June 22, 2017

Thank you for the opportunity to comment on the Massachusetts Pharmacy regulations. This presents an important avenue for the State of Massachusetts to update its pharmacy regulations to ensure safe and appropriate access to medications with FDA approved Risk Evaluation Mitigation Strategies (REMS) and consistency with Federal regulations around these medications.

Authorized by Congress, the Food and Drug Administration Amendments Act of 2007 gave the FDA the authority to require a REMS from pharmaceutical manufacturers to ensure that the benefits of a prescription medication outweigh its risks.1 REMS programs provide millions of Americans with serious, life threatening diseases like cancer and multiple sclerosis the ability to access medicines that otherwise would not be approved by the FDA.

Celgene Corporation specializes in the discovery, development, and delivery of medicines for cancer, inflammatory, and immunological conditions. A select few of our FDA approved cancer medications have the potential for severe side effects to patients if they are prescribed, dispensed, or taken inappropriately. Specifically, those effects may include birth defects or death to an unborn child should there be fetal exposure.

Due to the potential for severe side effects from fetal-embryo product exposure and in an effort to prevent any such exposure, these medications are approved by FDA with a REMS program requirement and are only available under a tightly controlled REMS distribution program.

Only certified prescribers can prescribe and only certified pharmacies can dispense these medications. In addition, in order to receive the medication, all patients must be enrolled into the REMS program and agree to comply with the requirements of the REMS program.

Before receiving the medication to dispense, all pharmacies that dispense Celgene REMS products must be trained and subsequently classified as certified pharmacies. Each pharmacy must also ensure that they only accept prescriptions from REMS-certified prescribers, dispense medications within a certain timeframe, communicate with Celgene to obtain the appropriate documentation to dispense 1 21 U.S.C. § 355-1 1 each prescription, conduct and document the REMS-required patient counseling session before every product dispense, and are audited for REMS program compliance annually.

These significant mandatory REMS requirements provide essential safeguards for patients who need access to medications with serious risks. To ensure alignment between FDA requirements and Massachusetts’ pharmacy regulations, Celgene proposes the following language for insertion in Section 247 CMR 9.00: CODE OF PROFESSIONAL CONDUCT; PROFESSIONAL STANDARDS FOR REGISTERED PHARMACISTS, PHARMACIES AND PHARMACY DEPARTMENTS of the state’s pharmacy regulations:

A pharmacist, pharmacy or pharmacy department shall fully comply with all elements of a drug’s FDA required risk evaluation and mitigation strategy (REMS), including any distribution or dispensing restrictions included in its REMS.

Thank you for your consideration of this recommendation.

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