06-002899RP Florida Medical Association vs. Department Of Health, Board Of Pharmacy Status: Closed DOAH Final Order on Wednesday, November 1, 2006.

Summary: Proposed rule 64B16-27.830(4) is an invalid delegation of delegated legislative authority because Respondent failed to follow applicable rulemaking procedures; exceeded its grant of rulemaking authority; and the rule is arbitrary and capricious.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

FLORIDA MEDICAL ASSOCIATION, )

)

Petitioner, )

and )

) Case No. 06-2899RP

FLORIDA ACADEMY OF FAMILY )

PHYSICIANS, FLORIDA ACADEMY )

OF PAIN MEDICINE, THE FLORIDA )

ASSOCIATION OF OCCUPATIONAL )

AND ENVIRONMENTAL MEDICINE, )

FLORIDA CHAPTER OF THE AMERICAN )

COLLEGE OF CARDIOLOGY, FLORIDA )

CHAPTER OF THE AMERICAN COLLEGE )

OF PHYSICIANS, FLORIDA CHAPTER )

OF THE AMERICAN COLLEGE OF )

SURGEONS, FLORIDA GERIATRICS )

SOCIETY, FLORIDA OSTEOPATHIC )

MEDICAL ASSOCIATION, FLORIDA )

PEDIATRIC SOCIETY, FLORIDA )

PSYCHIATRIC SOCIETY, FLORIDA )

PULMONARY SOCIETY, FLORIDA )

SOCIETY OF ADDICTION MEDICINE, )

FLORIDA SOCIETY OF )

ANESTHESIOLOGISTS, FLORIDA )

SOCIETY OF CLINICAL ONCOLOGY, )

FLORIDA SOCIETY OF DERMATOLOGIC )

SURGEONS, FLORIDA SOCIETY )

OF FACIAL PLASTIC AND RE- )

CONSTRUCTIVE SURGERY, FLORIDA )

SOCIETY OF INTERVENTIONAL PAIN )

PHYSICIANS, FLORIDA SOCIETY OF )

NEUROLOGY, FLORIDA SOCIETY OF )

OTOLARYNGOLOGY HEAD AND NECK )

SURGERY, FLORIDA SOCIETY OF )

PATHOLOGISTS, AND THE FLORIDA )

SOCIETY OF PHYSICAL MEDICINE )

AND REHABILITATION, )

)

Intervenors, )

)

vs. )

)

DEPARTMENT OF HEALTH, )

BOARD OF PHARMACY, )

)

Respondent. )

)

FINAL ORDER

On September 15, 2006, a hearing was held in Tallahassee,

Florida, pursuant to the authority granted in Sections 120.56,

120.569 and 120.57(1), Florida Statutes. The case was considered

by Lisa Shearer Nelson, Administrative Law Judge.

APPEARANCES

For Petitioner: Francesca Plendl, Esquire

John M. Knight, Esquire

Florida Medical Association

123 South Adams Street

Tallahassee, Florida 32301

For Respondent: Reginald D. Dixon, Esquire

Assistant Attorney General

Office of the Attorney General

The Capitol, PL-01

Tallahassee, Florida 32399-1050

For Intervenors: Jeffrey M. Scott

123 South Adams Street

Tallahassee, Florida 32301

STATEMENT OF THE ISSUE

Whether proposed rule 64B16-27.830 of the Board of Pharmacy

(Board) is an invalid exercise of delegated authority pursuant to

Section 120.52(8), Florida Statutes?

PRELIMINARY STATEMENT

On August 14, 2006, the Florida Medical Association (FMA)

filed a Petition to Determine the Invalidity of Proposed Rule,

asserting that proposed rule 64B16-27.830 of the Florida Board of

Pharmacy is an invalid exercise of delegated legislative

authority. The FMA alleged that the Board has exceeded its grant

of rulemaking authority; the proposed rule sections are arbitrary

and capricious; the proposed rule is not supported by competent,

substantial evidence; and the Board's actions are not

substantially justified, in that there is no reasonable basis in

law or fact to support the promulgation of the proposed rule.

On August 16, 2006, Robert J. Cohen, Chief Judge of the

Division of Administrative Hearings, determined that the petition

challenging the proposed rule was in compliance with the

requirements of Section 120.56(2), Florida Statutes, and assigned

the case to Administrative Law Judge Lisa Shearer Nelson. On

August 17, 2006, the matter was set for hearing September 15,

2006.

On August 24, 2006, Petitioner filed a Motion for Summary

Final Order, alleging that the material facts were not in

dispute. On August 29, 2006, a Petition to Intervene was filed

on behalf of the Florida Academy of Family Physicians, Florida

Academy of Pain Medicine, the Florida Association of Occupational

and Environmental Medicine, Florida Chapter of the American

College of Cardiology, Florida Chapter of the American College of

Physicians, Florida Chapter of the American College of Surgeons,

Florida Geriatrics Society, Florida Orthapaedic Society, Florida

Osteopathic Medical Association, Florida Pediatric Society,

Florida Psychiatric Society, Florida Pulmonary Society, Florida

Society of Addiction Medicine, Florida Society of

Anesthesiologists, Florida Society of Clinical Oncology, Florida

Society of Dermatologic Surgeons, Florida Society of Facial

Plastic and Reconstructive Surgery, Florida Society of

Interventional Pain Physicians, Florida Society of Nephrology,

Florida Society of Neurology, Florida Society of Otolaryngology

Head and Neck Surgery, Florida Society of Pathologists and the

Florida Society of Physical Medicine and Rehabilitation.

Respondent opposed both Motions. On August 31, 2006, an Order

was entered denying the Motion for Summary Final Order and

granting the Petition to Intervene, subject to proof of standing

at final hearing.

The Board also moved to dismiss the Petition, asserting that

the FMA did not have standing and that the Petition was not

timely filed. After reviewing the response filed by Petitioner,

the Motion was denied. With respect to the timeliness of the

Petition, the undersigned advised the parties that the pleadings

on file with the Division did not conclusively establish the

timeline of activities contemplated by Sections 120.54 and

120.56, Florida Statutes, and that the Board was free to raise

the issue of timeliness at the hearing.

