07-003704RX Mylan Pharmaceuticals, Inc. vs. Department Of Health, Board Of Pharmacy And Board Of Medicine Status: Closed DOAH Final Order on Monday, January 28, 2008.

Summary: The inclusion of Levothyroxine Sodium on the negative drug formulary contravened Section 465.0251, Florida Statutes.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

MYLAN PHARMACEUTICALS, INC. , )

)

Petitioner , )

)

vs. ) Case No. 07 - 3704RX

)

DEPARTMENT OF HEALTH, BOARD OF )

PHARMACY AND BOARD OF MEDICINE , )

)

Respondents, )

)

and )

)

ABBOTT LABORATORIES, )

)

Intervenor . )

)

SUMMARY FINAL ORDER

Pursuant to notice, an oral argument was held in this case

on December 11, 2007, in Tallahassee, Florida, before Susan B.

Harrell, a designated Administrative Law Judge of the Division

of Administrative Hearings.

APPEARANCES

For Petitioner: William E. Williams, Esquire

Edwin A. Bayo, Esquire

Amy W. Schrader, Esquire

Gray Robinson, P.A.

301 South Bronough Street, Suite 600

Post Office Box 1189

Tallahassee, Florida 32302 - 3189

For Respondent Board of Pharmacy:

Reginald Dixon, Esquire

Office of the Attorney General

The Capitol, Plaza Level 01

Tallahassee, Florida 32399 - 1050

For Respondent Board of Medicine:

Edward A. Tellechea, Esquire

Office of the Attorney General

The Capitol, Plaza Level 01

Tallahassee, Florida 32399 - 1050

For Intervenor: Michael J. Glazer, Esquire

Ausley & McMullen

227 South Calhoun Street

Post Office Box 391

Tallahassee, Florida 32302

Peter Witty, Esquire

Abbot Laboratories

100 Abbott Park Road

Abbott Park, Illinois 60064

STATEMENT OF THE ISSUE

The issue in this case is whether Florida Administrative

Code Rule 64B16 - 27.500(6) regarding the negative drug formulary

is an invalid exercise of delegated legislative authority within

the meaning of S ubs ection 120.52(8), Florida Statutes (2 007). 1

PRELIMINARY STATEMENT

On August 17, 2007, Petitioner, Mylan Pharmaceuticals, Inc.

(Mylan), filed a Petition Seeking a n Administrative

Determination o f t he Invalidity o f a n Existing Rule, challenging

the validity of Florida Administrative Code Rule 6 4B16 - 27.500(6)

relating to the inclusion of Levothyroxine Sodium on the

negative drug formulary. On August 24, 2007, Intervenor, Abbott

Laboratories (Abbott), filed a Petition to I ntervene, which was

granted by O rder dated August 29, 2007. The final hear ing was

originally scheduled for September 17, 2007. The parties stated

that they intended to file motions for final summary judgment,

and the final hearing was continued and rescheduled for

December 10 and 11, 2007. On November 5, 2007, Mylan and Abbot t

filed motions for summary final judgment. On November 9, 2007,

Respondent, Board of Medicine, filed a Notice of Joining with

Intervenor in its Motion for Final Summary Judgment. On

November 19, 2007, the final hearing was continued and

rescheduled for January 3 and 4, 200 8 . On November 27, 2007,

Mylan and Abbott filed responses to each other’s motions for

final summary judgment, and the Board of Medicine joined in

Abbott’s response.

On December 11, 2007, the parties presented oral argument

on the motio ns for final summary judgment. The final hearing

scheduled to commence on January 3, 200 8 , was cancelled pending

a ruling on the motions for final summary judgment.

FINDINGS OF FACT

1. Levothyroxine Sodium is a drug used to treat

Hypothyroidism and Pitui tary TSH Suppression.

2. Mylan develops, manufactures, and sells generic

pharmaceuticals and is licensed as a non - resident prescription

drug manufacturer and an out - of - state prescription drug

wholesaler in Florida pursuant to Section 499.01, Florida

Statu tes. Mylan has received approval from the United States

Food and Drug Administration (FDA) to market 12 strengths of

generic Levothyroxine Sodium tablets, which the FDA has

determined to be bioequivalent and therefore therapeutically

equivalent to corresp onding strengths of four reference listed

drugs 2 : Unithorid® tablets, Synthroid® tablets, Levoxyl®

tablets, and Levothroid® tablets.

