2009 Sponsored Links Enforcement Past and Present.pdf
For Informational & Discussion Purposes | Use is Permitted with Credit to Author
OPDP’s 2009 Sponsored Links Enforcement Actions Against Fourteen
A Look at How Those with Products with a Boxed Warning Are Advertising on
In April 2009, FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) (now
Office of Prescription Drug Promotion) issued fourteen (14) enforcement letters against
pharmaceutical manufacturers for improper sponsored link promotion.
The sponsored links cited in these letters were considered to be misleading because they made
representations and/or suggestions about the efficacy of the products, but failed to communicate
any risk information associated with the use of these drugs.
In addition, the sponsored links inadequately communicated the drugs’ indications.
Some sponsored links also failed to use the required established name. Thus, DDMAC believed
the sponsored links misbranded the drugs in violation of the Federal Food, Drug, and Cosmetic Act
(the Act) and FDA implementing regulations.
DDMAC cited the following authorities: 21 U.S.C. 352(a) & (n), 321(n); 21 CFR 201.10(g)(1),
202.1(b)(1), (e)(3)(i), (ii) & (e)(6)(i).
DDMAC noted that the omission of risk information was particularly concerning for those products that
have Boxed Warnings. In addition, DDMAC stated “[f]or promotional materials to be truthful and nonmisleading, they must contain risk information in each part as necessary to qualify any claims made
about the drug.”
Click here to see the enforcement letters and promotional materials.
PRODUCTS WITH BOXED WARNINGS
nicodemo fiorendtino, jd
Nicodemo Fiorentino, JD