Genus Medical Technologies FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

The inspection revealed that your firm causes the introduction or delivery for introduction into interstate commerce of unapproved new drugs—Vanilla SilQ Barium Sulfate Liquid Suspension, and Vanilla SilQ MD Barium Sulfate Powder for Suspension, both for use as contrast agents for radiographic studies—in violation of Sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act (the “FD&C Act” or “the Act”) [21 U.S.C. §§ 331(d) and 355(a)]. Other sponsors have obtained FDA approval for their barium sulfate oral suspension products for use as contrast agents in radiographic studies. Marketing unapproved barium sulfate products for such use, particularly in direct competition with the approved products, undermines the drug approval system, which is designed to prevent patients from

Both Vanilla SilQ and Vanilla SilQ MD, which are intended for use as contrast agents in radiographic studies, are drugs within the meaning of section 201(g)(1) of the Act [21 U.S.C. 321(g)(1)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans. Further, both products are “new drugs” within the meaning of section 201(p) of the Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Moreover, consistent with our letter to you dated January 5, 2016, we remain unpersuaded by the documentation submitted by your firm on September 25, 2015 purporting to establish that your products are “grandfathered” under sectio

Due to the toxicity and other potential for harmful effect and the collateral measures necessary to their use, Vanilla SilQ and Vanilla SilQ MD are not safe for use except under the supervision of a licensed practitioner. In addition, Vanilla SilQ and Vanilla SilQ MD are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. For these reasons, they are prescription drugs as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], and adequate directions cannot be written so that a layman can use them safely for their intended uses. Consequently, the labeling of these drugs fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(l) of the Act [21 U.S.C

Potential Health Risks

Furthermore, these drugs are misbranded under section 502 of the FD&C Act [21 U.S.C. § 352], and by causing the introduction or delivery for introduction of these products into interstate commerce, you are in violation of section 301(a) of the FD&C Act [21 U.S.C. §§ 331(a)]. This violation is concerning from a public health perspective because the labeling of the drugs you introduced into interstate commerce provides neither adequate directions for safe and effective use nor adequate warnings for such use.

A drug is deemed to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if its labeling fails to bear adequate directions for use. Under 21 CFR 201.5, “adequate directions for use” means directions under which a layman can use the drug safely and for the purposes for which it is intended. “Prescription drugs,” as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], are drugs that, because of their toxicity or potential for harmful effect, method of use, or collateral measures necessary to their use, are not safe for use except under the supervision of a practitioner licensed by law to administer them. Accordingly, adequate directions cannot be written for prescription drugs so that a layman can use them safely for their intended uses.

Further, a drug is deemed to be misbranded under section 502(a) of the Act [21 U.S.C. 352(a)] if its labeling is false or misleading in any particular. Section 201(n) of the Act [21 U.S.C. § 321(n)], provides that, in determining whether an article’s labeling “is misleading, there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising . . . fails to reveal facts materials in light of such representations.” The labels collected by the FDA investigators for both Vanilla SilQ and Vanilla SilQ MD misleadingly state that the products are manufactured by Genus Medical Technologies, when in fact the products are manufactured by(b)(4). Further, Vanilla SilQ and Vanilla SilQ MD are also misbranded because their lab

Regulatory Context

Unapproved New Drug Violations

Under section 505(a) of the Act [21 U.S.C. § 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an application filed with FDA under section 505(b) or (j) of the Act [21 U.S.C. § 355(b) and (j)] is effective with respect to such drug. Based on our information, there are no FDA-approved applications on file for either of these drugs. The introduction or delivery for introduction (or the causing thereof) into interstate commerce of a new drug in violation of section 505 is prohibited under 301(d) of the Act [21 U.S.C. § 331(d)].

Misbranding Violations