3. Abbott is the manufacturer of Synthroid®, a

Levothyroxine Sodium product marketed in Florida and other

places.

4. The Board of Pharmacy “has authority to adopt rules

pursuant to ss. 120.536(1) and 120.54 to implement the

provisions of [Chapter 465] conferring duties upon it.”

§ 465.005, Fla. Stat. Subsection 465.025(6 ), Florida Statutes,

provides:

The Board of Pharmac y and the Board of

Medicine shall establish by rule a formulary

or generic drug type and brand name drug

products which are determined by the boards

to demonstrate clinically significant

biological or therapeutic inequivalence and

which, if substituted, wo uld pose a threat

to the health and safety of patients

receiving prescription medication.

5. Subsection 465.025(1)(a), Florida Statutes, defines

“brand name” as “the registered trademark name given to a drug

product by its manufacturer, labeler, or distr ibutor.”

“Generically equivalent drug product” is defined in Subsection

465.025(1)(b) , Florida Statutes, as “a drug product with the

same active ingredient, finished dosage form, and strength.”

6. Subsection 465.025(2), Florida Statutes, provides:

(2) A pharmacist who receives a

prescription for a brand name drug shall,

unless requested otherwise by the purchaser,

substitute a less expensive, generically

equivalent drug product that is:

(a) Distributed by a business entity doing

business, and subject t o suit and service of

legal process, in the United States; and

(b) Listed in the formulary of generic and

brand name products as provided in

subsection (5) for the brand name drug

prescribed unless the prescriber writes the

words “MEDICALLY NECESSARY,” i n her or his

own handwriting, on the face of a written

prescription; unless, in the case of an oral

prescription, the prescriber expressly

indicates to the pharmacist that the brand

name drug prescribed i s medically necessary;

or unless, in the case of a p rescription

that is electronically generated and

transmitted, the prescriber makes an overt

act when transmitting the prescription to

indicate that the brand name drug prescribed

is medically necessary. When done in

conjunction with the electronic transmi ssion

of the prescription, the prescriber’s overt

act indicates to the pharmacist that the

brand name drug prescribed is medically

necessary.

7. Subsection 465.025(5), Florida Statutes, provides:

Each community pharmacy shall establish a

formulary of gen eric and brand name drug

products which, if selected as the drug

product of choice, would not pose a threat

to the health and safety of patients

receiving prescription medication. In

compiling the list of generic and brand name

drug products for inclusion in the

formulary, the pharmacist shall rely on drug

product research, testing, information, and

formularies compiled by other pharmacies, by

states, by the United States Department of

Health, Education, and Welfare, by the

United States Department of Heal th and Human

Services, or by any other source which the

pharmacist deems reliable. Each community

pharmacy shall make such formulary available

to the public, the Board of Pharmacy, or any

physician requesting same. The formulary

shall be revised followin g each addition,

deletion, or modification of said formulary.

8. If a brand name drug or a generic drug type drug

product is listed on the negative drug formulary established by

the Board of Pharmacy and Board of Medicine, a pharmacist is

prohibited from substituting a generically equivalent drug

product for a prescribed brand name drug product.

§ 465.025(6)(b), Fla. Stat. The Board of Pharmacy has adopted a

negative drug formulary which is contained in Florida

Administrative Code Rule 64B16 - 27.500, an d Levothyroxine Sodium

is listed on the negative drug formulary. Thus, Mylan’s generic

products currently cannot be substituted where a prescription is

written for a brand name Levothyroxine Sodium product.

9. Mylan has challenged Florida Administrative Code

Rule 64B16 - 27.500(6) , which provides:

The negative drug formulary is composed of

medicinal drugs which have been specifically

determined by the Board of Pharmacy and the

Board of Medicine to demonstrate clinically

significant biological or therapeuti c

inequivalence and which, if substituted,

could produce adverse clinical effects, or

could otherwise pose a threat to the health

and safety of patients receiving such

prescription medications. Except where

certain dosage forms are included on the

negativ e drug formulary as a class, all

medicinal drugs are listed by their official

United States Pharmacopoeia Non - Proprietary

(generic) name. The generic name of a drug

shall be applicable to and include all

brand - name equivalents of such drug for

which a p re scriber may write a prescription.