On September 7, 2006, a second Petition to Intervene was

filed, this time on behalf of the Florida Society of Thoracic and

Cardiovascular Surgeons, Inc., Florida Gastroenterologic Society,

Inc., Florida Neurosurgical Society, Inc., and Florida Society of

Plastic Surgeons, Inc. A third Motion to Intervene was filed

September 13, 2006, on behalf of the Florida Society of

Rheumatology, Florida Society of Dermatology and Dermatologic

Surgery, Florida Thoracic Society, Florida Society of

Opthalmology and the Florida Obstetric and Gynecologic Society.

Despite the limited time before hearing, the Petitions were

served by regular mail and did not indicate whether counsel for

the Board of Pharmacy objected to either petition.

The FMA also filed a Motion for Leave to File Amended

Petition on September 13, 2006. The Amended Petition added as

grounds for challenge that the Board had failed to follow the

applicable rulemaking procedures set forth in Chapter 120,

Florida Statutes. A Joint Pre-hearing Statement was submitted on

behalf of Petitioner and Respondent 1/ in which the parties

stipulated to several factual matters that have been incorporated

into the Findings of Fact listed below.

The hearing was conducted as scheduled September 15, 2006,

and at that time the Second and Third Petitions to Intervene were

granted, subject to the same conditions imposed upon the first

set of Intervenors in terms of proof. All of those seeking to

intervene will be referred to collectively as Intervenors. The

Board stipulated to the facts alleged by each of the Intervenors

regarding their membership and purpose, but did not stipulate

that those facts constituted a sufficient basis to establish

standing. The Board agreed, however, that if it was determined

that the FMA had standing to challenge the proposed rule, then

the Intervenors also had standing. Petitioner's Motion for Leave

to File Amended Petition was granted, and the Amended Petition

was further amended at page 6 to correct the text of the

quotation from Section 465.003(13), Florida Statutes.

At hearing, the FMA presented the testimony of Louis

St. Petery, M.D., John O'Brien, R.Ph., Pharm.D., M.P.H., and

Lisette Gonzalez-Mariner. Petitioner's Exhibits 1 through 4 were

admitted into evidence. The Board called one witness, Rebecca

Poston, R.Ph., and Respondent's Exhibit 1 was admitted. Joint

Exhibit 1 was also admitted. No witnesses or exhibits were

submitted on behalf of the Intervenors.

A hearing transcript was prepared and filed with the

Division on September 29, 2006. Pursuant to agreement of the

parties, they were granted until October 16, 2006, to file

proposed final orders. All submissions were timely filed, and

these submissions have been considered in the preparation of the

final order.

FINDINGS OF FACT

1. Respondent, Board of Pharmacy is the state entity

charged with regulating the practice of pharmacy in the State of

Florida pursuant to Section 20.43 and Chapters 456 and 465,

Florida Statutes.

2. Petitioner, the FMA, is organized and maintained for the

benefit of the approximately 16,000 licensed Florida physicians

who comprise its membership. One of the primary purposes of the

FMA is to act on behalf of its members by representing their

common interests before various governmental entities in the

State of Florida, including the Department of Health and its

Boards.

3. Intervenors comprise 33 medical societies representing

physicians licensed pursuant to Chapters 458 and 459, Florida

Statutes. The membership totals for each of the Intervenors is

listed in Petitioner's Exhibit 1. A primary purpose of each of

the Intervenors is to act on behalf of its membership by

representing their common interests before the various

governmental entities of the State of Florida, including the

Department of Health and its Boards.

The Proposed Rule

4. The text of the proposed rule is as follows:

64B16-27.830 Standards of Practice - Drug

Therapy Management.

(1) through (3) No change

(4) A pharmacist may dispense a drug pursuant

to a prescription where the practitioner

indicates on the prescription "formulary

compliance approval" either in the

practitioner's own handwriting or preprinted

with a box where the practitioner indicates

approval by checking the box when:

(a) The pharmacist receives a formulary

change as a consequence of the patient's

third party plan or Medicaid.

(b) The product that the third party

formulary designates as its preferred product

is a therapeutic equivalent for the

prescribed product. A therapeutic equivalent

is a product that is in the same therapeutic

class as the prescribed drug.

(c) The pharmacist, within 24 hours of the

formulary compliance substitution, shall

provide to the practitioner either in writing

or by facsimile a statement indicating that

the pharmacist engaged in formulary

compliance and the therapeutic equivalent

that the pharmacist dispensed.

(d) The pharmacist has complied with the

requirements of Rule 64B16-27.530 with regard

to the notification to the patient.

The pharmacist may make adjustments in the

quantity and directions to provide for an

equivalent dose of the preferred formulary

therapeutic alternative.

(5) (4) No change.

Specific authority 465.005, 465.0155 F.S.

Law implemented 465.003(13), 465.0155,

465.022(1)(b) F.S.

5. Section 465.005, Florida Statutes, listed as specific

authority, provides the Board's general rulemaking authority.

6. Section 465.0155, Florida Statutes, listed as both

specific authority and law implemented, directs the Board to

adopt by rule standards of practice relating to the practice of

pharmacy.

7. Section 465.003(13), Florida Statutes, listed as law

implemented, defines the practice of pharmacy.

8. Section 465.022(1)(b), Florida Statutes, listed as law

implemented, provides:

(1) The board shall adopt rules pursuant to

ss. 120.536(1) and 120.54 to implement the

provisions of this chapter. Such rules shall

include, but shall not be limited to, rules

relating to:

. . . .

(b) Minimum standards for the physical

facilities of pharmacies.

The Rulemaking Process

9. On October 22, 2004, in Volume 30, Number 43, Florida

Administrative Weekly, the Board published its Notice of

Development of Proposed Rule 64B16-27.830, entitled "Standards of

Practice - Drug Therapy Management."

10. On October 29, 2004, the FMA requested a rule workshop.

11. On November, 19, 2004, in Volume 30, Number 47, Florida

Administrative Weekly, the Board published a notice of a rule

workshop on the proposed rule to be held December 7, 2004, in

Jacksonville, Florida.

