On May 16, 2014, the U.S. Food and Drug Administration (“FDA”), with assistance by the U.S. Attorney for the Southern District of Ohio, seized unapproved drugs valued at more than $11 million, which were marked by Ascend Laboratories of Montvale, N.J. and held by Masters Pharmaceuticals, Inc. of Cincinnati, OH. The products seized by the FDA included those marketed for the treatment of inflamed hemorrhoids, colitis and other inflammatory conditions (Hydrocortisone Acetate Suppositories, 25 mg) and skin thickening conditions such as dermatitis and eczema (Urea Cream 39%, Urea Cream 40% and Urea Lotion 40%). The FDA announcement can be found here.
The action taken against Ascend Laboratories and Masters Pharmaceuticals (“the Companies”) was taken as a follow up to a November 2013 inspection of Ascend, which found that these products had been marketed in the absence of an FDA-approved drug application. The inspection further found that these products were misbranded and were being sold contrary to the guidance provided by the FDA for the proper labeling and marketing of a drug or cosmetic.
The FDA took action by filing a complaint in the U.S. District Court for the Southern District of Ohio, citing that the Companies violated the provisions of the Federal Food, Drug and Cosmetic Act (“FFDCA”) found in Title 21, Code of Federal Regulations as promulgated under 21 U.S.C. 321 and 387. Under FFDCA and accompanying FDA regulations, products that intended to be used in the diagnosis, cure, treatment or prevention of a disease or condition are considered drugs. As noted in this case, the Companies marketed products for various diseases and/or conditions, including hemorrhoids, colitis and eczema. Further, while the FDA did not allege the products themselves contained active pharmaceutical ingredients, it was the statements made in marketing that caused the products to be deemed unapproved new drugs. Accordingly, it is important to ensure compliance with certain marketing limitations in order to avoid misbranding and other FDA violations.
In sum, this case illustrates the importance of ensuring that the marketing materials of FDA-regulated products, including websites, print media and product labels, are properly worded because statements made in marketing play a key role in determining how FDA-regulated products are regulated. Second, this case illustrates the importance of being responsive and remaining committed to taking all necessary corrective actions after deficiencies are alleged, as the Agency will pursue legal action for violations of the laws and regulations it enforces.
If you have any questions about the FDA’s food, drug and cosmetic regulations or how you can maintain compliance with these regulations, please contact us at firstname.lastname@example.org.