CopyCited 5 times | Published | Florida 1st District Court of Appeal | 2009 Fla. App. LEXIS 8512, 2009 WL 1741035
..., Inc. (Mylan), appellee, the manufacturer of a competing generic drug. In the summary final order, the ALJ ruled that Florida Administrative Code Rule 64B16-27.500(6), which was part of the negative drug formulary (NDF) rule established pursuant to section 465.025(6), Florida Statutes (2007), and which listed LS on the NDF, was invalid on the grounds that it constituted an invalid exercise of legislative delegated authority because it conflicted with the provisions of section 465.0251(1), Florida Statutes (2007). Section 465.0251(1) removes a generic drug from the NDF if the generic drug is "A" rated as therapeutically equivalent to a reference listed drug as referred to in the "Orange Book" [1] published by the United States Food and Drug Administration (FDA). The ALJ's order, in effect, removes LS from the NDF and permits Florida pharmacists to substitute Mylan's generic LS product for a prescription for Synthroid® or any other "A" rated LS drug product, except as provided in section 465.025(2), Florida Statutes (2007). Because the ALJ erred in interpreting section 465.0251(1) to apply to editions of the *645 Orange Book subsequent to the date of the 2001 enactment of the statute, we reverse and remand....
...Instead, the FDA requires a showing that, with regard to certain characteristics, the proposed generic product is essentially the same as the approved product it purports to copy, which is referred to as the "listed drug." See 21 U.S.C. § 355(j) (2006) (because of the language in section 465.0251(1), we will refer to a "reference listed drug")....
...harmacy to establish by rule a list of those drugs that "demonstrate clinically significant biological or therapeutic inequivalence and which, if substituted, would pose a threat to the health and safety of patients receiving prescription medicine." § 465.025(6), Fla....
...Thus, in Florida, when a patient receives a prescription for a brand name drug and takes it to a Florida pharmacy, the pharmacist is required by law to substitute a less expensive generic drug unless: (1) the patient requests otherwise; (2) the doctor directs otherwise; or (3) the drug is listed on Florida's NDF. § 465.025(2), Fla. Stat. Because LS was listed on the NDF, prior to the invalidation of rule 64B16-27.500(6), when a doctor prescribed a specific LS drug product, the patient would only receive that product, whether it was a brand name or a generic. § 465.025(6)(b), Fla. Stat. As a result of the order under review, except as provided in section 465.025(2), Florida pharmacists may substitute Mylan's generic LS product for a prescription for Synthroid® or any of the other brand name or generic LS products. The ALJ's decision invalidating rule 64B-27.500(6) rests on the interpretation and application of section 465.0251, enacted in 2001, and section 465.025 first enacted in 1979. Section 465.025, Florida Statutes (2007), entitled "Substitution of Drugs" provides, in pertinent part, as follows: (1) As used in this section: (a) "Brand name" means the registered trademark name given to a drug product by its manufacturer, labeler, or distributor....
...h formulary into its rules. No pharmacist shall substitute a generically equivalent drug product for a prescribed brand name drug product if the brand name drug product or the generic drug type drug product is included in the said formulary. Reading section
465.025(6) in its entirety, a party seeking to remove a drug product from the NDF has the burden of proof to show that the removal would not "pose a threat to the health and safety of patients receiving prescription medication." Section
465.0251, Florida Statutes (2007), permits removal from the NDF under specific circumstances and states:
465.0251 Generic drugs; removal from formulary under specified circumstances. (1) The Board of Pharmacy and the Board of Medicine shall remove any generic named drug product from the formulary established by s.
465.025(6), if every commercially marketed equivalent of that drug product is "A" rated as therapeutically equivalent to a reference listed drug or is a reference listed drug as referred to in "Approved Drug Products with Therapeutic Equivalence Evaluations" (Orange Book) published by the *648 United States Food and Drug Administration. (2) Nothing in this act shall alter or amend s.
465.025 as to existing law providing for the authority of physicians to prohibit generic drug substitution by writing "medically necessary" on the prescription. Although subsection (1) of section
465.0251 requires removal of a drug product from the NDF without an express finding that the removal will not pose a threat to the health and safety to patients as required by section
465.025, subsection (2) emphasizes that section
465.0251 does not "alter or amend s.