12. On December 7, 2004, the Board held a rule workshop on

the proposed rule.

13. On December 17, 2004, in Volume 30, Number 51, Florida

Administrative Weekly, the Board published a notice of withdrawal

of the proposed rule.

14. On April 29, 2005, in Volume 31, Number 17, Florida

Administrative Weekly, the Board published the same rule language

again, this time as a proposed rule.

15. On April 29, 2005, the FMA requested a rule hearing.

16. On May 12, 2005, Suzanne G. Printy, Chief Attorney for

the Joint Administrative Procedures Committee (JAPC), sent to Ann

Cocheu, Assistant Attorney General for the Board of Pharmacy, a

letter indicating that she had "completed a review" of the rule

and questioning the Board's authority to promulgate the rule.

17. On May 20, 2005, in Volume 31, Number 20, Florida

Administrative Weekly, the Board published a notice of a rule

hearing on the proposed rule to be held June 14, 2005, in Tampa,

Florida.

18. On June 14, 2005, the rule hearing was held before the

Board. At that time, several individuals spoke in opposition to

the proposed rule. The Board voted to conduct a further public

meeting with respect to the proposed language.

19. On July 14, 2005, F. Scott Boyd, Executive Director and

General Counsel for JAPC sent to Ann Cocheu a letter advising her

of the deadlines applicable to the rulemaking process.

Specifically, Mr. Boyd's letter stated:

According to our records, the above-styled

rule was noticed in the Florida

Administrative Weekly on April 29, 2005.

Paragraph 120.54(3)(e), F.S., requires that

rules be filed for adoption not more than 90

days from the date of the original notice

unless specified circumstances prevail. The

90-day period for filing the rule expires on

July 28, 2005.

If you intend to adopt the rule, we remind

you that paragraph 120.54(3)(d), F.S.,

requires that if the rule has not been

changed since the rule was filed with the

Committee, or if the rule contains only

technical changes, you must file a notice to

that effect with this Committee at least 7

days prior to filing the rule for adoption.

If any change has been made in the rule,

other than a technical change, you must

publish a notice, and file a copy with the

committee, at least 21 days prior to filing

the rule for adoption.

If the rule is not filed within 90 days, and

if an exception is not applicable, you must

notice withdrawal of the rule. Any further

action to adopt the rule must comply with the

rulemaking procedures of § 120.54, F.S.

Please advise us of any exceptions which

apply to the rule so that we may keep our

records current.

20. On July 21, 2005, a paralegal from the Office of the

Attorney General wrote to Suzanne Printy at JAPC and requested to

"toll" the proposed rule. The July 21, 2005, letter advised that

the Board had scheduled a review of the rule at a committee

meeting to be held on August 15, 2005. While the July 21, 2005,

letter refers to a copy of the meeting notice for August 15,

2006, no notice for the meeting is included in the record.

21. At no time did JAPC notify the Board that an objection

to the proposed rule was being considered.

22. On August 15, 2005, the Board's Rules Committee met

again to review the proposed rule. Minutes from the committee

meeting reflect that the Rules Committee reviewed letters from

the Florida Medical Association and the Chair of the Osteopathic

Board of Medicine in opposition to the rule. These written

materials, however, are not included in Respondent's Exhibit 1,

which purports to be the Board's entire record with respect to

the rulemaking proceedings for amendments to Rule 64B16-27.830.

The Executive Director of the Board acknowledged receiving

letters from Laurie Davies, M.D., Chair of the Board of Medicine

and from the Coalition to Protect Health Care Access,

representing several patient advocacy organizations expressing

opposition to the proposed rule. These documents, likewise, are

not in the Board's rulemaking record.

23. The minutes of the August 15, 2005, meeting indicate

that the Committee voted to hold the rule until statutory

authority was obtained to enact it. Ms. Poston, the Board's

Executive Director, was to send a letter to the Attorney

General's office asking for a formal opinion regarding the

Board's statutory authority.

24. There is no indication in the record of any activity

with respect to the proposed rule from August 15, 2005, until

April 26, 2006, when Suzanne Printy wrote to Reginald Dixon,

Assistant Attorney General, regarding its status. Her letter

states in part:

On July 21, 2005, the Office of the Attorney

General, Administrative Law Bureau, notified

this office that the board was tolling the 90

day time limit for adoption of those

amendments in order to accommodate review of

the amendments by this Committee. That

original 90 day time limit would have expired

on July 28, 2005.

As of this date, we have not received any

proposed revisions or notices of change in

response to my concerns. Please be aware

that if I have not received a notice of

change or a notice of additional public

hearing on the amendments within the next two

weeks, I will have to conclude that my review

of the rule is complete. The tolling of the

adoption will then come to an end, and the

board will have 7 days within which to

change, adopt or withdraw the amendments.

25. On May 19, 2006, in Volume 32, Number 20, Florida

Administrative Weekly, the Board noticed an additional public

meeting on the proposed rule to be held June 6, 2006, in Fort

Lauderdale. A copy of the notice was provided to Suzanne Printy

on May 11, 2006, one day after the two-week period set out in her

letter of April 26, 2006, expired.

26. Nothing in the Notice of Public Hearing for the June 6,

2006, public hearing gives any indication that this will be the

final public hearing related to proposed amendments to Rule

64B16-27.830.

27. On May 22, 2006, Suzanne Printy acknowledged receipt of

the Notice of Public Hearing published May 19, 2006. In a letter

addressed to Reginald Dixon, she stated:

Please be advised that at the conclusion of

the hearing, presumably June 6, 2006, the

Board of Pharmacy will have 45 days from the

conclusion of the hearing, or until July 21,

2006, within which to either publish a notice

of change, publish another notice of public

hearing, or to adopt the rules.

28. On June 6, 2006, the rule hearing was held. The Board

did not publish a notice of change, publish another notice of

public hearing or adopt the proposed rule by July 21, 2006. Nor

did the Board publish any notice that would indicate the June 6,

2006, hearing was intended to be the last public hearing on the

proposed rule. However, Rebecca Poston, Executive Director for

the Board of Pharmacy, testified that the Board voted to "move

forward" with the rule.

