Source: https://www.nutraceuticalsworld.com/blog/blogs-and-guest-articles/2015-11-10/lessons-for-industry-from-bayers-victory/?widget=suggestedbox
Timestamp: 2019-04-21 14:05:38+00:00

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These insights may help companies ward off litigation.
For well over a decade, the law regulating dietary supplements was clear. Recognizing the many health benefits of supplements, Congress enacted the Dietary Supplement Health & Education Act of 1994 (DSHEA), Pub. L. No. 103-417, sec. 8, § 413(c) (codified at 21 U.S.C. § 350(b)), to ensure that supplements can be marketed and sold without following the stringent requirements imposed on prescription drugs.
The government sought hundreds of millions of dollars in contempt damages and $25,000 a day in fines. The government’s sole basis for contempt was that “competent and reliable scientific evidence” did require drug-level, randomized, double-blind, placebo-controlled clinical trials, notwithstanding the published Guidance.
First, it is essential that dietary supplement companies implement a robust copy-review process. In ruling for Bayer, the Court relied heavily on Bayer’s copy-review process and dedicated a significant portion of the opinion to describing Bayer’s process. The Court explained that “in order to ensure that it complies with the Consent Decree, [Bayer] follows an extensive process known as the Legal, Medical, Regulatory (LMR) review.” This process requires one member of the legal, medical, and regulatory groups to regularly attend meetings and to review every single piece of promotional material the company wished to publicize.
At these meetings, the medical representative is responsible for ensuring scientific and medical substantiation for all claims. The regulatory representative ensures that all FDA regulations, including those on structure-function claims and required disclaimers are complied with. The individual from the legal team reviews the advertisements for general legal compliance.
If Bayer’s scientist is not convinced that every single claim is completely truthful and fully substantiated, she will not approve the advertisement, and it will not be published. Similarly, if the legal or regulatory representative does not believe that the advertisement complies with all laws and regulations, it will be rejected. This process starts at idea generation and continues through the life of every product Bayer sells. This process was significant to the Court’s decision and Bayer’s success in this case.
Bayer’s LMR process is just one example of a robust and successful copy-review process. Each company should have its own individual process tailored to its structure, products and culture, and preferably reviewed by counsel that has substantial experience in drafting and reviewing procedures for supplement copy-review.
The benefits of a copy-review process begin well before litigation. A process that ensures proper claims on the front end can help companies minimize litigation risk and legal expense down the road. Further, in the event there is litigation, a robust process goes a long way to showing that the company acted in good faith and made substantial efforts to comply with the law.
Both of Bayer’s experts testified that drug-level randomized controlled trials were not required for probiotic supplements. The Court credited this testimony, and rejected the testimony of the government expert who lacked expertise in probiotics. Dr. Laine admitted that he “is not an expert on probiotics” and “does not regularly use them in his practice.” Dr. Laine also conceded that he was not familiar with DSHEA, “did not review or consider FDA regulations in any way,” was not aware of the distinction between “structure function claims for dietary supplements and disease claims for drugs.” In fact, during cross-examination, Dr. Laine confessed he was “not paying attention to the law or regulation about the difference between dietary supplement and drugs.” Given this testimony, it is unsurprising that the Court held: “Dr. Laine lacks the expertise necessary to prove what experts in the field would require” and he simply “is not in a position to testify” regarding the relevant standard.
The Court’s decision in U.S. v. Bayer is welcome news to industry. These two insights from the trial should help companies ward off litigation, and, if necessary, win at trial when the FTC oversteps its bounds.
Jonathan F. Cohn is a partner and Benjamin M. Mundel is an associate at Sidley Austin LLP in the firm’s Washington, D.C. office.
Disclaimer: Jonathan F. Cohn and Benjamin M. Mundel were members of the Sidley Austin LLP trial team that represented Bayer Corp. in this litigation.
This article has been prepared for informational purposes only and does not constitute legal advice. This information is not intended to create, and the receipt of it does not constitute, a lawyer-client relationship. Readers should not act upon this without seeking advice from professional advisers. The content therein does not reflect the views of the firm.
1) See 21 U.S.C. § 331(d); id. § 355(a).
2) 21 U.S.C. § 343(r)(6)(B); see also id. § 321(ff) (defining “dietary supplement” as any non-tobacco product “intended to supplement the diet”); id. § 343(r)(6)(A) (identifying types of dietary supplement claims, including structure-function claims); id. § 343(r)(6)(A) (defining a structure-function claim as a claim that “describe[s] the role of a nutrient or dietary ingredient intended to affect the structure or function in humans [or] characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function”).
3) Dietary Supplements: An Advertising Guide for Industry at 3 (“FTC Guidance”).
5) “Priorities for Dietary Supplement Advertising Enforcement” Remarks by David C. Vladeck, Director FTC Bureau of Consumer Protection, October 22, 2009.
6) See e.g., FTC v. Iovate Health Sci USA, Consent Decree at 7, No. 10-CV-587 (W.D.N.Y. July 29, 2010); United States v. Jason Pharm., Inc., Consent Decree at 3, 6, No. 12-CV-01476 (D.D.C. Sept. 17, 2012).

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