Substitution by a dispensing pharmacist on a

prescription written for any brand name

equivalent of a generic named drug product

listed on the negative drug formulary or for

a drug within the class of certain dosage

forms as listed, is strictly prohibited. In

cases where the prescription is written for

a drug listed on the negative drug formulary

but a name brand equivalent is not specified

by the prescriber, the drug dispensed must

be one obtained from a manufacturer or

d istributor holding an approved new drug

application or abbreviated new drug

application issued by the Food and Drug

Administration, United States Department of

Health and Welfare permitting that

manufacturer or distributor to market those

medicinal drugs o r when the former is not

applicable, those manufacturers or

distributors supplying such medicinal drugs

must show compliance with other applicable

Federal Food and Drug Administration

marketing requirements. The following are

included on the negative drug formulary:

* * *

(6) Levothyroxine Sodium.

10. Subsection 465.0251(1), Florida Statutes, provides:

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 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) pub lished by the

United States Food and Drug Administration.

11. The Orange Book identifies drug products approved on

the basis of safety and effectiveness by the FDA under the

Federal Food, Drug, and Cosmetic Act. It also includes

therapeutic equivalence evaluations for approved multisource

prescription drug products. The Orange Book is updated annually

and is supplemented with monthly cumulative updates.

Additionally, the FDA has a website containing an electronic

version of the Orange Book , which is al so updated. The Orange

Book used in 2007 is the 27 th Edition. The Orange Book in

effect at the date of the enactment of Section 465.0251, Florida

Statutes, 3 was the 21 st Edition.

12. Generally, approval by the FDA is required before a

prescription drug product may be marketed, distributed, or sold

in the United States. See 21 U.S.C. § 355(a). When a product

contains a new active ingredient or otherwise differs

significantly from previously approved products, the sponsor

must provide the FDA with data d emonstrating the product’s

safety and effectiveness for the intended use. See , e.g. ,

21 U.S.C. § 355(b). When a product is a copy of a previously

approved product — - what is commonly called a “generic” version of

the original drug — - proof of safety and eff ectiveness is not

required. 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 called the “reference listed drug.” S ee

21 U.S.C. § 355(j). The FDA’s previous finding that the

reference listed drug is safe and effective is then imputed to

the generic product.

13. In general, the generic product must contain the same

active ingredient in the same strength, and it must b e in the

same dosage form ( e.g. , tablet, capsule, solution) as the

reference listed drug. See 21 U.S.C. § 355(j). Products that

share these characteristics are considered “pharmaceutical

equivalents” by the FDA. Orange Book , 27 th E d., at v - vi

(Jan. 200 7). S ubs ection 465.025(1)(b), Florida Statutes, uses

the term “generically equivalent drug products” to describe such

products. “Drug products are considered to be therapeutic

equivalents only if they are pharmaceutical equivalents and if

they can be exp ected to have the same clinical effect and safety

profile when administered to patients under the conditions

specified in the labeling.” Orange Book , 27 th Ed. at vi.

14. The FDA classifies as therapeutically equivalent those

products that meet the follow ing criteria:

(1) they are approved as safe and

effective;

(2) they are pharmaceutical equivalents in

that they (a) contain identical amounts of

the same active drug ingredient in the same

dosage form and same route of

administration, and (b) meet compe ndial or

other applicable standards of strength,

quality, purity, and identity; (3) they are

bioequivalent in that (a) they do not

present a known or potential bioequivalence

problem, and they meet an acceptable in

vitro standard, or (b) if they do present

such a known or potential problem, they are

shown to meet an appropriate bioequivalence

standard; (4) they are adequately labeled;

(5) they are manufactured in compliance with

Current Good Practice Manufacturing Practice

regulations.

Id. These criteria are essentially the same criteria that

existed in 2001 as shown in the final staff analysis of HB69,

which was passed and became Chapter 2001 - 146, Laws of Florida,

now codified as Sect ion 465.0251, Florida Statutes.

15. Drug products that have been relied on as reference

listed drugs are so identified in the Orange Book, and products

that are therapeutically equivalent to each other are identified

by a shared therapeutic equivalence evaluation code (TE code).

