Amsterdam, Daniel Erie County Medical Center Corp. Buffalo, NY (11/17). Inspected 7/12-21. Clinical studies violations: Investigator enrolled 225 low risk subjects in the study, but failed to document that the subjects met the enrollment criteria of health status and age. Investigator also violated the protocol and the requirements for obtaining informed consent by conducting repeat testing of 11 subjects. The protocol and informed consent form do not provide any circumstances by which subjects could be recalled to the clinic for additional testing. Investigator violated the protocol by having two separate groups conduct subject and control testing for this study, and each group failed to run daily controls, etc. (device study); 21CFR 812.100, 812.140(a)(3) (CBER-05-005)
http://www.fda.gov/foi/warning_letters/g5099d.pdf
Bradley Pharmaceuticals, Inc. Fairfield, NJ (11/9). Misbranded: DDMAC reviewed a professional sales aid for Pamine 2.5 mg tablets and a patient brochure for Pamine Forte 5 mg tablets. DDMAC says the professional sales aid, patient brochure, and Web site contain numerous effectiveness claims for the drugs that are not supported by substantial evidence or substantial clinical experience. Statements from the sales aid are: “Not likely to produce CNS side effects such as lightheadedness, blurred vision, fatigue/drowsiness, and dizziness.” The Web site includes statements such as “Does not cross the blood-brain barrier, No Significant CNS Effects, and Unlike hyoscyamine sulfate, dicyclomine hydrochloride USP.” DDMAC notes that these statements suggest that Pamine is not likely to produce central nervous system side effects because it does not penetrate the blood-brain barrier. DDMAC adds that this is false or misleading. The agency points out that Pamine is associated with several CNS side effects, including drowsiness, blurred vision, headache, nervousness, mental confusion, and dizziness, and limited ability to cross the blood-brain barrier. (Pamine) FDCA 352(a),(n), 321(n), 202.1(e)(5), 21CFR 314.81(b)(3)(i)
