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FDA Letter for ANDA Applicants with Bioequivalence Protocols Comparable to RLD Required Risk Management

To get an abbreviated new drug application (ANDA) approved, an applicant must prove that its generic drug is bioequivalent to the brand name drug, known as the reference listed drug (RLD). To compare its generic drug with the RLD, the ANDA applicant must have access to a sufficient quantity of the RLD.

For some drugs, the U.S. Food and Drug Administration (FDA) requires that applicants submit a proposed risk management plan called a risk evaluation and mitigation strategy (REMS) to ensure that the benefits of the drug outweigh its risks. FDA may also require elements to assure safe use (ETASU). Some RLD sponsors seek to hinder competition by using REMS and ETASU requirements as justification to refuse to sell their drug to generic drug manufacturers.

In December 2014, FDA published a draft guidance to help generic drug facilities obtain a letter from FDA stating that the agency “will not consider it a violation of the REMS for the RLD sponsor to provide a sufficient quantity of the RLD to the interested generic firm or its agent to allow the firm to perform the testing necessary to support its ANDA.” In order to obtain the letter, the ANDA applicant must prove that its bioequivalence (BE) protocols are comparable to those in the RLD’s REMS ETASU. If obtained, the letter does not require an RLD sponsor to sell its drug to the generic drug company, but rather eliminates REMS as a justification for not doing so.

An ANDA applicant that wishes to obtain such a letter should first make sure that the RLD for which it seeks to create a generic version is subject to REMS approval with ETASU. If so, the ANDA applicant should prepare one or more complete BE protocols that include necessary aspects of the RLD’s labeling and ETASU to conduct the BE study or studies in a safe manner. The draft protocols, along with all informed consent documents and informational materials to be distributed to the study investigators, pharmacists, and subjects, should be submitted to [email protected].

After FDA reviews the documents, it will either suggest changes to the ANDA applicant or notify the applicant that the safety protections contained in the protocol(s) are determined to be comparable to those in the REMS ETASU. If the latter occurs and the ANDA applicant wants FDA to issue a letter to the RLD sponsor, the applicant should complete the authorization form contained in the guidance.

Registrar Corp assists companies with U.S. FDA drug regulations. Registrar Corp can help a drug facility register with FDA, list its products, review its product labels for FDA compliance, and more. If you have any questions about FDA requirements for drug facilities, contact Registrar Corp at +1-757-224-0177 or speak with a Regulatory Advisor 24 hours a day at http://www.registrarcorp.com/LiveHelp.