465.025." Section
120.56 Proceeding This proceeding began on August 17, 2007, when Mylan filed a petition seeking to have rule 64B16-27.500(6) declared invalid....
...Mylan, as the petitioner, had the "burden of proving by a preponderance of the evidence that the existing rule is an invalid exercise of delegated legislative authority as to the objections raised." §
120.56(3)(a), Fla. Stat. (2007). Mylan contended that the inclusion of LS on the NDF in rule 64B16-27.500(6) contravenes subsection
465.0251(1), which requires that a drug be removed from the NDF "if every commercially marketed equivalent of that drug product is `A' rated as therapeutically equivalent to a reference listed drug or is a reference listed drug as referred to in" the Orange Book. In response, Abbott argued that it would be unconstitutional to utilize the Orange Book as it exists in 2007 and that the 2001 Orange Book, in effect when section
465.0251 was enacted, must be used to determine the validity of rule 64B16-27.500(6)....
...Id., citing Drugs @ FDA Glossary of Terms, http://www.fda.gov/cder/ drugsatfda/glossary.htm. Products are bioequivalent if they release the active ingredient into the bloodstream at essentially the same rate and essentially to the same extent. See 21 U.S.C. § 355(j)(8)(B) (2006). In addition, section 465.025(5) provides that each community pharmacy must establish "a formulary of generic and brand named drug products, which, if selected as the drug of choice, would not pose a threat to the health and safety of patients...." Although a pharmacist is required to rely on drug product research, testing, information, and formularies by other agencies, including the FDA, under the statute the pharmacist's formulary is not required to be consistent with the Orange Book formulary. Id. Under section 465.025(2), pharmacists are required to substitute a "less expensive, generically equivalent drug product" for a brand name, unless the prescriber expressly indicates the brand named drug is medically necessary or the purchaser requests otherwise. Section 465.025(1)(b) defines "generically equivalent drug product" as a drug product with the same active ingredient, finished dosage form, and strength....
...As a result, a substituted generic product could differ materially from the prescribed drug in the manner in which the active ingredient is released into the bloodstream. Of course, drug products listed in the NDF may not be substituted. Fla. Admin. Code R. 64B16-27.500. As noted, pursuant to section 465.025(6), a person seeking to remove a drug from the NDF has the burden of demonstrating that substitution of the drug would not "pose a threat to the health and safety of patients." The record reflects that previous efforts to remove LS from the NDF utilizing that standard have been unsuccessful. In this proceeding, Mylan has argued that, by operation of law, LS must be removed from the NDF because section 465.0251, Florida Statutes (2007), requires removal as a matter of law. Although Abbott submitted evidence by affidavit in the proceeding below that substituting generic LS drugs could be harmful to patients, that evidence was not considered by the ALJ, because the ALJ determined that section 465.0251(1) required removal as a matter of law....
...adopting federal agency rules or federal laws that take effect after the enactment of the Florida Statute. See Fla. Indus. Comm'n v. State,
155 Fla. 772,
21 So.2d 599 (1945); Freimuth v. State,
272 So.2d 473 (Fla.1972). *650 Abbott also argued that section
465.0251 was ambiguous and should be construed to require that "A" rated reference listed drugs and generic drugs must be therapeutically equivalent to all the other reference listed drugs. The ALJ rejected this interpretation of the statute, reasoning, as follows: The plain and obvious meaning of Subsection
465.0251(1), Florida Statutes, is that a generic named drug product is to be removed from the negative drug formulary if the generic equivalent is "A" rated as therapeutically equivalent to a reference listed drug as referred to in the Orange Book....
...Following a hearing on December 11, 2007, the ALJ found that an evidentiary hearing was not necessary and issued a summary final order on January 28, 2008. In the summary final order, the ALJ accepted Mylan's argument that the 2007 version of the Orange Book could be used in applying section 465.0251 on the authority of Eastern Air Lines, Inc....
...ates a federal index to provide aid in making a ministerial determination. Id. at 316. The ALJ found the FDA revisions to the Orange Book analogous to the CPI index in Eastern Air Lines. In the order under review, the ALJ explained her reasoning: In section 465.0251, Florida Statutes, the Legislature has set out specific standards, which when met require the removal of a drug product from the negative drug formulary....
