Source: https://quackwatch.org/cases/fdawarning/comp/murray/
Timestamp: 2020-08-04 23:25:34
Document Index: 347513247

Matched Legal Cases: ['§ 352', '§ 355', '§ 352', '§ 321', '§ 321', '§ 355', '§ 355', '§ 321', '§ 355', '§ 352', '§ 201']

Warning Letter to Murray Avenue Apothecary | Quackwatch
Warning Letter to Murray Avenue Apothecary
08-PHI-03
Ms. Susan Merenstein, Owner
Dear Ms. Merenstein:
We recently reviewed your firm’s website, www.murrayavenuerx.com. As explained below, your website contains false and misleading claims for your firm’s compounded hormone therapy drugs, causing those drugs to be misbranded in violation of Section 502(a) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 USC § 352(a)]. Additionally, your firm compounds a hormone therapy drug containing estriol, without an FDA-approved new drug application or an FDA-sanctioned investigational new drug application, in violation of Section 505 of the FDCA (21 USC § 355). Hormone therapy drugs containing estriol are also misbranded in violation of section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)] in that their labeling fails to bear adequate directions for use.
Under section 502(a) of the FDCA, a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FDCA [21 U.S.C. § 321(n)] provides that, in determining whether a drug’s labeling or advertising “is misleading, there shall be taken into account… not only representations made or suggested… but also the extent to which the labeling or advertising… fails to reveal facts material in tight of such representations….”
“Reduce risk of Heart Disease”
“Reduce risk of… breast cancers”
“Prevention of Alzheimer [sic] Disease and Senility”
2 . Unsubstantiated Superiority Claims
“Less unwanted side effects than synthetics”
“These plant-derived bio-identical hormones are almost entirely without the side effects of the synthetic or semi-synthetic HRT drugs commonly prescribed.”
“Another goal of natural HRT is to imitate the body’s natural processes as much as possible, thereby eliminating most of the unwanted effects and long term risks of the traditional synthetic hormone replacement therapies.”
These statements represent and suggest that your firm’s compounded hormone therapy drugs are superior to other hormone therapy products, including FDA-approved drugs. These claims – which are unsupported by substantial evidence (consisting of adequate and well controlled clinical investigations) – are false and misleading.
Your website claims that your firm’s compounded hormone therapy drugs are “bio-identical.” This claim, implies that your compounded hormone therapy drugs are natural, or identical to the hormones made by the body. FDA is unaware of substantial evidence (consisting of adequate and well controlled clinical investigations) to support the claimed “bio-identical” nature of your hormone therapy drugs.
Because your products are intended to treat, mitigate, and prevent disease (a conclusion supported by the claims described above), the estriol products compounded by your firm are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. 321(g)]. Further, as these products are not generally recognized by qualified experts as safe and effective for their labeled uses, they are new drugs, as defined by section 201(p) of the FDCA [21 U.S.C.§ 321(p)]. No FDA-approved applications pursuant to section 505 of the FDCA [21 U.S.C. § 355] are effective with respect to these drugs. Accordingly, their introduction or delivery for introduction into interstate commerce violates section 505(a) of the Act [21 U.S.C. § 355(a)].
The FDCA establishes agency jurisdiction over “new drugs,” Including compounded drugs. Compounded drugs are ,new drugs within the meaning of 21 U.S.C. § 321(p), because they are not “generally recognized, among experts… as safe and effective” for their labeled uses. See Weinberger v. Hynson, Westcott & Dunning, 412 U.S. 609, 619, 629-30 (1973) (explaining the definition of “new drug”). There is substantial judicial authority supporting FDA’s position that compounded drugs are not exempt from the new drug definition: See Prof’ls & Patients for Customized Care v. Shalala, 56 F.3d 592, 593 n.3 (5th Cir. 1995) (“Although the [FDCA] does not expressly exempt ‘pharmacies’ or compounded drugs’ from the new drug… provisions, the FDA as a matter of policy has not historically brought enforcement actions against pharmacies engaged in traditional compounding.”); In the Matter of Establishment Inspection of: Wedgewood Village Pharmacy, 270 F. Supp. 2d 525, 543-44 (D.N.J. 2003), aff’d, Wedge wood Village Pharmacy v. United States, 421 F.3d 263, 269 (3d Cir. 2005) (“The FDCA contains provisions with explicit exemptions from the new drug… provisions. Neither pharmacies nor compounded drugs are expressly exempted.”). Because they are “new drugs” under the FDCA, compounded drugs may not be introduced into interstate commerce without FDA approval.1
FDA’s current enforcement policy with respect to the compounding of human drugs is articulated in Compliance Policy Guide section 460.200 [Pharmacy Compounding”], issued by FDA on May 29, 2002 (see Notice of Availability, 67 Fed. Reg. 39,409 (June 7, 2002)).2 The CPG identifies factors that the Agency considers in deciding whether to initiate enforcement action with respect to compounding.3 These factors include whether a firm is “[c]ompounding finished drugs from bulk active ingredients that are not components of FDA approved drugs without an FDA sanctioned investigational new drug application (IND) in accordance with 21 U.S.C. § 355(i) and 21 CFR 312.”
C. Misbranded Drugs Under Section 502(0(1) of the FDCA: Estriol
The estriol drug compounded by your firm are also misbranded under section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)] in that their labeling fails to bear adequate directions for their use. Further, these drugs are not exempt from this requirement under 21 CFR § 201.115 because they are new drugs within the meaning of section 201(p) of the FDCA and they lack approved applications filed pursuant to section 505 of the FDCA.