These are primarily, but not exclusively, refe rence listed drugs

and the generic drugs approved on the grounds of pharmaceutical

equivalence and bioequivalence to those reference listed drugs.

16. Generally, the FDA uses a two - letter TE code, with a

code of “AB” given to solid oral dosage form produc ts that have

demonstrated therapeutic equivalence. Orange Book , 27 th E d. at

xii - xiii. For the vast majority of most multi - source drugs,

there is one product that is the reference listed drug and one

or more generic versions of that product, and all the p roducts

share a TE code of AB. However, there are situations in which

there is more than one reference listed drug. These situations

are discussed in the Orange Book , 27 th E d. at xiv.

In certain instance, a number is added to

the end of the AB code to ma ke a three

character code ( i.e., AB1, AB2, AB3, etc.).

Three - character codes are assigned only in

situations when more than one reference

listed drug of the same strength has been

designated under the same heading. Two or

more reference listed drugs are generally

selected only when there are at least two

potential reference drug products which are

not bioequivalent to each other. If a study

is submitted that demonstrates

bioequivalence to a specific listed drug

product, the generic product will be given

the same three - character code as the

reference listed drug it was compared

against. . . . Drugs coded as AB under a

heading are considered therapeutically

equivalent only to other drugs coded as AB

under that heading. Drugs coded with a

three - character code under a heading are

considered therapeutically equivalent only

to other drugs coded with the same three -

character code under that heading.

The FDA first officially described the three - character code

rating system in the 16 th edition of the Orange Boo k in 1996.

17. Levothyroxine S odium tablets are a drug product for

which there are multiple reference listed drugs. Currently the

Orange Book identifies seven L evothyroxine S odium products

approved for sale in the United States: Synthroid ® , Levo - T ® ,

Lev oxyl ® , Levothroid ® , Unithroid ® , a generic - named product

manufactured by Genpharm, and a generic manufactured by Mylan.

The current Orange Book also contains the following

levothyroxine sodium products in a section identifying

“Discontinued” products that, although approved for distribution

in the United States, are not being marketed: Novothyrox,

Levolet, and Tirosint. The following drug products are

currently identified in the Orange Book as reference listed

drugs: Synthroid ® , Levo - T ® , Levoxyl ® , Levoth roid ® , and

Unithroid ® .

18. In the case of Levothyroxine S odium products, not all

the reference listed drugs are considered therapeutically

equivalent to one another. The Orange Book discusses this

situation and explains the therapeutic evaluations for

Le vothyroxine Sodium products as follows:

Because there are multiple reference listed

drugs of levothyroxine sodium tablets and

some reference listed drugs’ sponsors have

conducted studies to establish their drugs’

therapeutic equivalence to other reference

listed drugs, FDA has determined that its

usual practice of assigning two or three

character TE codes may be potentially

confusing and inadequate for these drug

products. Accordingly, FDA provides the

following explanation and chart of

therapeutic equival ence evaluations for

levothyroxine sodium products.

Levothyroxine Sodium (Mylan ANDA 76187)

tablets have been determined to be

therapeutically equivalent to corresponding

strengths of Unithroid (Jerome Stevens NDA

021210) tablets.

Levo - T (Alara NDA 02134 2), Levothyroxine

Sodium (Mylan ANDA 76187), Unithroid (Jerome

Stevens NDA 021210) and Levothyroxine Sodium

(Genpharm ANDA 76752) tablets have been

determined to be therapeutically equivalent

to corresponding strengths of Synthroid

(Abbott NDA 021402) tabl ets.

Levo - T (Alara NDA 021342), Unithroid (Jerome

Stevens NDA 021210), Levothyroxine Sodium

(Mylan ANDA 076187) and Levothyroxine Sodium

(Genpharm ANDA 76752 ) tablets have been

determined to be therapeutically equivalent

to corresponding strengths of Levo xyl

(King/Jones Pharma NDA 021301) tablets.

Levothyroxine Sodium (Mylan ANDA 76187)

tablets have been determined to be

therapeutically equivalent to corresponding

strengths of Levothroid (Lloyd NDA 021116)

tablets.