29. On July 20, 2006, Reginald Dixon advised Suzanne Printy

of the Board's consideration of JAPC's concerns regarding the

proposed amendments to Rule 64B16-27.830, and stated that the

Board believed the amendment to the rule was authorized by the

1999 change to Section 465.003(15), adding "other pharmaceutical

services" to the definition of the practice of the profession of

pharmacy. Mr. Dixon stated that "The Board believes that this

explanation addresses JAPC's concerns regarding the 64B16-

27.830(4), F.A.C., and has voted to go forward with the

promulgation of the rule."

30. On August 11, 2006, Ms. Printy again wrote to

Mr. Dixon, reiterating JAPC's concerns about the rule:

This rule authorizes pharmacists to dispense

drugs from the same therapeutic class as the

prescribed drug, pursuant to a prescription

where the practitioner authorizes on the

prescription "formulary compliance approval."

Please explain whether a "therapeutic

equivalent" of a prescribed drug which is in

the same "therapeutic class" constitutes a

generic equivalent. If a "therapeutic

equivalent" of a prescribed medication does

not constitute a general generic equivalent,

please explain why changing the

practitioner's prescription does not violate

the following prohibition in s. 465.003(13),

F.S.:

However, nothing in this subsection may be

interpreted to permit an alteration of a

prescriber's directions, the diagnosis or

treatment of any disease, the initiation of

any drug therapy, the practice of medicine,

or the practice of osteopathic medicine,

unless otherwise permitted by law.

31. On August 14, 2006, the FMA filed its petition to

challenge the proposed rule.

32. On August 30, 2006, Mr. Dixon wrote to Ms. Printy

advising that a "therapeutic equivalent" is not a "generic"

equivalent." He advised that the Board was relying on the "other

pharmaceutical services" portion of Section 465.003(13) as

authority for the proposed rule.

The Contents of the Rule

33. There is no generally accepted definition of

"therapeutic equivalent" or "therapeutic class." The proposed

rule simply states: "The product that the third party formulary

designates as its preferred product is a therapeutic equivalent

for the prescribed product. A therapeutic equivalent is a

product that is in the same therapeutic class as the prescribed

drug."

34. The Board of Pharmacy did not conduct any research or

determine whether any studies existed that examined the safety,

benefits or detriments of following the course of conduct

permitted by the proposed rule. Likewise, no studies were

conducted regarding the definition of "therapeutic equivalent."

35. A "generically equivalent drug product" is defined by

statute as "a drug product with the same active ingredient,

finished dosage form, and strength." § 465.025, Fla. Stat.

36. Section 465.025(6) allows the Boards of Pharmacy and

Medicine to establish a formulary of generic drug type and brand

name products which the boards determine "demonstrate clinically

significant biological or therapeutic inequivalence and which, if

substituted, would pose a threat to the health and safety of

patients receiving prescription medication." No pharmacist may

substitute a generically equivalent drug product for a prescribed

name brand product, if the brand name drug or generic drug is

included in the formulary established by the Boards of Medicine

and Pharmacy. § 465.025(6)(b), Fla. Stat. Thus, there are

instances where even drugs having the same active ingredient,

finished dosage form, and strength cannot be substituted for a

brand name drug prescribed by a health care practitioner.

37. According to John O'Brien, The United States Food and

Drug Administration defines "therapeutic equivalent" to mean

drugs that contain the same active ingredients and route of

administration and strength; and they are assigned by the FDA the

same therapeutic equivalence codes starting with the letter "A."

There is no indication on the record presented that the Board's

definition of therapeutic equivalent, i.e., a product in the same

therapeutic class, is tied to or consistent with the Food and

Drug Administration's use of that term.

38. Formularies differ based upon the third party entity

developing the formulary. As a consequence, a drug may be

designated as part of different therapeutic classes, depending on

the persons making up the formulary. For example, the drug

Digoxin is listed on the Capital Health Plan formulary as an

anti-eurhythmic, while it is listed under Blue Cross Blue

Shield's formulary as a cardiac glycoside. The drug can be used

for both purposes.

39. Similarly, drugs with different side effects and

contra-indications may be listed under the same class under a

particular formulary. There is a group of blood pressure drugs

known as angiotensin receptor blockers (ARBs). These drugs have

a low side effect profile. There is another group of blood

pressure medications called ACE inhibitors. These drugs have a

higher side effect profile than ARBs. Under Florida's Medicaid

formulary, ACE inhibitors and ARBs are both in the hypotensive

category of drugs, as are beta blockers. Some studies suggest

that beta-blockers may either mask the symptoms of or cause

diabetes. Likewise, beta blockers should not be taken by

patients who have asthma. It is possible, should the proposed

rule be adopted, that a physician would prescribe a drug with the

chemical make-up of an ARB and check the formulary compliance box

thinking only another ARB could be substituted. Florida's

Medicaid formulary, however, would allow a pharmacist to

substitute either an ACE inhibitor or a beta-blocker for the

originally prescribed ARB. This substitution could have

significant negative effects on patient care.

40. The proposed rule also removes any requirement the

pharmacist currently has to speak to the prescribing physician

before substituting a drug on the compliance formulary for the

drug specified by the physician. Instead, the pharmacist need

only notify the physician, in writing or by facsimile, within 24

hours after the substitution, that the pharmacist has engaged in

formulary compliance and what "therapeutic equivalent" has been

dispensed to the patient.

41. While pharmacies keep records regarding drugs already

prescribed to patients, those records are limited to those

medications dispensed by that pharmacy. They would not

necessarily have access to patient records indicating problems

with another drug. By the time the physician knows of a

substitution made by a pharmacist, the patient may have already

received, and used, a medication that is not consistent with that

person's particular needs.

CONCLUSIONS OF LAW

42. The Division of Administrative Hearings has

jurisdiction over the subject matter and the parties to this

action in accordance with Sections 120.569 and 120.57(1), Florida

Statutes.

