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January 02, 2013

FDA Implementation Timeline and Tracking for the Food and Drug Administration, Safety and Innovation Act (FDASIA)

2013 Calendar
In recent post on the Food and Drug Administration’s (FDA) FDA Voice Blog, two members of FDA’s Office of Policy announced a new Web Page that will track how the agency is implementing the Food and Drug Administration Safety and Innovation Act (FDASIA)—which included the fifth reuauthorization of the Prescription Drug User Fee Act.  The legislation also authorized user fees for medical devices, generics, and biologics and included provisions to help combat drug shortages and patient focused drug development

The FDA officials explained that the requirements of the 11 Titles contained in FDASIA vary: “some direct FDA to write new regulations or guidance documents that will help industry meet the law’s requirements, while some call for the agency to issue reports or develop strategic plans.  Some provisions set specific timetables for action, others don’t.” 

To ensure the successful implementation of FDASIA, the agency set up a steering committee shortly after the law was passed to oversee the task of integrating the requirements of FDASIA into the agency’s ongoing workload.  One of the committee’s projects has been to create a table that tracks what FDA must do to comply with the statute.  That table was published on the new website, and lists information about FDASIA tasks such as the citation to the section of the law, a description of the task, the statutory due date, and the name of a primary contact person.  The table will also include links to pertinent documents as they are completed and published. 

Initially, the table will include only those requirements with a due date set by Congress. In 2013, other requirements that were not given a specific due date will be added, along with FDA’s target completion date.  Below is a list of some of the guidance, regulations and rules we thought our readers would find important. 

FDA Guidance Requirements Under FDASIA 

By January 9, 2013, FDA must promulgate guidance on the development of abuse-deterrent drug products. 

By June 30, 2013, FDA must publish draft guidance that addresses how data may be used for the efficient and streamlined development of antibacterial drugs to treat serious or life-threatening bacterial infections, including approaches for developing limited-spectrum antibacterials. 

By May 7, 2013, FDA must issue final Unique Device Identifier (UDI) regulations not later than 6 months after the close of the comment period for the proposed rule. FDA must implement these final UDI regulations for devices that are implantable, life-saving, and life-sustaining, not later than 2 years after regulations are finalized. 

By July 9, 2013, FDA’s Center for Drug Evaluation and Research (CDER) must issue draft guidance to implement requirements relating to the submission of plans to study drugs in children.

By July 9, 2013, FDA must issue guidance that describes the circumstances that would constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection. 

By July 9, 2013, FDA must issue draft guidance on the clarified standard for accelerated approval and fast track processes, including issues for drugs for a rare disease or condition. 

By July 9, 2013, FDA must issue guidance describing the types of modifications to approved Risk Evaluation and Mitigation Strategies (REMS) that shall be considered to be minor modifications of such strategies for the purposes of section 505-1(h)(2)(A). 

By September 30, 2013, FDA will develop and issue guidance on how to apply the statutory criteria to determine whether a Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the benefits of a drug outweigh the risks. 

By the end of FY 2013, FDA will initiate one or more public workshops on methodologies for assessing whether REMS are mitigating the risks they purport to mitigate and for assessing the effectiveness and impact of REMS, including methods for assessing the effect on patient access, individual practitioners, and the overall burden on the healthcare delivery system. 

By the end of FY 2013, FDA will hold one or more public meetings to include the pharmaceutical industry, other government healthcare providers, patient groups, and partners from other sectors of the healthcare delivery system to explore strategies to standardize REMS, where appropriate, with the goal of reducing the burden of implementing REMS on practitioners, patients, and others in various healthcare settings. 

By January 9, 2014, FDA must issue draft guidance implementing the requirements on breakthrough therapies to treat a serious or life-threatening condition where early evidence indicates the drug may offer substantial improvement over existing treatments.

By January 9, 2014, FDA must adopt final regulations implementing provisions regarding drug shortages, including defining certain terms. 

By January 9, 2014, FDA, in consultation with the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC), must post on the FDA, ONC, and FCC websites, a report containing a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication. 

By July 9, 2014, FDA’s Center for Devices and Radiological Health must issue final guidance on replication of custom devices used to treat rare conditions where production of such devices is limited to no more than 5 units per year of the device type.  

By July 9, 2014, FDA must issue guidance describing FDA policy regarding Internet promotion, including social media, of medical products regulated by FDA. 

By July 9, 2014, FDA shall issue final guidance on the clarified standard for accelerated approval and fast track processes, including issues for drugs for a rare disease or condition. 

By July 9, 2014, FDA must adopt final regulations, following specified procedures, to implement the 5 years of market exclusivity awarded to drugs designated as qualified infectious disease products and include the list of qualifying pathogens. 

By September 30, 2014, FDA will issue guidance “on methodologies for assessing a Risk Evaluation and Mitigation Strategy. This guidance should specifically address methodologies for determining whether a specific Risk Evaluation and Mitigation Strategy with elements to assure safe use (ETASU) is: (i) commensurate with the specific serious risk listed in the labeling of the drug and (ii) considering the observed risk, not unduly burdensome on patient access to the drug.” 

Not later than December 31, 2014, FDA shall publish final guidance, after notice and opportunity for public comment, that addresses how data may be used for the efficient and streamlined development of antibacterial drugs to treat serious or life-threatening bacterial infections. 

By March 31, 2015, FDA will publish draft guidance for review staff and industry describing best practices for communication between FDA and IND sponsors during drug development. 

By September 30, 2015, and considering feedback and input received through a public meeting, FDA will publish draft guidance for comment describing FDA’s intended approach to the use of meta-analyses in the FDA’s regulatory review process by the end of FY 2015.

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