Bill Summary – FastDemocracy

ENROLLED ORIGINAL

                                            AN ACT

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                   IN THE COUNCIL OF THE DISTRICT OF COLUMBIA

                                      _________________

To amend the District of Columbia Prescription Drug Price Information Act to authorize licensed

      pharmacists to dispense interchangeable biological products, and to require notifications

      to physicians, with certain exceptions, when interchangeable biological products are

      dispensed.

       BE IT ENACTED BY THE COUNCIL OF THE DISTRICT OF COLUMBIA, That this

act may be cited as the Access to Biosimilars Amendment Act of 2020.

         Sec. 2. The District of Columbia Prescription Drug Price Information Act, effective

September 10, 1976 (D.C. Law 1-81; D.C. Official Code  48-801.01 et seq.), is amended as

follows:

         (a) Section 2 (D.C. Official Code  48-804.51) is amended by adding new paragraphs

(1A) and (2A) to read as follows:

                 (1A) Biological product shall have the same meaning as provided in 42 U.S.C.

 262.

                 (2A) Interchangeable biological product means a biological product that is:

                        (A) Licensed and determined by the United States Food and Drug

Administration to meet the standards for interchangeability under 42 U.S.C.  262(k)(4); or

                        (B) Determined to be biosimilar to and interchangeable with a reference

biological product as stated in the latest edition of, or supplement to, the United States and Food

and Drug administrations (FDA) publication, Lists of Licensed Biological Products with

Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (known as

the Purple Book)..

         (b) Section 301 (D.C. Official Code  48-803.01) is amended by adding a new subsection

(d) to read as follows:

         (d) The Board of Pharmacy and the Board of Medicine shall maintain a link on their

websites to the current list of biological products determined by the FDA to be interchangeable

with a specific biological product..

         (c) Section 302 (D.C. Official Code  48-803.02) is amended as follows:

                 (1) The section heading is amended to read as follows:

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        Sec. 302. Dispensing of generically equivalent drug product or interchangeable

biological product..

                (2) Subsection (a) is amended by striking the phrase generically equivalent drug

product wherever it appears and inserting the phrase generically equivalent drug product or

interchangeable biological product in its place.

                (3) Subsection (b) is amended by striking the phrase drug by generic name and

inserting the phrase drug by generic name or interchangeable biological product in its place.

        (d) Section 303(2) (D.C. Official Code  48-803.03(2)) is amended by striking the phrase

generically equivalent drug product and inserting the phrase generically equivalent drug

product or interchangeable biological product in its place.

        (e) Section 303a(a) (D.C. Official Code  48-803.03a(a)) is amended by striking the

phrase drug substitution and inserting the phrase drug substitution, including an

interchangeable biological product, in its place.

        (f) Section 304 (D.C. Official Code  48-803.04) is amended by striking the phrase

substituted under this title, and inserting the phrase substituted under this title, including the

substitution of an interchangeable biological product, in its place.

        (g) Section 305 (D.C. Official Code  48-803.05) is amended as follows:

                (1) Subsection (a) is amended by striking the phrase under this title and

inserting the phrase under this title, including the substitution of an interchangeable biological

product in its place.

                (2) Subsection (b) is amended by striking the phrase generically equivalent drug

products drugs and inserting the phrase generically equivalent drugs products or an

interchangeable biological product in its place.

        (h) A new section 306 is added to read as follows:

        Sec. 306. Pharmacist notification to prescriber of substitution of interchangeable

biological product.

        (a) Within 5 business days after dispensing a biological product to a patient, the

dispensing pharmacist or the pharmacists designee shall communicate to the prescriber the

specific biological product dispensed, including the name and manufacturer of the biological

product; except, that this communication shall not be required if the FDA has not approved an

interchangeable biological product for the biological product prescribed to the patient or a refill

prescription is not changed from the biological product dispensed on the most recent filling of

the prescription.

        (b)(1) Except as provided under subsection (c) of this section, the communication

required under subsection (a) of this section shall be provided by making an entry that is

electronically accessible to the health care provider through:

                        (A) An interoperable electronic medical records system;

                        (B) An electronic prescribing technology; or

                        (C) A pharmacy benefits management system.

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                                                                      ENROLLED ORIGINAL

                 (2) Making an entry through a mechanism listed in paragraph (1) of this

subsection shall be presumed to provide the communication to the prescriber required under

subsection (a) of this section.

        (c) If the mechanisms listed in subsection (b)(1) of this section are unavailable, the

communication required under subsection (a) of this section may be provided by facsimile,

telephone, electronic transmission, or other means.

        (d) The requirements under subsections (a) through (c) of this section shall not apply to

dispensing pharmacists or their designees at a health maintenance organization that operates as a

group model for services furnished through internal pharmacy operations for members and

patients of the health maintenance organization..

       Sec. 3. Fiscal impact statement.

       The Council adopts the fiscal impact statement in the committee report as the fiscal

impact statement required by section 4a of the General Legislative Procedures Act of 1975,

approved October 16, 2006 (120 Stat. 2038; D.C. Official Code  1-301.47a).

       Sec. 4. Effective date.

       This act shall take effect following approval by the Mayor (or in the event of veto by the

Mayor, action by the Council to override the veto), a 30-day period of congressional review as

provided in section 602(c)(l) of the District of Columbia Home Rule Act, approved December

24, 1973 (87 Stat. 813; D.C. Official Code  1-206.02(c)(l)), and publication in the District of

Columbia Register.

               ______________________________

               Chairman

               Council of the District of Columbia

_________________________________

Mayor

District of Columbia

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