Bill Text: IA SSB3155 | 2019-2020 | 88th General Assembly | Introduced

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Bill Title: A bill for an act relating to pharmaceutical drug manufacturers and prescription drug prices, and including applicability provisions.

Spectrum: Committee Bill

Status: (Introduced - Dead) 2020-02-18 - Subcommittee recommends amendment and passage. [SSB3155 Detail]

Download: Iowa-2019-SSB3155-Introduced.html

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Senate Study Bill 3155 - Introduced
SENATE FILE _____
BY (PROPOSED COMMITTEE
ON COMMERCE BILL BY
CHAIRPERSON DAWSON)
A BILL FOR
An Act relating to pharmaceutical drug manufacturers and
prescription drug prices, and including applicability
provisions.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
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Section 1. NEW SECTION . 510D.1 Definitions.
As used in this chapter, unless the context otherwise
requires:
1. “Commissioner” means the commissioner of insurance.
2. “Dispenser” means the same as defined in 21 U.S.C.
§360eee(3).
3. “Established name” means the same as defined in 21 C.F.R.
§299.4.
4. “New prescription drug” or “new drug” means a
prescription drug approved by the United States food and drug
administration for which a wholesale acquisition cost has not
been previously established.
5. “Newly acquired prescription drug” or “newly acquired
drug” means a prescription drug approved by the United States
food and drug administration that has been researched and
developed by an entity other than the pharmaceutical drug
manufacturer that acquires the right to sell the prescription
drug.
6. “Patient assistance program” means a program a
pharmaceutical drug manufacturer offers to the general public
in which a consumer may reduce the consumer’s out-of-pocket
cost for a prescriptions drug by using a coupon, discount card,
pharmaceutical drug manufacturer debit card, or other means
provided by the pharmaceutical drug manufacturer.
7. “Pharmaceutical drug manufacturer” or “manufacturer” means
any person engaged in the business of producing, preparing,
converting, processing, packaging, labeling, or distributing
a prescription drug that is sold to any person in this state.
“Pharmaceutical drug manufacturer” or “manufacturer” does not
include a wholesaler distributor or a dispenser.
8. “Prescription drug” means the same as defined in 21
U.S.C. §360eee(12).
9. “Price” means the wholesale acquisition cost as defined
in 42 U.S.C. §1395w-3a(c)(6)(B).
10. “Wholesale acquisition cost” means the same as defined
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in 42 U.S.C. §1395w-3a(c)(6)(B).
11. “Wholesale distributor” means the same as defined in 21
U.S.C. §360eee(29).
Sec. 2. NEW SECTION . 510D.2 Pharmaceutical drug
manufacturers —— prescription drugs —— reporting requirements.
1. A pharmaceutical drug manufacturer shall submit the
information pursuant to subsection 2 to the commissioner for
each prescription drug manufactured by the manufacturer to
which all of the following apply:
a. The price of the prescription drug is one hundred dollars
or more for a thirty-day supply, or for a course of treatment
lasting less than thirty days.
b. The price of the prescription drug increases an amount
greater than the percentage increase in the most recent
consumer price index published in the federal register by the
United States department of labor, bureau of labor statistics.
2. Within sixty calendar days of the date of a price
increase pursuant to subsection 1, paragraph “b” , the
manufacturer shall submit, in the form and manner prescribed by
the commissioner, all of the following information:
a. The established name and the brand name of the
prescription drug, the current price of the prescription drug,
and the net price increase of the prescription drug expressed
as a percentage.
b. A statement detailing all factors that contributed to
the price increase of the prescription drug and an explanation
regarding the impact each factor had on the price increase.
c. The brand name of all generic versions of the
prescription drug currently available on the consumer market.
d. The initial price of the prescription drug after it was
approved by the United States food and drug administration.
e. If applicable, the annual net price increase, expressed
as a percentage, of the prescription drug for each of the five
immediately preceding calendar years.
f. For the immediately preceding twelve consecutive months,
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the average price of the prescription drug in each of the ten
countries outside of the United States with the highest sales
of the prescription drug.
g. The aggregate direct and administrative costs incurred by
the manufacturer related to any of the following:
(1) Manufacturing the prescription drug.
(2) Marketing and advertising the prescription drug.
(3) Researching and developing the prescription drug.
(4) Distributing the prescription drug.
h. The net revenue generated for the manufacturer