43. The Amended Petition challenging the proposed rule

states with particularity the objections to the proposed rule,

the reasons why Petitioner believes the proposed rule to be an

invalid exercise of legislative authority and why Petitioner

believes that the Board failed to comply with the rulemaking

requirements of Section 120.54, Florida Statutes.

44. Petitioner challenges the proposed rule in accordance

with the definition of "invalid exercise of delegated legislative

authority" in Section 120.52(8)(b), Florida Statutes (2006),

which states:

(8) "Invalid exercise of delegated

legislative authority" means action which

goes beyond the powers, functions, and duties

delegated by the Legislature. A proposed or

existing rule 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 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 it is not supported by

logic or the necessary facts; a rule is

capricious if it is adopted 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 directives.

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 and 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 any

agency shall be construed to extend no

further than implementing or interpreting the

specific powers and duties conferred by the

same statute.

45. In a proceeding to challenge a proposed rule, the

petitioner has the burden of going forward. The agency then has

the burden to prove by a preponderance of the evidence that the

proposed rule is not an invalid exercise of delegated legislative

authority as to the objection raised. § 120.56(2), Fla. Stat.;

St. Johns River Water Management District v. Consolidated-Tomoka

Land Co. , 717 So. 2d 72 (Fla. 1st DCA 1998). The proposed rule

is not presumed to be valid or invalid. § 120.56(2)(c), Fla.

Stat.

Whether the Petition Was Timely Filed

46. Section 120.56(2)(a), Florida Statutes, provides the

time frame for challenging a proposed rule:

(a) Any substantially affected person may

seek an administrative determination of the

validity of any proposed rule by filing a

petition seeking such a determination with

the division within 21 days after the date of

publication of the notice required by s.

120.54(3)(a), within 10 days after the final

public hearing is held on the proposed rule

as provided by s. 120.54(3)(c), within 20

days after the preparation of a statement of

estimated regulatory costs required pursuant

to s. 120.541, if applicable, or within 20

days after the date of publication of the

notice required by s. 120.54(3)(d). . . .

47. There is no dispute that the FMA did not file its

challenge within 21 days after the publication of the proposed

rule, within 20 days after a statement of estimated regulatory

costs (as none was prepared), or within 20 days of a notice of

change (as none was ever filed).

48. The issue then becomes whether FMA filed its challenge

within 10 days "after the final public hearing is held in the

proposed rule." The record indicates that a public hearing was

held June 6, 2006, and the FMA did not file its petition until

August 14, 2006, over two months later. If the June 6, 2006,

public hearing was the "final public hearing," then FMA's

petition is untimely. If it is not the final public hearing,

then FMA's petition is within the time limits allowed by Section

120.56.

49. In order to determine whether the June 6, 2006, public

hearing was the "final public hearing," one must consider the

notices provided by the Board, any vote taken at the Board's

hearings, and the actions of the Board and its staff subsequent

to June 6, 2006. First, nothing in the notices regarding the

public hearing indicates that the Board considered the June 6,

2006, hearing to be the final opportunity for public input on the

proposed rule. Second, the vote taken by the Rules Committee was

to "go forward" with the rule. This vote provides no real

guidance, as "going forward" with the rule does not indicate

whether the Board intended to direct staff to file the proposed

rule for adoption or simply to proceed with the rulemaking

process.

50. Finally, if the Board intended to direct the rule to be

filed, its direction was not followed. If the June 6, 2006,

public hearing was intended to be the "last public hearing,"

the deadline for filing the rule was July 21, 2006. See

§ 120.54(3)(e)2., Fla. Stat. The Board did not file the rule by

that date and had not filed the rule by the time FMA filed its

petition in this proceeding. In light of the Board's failure to

file the rule within the statutory time frame, it must be

concluded that the June 6, 2006, public hearing was not intended

to be the "last public hearing" on the proposed rule. Under this

circumstance, the FMA's petition was timely filed.

51. The FMA has also argued that the doctrine of equitable

tolling would apply to in order to allow the late filing of its

petition, citing Machules v. Department of Administration , 523

So. 2d 1132, 1134 (Fla. 1988). The doctrine of equitable tolling

generally applies when a person has been misled or lulled into

action, or has in some extraordinary way been prevented from

asserting his rights, or has timely asserted his rights but in

the wrong forum.

52. The FMA was never prevented from asserting its rights.

Neither did it assert its rights in the wrong forum. It relies

on that part of the doctrine that excuses those who have been

"lulled into inaction," claiming that it was the FMA's belief

that due to the extremely long amount of time (13 months) that

passed between the last advertisement of the rule and the final

public hearing, the Respondent would be required to readvertise

the proposed rule. Once it discovered that JAPC was not going to

require the proposed rule to be readvertised, it filed the

instant proceeding.

53. Under a normal rulemaking schedule, the Board would

have been required to withdraw the rule or adopt it by July 2005.

Clearly, it did neither. Whether the Board was justified in its

inaction is discussed below. However, given that it did not and

has not followed the required rulemaking schedule, the FMA was

justified in believing that the Board was not finished with its

rulemaking efforts. However, its petition is timely because

there was nothing to indicate that the June 6, 2006, meeting was

the final public hearing as opposed to one in a series of

hearings. There is no reason to apply the doctrine of equitable

tolling because the time frame for challenging the proposed rule

had not yet run.

Whether FMA and The Intervenors Have Standing To Challenge

The Proposed Rule

54. The Board has asserted that the FMA and the Intervenors

do not have standing to challenge the validity of the proposed

rule. The Board has agreed that should the FMA be found to have

standing, then the Intervenors also have standing.

55. Standing to challenge a proposed rule is governed by

Section 120.56(1)(a), Florida Statutes, which provides that

"[a]ny person substantially affected by a rule or a proposed 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."

56. The Florida Supreme Court considered the issue of

standing for associations in Florida Home Builders Association v.

Department of Labor and Employment Security , 412 So. 2d 351 (Fla.