Novothyrox (Genpharm NDA 021292) requir es

further investigation and review to

establish therapeutic equivalence to

corresponding strengths of any other

Levothyroxine Sodium drug products and is

rated BX.

Levolet (Vintage NDA 021137) requires

further investigation and review to

establish therap eutic equivalence to

corresponding strengths of any other

Levothyroxine Sodium drug products and is

rated BX.

The chart outlines TE codes for all 0.025mg

products with other products being similar.

Therapeutic equivalence has been established

between pro ducts that have the same

AB黩魺 TE code. More than one TE code

may apply to some products. One common TE

code indicates therapeutic equivalence

between products.

Trade Name Applicant Potency TE Appl Product

CODE No No

UNITHROID STEVENS J 0.025mg A B1 21210 001

LEVOTHYROXINE SODIUM MYLAN 0.025mg AB1 76187 001

LEVOXYL JONES PHARMA 0.025mg AB1 21301 001

SYNTHROID ABBOTT 0.025mg AB1 21402 001

SYNTHROID ABBOTT 0.025mg AB2 21402 001

LEVOTHYROXINE SODIUM MYLAN 0.025mg AB2 76187 001

LEVO - T ALAR A PHARM 0.025mg AB2 21342 001

UNITHROID STEVENS J 0.025mg AB2 21210 001

LEVOTHYROXINE SODIUM GENPHARM 0.025mg AB2 76752 001

LEVOXYL JONES PHARMA 0.025mg AB3 21301 001

LEVO - T ALARA PHARM 0.025mg AB3 21342 001

UNITHROID STEVENS J 0.025mg AB3 2121 0 001

LEVOTHYROXINE SODIUM MYLAN 0.025mg AB3 76187 001

LEVOTHYROXINE SODIUM GENPHARM 0.025mg AB3 76752 001

LEVOTHROID LLOYD 0.025mg AB4 21116 001

LEVOTHYROXINE SODIUM MYLAN 0.025mg AB4 76187 001

NOVOTHYROX GENPHARM 0.025mg BX 21292 001

LEVOLET VINTAGE PHARMS 0.025mg BX 21137 001

Orange Book , 27 th E d. at xix - xx.

19. In the Orange Book , 21 st E d. (Cumulative Supplement 6,

June 2001), only two Levothyroxine Sodium tablet products were

listed, Levoxyl ® and Unithroid ® , and both were rated as BX,

meaning that the data that had been reviewed by FDA was

insufficient to determine therapeutic equivalence. There were

also 12 additional Levothryroxine Sodium products that were

being commercially marketed in the United States and were not

listed in the Orange Book.

CONCLUSIONS OF LAW

20. The Division of Administrative Hearings has

jurisdiction over the parties to and the subject matter of this

proceeding. §§ 120.56(1) and (3), Fla . Stat.

21. Subsection 120.56(1)(a), Florida Statutes, pro vides

that “any person substantially affected by a rule . . . may seek

an administrative determination of the invalidity of the rule on

the ground that the rule is an invalid exercise of delegated

legislative authority.” Subsection 120.52(8), Florida Stat utes ,

defines “invalid exercise of delegated legislative authority” as

follows:

“Invalid exercise of delegated legislative

authority” means action which goes beyond

the powers, functions, and duties delegated

by the Legislature. A proposed or existing

rul e is an invalid exercise of delegated

legislative authority if any one of the

following applies:

(a) The agency has materially failed to

follow the applicable rulemaking procedures

or requirements set forth in this chapter;

(b) The agency has exceeded its grant of

rulemaking authority, citation to which is

required by s. 120.54(3)(a)1.;

(c) The rule enlarges, modifies, or

contravenes the specific provisions of law

implemented, citation to which is required

by s. 120.54(3)(a)1.;

(d) The rule is vague , fails to establish

adequate standards for agency decisions, or

vests unbridled discretion in the agency;

(e) The rule is arbitrary or capricious. A

rule is arbitrary if not supported by logic

or the necessary facts; a rule is capricious

if it is adopt ed without thought or reason

or is irrational; or

(f) The rule imposes regulatory costs on

the regulated person, county, or city which

could be reduced by the adoption of less

costly alternatives that substantially

accomplish the statutory objectives.