attributable to the sale of the prescription drug during the
immediately preceding twelve consecutive months.
i. The net profit generated for the manufacturer
attributable to the prescription drug during the immediately
preceding twelve consecutive months.
j. The aggregate cost to the manufacturer of any patient
assistance programs associated with the prescription drug.
k. If applicable, the patent expiration date for the
prescription drug.
l. If applicable, the exclusivity expiration date for the
prescription drug.
m. Whether an agreement exists between the manufacturer
and any another entity or entities requiring the other
entity or entities to delay offering a generic version of the
manufacturer’s prescription drug on the open market.
Sec. 3. NEW SECTION . 510D.3 Pharmaceutical drug
manufacturers —— new prescription drugs —— reporting
requirements.
1. A pharmaceutical drug manufacturer shall submit the
information pursuant to subsection 2 to the commissioner for
each prescription drug manufactured by the manufacturer to
which any of the following apply:
a. The prescription drug is a new drug that has a price
greater than five hundred dollars for a thirty-day supply.
b. The prescription drug is a generic new drug that has a
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price greater than two hundred dollars for a thirty-day supply.
2. Within sixty calendar days of the first date the
manufacturer offers the new drug in this state, the
manufacturer shall submit, in the form and manner prescribed by
the commissioner, all of the following information:
a. The price of the new drug.
b. The established name and the brand name of the new drug.
c. The brand name of the generic version, if applicable.
d. Whether the new drug received a breakthrough
therapy designation from the United States food and drug
administration.
e. Whether the new drug received a priority review
designation from the United States food and drug
administration.
f. The aggregate direct and administrative costs incurred by
the manufacturer for all of the following:
(1) Manufacturing the new drug.
(2) Marketing and advertising the new drug.
(3) Researching and developing the new drug.
(4) Distributing the new drug.
g. If applicable, the patent expiration date for the new
drug.
h. If applicable, the exclusivity expiration date for the
new drug.
Sec. 4. NEW SECTION . 510D.4 Pharmaceutical drug
manufacturers —— newly acquired prescription drugs —— reporting
requirements.
1. For each newly acquired prescription drug for which
the net price increases by more than one hundred dollars on
or after the date of a manufacturer’s acquisition of the
new drug, the acquiring manufacturer shall submit to the
commissioner, within sixty calendar days of the date the
acquiring manufacturer offers the newly acquired drug in this
state, all of the following information:
a. The date on which the newly acquired drug was acquired.
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b. The price of the newly acquired drug on the date of
acquisition.
c. If applicable, the average price of the newly acquired
drug during each of the twelve consecutive months immediately
preceding the date of acquisition.
d. If applicable, the average net price of the newly
acquired drug during each of the five consecutive calendar
years immediately preceding the date of acquisition.
e. The identity of the entity from which the acquiring
manufacturer acquired the newly acquired drug.
f. The date that the newly acquired drug was originally
offered on the consumer market and the price of the newly
acquired drug on that date.
g. Whether an agreement exists between the manufacturer
and any another entity or entities requiring the other
entity or entities to delay offering a generic version of the
manufacturer’s newly acquired drug on the consumer market.
h. If applicable, the new drug’s patent expiration date.
i. If applicable, the new drug’s exclusivity expiration
date.
Sec. 5. NEW SECTION . 510D.5 Prescription drug pricing ——
public availability.
1. Information provided by a pharmaceutical drug
manufacturer to the commissioner pursuant to sections 510D.2,
510D.3, and 510D.4 that may reveal any of the following
as related to a specific prescription drug or class of
prescription drugs shall be considered a confidential record,
and be recognized and protected as a trade secret pursuant to
section 22.7, subsection 3:
a. The amount the manufacturer charges a specific health
carrier, specific pharmacy benefit manager, or a specific
dispenser.
b. The dollar value of the rebates the manufacturer provides
a specific health carrier, specific pharmacy benefit manager,
or a specific dispenser.
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c. The identity of a specific health carrier, specific
pharmacy benefit manager, or a specific dispenser.
2. Within sixty calendar days of receipt, the commissioner
shall publish the nonconfidential information provided pursuant
to sections 510D.2, 510D.3, and 510D.4 on a publicly accessible
internet site.
Sec. 6. NEW SECTION . 510D.6 Rules.
The commissioner may adopt rules pursuant to chapter 17A as
