Senator’s 7 Questions to FDA about Stem Cell Clinics: Politics of Stem Cells
​​[Posted on: Thursday, April 26, 2018]

Last week Senator Chuck Grassley of Iowa sent a letter to FDA asking about the outcome of a Warning Letter issued last year to a stem cell clinic and in the process raised issues that could affect regulation of all similar clinics by FDA. In August 2017, FDA issued a Warning Letter to US Stem Cell for several violations of GMP and “improper” clinical trials with stem cells which led to three patients going completely blind. It seems FDA has not done much else since, at least publicly, to address the violations. Among his seven questions, Senator Grassley asked if the FDA investigation is still ongoing, if it has or plans to penalize the company for impeding FDA inspection, if FDA has decided to or plans to take criminal action against the company or its employees, and if the company is allowed to operate since the Warning Letter. But then the Senator asked questions about regulation of information on clinicaltrials.gov and if FDA is planning any far reaching policies to regulate what trials appear on the government website. While the questions may appear about a specific case, they have much wider implications. FDA is expected to reply by this weekend but we can assume what FDA’s answers will be based on the current processes. Regarding the violations of GMP, FDA gave the company a list of specific issues and once the company shows it has addressed those issues, there isn’t much FDA can do to penalize them. For conducting the clinical trial in patients, the company was clearly noncompliant with US regulations governing such trials. The company had already stopped the trial at the time of the Warning Letter last year. Since this was the first notice by FDA, and since the company already stopped the trial, FDA’s options are limited. To take criminal action, FDA would need to prove that the company knowingly harmed patients, which is very hard, if not impossible. The company was acting within the current regulatory paradigm. Although, FDA has repeatedly clarified its position that it considers trials of the kind conducted by US Stem Cells to be illegal, it has also emphasized that it plans to use enforcement discretion for clinics conducting such trials. Most such stem cell trials are a cover for fee-for-service treatments and patients participate in such treatments knowing that such treatments are not approved by the FDA. In the past FDA has refrained from taking action against such clinics fearing public outcry. In fact, there is significant public support for unapproved stem cells therapies with at least two States recently passing laws allowing most such stem cell treatments. Hence, strict punitive actions against US Stem Cell will be hard. Even if FDA decides to make an example of this one company, courts may find it unfair on FDA’s part to enforce its rules on one company while allowing many others like it to openly operate. Regarding posting clinical trials on the clinicaltrials.gov registry, again, the laws governing such registries make it hard for regulators to reject postings for trials like the ones pointed out by Senator Grassley. From the regulatory perspective, FDA’s hands are tied, but the politics of stem cells is changing at a very rapid pace. It’s not a regulatory issue but a legislative issue; we need better laws if we expect FDA to do its job. It does not appear if anything significant will arise from these questions. We will find out soon.