A grant of rulemaking authority is necessary

but not sufficient to allow an agency to

adopt a rule; a specific law to be

implemented is also required. An agency may

adopt only rules that implement or interpret

the specific powers and duties granted by

the enabling statute. No agency shall have

authority to adopt a rule only because it is

reasonably related to the purpose of the

enabling legislation and is not arbitrary

and capricious or is within the agency’s

class of powers and duties, nor shall an

agency have the authority to implement

statutory provisions setting forth general

legislative intent or policy. Statutory

language granting rulemaking authority or

generally describing the powers and

functions of an agency shall be construed to

extend no furthe r than implementing or

interpreting the specific powers or duties

conferred by the same statute.

22. As the petitioner, Mylan has the “burden of proving by

a preponderance of the evidence that the existing rule is an

invalid exercise of delegated legisla tive authority as to the

objections raised.” § 120.56(3)(a), Fla. Stat.

23. Mylan a r gues that the inclusion of L evothyroxine

S odium in the negative drug formulary of Florida Administrative

Code Rule 64B16 - 27.500 contravenes S ubs ection 465.0251(1),

Flori da Statutes, which requires that a drug be removed from the

negative drug formulary “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 refer red to in” the Orange Book.

24. For Levothyroxine Sodium, the 27 th edition of the

Orange Book lists five reference listed drug products and two

generic drugs which are commercially marketed. They are all “A”

rated. One of the generic drug products is th erapeutically

equivalent to some but not all the reference listed drug

products, and one of the generic drug products is

therapeutically equivalent to all the reference listed drug

products. Thus, the commercially marketed generic drug products

for Levoth yroxine Sodium are therapeutically equivalent to at

least one of the reference listed drug products. Not all the

reference listed products are therapeutically equivalent to all

the ot her reference listed products.

25. Abbott and the Board of Medicine arg ue that Subsection

425.0251(1), Florida Statutes, requires that all commercially

marketed generic drug products for Levothyroxine Sodium and

apparently all commercially marketed reference listed drug

products for Levothyroxine Sodium be therapeutically equ ivalent

to one another.

26. Subsection 425.0251(1), Florida Statutes, is clear and

unambiguous. As the Florida Supreme Court stated in A. R.

Douglass, Inc. v. McRainey , 102 Fla. 1141, 1144, 137 So. 157,

159 (Fla. 1931):

The intention and meaning of the Legislature

must primarily be determined from the

language of the statute itself and not from

conjectures aliunde. When the language of

the statute is clear and unambiguous and

conveys a clear and definite meaning, there

is no occasion for resorting to t he rules of

statutory interpretation and construction;

the statute must be given its plain and

obvious meaning.

27. 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. The

statute does not state that all generic drug products must be

“A” rated as therapeutically equiv alent to all the reference

listed drugs in the Orange Book listed for a specific generic

named drug product. It just requires that every commercially

marketed generic drug be “A” rated as therapeutically equivalent

to a reference listed drug in the Orange Book. “A” is singular,

meaning one.

28. At the time that Section 465.0251, Florida Statutes,

was enacted, the FDA had been listing more than one referenced

drug product in certain situations and had been utilizing the

three - character TE codes. Obviousl y since the Legislature

referenced the Orange Book in the statute, the Legislature was

aware that the Orange Book used multiple reference listed drug

products at times and had adopted a three - character rating code

for those situations. The Legislature is presumed to know that

“a” means one. In Ward v. State , 936 So. 2d 1143, 1146 (Fla.

3 rd DCA 2006), the court stated:

We presume the legislature understands the

meaning of the language it uses and the

implications of its placement in a statute.

See , e.g. , Rinker Materials Corp. v. City of

N. Miami , 286 So. 2d 552, 553 (Fla.

1972)(“In statutory construction, statutes

must be given their plain and obvious

meaning and it must be assumed that the

legislative body knew the plain and ordinary

meanings of the word s.”); State ex rel. Bie

v. Swope , 159 Fla. 18, 24 So. 2d 748, 751

(1947) (“[t]he legislator is presumed to

know the meaning of words and the rules of

grammar . . .”).

If the Legislature had intended to mean that all generic drugs

must be therapeutically e quivalent to all reference listed drugs

for a specific drug, it could have worded the statute to say so.

It did not.

