Regulators and generic pharmaceutical companies, start your engines. The race to the next reauthorization of the Generic Drug User Fee Act (GDUFA) has begun.
In a Federal Register notice on 21 April 2015, the US Food and Drug Administration (FDA) announced that it will begin accepting comments regarding the first-ever reauthorization of GDUFA—a user fee arrangement which funds much of FDA's generic pharmaceutical regulatory activities.
GDUFA was first passed into law in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA)—a massive piece of legislation which contained hundreds of reform measures and several user fee components meant to increase funding for FDA.
GDUFA, which is modeled off similar user fee programs for pharmaceuticals (PDUFA) and medical devices (MDUFA), is built around a simple premise. Generic drug companies would like to see their products approved more quickly. FDA is capable of approving drug products more quickly, but not without a sizeable increase in staff and improvements to its regulatory infrastructure.
GDUFA bridges this gap by requiring generic pharmaceutical companies to pay a fee to FDA for many of its routine activities, including generic drug filings and manufacturing facility inspections.
|Generic Drug User Fee Act (GDUFA)||2015||2014||2013|
|Abbreviated New Drug Application||$58,730||$63,860||$51,520|
|Prior Approval Supplement||$29,370||$31,930||$25,760|
|Drug Master File||$26,720||$31,460||$21,340|
|Finished Dosage Form Facility (Domestic)||$247,717||$220,152||$175,389|
|Finished Dosage Form Facility (Foreign)||$262,717||$235,152||$190,389|
|Active Pharmaceutical Ingredient Facility (Domestic)||$41,926||$34,515||$26,458|
|Active Pharmaceutical Ingredient Facility (Foreign)||$56,926||$49,515||$41,458|
In return, FDA commits to reviewing generic drug applications within a certain time frame, which allows generic drug companies to—in theory—bring their products to market more quickly. The first authorization of GDUFA also contained extra money for FDA to reduce a massive backlog of generic drug applications that were slowing down drug approvals.
Read our extensive coverage of GDUFA here.
Reauthorization Process Begins Again
Now, nearly four years after GDUFA was first passed into law and with GDUFA creeping up on its 2017 date of expiry, FDA is starting up the reauthorization process for GDUFA II.
FDA's reauthorization processes are by any measure extraordinarily unusual. With the exception of trade agreements, Congress is typically the first and last word in any agreement between a government agency and the industries it regulates. But that's not the case with FDA's user fee agreements, which are hashed out in direct negotiations between FDA and each of the respective industries it regulates. Congress is then given the draft of the user fee bill for final approval.
Stakeholders involved in the negotiating process for past user fee agreements have said this process results in an agreement that is tenable for both parties, and prevents the user fee agreements from becoming politicized or heavily modified by legislators lacking a deep understanding of the drug approvals process.
The reauthorization process is also controlled in part by federal legislation, the Federal Food, Drug and Cosmetic Act, which requires FDA to request "public input on the reauthorization" prior to starting any negotiations with industry. In addition, FDA is required to hold a public meeting, during which time the public may comment on the reauthorization process and recommend changes to be made to the upcoming user fee agreement and accompanying Commitment Letter, which describes in detail the commitments to be carried out by FDA.
In particular, FDA asks two questions of the public:
- What is your assessment of the overall performance of the GDUFA program to date?
- What aspects of GDUFA should be retained, changed or discontinued to further strengthen and improve the program?
As noted by Bob Pollock, former acting deputy director of the Office of Generic Drugs, major issues expected to be brought up during the GDUFA reauthorization process are the number of generic drugs approved, the communication of application status after approval, the quality of some generic drug applications, and the financial resources available for a new user fee agreement.
FDA's GDUFA meeting will take place on 15 June 2015 on FDA's White Oak campus in Silver Spring, MD.
Federal Register Notice