Posted: 01 Mar 2017 11:40 AM PST
By Douglas B. Farquhar –
In the absence of blogworthy FDA regulatory pronouncements (draft regulations, draft guidances, and oxymoronically named “tentative final rules”), material for FDA Law Blog posts is harder to come by these days (meaning, since President Trump’s inauguration, not coincidentally). Now comes across our computer screen a district court denial of a motion to dismiss filed by a defendant indicted for illegally selling herbal supplements, which, it is alleged, are illegal misbranded drugs.
Judge Danny Reeves of the federal district court in Lexington, Kentucky, issued a very brief order, but some of the defendant’s claims prompt sympathetic smiles from attorneys familiar with the Federal Food, Drug, and Cosmetic Act (“FDCA”). The Order, filed February 27, 2017, in United States v. Girod, Criminal Action No. 5:15-87-S-DCR (2017 U.S. Dist. LEXIS 26682), stated that the Defendant in the case basically claimed that the FDCA “lacks a rational basis and, therefore, violates his constitutional rights to equal protection and due process.” That argument failed.
Next, the defendant contended that “people of ordinary intelligence cannot understand what 21 U.S.C. § 352 means.” The prohibition on distribution of misbranded drugs has confounded many a person of extraordinary intelligence, in light of the interplay of the First Amendment with off-label promotion. But that argument failed, as well.
Finally, reflecting the frustration that we have heard from many clients, the defendant complained that he was being unfairly singled out. Others, according to the order, “are selling bloodroot and chickweed salve via the internet.” As had other judges in other courts, Judge Reeves rejected that argument, since the defendant had not shown that the “decision to prosecute the defendant was based on any impermissible reason.”
The decision can be accessed here.
In the absence of blogworthy FDA regulatory pronouncements (draft regulations, draft guidances, and oxymoronically named “tentative final rules”), material for FDA Law Blog posts is harder to come by these days (meaning, since President Trump’s inauguration, not coincidentally). Now comes across our computer screen a district court denial of a motion to dismiss filed by a defendant indicted for illegally selling herbal supplements, which, it is alleged, are illegal misbranded drugs.
Judge Danny Reeves of the federal district court in Lexington, Kentucky, issued a very brief order, but some of the defendant’s claims prompt sympathetic smiles from attorneys familiar with the Federal Food, Drug, and Cosmetic Act (“FDCA”). The Order, filed February 27, 2017, in United States v. Girod, Criminal Action No. 5:15-87-S-DCR (2017 U.S. Dist. LEXIS 26682), stated that the Defendant in the case basically claimed that the FDCA “lacks a rational basis and, therefore, violates his constitutional rights to equal protection and due process.” That argument failed.
Next, the defendant contended that “people of ordinary intelligence cannot understand what 21 U.S.C. § 352 means.” The prohibition on distribution of misbranded drugs has confounded many a person of extraordinary intelligence, in light of the interplay of the First Amendment with off-label promotion. But that argument failed, as well.
Finally, reflecting the frustration that we have heard from many clients, the defendant complained that he was being unfairly singled out. Others, according to the order, “are selling bloodroot and chickweed salve via the internet.” As had other judges in other courts, Judge Reeves rejected that argument, since the defendant had not shown that the “decision to prosecute the defendant was based on any impermissible reason.”
The decision can be accessed here.
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