markets for repairing injured tendons and other connective tissues.
The company would like to expand its market overseas and boost its American workforce. It likely would have already done so, if not for being trapped in a bizarre regulatory limbo by the FDA.
Regenative Labs has tried multiple times to get a Certificate to Foreign Governments (CFG), but the FDA has refused to even look at those applications, the complaint alleges. Under federal law, the FDA is supposed to review those applications within 20 days—but more than 10 months have now elapsed since the company's last application.
In response to that application, the FDA pointed to issues raised in a letter it sent to Regenative Labs in 2023. In that letter, the FDA said Regenative's products might need to be regulated as drugs, rather than as human cell and tissue products—a category of health products known as "HCT/Ps."
Around the same time, the FDA sent letters to several birth tissue therapy companies making the same claim: That their products might have to be regulated as drugs, rather than as HCT/Ps. If the FDA made that decision official, it would trigger additional testing and approvals.
In the years since then, the FDA hasn't acted to change its policy toward human tissue therapy—but it has used the possibility of that change to hold up Regenative Lab's application for a CFG.
In the complaint filed Thursday, Regenative says the FDA's refusal to act on the CFG applications has caused material harm—as the company has fallen behind in the global marketplace for human tissue therapies and treatments—and has left Regenative in a state of regulatory purgatory, with no clear path forward toward resolving the situation.
The FDA's handling of the matter has been "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law," the complaint argues.
At its core, the question raised by the new lawsuit is a bit simpler than it might at first seem: Can the FDA arbitrarily refuse to let an American company operate overseas because it might someday change how it regulates that company's products?
The other underlying question—about whether Regenative Lab's products are drugs or HCT/Ps—remains unsettled. Last year, the Supreme Court declined to review a case in which the FDA determined that products made from human tissue cells were drugs.
While Regenative Labs is obviously hoping for a legal result, the new lawsuit might be best understood as an attempt to push this issue in front of the Trump administration, which now has an opportunity to fix a mess created during the Biden administration. It also presents the Trump FDA with a chance to provide some much-needed regulatory certainty to an American small business that's trying to expand.
Regardless of what happens from here, it's obvious that the FDA's handling of Regenative Labs' application has been unacceptable. American businesses shouldn't face endless waits while regulators try to decide what rules they might apply tomorrow.
*CORRECTION: This article has been updated to clarify that Regenative Labs is involved in human tissue therapy using material drawn from umbilical cords.