...tandards used in 2007.... Naturally, as new drugs are *651 sought to be approved, the list of reference listed, "A" rated, and therapeutically equivalent drug products will vary, like the CPI will vary. When drug products meet the criteria listed in section 465.0251, Florida Statutes, the removal becomes a ministerial duty. As a result, because Mylan had demonstrated that LS under the 2007 Orange Book now meets the criteria of section 465.0251(1), the ALJ ruled that rule 64B16-27.500(6) was invalid and that LS must be removed from the NDF....
...Thus, section
120.56(3) delays the date on which a rule shall become void until after appellate proceedings have ended. To interpret this statute in any other manner would deny a party the right to appellate review of an ALJ order invalidating a rule in the absence of a stay. Such a result is not supported by any authority. Section
465.0251 We now turn to the merits of the parties' arguments with respect to section *654
465.0251....
...not supported by competent, substantial evidence established in the record of the administrative hearing. Wise v. Dep't of Mgmt. Servs., Div. of Ret.,
930 So.2d 867, 870-71 (Fla. 2d DCA 2006). As it did below, on appeal Abbott asserts that, because section
465.0251 provides that "if every commercially marketed equivalent of that drug product is `A' rated as therapeutically equivalent to a reference listed drug ..." (emphasis applied), every commercially marketed LS product must be "A" rated to all of the reference listed drugs. If that position had been accepted by the ALJ, the ALJ would have been required to leave LS on the NDF because it is uncontroverted that no generic LS is "A" rated to Levothroid®. We hold that the ALJ correctly interpreted section
465.0251(1) in ruling that the statute is clear and unambiguous and provides that a generic drug product is to be removed from the NDF list if the generic equivalent is "A" rated as therapeutically equivalent to any single reference listed drug in the Orange Book....
...Accordingly, we reject Abbott's contention that a named drug product like LS can be removed from the negative drug formulary only if all generic LS products are "A" rated as to each reference listed drug. Alternatively, Abbott argues that reversal is nonetheless required because the ALJ unconstitutionally applied section 465.0251. Abbott contends that the legislature could not have intended to incorporate updated editions of the Orange Book to govern section 465.0251 because of the long-established constitutional rule in Florida that the legislature's adoption "in advance [of] any federal act or ruling of any federal administrative body which may be adopted in the future would amount to an unlawful delegation of legislative authority." State v....
...In short, we conclude that the drug products listed in the Orange Book are much more like the list of hallucinogenic drugs in Freimuth than the CPI index in Eastern Air Lines. Because the FDA makes substantive changes to the Orange Book, to interpret section 465.0251 as allowing the FDA's Orange Book to determine which drugs should be on the NDF would constitute an unlawful delegation of legislative authority to the FDA. See Freimuth. Moreover, we are persuaded that, when the legislature enacted section 465.0251, it did not intend the result obtained *657 by the ALJ's order. Subsection (2) of that statute clearly states the legislative intent that the statute was not meant to override section 465.025....
..."Where possible, courts must give effect to all statutory provisions and construe related statutory provisions in harmony with one another." Forsythe v. Longboat Key Beach Erosion Control Dist.,
604 So.2d 452, 455 (Fla.1992). With these principles in mind, we read section
465.0251 as only applying the edition of the Orange Book in effect on or before the date on which the statute was enacted. This interpretation leaves in full force and effect the provisions of section
465.025(6), which delegates the authority to establish the NDF to the Board of Pharmacy and the Board of Medicine. Thus, those Boards are left with the authority to determine whether certain drug substitutions would pose a threat to the health and safety of Florida patients. We cannot accept that in section
465.0251 the legislature intended to delegate to the FDA the legislative authority to determine, on a continuing basis, which drug substitutions would pose a threat to health and safety of Florida patients. If, indeed, the legislature intends the NDF to be governed by the revised versions of the Orange Book, as Mylan asserts, then the legislature can update section
465.0251 each year "by bringing forward [the Orange Book] each year." Rodriquez,
365 So.2d at 160....
...of Cosmetic Surgery, Inc.,
808 So.2d 243, 250 (Fla. 1st DCA 2002). See also Florida Dep't of Offender Rehabilitation v. Jerry,
353 So.2d 1230, 1236 (Fla. 1st DCA 1978). It cannot be disputed that both parties' interests are within the zone of interest regulated by §§
465.025 and
465.0251 and rule 64B16-27.500....
