98TH GENERAL ASSEMBLY
State of Illinois
2013 and 2014
HB0084

 

Introduced 1/9/2013, by Rep. Jack D. Franks

 

SYNOPSIS AS INTRODUCED:
 
New Act

    Creates the Life-Saving Drug Shortage Prevention Act. Provides that a notification to the Director of Public Health shall be required from a manufacturer of a drug concerning a discontinuance, interruption, or adjustment of the manufacture of a drug that would likely result in a shortage. Provides that the notification shall be required at least 6 months prior to the date of the discontinuance or planned interruption or adjustment, and in the case of any other interruption or adjustment a notification shall be required as soon as possible. Provides that the Director may modify the time frames. Provides that the Director shall implement evidence-based criteria for identifying drugs that may be vulnerable to a shortage, and sets forth certain criteria. Sets forth provisions concerning public notification. Effective immediately.


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A BILL FOR

 

HB0084LRB098 02833 RPM 32842 b

1    AN ACT concerning public health.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 1. Short title. This Act may be cited as the
5Life-Saving Drug Shortage Prevention Act.
 
6    Section 5. Purpose. In order to prevent the shortages of
7drugs in this State, the General Assembly finds that creating a
8system for notifying the Department of Public Health concerning
9the discontinuance or interruption of the manufacture of a drug
10is necessary.
 
11    Section 10. Definitions. In this Act.
12    "Adjustment", with respect to the notification
13requirements of this Act, means an adjustment related to the
14supply or raw materials and active pharmaceutical ingredients,
15product capabilities, and business decisions that may affect
16the manufacture of a drug. "Adjustment" includes any other
17adjustments as determined appropriate by the Director.
18    "Department" means the Department of Public Health.
19    "Director" means the Director of Public Health.
20    "Drug" has the same meaning as defined in the Illinois
21Food, Drug and Cosmetic Act.
22    "Drug shortage" or "shortage", when used with respect to a

 

 

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1drug, means a period of time when the total supply of all
2versions of a drug available at the user level will not meet
3the current demand for the drug at that user level.
4    "Notification" means the required reporting of a
5manufacturer of a drug to the Director of a discontinuance,
6interruption, or adjustment of the manufacture of a drug that
7would likely result in a shortage.
 
8    Section 15. Notifications.
9    (a) A notification to the Director shall be required from a
10manufacturer of a drug concerning a discontinuance,
11interruption, or adjustment of the manufacture of a drug that
12would likely result in a shortage.
13    (b) The notification required under subsection (a) of this
14Section shall be required at least 6 months prior to the date
15of the discontinuance or planned interruption or adjustment,
16and in the case of any other interruption or adjustment a
17notification shall be required as soon as possible.
18    (c) The Director may modify the time frames depending on
19the type of interruption or adjustment or any other factor as
20determined to be appropriate.
 
21    Section 20. Identification of potential shortages.
22    (a) The Director shall implement evidence-based criteria
23for identifying drugs that may be vulnerable to a shortage. The
24criteria shall be based on the following:

 

 

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1        (1) the number of manufacturers of the drug;
2        (2) the sources of raw materials and active ingredients
3    for the drug;
4        (3) the supply chain characteristics of the drug; and
5        (4) the availability of therapeutic alternatives to
6    the drug.
7    (b) Using the criteria established in subsection (a) of
8this Section, the Director shall determine if a drug may be
9vulnerable to a shortage and notify the manufacturer of the
10drug of this determination.
 
11    Section 25. Public notification.
12    (a) The Director shall make available to the public
13up-to-date notifications of any shortage or adjustments
14concerning which a notification is required.
15    (b) The information to the public regarding the
16notifications shall be displayed on the Department's Internet
17website.
18    (c) Notification information shall be distributed to
19appropriate health care provider and patient organizations by
20the Department to the maximum extent practicable.
21    (d) The Director shall honor the privacy of proprietary
22information submitted in the notifications and exclude such
23information from the public notification.
 
24    Section 99. Effective date. This Act takes effect upon
25becoming law.