July 7, 2020

The Niche

Knoepfler lab stem cell blog

Tom Price & MiMedx: a stem cell connection?

What’s the deal with Trump’s HHS Secretary pick Rep. Tom Price (now testifying before the Senate) and the amniotic tissue/stem cell company MiMedx that’s caused some buzz in the last 48 hours?
tom-price-hhs-senateI’ve been following MiMedx for a few years since it received an untitled letter from the FDA and I noted its claim of one its product acting like a “stem cell magnet.” More recently I did a 2nd post mentioning the company a few months back focusing on its contributions to former Sen. Mark Kirk, whose legislative baby the REGROW Act would have codified risky reductions in stem cell oversight by the FDA.MiMedx

Now Kaiser Health News (KHN) just reported that Price received more than $40,000 in total contributions from the MiMedx PAC, the MiMedx CEO and others linked to the company for his congressional election campaign:

“With combined PAC and individual donations, the company (MiMedx) was ranked as Price’s top contributor for 2015-2016 by the nonpartisan Center for Responsive Politics.”

According to KHN, the MiMedx CEO Parker H. “Pete” Petit allegedly pressured employees to contribute to the company’s PAC, potentially raising questions about election contribution rules. RollCall first reported on the Price-MiMedx connection in mid-December. While this KHN story seems more about the MiMedx PAC than about Tom Price, since Price is reportedly the top receiver of MiMedx PAC funds, the connection is worth some thought.

Is there a stem cell connection here? Could some companies in the stem cell/regenerative medicine arena hope that Price will exert pressure on the FDA to soften oversight?

And what exactly are Price’s views on stem cells?

Price has gone on the record as opposed to embryonic stem cell (ESC) research, but his views on other types of stem cell-related or tissue products other than ESCs such as of the amniotic type sold by MiMedx seem less clear.

MiMedx has been critical of aspects of FDA oversight of regenerative medicine therapies based on stem cells or similar products such as birth-related materials including amniotic products. These biological materials may in some circumstances be viewed by the FDA as drugs requiring approval before use in patients (a.k.a. pre-market approval).

You can get the gist of the company’s sentiments, for example, on the recent FDA draft guidances on stem cells here. These draft guidances (i.e. rules in the making) that MiMedx and some others in the regenerative medicine arena oppose would likely make some biological materials more clearly become classified as drugs requiring pre-market approval by the FDA. I view the draft guidances as a positive step. More broadly, there is healthy debate going on regarding the draft guidances within the regenerative medicine sphere so of course there’s nothing untoward with MiMedx opposing them.

The new KHN story broke within the last couple days and Price just appeared before a senate committee regarding his nomination to HHS so the timing isn’t great. Adding fuel to the fire is a report out alleging that Price may have engaged in insider trading of a medical company. Concrete details on that allegation are sketchy at the moment and Price disputed them in his Senate testimony. If confirmed, it’s difficult to know how Price might approach the FDA and oversight of regenerative medicine products, and it is unclear who will lead the FDA under Trump.

Back around the time of the FDA letter to MiMedx, ABC news reported this remarkable claim about how the company supposedly views FDA oversight as not necessarily needed:

“Mother nature did safety and efficacy testing on the tissue,” MiMedx CEO Pete Petit told ABCNews.com, likening treatment with a placenta-based product to a kidney transplant rather than the use of a drug. Since the placenta product is made from human tissue, he said testing is unnecessary because placental cells already work in the human body.”

Would you be comfortable with having some untested, non-FDA approved product injected into you? Seems highly risky.

Overall, we all may learn more about Price’s views on stem cells and the situation with MiMedx after today’s hearing and in coming weeks.

You can watch video of Price’s Senate testimony today here.

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