After more than a year of negotiations with the generic drug industry, the Food and Drug Administration (FDA) has recently released the draft performance goals and program enhancements for the Generic Drug User Fee Act for FYs 2018-2022 (GDUFA II). The focus is on achieving faster approvals, dealing with the backlog of Abbreviated New Drug Applications (ANDAs), and streamlining the channels of communication between the FDA and generic drug manufacturers.

Faster approvals

The time taken for the FDA to review and approve ANDAs has been a consistent issue, but more so in the past year, as drug prices have increased dramatically and the public have been calling for greater access to alternative treatment options to expensive brand name drugs.

In response to this, the FDA has agreed to review and act upon 90% of standard original ANDAs within 10 months of the date that the submission was made. This is a big step up from the FDA’s last commitment, made in 2012, which was to review and act upon 60% within 15 months of the submission date.

The FDA will also introduce a new priority review for generic applications. If a complete and accurate Pre-Submission Facility Correspondence is sent two months prior to the date of ANDA submission, the FDA will review and act within 8 months of the ANDA submission date.

There will also be quicker reviews of ANDA amendments, with the FDA agreeing to review and act within 8 months of submission, if a preapproval inspection is not required, or 10 months, if a preapproval inspection is required.

Dealing with the backlog of ANDAs

The FDA has also acknowledged that, despite bringing on more than 1,000 new employees, there is still a significant backlog of ANDAs. To deal with this issue, the FDA has released a new user fee structure plan for GDUFA II, which will see the generic drug industry paying nearly $200 million more annually.

The FDA justifies this drastic increase by claiming that the original payment price was set based on the assumption that the FDA would receive around 750 ANDAs a year, but, in actuality, the agency received over 1000 ANDAs per year over the first four years of GDUFA I.

The extra cost paid by the generic industry will allow the FDA to hire additional staff and implement negotiated improvements to the review process, which will help the agency work towards tackling the current backlog of applications.

Additionally, changes will be made to who pays the user fee and how much is paid. Under GDUFA I, any company that had submitted an ANDA would pay an annual fee, even if the ANDA was pending and not yet approved. However, under GDUFA II, only companies with an approved ANDA will be charged a user fee, as these are the only companies generating a generic drug revenue stream. Furthermore, the amount that each company pays will depend on the number of approved ANDAs that the firm owns; the more a company owns, the more it will pay.

Streamlining channels of communication

The FDA has determined that improved communication between itself and the generic drug industry will also help to speed up approvals and tackle the backlog of applications. As such, the agency has made a commitment to streamline the channels of communication.

The FDA will now respond to 90% of standard controlled correspondence within 60 days of the date of submission, and complex controlled correspondence within 120 days of submission. It will also release information requests and (IRs) discipline review letters (DRLs) at an earlier stage in the review process.

Furthermore, in an effort to make the process easier for generic drug manufacturers, the FDA will release product-specific guidance identifying the best methodology for developing drugs and generating the evidence needed to support ANDA approval. This form of educational communication is intended to further support the generic drug industry.