necessary to administer this chapter.
Sec. 7. NEW SECTION . 510D.7 Enforcement.
The commissioner may take any action within the
commissioner’s authority to enforce compliance with this
chapter.
Sec. 8. APPLICABILITY.
1. The section of this Act requiring a manufacturer to
submit a report regarding existing prescription drugs to
the commissioner applies to a manufacturer that sells a
prescription drug to any person in this state on or after July
1, 2020.
2. The section of this Act requiring a manufacturer to
submit a report regarding new prescription drugs to the
commissioner applies to a manufacturer that sells a new
prescription drug to any person in this state on or after March
15, 2021.
3. The section of this Act requiring a manufacturer to
submit a report regarding newly acquired prescription drugs to
the commissioner applies to a manufacturer that sells a newly
acquired prescription drug to any person in this state on or
after July 1, 2021.
EXPLANATION
The inclusion of this explanation does not constitute agreement with
the explanation’s substance by the members of the general assembly.
This bill relates to pharmaceutical drug manufacturers and
prescription drug prices.
If the price of a prescription drug is $100 or more for a
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30-day supply or for a course of treatment lasting less than
30 days; or the price of a prescription drug increases by an
amount greater than the percentage increase of the most recent
consumer price index published by the United States department
of labor, bureau of labor statistics, the bill requires a
pharmaceutical drug manufacturer (manufacturer) to submit a
report to the commissioner of insurance (commissioner) that
includes information as outlined in the bill. The report
must be submitted within 60 calendar days of the date of the
applicable price increase. “Price” is defined in the bill
as the wholesale acquisition cost of the drug. “Wholesale
acquisition cost” is the manufacturer’s list price for a drug
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 pricing data. “Pharmaceutical drug
manufacturer” or “manufacturer” is defined in the bill as
any person engaged in the business of producing, preparing,
converting, processing, packaging, labeling, or distributing
a prescription drug that is sold to any person in this state.
The definition does not include a wholesale distributor or a
dispenser, both of which are also defined in the bill.
If a manufacturer’s new drug has a price greater than $500
for a 30-day supply, or a generic new drug that has a price
greater than $200 for a 30-day supply, within 60 calendar days
of the first date the manufacturer makes the new drug available
in this state, the manufacturer must submit a report to the
commissioner that contains the information outlined in the
bill. The bill defines “new prescription drug” or “new drug”
as a prescription drug approved by the United States food and
drug administration for which a wholesale acquisition cost has
not been previously established.
For each newly acquired prescription drug for which the
net price increases by more than $100 on or after the date of
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a manufacturer’s acquisition of the new drug, the acquiring
manufacturer must submit a report to the commissioner, within
60 calendar days of the date the acquiring manufacturer
offers the newly acquired drug in this state, that contains
information as detailed in the bill. “Newly acquired
prescription drug” or “newly acquired drug” is defined in the
bill as a prescription drug approved by the United States food
and drug administration that has been researched and developed
by an entity other than the pharmaceutical drug manufacturer
that acquires the right to sell the prescription drug.
Within 60 calendar days of receipt, the bill requires the
commissioner to publish the nonconfidential information, as
described in the bill, from the required reports filed by
manufacturers on a publicly accessible internet site.
The commissioner may adopt rules as necessary to administer
the provisions contained in the bill. The commissioner may
also take any action within the commissioner’s authority to
enforce compliance with the provisions contained in the bill.
The section of the bill requiring a manufacturer to
submit a report regarding existing prescription drugs to
the commissioner applies to a manufacturer that sells a
prescription drug to any person in this state on or after July
1, 2020. The section of the bill requiring a manufacturer
to submit a report regarding new prescription drugs to the
commissioner applies to a manufacturer that sells a new
prescription drug to any person in this state on or after March
15, 2021. The section of the bill requiring a manufacturer to
submit a report regarding newly acquired prescription drugs to
the commissioner applies to a manufacturer that sells a newly
acquired prescription drug to any person in this state on or
after July 1, 2021.
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