1982), when some or all of the association's members, as opposed

to the association itself, is substantially affected by a

proposed rule. The Court concluded that to meet the requirements

of Section 120.56(1), Florida Statutes, an association must

demonstrate that:

substantial number of its members, although

not necessarily a majority, are substantially

affected by the proposed rule. Further, the

subject matter of the rule must be within the

association's general scope of interest and

activity, and the relief requested must be of

the type appropriate for a trade association

to receive on behalf of its members.

412 So. 2d at 353-54. The Court reiterated this standard in

NAACP, Inc. v. Florida Board of Regents , 863 So. 2d 294 (Fla.

2003), and stated that an association need not show an immediate

and actual harm to demonstrate standing: rather, the required

showing is that there would be a substantial effect of the rule

change on a substantial number of the association's members.

57. In Florida Medical Association v. Department of Health,

Board of Nursing , DOAH Case No. 99-5337RP (Final Order 2000), the

FMA and several of the Intervenors now before the Division

challenged a proposed rule of the Board of Nursing which would

have allowed advanced registered nurse practitioners to prescribe

controlled substances. The reasoning used to determine that the

FMA and Intervenors had standing in that case is equally

applicable here:

25. [B]oth Sections 464.003(3)(c) and

464.012(3), Florida Statutes (1999),

recognize the role which physicians licensed

in accordance with Chapters 458 and 459,

Florida Statutes, play in the supervision of

ARNPs in the framework of standing protocols

where drugs are prescribed by the ARNPs.

Unlike the optometrists in Board of Optometry

[v. Society of Opthalmology , 538 So.2d 878

(Fla. 1st DCA 1989)], supra , ARNPs do not

have exclusive authority in providing health

care in the process of prescribing

medications. The proposed rule contemplates

a role by physicians which is both real and

immediate. Physicians are affected by the

proposed rule. That affect is substantial.

The opportunity to participate or to decline

participation with ARNPs in practices for

prescribing controlled substances does not

alter the fact that those physicians who

would participate are substantially affected

by the rule. For them the consequences of

the proposed rule are not a matter of

speculation or conjecture. By comparison to

the physicians involved in ophthalmologic

medicine described in Board of Optometry ,

supra , the physicians contemplated by the

proposed rule have a vital role to play in

the process wherein ARNPs are allowed to

prescribe medications. . . .

58. Likewise, Section 465.003(13), along with other

provisions in Chapter 465 recognize the role physicians play in

the prescribing of medications. Proposed rule 64B16-27.830(4)

contemplates a role by physicians that is real and immediate, and

the affect on physicians is substantial. Moreover, regardless of

whether an individual physician opts to decline default to the

formulary medications as contemplated by the proposed rule, there

is a very real possibility that patients for whom a physician

prescribes medication will seek refills through a doctor on call

and end up with a medication that does not comport with the

original prescribing physician's intent for the care and

wellbeing of that patient. Under these circumstances, both the

FMA and the Intervenors have standing to challenge the proposed

rule.

Whether The Board Complied With The Technical Requirements

Of Section 120.54

59. The FMA asserts that the Board has not complied with

the technical requirements of Section 120.54, Florida Statutes,

in its effort to adopt the proposed rule. In its Amended

Petition, the FMA asserts:

13. . . . In this case, the Proposed Rule

was published in the Florida Administrative

Weekly pursuant to 120.54(3)(e)2, Florida

Statutes, on April 29, 2005. The 90-day

period for filing the Proposed Rule for

adoption ended on July 28, 2005. On May 20,

2005, the Board published a notice of a

public hearing on the Proposed Rule in the

Florida Administrative Weekly to be held

June 14, 2005 in Tampa, Florida. As such,

the period during which the Proposed Rule was

required to be filed for adoption was

extended to 45 days after adjournment of the

final hearing on the rule, or until July 29,

2005. As of this date, this petition [sic]

has not been filed for adoption. The Board,

therefore, failed to file the Proposed Rule

in accordance with the requirements of

Section 120.54(3)(e), Florida Statutes, and

must withdraw the proposed rule.

Even assuming, for the sake of argument, that

the public hearing held on June 6, 2006

served to extend the time for filing the

Proposed Rule, the Board failed to file the

Proposed Rule by the time required by Section

120.54(3)(e), Florida Statutes. The time for

filing a proposed rule is extended only if

the notice of a public hearing is published

prior to the expiration of the time to file

the rule for adoption. In this case,

arguably, the time for filing the Proposed

Rule for adoption expired in July 29, 2005.

In order to avail itself of a further

extension, the Board would have been required

to file a notice of an additional public

hearing on the Proposed Rule prior to

July 29, 2005. The Board, therefore, failed

to file the Proposed Rule in accordance with

the requirements of Section 120.54(3)(e),

Florida Statutes, and must withdraw the Rule.

60. In response, the Board argues that the deadline for

filing the proposed rule for adoption was tolled and continues

to be tolled pursuant to Section 120.54(3)(e)6., Florida

Statutes. Relevant portions of Section 120.54(3)(e) state:

3. At the time a rule is filed, the agency

shall certify that the time limitations

prescribed by this paragraph have been

complied with, that all statutory rulemaking

requirements have been met, and that there is

no administrative determination pending on

the rule.

4. At the time a rule is filed, the

committee shall certify whether the agency

has responded in writing to all material and

timely written comments or written inquiries

made on behalf of the committee. The

department shall reject any rule not filed

with the prescribed time limits; that does

not satisfy all statutory rulemaking

requirements; upon which an agency has not

responded in writing to all material and

timely written inquiries or written comments;

upon which an administrative determination is

pending; or which does not include a

statement of estimated regulatory costs, if

required.

5. If a rule has not been adopted within the

time limits imposed by this paragraph or has

not been adopted in compliance with all

statutory rulemaking requirements, the agency

proposing the rule shall withdraw the rule

and give notice of its action in the next

available issue of the Florida Administrative

Weekly.

6. The proposed rule shall be adopted on

being filed with the Department of State and

become effective 20 days after being filed,

on a later date specified in the rule, or on

a date required by statute. . . . If the

committee notifies an agency that an

objection to a rule is being considered, the

agency may postpone the adoption of the rule

to accommodate review of the rule by the

committee. When an agency postpones adoption

of a rule to accommodate review by the

committee, the 90-day period for filing the

rule is tolled until the committee notifies

the agency that it has completed its review

of the rule.

