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Prokarin™ was formerly known as "Procarin". The revised spelling was adopted to avoid potential conflicts with other existing trademarks.

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Contributing Author: Jeanette Bowers Weaver
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The information contained and presented herein is intended to provide general information only. It should not be construed or relied upon as individual legal advice and does not constitute an offer to represent you. The legal considerations discussed herein may differ widely based upon the specific situation. In addition, some information may be incomplete, out-of-date, or inapplicable to your jurisdiction (State).

JEANETTE BOWERS WEAVER AND JEANETTE BOWERS & ASSOCIATES, PLLC MAKE NO WARRANTY, EITHER EXPRESS OR IMPLIED, REGARDING THE COMPLETENESS, ACCURACY OR CURRENCY OF THIS INFORMATION OR ITS SUITABILITY FOR ANY PARTICULAR PURPOSE.


PROKARIN™ is a compounded drug exempt from FDA approval

The Federal Food, Drug and Cosmetic Act (FFDCA) prohibits the marketing of any “new drug” without prior approval of the Food and Drug Administration (FDA).[1]A “drug” is defined as “articles recognized in the official United States Pharmacopoeia” and “articles (other than food) intended to affect the structure or any function of the body of man . . .”[2] The term refers not only to the active ingredient in a drug product, but refers to the entire product.[3] The term “new drug” is defined as “[a]ny drug . . . [which is] not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof. . .” or any drug that “has become so recognized, but which has not . . . been used to a material extent or for a material time under such conditions.”[4]The newness of a drug may arise from a new drug use of a combination of two or more substances, none of which is a new drug, or the newness of the proportion of a substance in a combination, or the newness of the method of administration or application of such drug, even though the drug when used in another method of administration or application is not a new drug.[5]

When a drug product is compounded by a licensed pharmacist or licensed physician using drug substances that are components of FDA approved drugs, then FDA approval is not required to prescribe the product.[6]The FDA has long recognized that “once a product has been approved for marketing, a physician may prescribe it for [off-label] uses or in treatment regimens of patient populations that are not included in approved labeling.”[7] Prokarin™ is an off-label drug prescribed by physicians and compounded by pharmacists using drugs that are FDA approved.[8]The FDA entrusts physicians and pharmacists with the knowledge and skill to provide safe and effective off-label prescriptions to their patients, and consequently does not require off-label drugs such as Prokarin™ to be approved by the FDA for the use in treatment of MS.
PROKARIN™ does not require an NDC number
NDC numbers are 10-digit numbers used to identify manufactured drug products.[9]They are assigned when establishments engaged in the “manufacture, preparation, compounding, or processing” of drugs register their business and list their products with the Secretary of Health and Human Services (Secretary). [10]Generic drugs that have the same active ingredients and excipients together are covered by the NDA of the pioneer drug copied and do not require an NDA to be marketed.[11]EDMS is not engaged in any activity that requires registration of its business or product. Pharmacies which prepare Prokarin™ for sale in the regular course of their business are exempt from the requirement to register and list the drug because Prokarin™ consists of drug articles already registered and listed by other manufacturers.[12]Subsequently, Prokarin™ will never receive an NDC number even if EDMS elects to submit listing information because the most it can obtain is a 5-digit Labeler Code.13]

PROKARIN™ is not an “investigational new drug” in practice.

The Secretary has been granted authority to promulgate regulations for the efficient enforcement of the Federal Food, Drug, and Cosmetic Act (FFDCA) (§§ 201-902, 52 Stat. 1040 et seq., as amended, codified at 21 USC §§ 301-392).[14] These regulations define the term “investigational new drug” as a “new drug . . . that is used in a clinical investigation. 15]A clinical investigation is “any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.” [16]An experiment is “any use of a drug except for the use . . . in the course of medical practice.”[17] Because Prokarin™ is not a new drug currently undergoing clinical trials, it is not an "investigational new drug" as that term is defined by the FFDCA.

However, patients have two methods of obtaining access to investigational new drugs. One method is to obtain the drug from a licensed pharmacist who compounds the drug based upon an unsolicated prescription. [19]The other method involves obtaining the drug directly from the manufacturer or distributor of the drug, which is currently not the method used for obtaining Prokarin™. [20]Patients now have the right to obtain access to investigational drugs intended for serious diseases such as MS directly from a manufacturer through their physician [21]This method of access can be achieved by several methods, one of which is when a protocol for widespread use is submitted by the drug sponsor or a physician to the Secretary. [22]The Secretary must permit this method of expanded direct access to the new drug if the following conditions are met:

  • the new drug is intended for use in the treatment of a serious disease or condition;
  • there is no comparable or satisfactory alternative therapy available to treat the disease or condition in the patients for which the drug is intended;
  • the drug is under investigation in a controlled clinical trial for the use intended under an investigational drug application in effect under 21 USC § 355(i);
  • the sponsor is actively pursuing marketing approval for the use intended with due diligence; and
  • there is sufficient evidence of safety and effectiveness to support the intended use. [23]

However, when a so-called investigational new drug is obtained from and compounded by a licensed pharmacist, it is exempt from FDA application and approval procedures normally required of all investigational new drugs. [24]

