May 26, 2020 – Since 2015, the FDA’s Office of Prescription Drug Promotion (OPDP) has issued a yearly high of 11 enforcement letters (2016) and a low of five enforcement letters (2017), and so far in 2020, OPDP has issued just one enforcement letter.
The three Warning Letters and seven Untitled Letters issued by OPDP last year were the second-highest numbers since 2015, but it remains to be seen whether 2020 will be a higher or lower enforcement year. By May 25, 2019, OPDP had issued just two enforcement letters, but then proceeded to issue roughly one or more letters per month for the remainder of the year.
The only enforcement letter issued to date in 2020 — a Feb. 21 Warning Letter to Outlook Pharmaceuticals Inc. – addressed a sponsored link on Google for PROCENTRA® (dextroamphetamine sulfate) oral solution, CII, a drug used to treat attention deficit disorder with hyperactivity, distributed by Independence Pharmaceuticals LLC on behalf of Outlook. The FDA’s Bad Ad Program was cited by OPDP as a source of complaints about this sponsored link.
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,” according to OPDP. “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,” information about prolonged use of amphetamines and drug dependence, and a warning that sudden death and serious cardiovascular adverse events can occur with misuse, among other concerns.
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.
The Warning Letter also stated that because the sponsored link fails to present the drug’s required established name, ProCentra is misbranded.
In reviewing enforcement activity since 2015, it appears that OPDP issues twice as many Untitled Letters (29 since 2015) than Warning Letters (14 since 2015).