61. The request for "tolling" referred to in paragraph 20,

however, is not sufficient to invoke the provisions of Section

120.54(e)(e)6. Tolling is only available in order to accommodate

review of a proposed rule by the JAPC upon notice that an

objection to a rule is being considered. It is not available to

accommodate additional review by the agency proposing the rule.

While the Board received comments or written inquiries from JAPC

staff, as envisioned by Section 120.54(3)(e)4., there is no

indication that it received notice that JAPC was considering an

objection to the rule. To the contrary, correspondence from

JAPC's general counsel a week before the request to invoke the

tolling provision simply reminded the Board of the deadlines for

filing. No such reminder would have been applicable if JAPC was

considering an objection.

62. It appears that JAPC's staff may have treated the

proposed rule as if it were tolled, as is evident from

Ms. Printy's letters of April 26, 2006, and May 22, 2006.

However, there is simply no authority for doing so. In any

event, it is clear that JAPC's position was that, as of May 22,

2006, the proposed rule was no longer tolled and that the Board

had until July 21, 2006, to either publish a notice of change,

publish another notice of public hearing, or to adopt the rule.

The Board did none of these things.

63. Failure to follow the applicable rulemaking procedures

or requirements set forth in Chapter 120 is presumed to be

material. An agency may rebut this presumption by showing that

the substantial interests of the petitioner and the fairness of

the proceedings have not been impaired. § 120.56(1)(c), Fla.

Stat.; Osterback v. Ogwunobi , 873 So. 2d 437, 442 (Fla. 3d DCA

2004).

64. Respondent argues that it conducted multiple hearings

regarding the proposed rule amendments and that Petitioner and

Intervenors availed themselves of the opportunity to participate

in those hearings. It also notes that Petitioner has had the

opportunity to challenge the rule via Section 120.56, Florida

Statutes (although it has also argued that the rule challenge

should be dismissed as untimely). Under these circumstances, the

Board asserts that the asserted failure to abide by the 90-day

time frame has not affected the substantial interests of

Petitioner or Intervenors or the fairness of the proceedings.

65. Under the unique circumstances presented here, it

cannot be said that the failure to abide by the statutory

timeframe has affected the fairness of the proceedings. Because

of the Board's decision to hold multiple public hearings and

failure to notify the public when those public hearings would

come to an end, Petitioner continued to have a window of

opportunity to seek invalidation of the proposed rule. Neither

Petitioner nor the Intervenors were deprived of the ability to

voice their concerns regarding the proposed rule, either through

the public hearings or through this proceeding.

66. However, the Board cannot overcome the presumption that

the failure to meet statutory requirements is material in this

case. Subsections 120.54(3)(e) 3. and 4., require the agency to

certify that the time limitations in the statute have been met

and that the agency has responded to all material and timely

written comments or inquiries made on behalf of JAPC. In this

case, no such certification can be made. Moreover, Subsection

120.54(3)(e)5. mandates that if a rule has not been adopted

within the statutorily imposed time limits and or has not been

adopted in compliance with all rulemaking requirements, the

agency proposing the rule shall withdraw the rule. To allow the

proposed rule to be adopted in light of this mandate is simply

not permitted. Therefore, it is found that the Board has failed

to follow applicable rulemaking procedures in violation of

Section 120.52(8)(a), Florida Statutes.

Whether The Proposed Rule Exceeds The Board's Grant Of

Rulemaking Authority

66. Section 120.52(8)(b), Florida Statutes, provides that

a proposed or existing rule is an invalid exercise of

legislative authority if the agency has exceeded its grant of

rulemaking authority.

67. The Board relied on Sections 465.005 and 465.0155,

Florida Statutes, as its statutory authority for adopting the

proposed rule amendments. Section 465.005, Florida Statutes,

sets forth the Board's general grant of rulemaking authority,

which, by definition, is not enough to support adoption. See

§ 120.52(8), Fla. Stat.

68. Section 465.0065, which the Board listed as both

specific authority and the law implemented, provides:

Consistent with the provisions of this act,

the board shall adopt by rule standards of

practice relating to the practice of pharmacy

which shall be binding on every state agency

and shall be applied by such agencies when

enforcing or implementing any authority

granted by any applicable statute, rule, or

regulation, whether federal or state.

In order for a rule to be within the scope of this grant of

authority, it must be "consistent with the provisions of this

act." Moreover, inasmuch as the grant of rulemaking authority

directs the Board to establish standards of practice relating to

the practice of pharmacy, such rules must conform to the

definition of the practice of pharmacy provided by the

Legislature. In this case, the proposed rule is not consistent

with the legislative definition.

69. The Board asserts that the definition of the practice

of pharmacy was amended in 1999 to include "other pharmaceutical

services," and that the proposed rule amendment fits within

those services. The 1999 amendment, however, must be read as a

whole. It provided:

(13) (12) "Practice of the profession of

pharmacy" includes compounding, dispensing,

and consulting concerning contents,

therapeutic values, and uses of any medicinal

drug; and consulting concerning therapeutic

values and interactions of patent or

proprietary preparations, whether pursuant to

prescriptions or in the absence and entirely

independent of such prescriptions or orders;

and other pharmaceutical services. For

purposes of this subsection, "other

pharmaceutical services" means the monitoring

of the patient's drug therapy and assisting

the patient in the management of his or her

drug therapy, and includes review of the

patient's drug therapy and communication with

the patient's prescribing health care

provider as licensed under chapter 458, 459,

chapter 461, or chapter 466, or similar

statutory provision in another jurisdiction,

or such provider's agent or such other

persons as specifically authorized by the

patient, regarding the drug therapy.

