Technology Blueprints for PDUFA, GDUFA Programs Released for Comment

US regulators last week released the texts of two reports, mandated under the terms of the most recent user fee agreements, detailing two five-year plans to improve the information technology services of the agency's novel and generic drug departments.

Background

Both reports, required under the Food and Drug Administration Safety and Innovation Act (FDASIA), are essentially blueprints for how FDA can improve its technological capacities in order to make its regulatory processes more efficient.

Since nearly all drug applications are now submitted through electronic submission gateways and data stored on FDA's servers, FDA's ability to efficiently handle, track and process data-and do so securely-is hugely important to its ability to meet deadlines and otherwise operate.

And as a government agency, FDA isn't exactly on the cutting edge of technological innovation. But where other agencies struggle to come up with any funding for IT improvements, FDA is fortunate to obtain funding through its user fee programs, including the Prescription Drug User Fee Act (PDUFA) and the Generic Drug User Fee Act (GDUFA), both of which were included in FDASIA.

Both acts contain a significant amount of money to help FDA make improvements, and the reports are intended to show to industry how FDA plans to spend the money it has been given.

The Reports

While each respective report-one for PDUFA and the other for GDUFA-differs from the other on certain minor points, they are nearly identical with the exception of the data standards section.

For example, both include the same five main topic areas:

1. Supporting Regulatory Operations-describing the approach to strengthening the Electronic Submissions Gateway to support the long-term exchange and review of drug and biologics applications
2. Electronic Regulatory Submissions-providing a consistent approach to the creation and review of regulatory submissions
3. Data Standards-defining and implementing standards supporting drug efficacy, drug safety, manufacturing, product identification, and other areas
4. Metrics and Measures-tracking progress and assessing implementation of goals
5. Communications and Technical Interactions-disseminating information to stakeholders to help improve the program

Pending Changes

The reports also both note that FDA will soon require all submissions in the electronic Common Technical Document (eCTD) format (2016-17), with guidance coming in 2014 on how to make those submissions.

Other various changes coming soon:

• FDA is continuing work on version 4.0 of the eCTD format, which it hopes to implement by 2016.
• A draft guidance on the submission of standardized data is due in 2014
• FDA is instituting in 2014 an ISO Identification of Medicinal Products (IDMP) standard-similar to a national drug code (NDC)-to keep track of drugs for postmarketing surveillance purposes.
• Various study data standards will be published starting in 2014 through the end of 2017.

Comments on both draft reports are due to FDA by 24 February 2014.

PDUFA Report (FR)

GDUFA Report (FR)