Some Clinical Trial Calls Now Eligible for the FCC’s Revised TCPA Exemption

The TRACED Act’s December 30, 2020 deadline was not the end of the FCC’s recent series of actions to bring more clarity to certain forms of TCPA exemptions. Most recently, on January 15, 2021, the FCC issued a Declaratory Ruling “clarify[ing] that a call to a residential telephone line seeking an individual’s participation in a clinical pharmaceutical trial is not subject to the TCPA’s restrictions on prerecorded calls.” Instead, the FCC stated that these calls are eligible for exemption from the TCPA’s prior express written consent requirement as other calls to a residence that do not constitute telemarketing.

This Declaratory Ruling finally addresses and grants a 2014 Petition filed by Acurian, Inc., “a company that identifies and contacts potential candidates for particular clinical drug trials and then refers such individuals to doctors who are participating in such trials.” In its long-pending Petition, Acurian described its methods, calling potential candidates for a particular clinical trial on behalf of pharmaceutical companies, “using prerecorded messages to provide introductory information with the opportunity for live follow-up [and] to inform them of a clinical trial being conducted in their area.” If an individual shows interest and meets eligibility requirements for the particular trial, Acurian then requests that individual to give consent to be called again regarding future trials. Acurian ceases calling that same individual if he or she declines to grant such consent.

Acurian argued that these calls “fall squarely within” one of two exemptions – “calls not made for a commercial purpose” and “calls made for a commercial purpose but that do not introduce or include an advertisement or constitute telemarketing.” According to Acurian, its calls “do not, and are not intended to, encourage the called party to engage in a commercial transaction” and “are analogous to the pure research calls that the Commission has twice deemed to be exempt.” The company asserted that these calls are not “advertisements or telemarketing” because they do “not convey any information about the commercial availability of goods or services and do[] not solicit payment from the individuals it contacts.” Rather, Acurian noted that “many of these individuals end up receiving reimbursements for their costs in participating in the trial” as a result of these calls.

Following the nearly seven-year period when the petition was pending, the FCC now concluded that Acurian’s calls are exempt from the TCPA’s prior express written consent requirement when they “do not include or introduce an advertisement or constitute marketing,” regardless of whether these calls might be considered commercial in nature. Because of the conclusion that an exemption applied, the FCC determined that it was not necessary to take the additional step of addressing the issue of whether Acurian’s calls are made for a “commercial” purpose.

The FCC specifically agreed with Acurian’s characterization that its calls “do not identify property, goods, or services offered for sale by Acurian or its clients.” The FCC found it significant that drugs involved in clinical trials typically have not received approval from the U.S. Food and Drug Administration and as such, cannot be legally marketed or sold. This formed the basis for the FCC’s determination that drugs that clinical trial participants may receive are not in the same category as a “product or service” that telemarketing calls typically offer.

The FCC was also convinced that “[t]he sole aim of Acurian’s calls appears to be to encourage the called party to participate in an FDA-mandated clinical trial.” It found no evidence contrary to Acurian’s statements that “at no time are consumers asked to purchase any product or service” “[n]or does Acurian couple its offer to reimburse individuals for their time participating in the trial or free participation in a trial with any other offer or marketing effort to sell anything.” These calls, by offering free participation and monetary reimbursement to the clinical trial participants, are therefore not a “part of an overall marketing campaign to sell property, goods, or services” and are not “dual purpose” calls.

Comparing these calls with “a recruiter’s call to discuss potential employment or service in the military,” the FCC found them to be similar in nature and are similar in having strong policy reasons supporting exemption from the TCPA. In particular, pharmaceutical trials carry great importance, “especially at a time when researchers search for therapeutics and vaccines to treat or prevent COVID-19.” This observation alone could be the motivating factor as to why the FCC revived a nearly seven-year-old petition and granted it.

As a Declaratory Ruling, the FCC’s clarification took immediate effect. Entities that make similar calls, especially pharmaceutical companies and their vendors, should assess whether the Ruling might cover their particular public telephone outreach programs. Notably, however, any party relying on this exemption must also carefully observe the FCC’s December 2020 rule amendment that limits the number of calls that can be made to a phone number under this exemption to “three [artificial or prerecorded voice] calls within any consecutive 30-day period” and that requires “callers to allow consumers to opt out even before callers reach that limit.”

Qiusi Y. Newcom

About the Author: Qiusi Y. Newcom

Qiusi Newcom brings efficiency and reliability in navigating clients through regulatory issues in telecommunications, export controls, economic sanctions and global privacy laws. Her experience in these areas uniquely positions her to help companies bridge compliance gaps in light of emerging legal developments such as multi-agency actions to protect U.S. communications supply-chain security and foreign direct-investment considerations involving critical telecommunication infrastructures or sensitive personal data. Having lived in and obtained law degrees in both China and the U.S., Qiusi’s understanding of cultural factors and local customs adds immense value to her counsel for business activities across borders.

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