However, nothing in this subsection may be

interpreted to permit an alteration of a

prescriber's directions, the diagnosis or

treatment of any disease, the initiation of

any drug therapy, the practice of medicine,

or the practice of osteopathic medicine,

unless otherwise permitted by law. "Practice

of the profession of pharmacy" The phrase

also includes any other act, service,

operation, research , or transaction

incidental to, or forming a part of, any of

the foregoing acts, requiring, involving, or

employing the science or art of any breach of

the pharmaceutical profession, study, or

training, and shall expressly permit a

pharmacist to transmit information from

persons authorized to prescribe medicinal

drugs to their patients.

§ 118, Ch. 99-397, Laws of Fla.

70. Substituting one drug for another is not monitoring or

reviewing a patient's drug therapy; is not assisting the patient

in managing drug therapy; and is not communicating with the

patient's health care provider. Likewise, making adjustments in

the quantity and directions originally prescribed is not

monitoring or reviewing a patient's drug therapy; is not

assisting a patient in managing drug therapy; and is not

communicating with a health care provider. Even if the actions

permitted by the proposed rule could be characterized as

assisting the patient in managing his or her drug therapy, it

runs afoul of the specific prohibition in the definition of the

practice of pharmacy contained in Section 465.005(13), as amended

in Chapter 99-397. The same amendment that includes "other

pharmaceutical services" expressly limits the definition of the

practice of pharmacy to prohibit any alteration of a prescriber's

directions. Given this express limitation by the Legislature,

the Board's proposed rule exceeds the Board's grant of rulemaking

authority.

Whether The Proposed Rule Is Arbitrary And Capricious

71. Section 120.52(8)(e), Florida Statutes, provides that a

rule is arbitrary if it is not supported by logic or the

necessary facts, and a rule is capricious if it is adopted

without thought or reason or is irrational. Compare Agrico

Chemical Co. v. Department of Environmental Regulation , 365

So. 2d 759 (Fla. 1st DCA 1979).

72. The proposed rule at issue is arbitrary and capricious

in that the Board neither conducted nor reviewed any studies or

treatises and received no evidence to support the definition of

therapeutic equivalent in the proposed rule, and likewise

reviewed no studies as to the safety or benefits/detriments of

having a pharmacist substitute a drug for one prescribed by the

physician. In addition, the proposed rule is arbitrary in that

it provides no definition for the term "therapeutic class."

73. Moreover, the proposed rule places the pharmacists'

choices for substitution not in the hands of the Legislature, or

a regulatory board or group of boards, as is the case for generic

drugs pursuant to Section 465.025 or for pharmacists' order and

dispensing of certain drugs pursuant to 465.186, Florida

Statutes. It places the development of formularies, at least in

part, in the hands of third party providers who have no

obligation to subject their choices to the rigors of rulemaking

or public debate.

74. Petitioner has also alleged that the proposed rule is

not supported by competent, substantial evidence. In 2003, the

Legislature amended Section 120.52(8), so as to eliminate the

former subsection (f) and, in the same chapter law, amended to

clarify that hearings held with respect to challenges to an

existing or proposed agency rule "shall be de novo in nature" and

that the "standard of proof shall be the preponderance of the

evidence." §§ 1, 3, Ch. 2003-94, Laws of Fla. See Department of

Health v. Merritt , 919 So. 2d 561 (Fla. 1st DCA 2006). Inasmuch

as the legislature has deleted this ground as a basis for

challenge pursuant to Section 120.52(8), the undersigned has not

addressed this issue.

75. Finally, Petitioner has requested attorney's fees and

costs pursuant to Section 120.595(2), Florida Statutes, which

provides:

If the court or administrative law judge

declares a proposed rule or portion of a

proposed rule invalid pursuant to s.

120.56(2), a judgment or order shall be

rendered against the agency for reasonable

costs and reasonable attorney's fees, unless

the agency demonstrates that its actions were

substantially justified or special

circumstances exist which would make the

award unjust.

76. Petitioner is entitled to an award of reasonable fees

and costs "unless the agency demonstrates that its actions were

substantially justified or special circumstances exists which

would make the award unjust." If the parties are unable to agree

upon the amount of reasonable costs and fees, or if the Board

disputes Petitioner's legal entitlement based upon the statutory

defenses of "substantial justification" and/or special

circumstances," then Petitioner shall file a motion seeking an

award of fees and costs (with supporting documentation), and an

evidentiary hearing will be held.

Upon consideration of the facts found and conclusions of law

reached, it is

ORDERED:

1. Proposed rule 64B16-27.830(4) is an invalid exercise of

delegated legislative authority.

2. Jurisdiction is retained for the limited purpose of

considering Petitioner's motion for an award of reasonable

attorney's fees and costs pursuant to Section 120.595(2), Florida

Statutes, if filed.

DONE AND ORDERED this 1st day of November, 2006, in

Tallahassee, Leon County, Florida.

S

LISA SHEARER NELSON

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

[phone] SUNCOM 278-9675

Fax Filing [phone]

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 1st day of November, 2006.

ENDNOTE

1/ There is no indication that counsel for the Intervenors

participated in the preparation of the Joint Pre-Hearing

Statement.

COPIES FURNISHED:

Francesca Plendl, Esquire

John M. Knight, Esquire

Florida Medical Association

123 South Adams Street

Tallahassee, Florida 32301

Reginald D. Dixon, Esquire

Department of Legal Affairs

The Capitol, Plaza Level 01

Tallahassee, Florida 32399-1050

Jeffery M. Scott, Esquire

123 South Adams Street

Tallahassee, Florida 32301

Rebecca Poston, R.Ph., Executive Director

Board of Pharmacy

Department of Health

4052 Bald Cypress Way, Bin C04

Tallahassee, Florida 32399-3254

Timothy M. Cerio, General Counsel

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399-1701

Scott Boyd, Acting Executive Director

and General Counsel

Joint Administrative Procedures Committee

Holland Building, Room 120

Tallahassee, Florida 32399-1300

Liz Cloud, Chief

Bureau of Administrative Code

The Elliott Building, Room 201

Tallahassee, Florida 32399-0250

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 proceedings are governed by the Florida Rules of Appellate

Procedure. Such proceedings are commenced by filing the original

notice of appeal with the Clerk of the Division of Administrative

Hearings and a copy, accompanied by filing fees prescribed by

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.