Stem cell statutes
Stem cell statutes are laws cited by the FDA in trying to shut down stem cell therapy. These laws invoked by the FDA include:
- 21 U.S.C. § 331(k) (prohibiting the adulteration of drugs)
- 21 U.S.C. § 331(k) (prohibiting the causing the misbranding of drugs)
- 21 U.S.C. § 331(c) (prohibiting the receipt of drugs that are misbranded)
Some stem cell therapies are provided under laws providing for experimental treatment, which include:
- 21 U.S.C. § 355(b) or (j) (relating to approved new drug applications for the surgical treatments ("NDAs") filed with FDA)
- 42 U.S.C. § 262 (relating to approved biologics license applications ("BLAs") filed with FDA for treatments)
Other related statutes:
- 21 U.S.C. § 360(b), (g)(2) (exempting from the requirement that drug manufacturers register with FDA licensed practitioners “who manufacture, prepare, propagate, compound, or process drugs or devices solely for use in the course of their professional practice”)
- 21 U.S.C. § 374(a)(2)(B) (narrowing FDA’s ability to review records when inspecting licensed practitioners “who manufacture, prepare, propagate, compound, or process drugs[] . . . solely for use in the course of their professional practice”).
- 21 U.S.C. § 396 (the only provision in the FDCA headed by the “Practice of Medicine,” which relates to medical devices rather than drugs).
21 U.S.C. §§ 360(k), 360e—so-called “off label” prescriptions: “[n]othing in this [Act] shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.” Id. § 396.
The FDCA applies even to drugs made on an individual basis, such as drugs that are “compounded” by a pharmacy or physician “for an identified individual patient.” 21 U.S.C. § 353a.