We have previously written about the downward slope of enforcement letters from the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP). Over the last five years, the highest number of enforcement letters sent was in 2016, with 11 enforcement letters. So far, in 2020, OPDP has issued one enforcement letter.
Recent Years Review
As mentioned above, since 2015, the year with the highest number of enforcement letters sent was 2016, with only 11 letters. Last year, in 2019, OPDP sent only three Warning Letters and seven Untitled Letters, for a total of ten enforcement letters. By mid-June 2019, OPDP had sent three Untitled Letters. The back half of the year was busier, with an enforcement letter of some kind being issued most months.
Additionally, in the last five years since 2015, OPDP has issued twice as many Untitled Letters (29) as compared to Warning Letters (14).
The Lone Letter
The only enforcement letter issued so far in 2020 is a Warning Letter dated February 21, 2020, and sent to Outlook Pharmaceuticals, Inc. The letter takes issue with a sponsored link on Google for PROCENTRA® oral solution, CII, a drug used to treat ADHD and distributed by Independence Pharmaceuticals, LLC, on behalf of Outlook. OPDP cited the FDA Bad Ad Program as a source of complaints about the sponsored link.
According to the letter, the sponsored link is false or misleading because it “presents information about the benefits of ProCentra, but fails to include any risk information about the drug.” The letter goes on to state, “These violations are especially concerning from a public health perspective because they create a misleading impression about the safety of ProCentra, a drug that is a schedule II controlled substance used in the vulnerable pediatric patient populations, and bears a Boxed Warning that describes the high potential for abuse, that administration of amphetamines for prolonged periods of time may lead to drug dependence, and states that misuse may cause sudden death and serious cardiovascular adverse events.”
The letter also notes that the “sponsored link fails to present the required established name, which misbrands ProCentra within the meaning of the Act and makes its distribution violative.”
Promotional materials can be found to misbrand a drug if they are false or misleading with respect to risk, including not only representations made or suggested in promotional materials, but also failure to reveal facts material in light of the representations made or with respect to consequences that may result from the use of the drug as recommended or suggested in the materials. The letter found that “by omitting the risks associated with ProCentra, the sponsored link fails to provide material information about the consequences that may result from the use of ProCentra and creates a misleading impression about the drug’s safety.”
OPDP takes issue with the sponsored link using claims such as “Liquid Treatment Option,” and “Bubblegum Flavor,” that “could appeal to parents as desirable properties for pediatric administration,” but fails to communicate the risks associated with the product.
Requested Action
At the close of the letter, OPDP requested that Outlook “immediately cease misbranding ProCentra and/or cease introducing the misbranded drug into interstate commerce.” OPDP also asked for a “comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audience(s) that received the violative promotional materials.”