29. Abbott and the Board of Medicine argue that if

Levothyroxine Sodium is removed from the negative drug formulary

that patients will be endanger ed because pharmacists will

substitute a generic drug which is not therapeutically

equivalent to the brand name drug prescribed and therefore is

harmful to the patient. The Legislature has addressed this

issue in Subsection 465.025(5), Florida Statutes, by requiring

“[e]ach community pharmacy [ to ] establish a formulary of generic

and brand name drug products, which i f selected as the drug

product of choice, would not pose a threat to the health and

safety of patients receiving prescribed medicat ion.” The

Legislature has left it to the professional judgment of licensed

pharmacists to determine what substitutions would not pose a

threat to the health and safety of the patients. The

Legislature has required the pharmacy in compiling the formulary

to “rely on drug product research, testing, information, and

formularies compiled by other pharmacies, by states, by the

United States Department of Health, Education, and Welfare, and

by the United States Department of Health and Human Services, or

by any other source which the pharmacist deems reliable.” The

Orange Book is a publication of the United States Department of

Health and Human Services and has listed the therapeutic

equivalents for the drug products listed under the hearing of

Levothyroxine So dium. Although, a pharmacy is not required by

law to follow the Orange Book, it is to consider the Orange Book

in developing the formulary.

30 . Abbott and the Board of Medicine have also argued that

by deleting Levothyroxine Sodium from the negative drug

formulary that a pharmacist could substitute a reference listed

drug product that is not therapeutically equivalent to another

reference listed drug product. Again, the Legislature left the

decision of what drugs could safely be substituted to the

pharma cists by requiring the pharmacies to develop the formulary

set forth in Subsection 465.025(5), Florida Statutes.

3 1 . It should be noted that Subsection 465.0251(1),

Florida Statutes, does not require that all reference listed

drug products be therapeutica lly equivalent to one another. The

statute provides that if every commercially marketed equivalent

of a generic named drug product is a reference listed drug as

referred to in the Orange Book that the drug product should be

removed from the negative drug formulary. Thus, in the case

where there are multiple reference listed drugs for one drug

product listed in the Orange Book and they are the only

commercially marketed products for that particular drug, the

drug should not be listed on the negative drug f ormulary.

3 2 . Abbott and the Board of Medicine argue that the

current version of the Orange Book should not be used to

determine whether a drug should be removed from the negative

drug formulary, contending that the 21 st Edition of the Orange

Book in effe ct at the time of the enactment of Section 465.0251,

Florida Statutes, is to be utilized. They cite Florida

Industrial Commission v. State , 21 So. 2d 599 (Fla. 1945), for

the general rule that the Legislature may adopt rules and laws

of federal bodies and other states that are in existence and in

effect at the time the Legislature adopts the rules and laws.

See also Freimuth v. State , 272 So. 2d 473 (Fla. 1972). In

Freimuth , the court held that a Florida statute defining

“hallucinogenic drug” by referenc e to federal law did not

include those drugs listed in the federal law after the

enactment of the Florida s tatute. Id. at 476.

3 3 . Mylan contends that the 27 th e dition of the Orange

Book should be used , citing Eastern Air Lines v. Department of

Revenue , 455 So. 2d 311 (Fla. 1984). In Eastern Air Lines ,

Eastern Air Lines sought a declaratory judgment that a fuel tax

calculated by reference to the F ederal Consumer Price Index

(CPI) then in effect was unconstitutional. Eastern Air Lines

contended that the use of the varying price component of the CPI

issued by the United States Department of Labor in determining

the amount of the fuel tax was an improper delegation of

legislative authority because the CPI which was being used was

not in existence at the ti me the statute requiring its use was

enacted.

3 4 . The Court in Eastern Air Lines held that the statute’s

reference to the CPI and basing tax adjustments on a changing

numerical figure did not amount to an unconstitutional

delegation of legislative power. Id. at 316. The Court stated:

Here, the legislature is merely setting

forth the manner in which the department is

to determine the appropriate total motor

fuel and special fuel retail price. The

department is directed with precision how to

make such a d etermination. We think the

language of Welch [ 4 ] and Freimuth should be

interpreted to apply to statutes which

incorporate federal statutes or

administrative rules which substantively

change the law, and not to a statute which

incorporates a federal index to provide aid

in making ministerial decisions.

