SB 51 / HB 195

The bill has officially been enrolled and sent to the Governor.

2015-2016 Session: Convene: 1/13/15 and Adjourn: 3/26/16

5/11/15: The bill has been signed by Governor Deal and enacted into law.

SB 51

Senate: 2/19/15: Passed Senate
House: 3/20/15: House Passed/Adopted By Substitute

HB 195:

Senate: 3/4/15: Read and referred.
House: 3/3/15: Passed / adopted by substitute.
On 3/25/15, the Senate Agreed to House Substitute on SB 51.

 

BioPharma Reporter: Georgia biosimilar substitution bill calls for labeling changes, heads to Governor for signature

By Zachary Brennan
March 30

A Georgia bill, which passed both the state House and Senate last week, calls for new language on biosimilar labels that say that the product is “interchangeable.”

Read the article here.

AJC: Georgia Senate OKs bill creating system for prescribing cheaper drugs
Feb. 19, 2015

The Senate approved legislation Thursday setting up a system for prescribing substitutions for costly biologic drugs that could help Georgia patients save money.

Senate Bill 51 creates rules for pharmacists to follow when distributing these similar medicines, which are approved by the Food and Drug Administration.

The bill, sponsored by Republican Sen. Dean Burke, a Bainbridge physician, requires pharmacists to notify a patient’s doctor when substituting medications and include information about the drug on the prescription label.

Read the article here.

 

Georgia Health News: Bill on ‘biosimilar’ drugs easily clears panel
Feb 12, 2015

$1,300 a month. That’s how much Kerry Tucker spends for the “biologic” medication to treat her arthritis. “And I have health insurance,’’ she told lawmakers Thursday.Biologic drugs are specially engineered drugs that have made a major difference in people’s ability to handle their symptoms from arthritis and other diseases. But they also carry a high price tag.

Tucker, an Atlanta resident, came to the state Capitol to testify for a bill that would make it easier for patients like her to get a cheaper medication that’s similar to a biologic drug they are currently taking.

Read full article here.

• Bill Information

  Defines “interchangeable biological product” as a biological product determined to be interchangeable by FDA or a product that has been deemed therapeutically equivalent by FDA.

  Permits dispensing an interchangeable biological product in place of a prescribed biologic, provided that:

  —pharmacist dispenses the lowest-priced biosimilar;

  —pharmacist records the substitution on the original prescription, the label (except for inpatient and specialty packaging);

  —patient does not object to substitution;

  —prescriber does not indicate that substitution is prohibited; and

  —pharmacist notifies the prescriber within 48 business hours, electronically if possible (and by other means if not), except when there is no FDA-approved interchangeable biosimilar or the prescription is a refill that is unchanged from the prior filling.

  Establishes that a substitution is not the practice of medicine.

  Directs the Board to maintain on its website a list of approved interchangeable products.

  HB 195 and the House Committee-amended SB 51 (but not SB 51 as passed Senate) add section (j), making The Pharmacy Audit Bill of Rights applicable to biological products and interchangeable biological products dispensed under this section.

  HB 195 and the House Committee-amended SB 51 (but not SB 51 as passed Senate) make notation of substitution on the product’s label applicable to hospital retail pharmacies and products dispensed by a hospital for home use.

  SB 51, as amended by the House Committee, exempts hospital-administered biologics from the requirement to have a notation of substitution on the product’s label.