Florida Statutes 499.026 – Notification of manufacturer prescription drug price increases
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(1) As used in this section, the term:
(a) “Course of therapy” means the recommended daily dose units of a prescription drug pursuant to its prescribing label for 30 days or the recommended daily dose units of a prescription drug pursuant to its prescribing label for a normal course of treatment which is less than 30 days.
Terms Used In Florida Statutes 499.026
- Department: means the Department of Business and Professional Regulation. See Florida Statutes 499.003
- Drug: means an article that is:(a) Recognized in the current edition of the United States Pharmacopoeia and National Formulary, official Homeopathic Pharmacopoeia of the United States, or any supplement to any of those publications;(b) Intended for use in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or other animals;(c) Intended to affect the structure or any function of the body of humans or other animals; or(d) Intended for use as a component of any article specified in paragraph (a), paragraph (b), or paragraph (c), and includes active pharmaceutical ingredients, but does not include devices or their nondrug components, parts, or accessories. See Florida Statutes 499.003
- Label: means a display of written, printed, or graphic matter upon the immediate container of any drug, device, or cosmetic. See Florida Statutes 499.003
- Manufacturer: means :
(a) A person who holds a New Drug Application, an Abbreviated New Drug Application, a Biologics License Application, or a New Animal Drug Application approved under the federal act or a license issued under…. See Florida Statutes 499.003- Person: means any individual, child, joint venture, syndicate, fiduciary, partnership, corporation, division of a corporation, firm, trust, business trust, company, estate, public or private institution, association, organization, group, city, county, city and county, political subdivision of this state, other governmental agency within this state, and any representative, agent, or agency of any of the foregoing, or any other group or combination of the foregoing. See Florida Statutes 499.003
- Pharmacy: means an entity licensed under chapter 465. See Florida Statutes 499.003
- Prescription drug: means a prescription, medicinal, or legend drug, including, but not limited to, finished dosage forms or active pharmaceutical ingredients subject to, defined by, or described by…. See Florida Statutes 499.003
(b) “Manufacturer” means a person holding a prescription drug manufacturer permit or a nonresident prescription drug manufacturer permit under s. 499.01.(c) “Prescription drug” has the same meaning as in s. 499.003 and includes biological products but is limited to those prescription drugs and biological products intended for human use.(d) “Reportable drug price increase” means, for a prescription drug with a wholesale acquisition cost of at least $100 for a course of therapy before the effective date of an increase:1. Any increase of 15 percent or more of the wholesale acquisition cost during the preceding 12-month period; or2. Any cumulative increase of 30 percent or more of the wholesale acquisition cost during the preceding 3 calendar years. In calculating the 30 percent threshold, the manufacturer must base the calculation on the wholesale acquisition cost in effect at the end of the 3-year period as compared to the wholesale acquisition cost in effect at the beginning of the same 3-year period.(e) “Wholesale acquisition cost” means, with respect to a prescription drug or biological product, the manufacturer’s list price for the prescription drug or biological product to wholesalers or direct purchasers in the United States, not including prompt pay or other discounts, rebates, or reductions in price, for the most recent month for which the information is available, as reported in wholesale price guides or other publications of drug or biological product pricing data.(2) On the effective date of a manufacturer’s reportable drug price increase, the manufacturer must provide notification of each reportable drug price increase to the department on a form prescribed by the department. The form must require the manufacturer to specify all of the following:(a) The proprietary and nonproprietary names of the prescription drug, as applicable.(b) The wholesale acquisition cost before the reportable drug price increase.(c) The dollar amount of the reportable drug price increase.(d) The percentage amount of the reportable drug price increase from the wholesale acquisition cost before the reportable drug price increase.(e) Whether a change or an improvement in the prescription drug necessitates the reportable drug price increase.(f) If a change or an improvement in the prescription drug necessitates the reportable drug price increase as reported in paragraph (e), the manufacturer must describe the change or improvement.(g) The intended uses of the prescription drug.This subsection does not prohibit a manufacturer from notifying other parties, such as pharmacy benefit managers, of a drug price increase before the effective date of the drug price increase.
(3) By April 1 of each year, each manufacturer shall submit a report to the department on a form prescribed by the department. The report must include all of the following:(a) A list of all prescription drugs affected by a reportable drug price increase during the previous calendar year and both the dollar amount of each reportable drug price increase and the percentage increase of each reportable drug price increase relative to the previous wholesale acquisition cost of the prescription drug. The prescription drugs must be identified using their proprietary names and nonproprietary names, as applicable.(b) If more than one form has been filed under this section for previous reportable drug price increases, the percentage increase of the prescription drug from the earliest form filed to the most recent form filed.(c) The intended uses of each prescription drug listed in the report and whether the prescription drug manufacturer benefits from market exclusivity for such drug.(d) The length of time the prescription drug has been available for purchase.(e) A listing of the factors contributing to each reportable drug price increase. As used in this section, the term “factors” means any of the following: research and development; manufacturing costs; advertising and marketing; whether the drug has more competitive value; an increased rate of inflation or other economic dynamics; changes in market dynamics; supporting regulatory and safety commitments; operating patient assistance and educational programs; rebate increases, including any rebate increase requested by a pharmacy benefit manager; Medicaid, Medicare, or 340B Drug Pricing Program offsets; profit; or other factors. An estimated percentage of the influence of each listed factor must be provided to equal 100 percent.(f) A description of the justification for each factor referenced in paragraph (e) must be provided with such specificity as to explain the need or justification for each reportable drug price increase. The department may request additional information from a manufacturer relating to the need or justification for any reportable drug price increase before approving the manufacturer’s report.(g) Any action that the manufacturer has filed to extend a patent report after the first extension has been granted.(4)(a) The department shall submit all forms and reports submitted by manufacturers to the Agency for Health Care Administration, to be posted on the agency’s website pursuant to s. 408.062. The agency may not post on its website any of the information provided pursuant to paragraph (2)(f), paragraph (3)(f), or paragraph (3)(g) which is marked as a trade secret. The agency shall compile all information from the forms and reports submitted by manufacturers and make it available upon request to the Governor, the President of the Senate, and the Speaker of the House of Representatives.(b) Except for information provided pursuant to paragraph (2)(f), paragraph (3)(f), or paragraph (3)(g), a manufacturer may not claim a public records exemption for a trade secret under s. 119.0715 for any information required by the department under this section. Department employees remain protected from liability for release of forms and reports pursuant to s. 119.0715(4).(5) The department, in consultation with the Agency for Health Care Administration, shall adopt rules to implement this section.(a) The department shall adopt necessary emergency rules pursuant to s. 120.54(4) to implement this section. If an emergency rule adopted under this section is held to be unconstitutional or an invalid exercise of delegated legislative authority and becomes void, the department may adopt an emergency rule pursuant to this section to replace the rule that has become void. If the emergency rule adopted to replace the void emergency rule is also held to be unconstitutional or an invalid exercise of delegated legislative authority and becomes void, the department must follow the nonemergency rulemaking procedures of the Administrative Procedure Act to replace the rule that has become void.(b) For emergency rules adopted under this section, the department need not make the findings required under s. 120.54(4)(a). Emergency rules adopted under this section are also exempt from:1. Sections 120.54(3)(b) and 120.541. Challenges to emergency rules adopted under this section are subject to the time schedules provided in s. 120.56(5).2. Section 120.54(4)(c) and remain in effect until replaced by rules adopted under the nonemergency rulemaking procedures of the Administrative Procedure Act.