3 5 . 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. It

is akin to the use of th e CPI in Eastern Air Lines . The

standards which the FDA used in 2001 to determine whether a drug

product is therapeutically equivalent are essentially the same

standards used in 2007. The final staff analysis of HB 169

listed those criteria, and they are listed in the current

version of the Orange Book. Naturally, as new drugs are 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 cri teria listed in

Section 465.0251, Florida Statutes, the removal becomes a

ministerial duty.

3 6 . Mylan has demonstrated that Levothyroxine Sodium does

meet the criteria listed in Subsection 465.0251(1), Florida

Statutes, and should be removed from the neg ative drug formulary

contained in Florida Administrative Code Rule 64B16 - 27.500.

Because Florida Administrative Code Rule 64B16 - 27.500(6) lists

Levot h yroxine Sodium on the negative drug formulary , the Rule

contravenes Subsection 456.0251(1), Florida Statu tes, and is an

invalid exercise of legislative delegated authority.

ORDER

Based on the foregoing Findings of Fact and Conclusions of

Law, it is ORDERED

1. Mylan's Motion for Summary Final Order is GRANTED.

2. Abbott's Motion for Summary Final Order is DE NIED.

3. Florida Administrative Code Rule 64 B 16 - 27.500(6) is an

invalid exercise of legislative delegated authority.

DONE AND ORDERED this 28th day of January , 2008 , in

Tallahassee, Leon County, Florida.

S

SUSAN B. HARRE LL

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399 - 3060

(850) 488 - 9675 SUNCOM 278 - 9675

Fax Filing (850) 921 - 6847

www.doah.state.fl.us

Filed with the Clerk of the

Divisio n of Administrative Hearings

this 28th day of January , 2008 .

ENDNOTES

1/ Unless otherwise indicated, references to the Florida

Statutes are to the 2007 version.

2/ The FDA defines a reference listed drug (RLD) as “an approved

drug product to which new generic versions are compared to show

that they are bioequivalent.”

3/ Section 465.0251, Florida Statutes, became law effective

June 1, 2001.

4/ State v. Welch , 279 So. 2d 11 (Fla. 1973).

COPIES FURNISHED :

William E. Williams, Esquire

Edwin A. Bayo , Esquire

Amy W. Schrader, Esquire

Gray Robinson, P.A.

301 South Bronough Street, Suite 600

Post Office Box 1189

Tallahassee, Florida 32302

Edward A. Tellechea, Esquire

Office of the Attorney General

The Capitol, Plaza Level 01

Tallahassee, Florida 3239 9 - 1050

Reginald D. Dixon, Esquire

Office of the Attorney General

The Capitol, P laza Level 01

Tallahassee, Florida 32399 - 1050

Michael J. Glazer, Esquire

Ausley & McMullen

227 South Calhoun Street

Post Office Box 391

Tallahassee, Florida 32302

Peter Wi tty, Esquire

Abbot Laboratories

100 Abbott Park Road

Abbott Park, Illinois 60064

Scott Boyd, General Counsel

Administrative Procedures Committee

Holland Building, Room 120

Tallahassee, Florida 32399

Josefina M. Tamayo, General Counsel

Department of Heal th

4052 Bald Cypress Way, Bin A - 02

Tallahassee, Florida 32399 - 1701

Rebecca Poston, R.Ph., Executive Director

Board of Pharmacy

Department of Health

4052 Bald Cypress Way, Bin C - 04

Tallahassee, Florida 32399 - 1701

Larry McPherson, Executive Director

Boar d of Medicine

4052 Bald Cypress Way

Tallahassee, Florida 32399 - 1701

NOTICE OF RIGHT TO JUDICIAL REVIEW

A party who is adversely affected by this Final Order is

entitled to judicial review pursuant to Section 120.68, Florida

Statutes. Review proceeding s are governed by the Florida Rules

of Appellate Procedure. Such proceedings are commenced by

filing one copy of a Notice of Appeal with the agency clerk of

the Division of Administrative Hearings and a second copy,

accompanied by filing fees prescribed b y law, with the District

Court of Appeal, First District, or with the District Court of

Appeal in the appellate district where the party resides. The

Notice of Appeal must be filed within 30 days of rendition of

the order to be reviewed.