Julie Tibbets, partner in the firm’s Health Care Group, participated in a roundtable discussion for a Compliance Week article titled “FDA Cautions Drug and Medical Companies on Promotional Pitfalls.”
The article discussed the enforcement activities of the Food and Drug Administration’s (FDA’s) Office of Prescription Drug Promotion (OPDP) and best practices for complying with FDA’s rules around advertising and promotion of drugs.
“The FDA has often stated that it takes a risk-based approach to enforcement. Thus, the agency is particularly concerned with promotional materials for drugs that pose serious health risks to the public,” Tibbets said.
Tibbets also advised that companies become familiar with, and take care to avoid, certain buzz words that may give rise to an OPDP enforcement letter—such as game changing, novel, rapid, and several others.
“The FDA has found—based on its review of these terms and claims—that those terms can often lead to unsubstantiated claims, inadvertently minimize risk information, or overstate product efficacy,” she said.
“The OPDP is also targeting public communications by drug companies outside the traditional advertising formats,” Tibbets said. “Even though investor communications historically have been outside FDA purview, for example, the agency seems to be paying more attention to materials geared toward investor audiences,” she continued.
Tibbets advised drug and medical device companies to focus their internal compliance efforts on all types of public communications, especially investor materials.
“There's the possibility that the FDA could view materials as promotional even if the company might not have thought of them that way,” she said.
“Companies that have received an enforcement letter in the past are especially vulnerable to getting additional letters,” Tibbets said. “They might be on the receiving end of one of these letters if they repeat some of those same promotional violations that the FDA identified in an earlier correspondence.”