References
[1]21 USC § 355.
[2]21 USC § 321(g)(1).
[3]See United States v. Generix Drug Corp., 460 U.S. 453, 454 (1983).
[4]21 USC § 321(p)(1), (p)(2).
[5]See 21 CFR § 310.3 (h).
[6]See 21 USC § 353a(a) (effective Nov. 21, 1998). NOTE: the Secretary of Health and Human Services will eventually issue regulations to implement § 353a, as required under § 353a(d)(1), and has reserved 21 CFR Pt. 216, Subpt. A and 21 CFR § 216.23 presumably for these regulations when made available.
[7]FDA Drug Bulletin 12:4, 1982, reprinted in 59 FR 59820, 59821, 1994.
[8]Histamine Phosphate (also known as Histamine di-phosphate) and caffeine.
[9]See 21 CFR § 207.35.
[10]21 USC § 360(b); See also 21 CFR § 207.20 and § 207.35.
[12]See 21 USC § 360(a),(g).
[13]See 21 CFR § 207.20 (b) and § 207.35(2)(i) (owners of an establishment not otherwise required to register that distribute under their own label or trade name a drug manufactured or processed by a registered establishment “may” elect to submit listing information directly to the FDA and obtain a 5-digit Labeler Code).
[14]See 21 USC § 371(a) and § 321(d).
[15]21 CFR § 312.3(b).
[16]21 CFR § 312.3(b).
[17] Id.
[18] At the moment, Prokarin™ is listed on the Internet as currently undergoing clinical studies. See http://www.cairx.com/page8.html
[19] See 21 USC § 353a(a).
[20] See 21 USC § 360bbb(b).
[21] See 21 USC § 360bbb(b). The term “serious disease” is not defined by the Act, but a debilitating disease with no known cure such as MS would likely fall within its meaning.
[22] See 21 USC § 360bbb(c).
[23] 21 USC § 360bbb(c).
[24] See 21 USC § 353a(a)(exempting pharmacy compounding from the provisions of § 355 on new drug applications).
[25] See Hoffman, supra note 25.
[26] Id. citing to Catherine A. Voigt & Kevin J. Conlon, Insurance Coverage for Experimental Treatment: New Hope for Patients, 83 Ill. B.J. 396, 398 (1995).
[27]See E. Farnsworth, Contracts 479-80 (1982); R. Jerry, Understanding Insurance Law 95-98 (1987); K. Abraham, Insurance Law and Regulation 47 (2d ed. 1995).
[28]See Johnson v. District Z Marine Eng’rs Beneficial Ass’n, 857 F.2d 514, 516 (9th Cir. 1988), cert. denied, 111 S.Ct. 581 (1990).
[29]See Zuckerberg v. Blue Cross & Blue Shield, 119 Misc.2d 834, 464 N.Y.S.2d 6787, 682 + n 83 (Sup. Ct. 1983), rev’d on other grounds, 108 A.D.2d 56, 487 N.Y.S.2d 595 (1985) (disagreeing in dicta with the trial court’s holding of ambiguity), aff’d, 67 N.Y.2d 688, 490 N.E.2d 839, 499 N.Y.S.2d 920 (1986) (declining to address the ambiguity issue).
[30]See Dozsa v. Crum & Forster Insurance Co., 716 F.Supp. 131, 139 (D.N.J. 1989) (cancer drug HDCT-ABMT held not experimental).
[31]See Zuckerbergsupra note 30.
[32] I.V. Services of America, Inc. v. Trustees of the American Consulting Engineers Council Ins. Trust Fund, 136 F.3d 114, 119 (2nd Cir. 1998).
[33] Id.
[34] Id.
[35] See Pirozzi v. Blue Cross-Blue Shield, 741 F. Supp. 586, 591 (E.D.Va. 1990).
[36] Id.
[37] Id.
[38] See Hoffman, supra note 25.
[39] Id., citing Harris v. Mutual of Omaha Cos., 992 F.2d 706 (7th Cir. 1993); Holder v. Prudential Ins. Co., 951 F.2d 89, 90 n.3 (5th Cir. 1992) (the policy excluded coverage of therapies that were not “commonly and customarily recognized throughout the doctor’s profession as appropriate in the treatment of the diagnosed sickness” or that were “educational or experimental in nature”).
[40]Id., citing Henderson v. Bodine Aluminum, Inc., 70 F.3d 958, 961 (8th Cir. 1995) (The health insurance plan in question covered high dose chemotherapy (HDCT) only for particular cancers, not including breast cancer, since it considered the treatment experimental for all but the specified cancers. The Eighth Circuit reversed and remanded the lower court's denial of plaintiff's motion for a preliminary injunction, finding that she showed a likelihood of success on the merits in proving that HDCT is an "accepted" therapy for breast cancer).
[41] Id., citing Schnitker v. Blue Cross/Blue Shield, 787 F. Supp. 903, 904 (D.C. Neb. 1991) (plan excluded from coverage any treatment that had not received final approval from the appropriate governmental entity or had been accepted by a consensus of opinion based on scientific evidence).
[42] , citing Leonhardt v. Holden Bus. Forms Co., 828 F. Supp. 657, 663 (D. Minn. 1993) (plan defined as "experimental" any treatment that is: (a) not proven in an objective manner to have therapeutic value or benefit; (b) restricted to use at medical facilities capable of carrying out scientific studies; or (c) of questionable medical effectiveness); Dozsa v. Crum & Forster Ins. Co., 716 F. Supp. 131, 134 (D.N.J. 1989) (plan excluded coverage for treatments that were not "commonly and customarily recognized throughout the doctor's profession as appropriate in the treatment of the sickness or injury" or that were "educational" or "experimental in nature" or were "provided primarily for research purposes").

 
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