FDA Chief Counsel on New Enforcement Precedent
FDA chief counsel Stacy Cline Amin says the Covid-19 emergency has offered the agency an opportunity to set a new legal precedent that will “inspire a new era of compliance and enforcement for FDA.” Delivering the annual chief counsel’s address at the Food and Drug Law Institute’s (FDLI) virtual annual conference 10/6, Amin explained that when FDA sees “violative conduct that poses an immediate risk to public safety and we can’t obtain voluntary compliance, now we can enjoin that conduct on an emergency timeline to protect the public.”
Amin told FDLI that working together with the Department of Justice (DoJ), FDA realized that Covid-19 “presented the opportunity to create a model for a more streamlined approach to compliance and enforcement. She said that Warning Letters issued against products marketed to treat or prevent Covid have been issued requesting a response in only two days. “We hope to obtain quick voluntary compliance and thereby mitigate the harm from unproven and potentially dangerous products marketed to a vulnerable public,” she told conference attendees.
In situations where FDA has not achieved quick compliance, agency attorneys have worked DoJ to bring temporary restraining orders for the first time in decades, Amin said. “We have obtained two temporary restraining orders and one was converted to a permanent injunction and the other converted to a preliminary injunctions, and we have other injunctions in the works. This kind of work is resource intensive and it is not the kind of thing we can do on every case during normal times, but I am incredibly proud of the teams at the agency that set this precedent for us anew...”
Accelerated compliance and enforcement work to combat unproven medical products marketed as tests or treatments for Covid-19 has been a priority, Amin told FDLI. Over the past several months, she said FDA has issued over 115 Warning Letters, sent hundreds of complaints to internet market places and domain name registrars, and supported eight criminal prosecutions under the Food, Drug & Cosmetic Act.
During her address, Amin also noted other important work moving through her office, such as a proposal last month that clarifies the regulatory language describing the types of evidence FDA considers relevant when determining a product’s intended uses, including that “any relevant source of evidence may be considered.” She said that the proposed revisions also clarify an important point — that a firm’s “knowledge that a healthcare provider has prescribed or used an approved or cleared medical product for an unapproved use standing alone is not sufficient to establish a product’s intended use.”
A Federal Register notice issued last month says the proposal also will repeal and replace portions of a 1/9/17 final rule that never became effective. “This action is intended to provide direction and clarity to regulated industry and other stakeholders,” the notice says. “We believe that by revising the text of our intended use regulations to better reflect our longstanding practice, and by providing additional examples and explanation in the preamble, we will give clarity to stakeholders and enhance consistency in our regulatory approach,” FDA commissioner Stephen Hahn said at the time the notice was released. “Such clarity and consistency are critical to ensuring that parties understand their regulatory obligations and that FDA can exercise effective oversight responsibility. For this reason, this rulemaking is an important priority for FDA.”