In a letter dated 10/29/14, the US Food & Drug Administration’s Office of Prescription Drug Promotion (OPDP) warned insomnia therapy pill manufacturer Sciecure Pharma Inc that its misleading sales aid is not acceptable. Sciecure Pharma manufactures Doral (quazepam) Tablets for oral use C-IV.
The OPDP says:
The sales aid is misleading because it omits important risk information associated with Doral, contains unsubstantiated superiority claims, and omits material facts. Thus, the sales aid misbrands Doral within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and makes its distribution violative. 21 U.S.C. 352(a); 321(n); 331(a); 21 CFR 1.21(a). Cf. 21 CFR 202.1(e)(5)(i), (iii); (e)(6)(ii). Sciecure Pharma also did not comply with 21 CFR 314.81(b)(3)(i).
In a section of the letter highlighting Sciecure Pharma’s omission of risk information, the OPDP says:
The four page sales aid includes numerous claims and presentations regarding the benefits of using Doral for the treatment of insomnia, yet omits all of the contraindications for the use of Doral. The sales aid also omits the warnings and precautions regarding benzodiazepine withdrawal syndrome, the need to evaluate for co-morbid diagnoses, severe anaphylactic or
anaphylactoid reactions, abnormal thinking and behavior changes, and worsening of depression. The omission of these serious risks associated with the drug is further exacerbated by the claims on pages two and four characterizing Doral as having a “[f]avorable safety profile.”
The letter also detailed other violations.
OPDP requested that Sciecure Pharma immediately cease violating the FD&C Act and submit a written response.
