Bayer Satisfies DoJ ‘Need To Know’ About Probiotic Claim Studies

A judge also grants Bayer’s request to depose an FTC attorney about the agency’s investigation that led to a contempt charge linked to allegedly violating a 2007 consent decree by making a drug claim for the Phillips’ Colon Health three-bacteria-strain formula.

Bayer HealthCare LLC provided sufficient detail on studies that support claims for its Phillips’ Colon Health probiotic, a federal judge says in denying a Department of Justice request for information that also covered when the firm learned of the studies.

U.S. Magistrate Judge Joseph Dickson in a March 13 ruling also granted the Bayer AG business’s request to depose a Federal Trade Commission attorney about the agency’s investigation that led to a contempt charge linked to allegedly violating a 2007 consent decree by making a drug claim for its Phillips’ Colon Health three-bacteria-strain formula.

DoJ attorneys sought an order requiring more details from Bayer on the question, “For any study, analysis, or other material that Bayer asserts substantiates claims that Bayer has made about the benefits, performance, efficacy, safety or side effects of PCH or any of its ingredients relating to constipation, diarrhea, or gas and bloating, provide the date upon which Bayer first became aware of the study, analysis or material, and identify the specific claim(s) that Bayer contends the study, analysis, or material substantiates” (Also see "Bayer Probiotic Claim Defense Argues FTC Wants Substantiation Standard That ‘Did Not Exist’" - Pink Sheet, 23 Feb, 2015.).

Dickson, however, agreed with Bayer that DoJ’s request was excessive. “The United States’ need to know the specific date(s) that each Bayer employee reviewed public information, which allegedly substantiates its claims, is outweighed by the burdensomeness that will result in the obtaining of such information,” according to the judge’s order in U.S. District Court for the District of New Jersey.

Bayer argued the claim that Philips’ Colon Health helps defend against occasional constipation, diarrhea, gas and bloating relies on “the totality of scientific evidence in the public domain, and while it is unaware of the date and time employees reviewed the studies, “such information is also irrelevant.”

The firm contends FTC based its contempt charge on a standard stated only in the allegation that Bayer violated the terms of the 2007 decree requiring the firm to substantiate all supplement product claims with competent and reliable scientific evidence.

“The only issue in this case is whether Bayer can be held in contempt under the government’s novel and erroneous substantiation standard, which the government unveiled for the first time in its contempt motion. Bayer admits that it does not meet this new standard that the government has proposed, and none of Bayer’s employees sought to comply with it. Nor could Bayer seek to comply with this standard because it did not exist until the government filed its motion for contempt on September 12, 2014,” according to Bayer’s response to the DoJ interrogatory on claims substantiation.

“Because Bayer has no drug-level clinical trial meeting the government’s novel standard, it is irrelevant when Bayer came across the hundreds, if not thousands, of studies in the public domain that support Bayer’s claims under the old, ‘flexible’ standard that governed this industry until the government filed its contempt motion,” the attorneys from Sidley Austin LLP in Washington representing Bayer said in a previous letter to Judge Dickson contesting DoJ’s request.

While FTC insists Bayer needs two randomized, controlled trials to substantiate the claim, Bayer and dietary supplement industry stakeholders contend RCTs are not required for the Phillips’ Colon Health structure/claim. RCTs are needed to substantiate drug claims, but neither FTC nor FDA regulations require clinical trials for structure/function claims.

“We’re talking about structure/function claims, we’re not talking about drug claims,” said Natural Products Association Executive Director and CEO Daniel Fabricant.

Stakeholders also assert that although FTC maintains it evaluates advertising claims on a case-by-case basis and the contempt charge against Bayer focuses narrowly on Phillips’ Colon Health claims, the agency is using this case as a platform to establish an RCT requirement for supplement product claims.

“It’s pretty clear that’s what they’re trying to do,” Fabricant added.

FTC Attorney Deposition Ordered

DoJ attorneys objected to the request by Bayer’s attorneys to depose an FTC attorney, arguing that the firm “seeks testimony that would invade attorney thought processes, strategy and other work product” and the witness’ testimony would cover information the firm already has.

The federal officials also argued that deposing the witness would not “address any legitimate discovery purpose.”

DoJ, Bayer responded, “should be amenable to not introducing testimony at trial from the witness” if a deposition is unnecessary.

Dickson again agreed with Bayer, but instructed the firm’s attorneys not to ask the witness about why DoJ and FTC “selected certain documents” for review in the investigation that led to the contempt charge.

The judge required the deposition to be done before March 20 and scheduled the next hearing in the case for March 30.

Bayer’s Phillips’ Colon Health claims are not challenged by FDA, which regulates label claims for probiotics and other supplement products, and the contempt charge against Bayer is closely watched by industry stakeholders as an indication of FTC's enforcement on advertising claims for supplements (Also see "Judge Takes Broad View On FTC's Bayer Complaint Despite DoJ's Narrow Focus" - Pink Sheet, 23 Oct, 2014.).