Posted 18 July 2017
By Michael Mezher
By the end of 2017, the US Food and Drug Administration (FDA) will issue two new documents to improve the review process for generic drugs, according to FDA Commissioner Scott Gottlieb.
Gottlieb made the announcement at a public hearing looking into barriers to generic drug competition held at FDA's campus in Silver Spring, MD on Tuesday.
While the hearing focused on gathering input from the public and industry issues such as risk evaluation and mitigation strategies (REMS) abuse and the use of citizen petitions to delay generic entrants, Gottlieb said the agency is already taking steps to improve competition.
The two documents, Gottlieb said, are meant to streamline the submission and review of abbreviated new drug applications under the agency's drug competition action plan.
The first document is a planned internal manual of policies and procedures (MAPP) entitled "Good ANDA Assessment Practices" that will look to cut "unnecessary" and "duplicative" procedures from the agency's reviews to make them more efficient.
But Gottlieb noted that the document will not alter any of the review goals the agency agreed to as part of the negotiations to reauthorize the Generic Drug User Fee Amendments (GDUFA).
"One lesson that we learned from GDUFA and [the Prescription Drug User Fee Act] PDUFA alike is that truncating review prevents applicants from fixing their submissions and getting them approved. The result is additional review cycles, not faster approval. The goal of the MAPP is to help make sure we work smarter," Gottlieb said.
Under the MAPP, Gottlieb says the level of supervisory oversight for ANDA reviews will scale based on the level of experience the primary reviewer has, as well as the relative risk and complexity of the product.
"Supervisors should validate, not re-do, the assessment," he said.
For applications that aren't approved, Gottlieb also said the MAPP will instruct reviewers to detail what needs to be fixed in the complete response letter, and provide follow up with sponsors by phone if the reasons in the letter are unclear.
The second document will be a guidance on "Good ANDA Submission Practices" that will be added to the Center for Drug Evaluation and Research's to-do list for the year, which already includes 13 other new and revised draft guidances for generic drugs.
The guidance, Gottlieb said, will detail common issues found in ANDA submissions and give sponsors advice on how to avoid those issues before submitting an application in the first place.
While Gottlieb said he believes improvements within FDA are essential to the success of its generic drugs program, he cautioned that the agency can only approve "complete submissions that are ready to approve."