FDA user fees reauthorized by House vote

In a bipartisan action, the House of Representatives today passed H.R. 2430, the FDA Reauthorization Act (FDARA) of 2017, by voice vote. FDARA reauthorizes the FDA’s user fee programs for prescription drug, medical device, generic drug, and biosimilar biological products. The current user fee programs are set to expire in September 2017 and account for almost a quarter of the FDA’s funding.

In April 2017, the House Energy and Commerce Committee, along with the Senate Health, Education, Labor and Pensions (HELP) Committee, released a discussion draft of the Food and Drug Administration (FDA) Reauthorization Act of 2017, reauthorizing the FDA’s user fee agreements (see Discussion draft of FDA user fee amendments is on the table, Health Law Daily, April 18, 2017). The draft followed a series of hearings examining the four individual user fee programs – the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA), and the Medical Device User Fee Amendments (MDUFA) (see HELP Committee hears ardent support for next round of user fee agreements, Health Law Daily, April 4, 2017 Committee holds optimistic hearing on medical device fees, Health Law Daily, March 29, 2017; PDUFA VI reauthorization would aid 21st Century Cures Act implementation, Health Law Daily, March 23, 2017; and User fee program reauthorizations necessary for product development, Health Law Daily, March 3, 2017).

FDARA is currently before the Senate (see HELP committee advances FDA user fee agreements to Senate floor, Health Law Daily, May 12, 2017).

Energy and Commerce committee unanimously approves FDA reauthorization

The House Energy and Commerce Committee voted unanimously—54 to zero—to approve H.R. 2430, the Food and Drug Administration Reauthorization Act of 2017 (FDARA), after a markup on June 7, 2017. The bill would reauthorize the FDA’s user fee programs for prescription drug, medical device, generic drug, and biosimilar biological products. Without the reauthorization, the use fee programs will expire at the end of September, 2017.

The FDARA would renew the FDA’s authority to collect user fees from the makers of prescription brand drugs, medical devices, generic drugs, and biosimilars. The fees account for more than one-fourth of the agency’s funding (see HELP committee advances FDA user fee agreements to Senate floor, May 12, 2017).

The bill passed the committee with six amendments, offered by: Chairman Greg Walden (R-Ore), Rep. Ryan Costello (R-Pa), Rep. Scott Peters (D-Calif), Rep. Mimi Walters (R-Calif), and Rep. Jan Schakowsky (D-Ill). Rep. Schakowsky offered two amendments. The amendments are designed to further the development of generic therapies, update approval and quality reporting requirements for medical devices, allow for risk-based classification of accessories, foster the development of medical device safety surveillance pilots, and encourage steps to lower the cost of prescription drugs.

Committee holds optimistic hearing on medical device fees

The Energy and Commerce Subcommittee on Health held a hearing on March 28, 2017, to consider the reauthorization of the FDA Medical Device User Fee Amendments (MDUFA). The MDUFA, set to expire in September 2017, authorizes the FDA to collect fees from the medical device industry in order to support product reviews. The MDUFA was last reauthorized in 2012 and must be reauthorized every five years. In his opening statement, Subcommittee Chairman Michael Burgess (R-Texas) noted that approving the reauthorization would “increase efficiency at the FDA and ensure that American patients benefit from advances in biomedical technology and innovation as soon as safely possible.”

MDUFA IV

The agreement under consideration (MDUFA IV) is an extension of previous MDUFA process improvements. The agreement builds on existing federal law, streamlines the development and review of medical devices, and would average approximately $200 million in negotiated fees for the FDA per year.

Approval time

Jeffery Shuren, Director of the FDA Center for Devices and Radiological Health, testified as to the previous success of the MDUFA, noting that between 2009 and 2015, the time it took to reach a decision on a premarket approval application (PMA) decreased 35 percent. Additionally, between 2010 and 2015, the time it took to reach a decision on a 510(k) decreased 11 percent. Shuren suggested that further progress can be made. Robert Kieval, a Board Member of the Medical Device Manufacturers Association (MDMA), testified that the most recent agreement includes updated decision time targets for 510(k)s and PMAs, and, for the first time, review time goals for de novo technologies and pre-submissions. Specifically, Patrick Daly of Cohera Medical testified the MDUFA IV aims to bring decision time for PMAs from 385 days to 290 days and bring decision times for 510(k)s from 124 days to 108 days.

Recommendations

Diane Wurzburger a regulatory affairs executive at GE Healthcare, testified on behalf of the Medical Imaging and Technology Alliance (MITA). She noted that the medical imaging community is looking for more predictability, consistency, transparency and timeliness in the premarket device review process. Specifically, she said manufacturers are interested in shortening 510(k) approval time, obtaining performance metrics for the pre-submission process, and third-party independent assessments. She also reiterated previous comments that the MDUFA advances shared goals between the FDA and the medical device industry.

User fee increases still outpace drug, device approvals

Although FDA drug, biologic, and medical device user fees have netted the agency $7.67 billion from manufacturers in the last quarter century, the drug or device approval process has not kept pace. In an Avalere analysis, fees have measurably increased in the last decade. User fees are increasingly important to the agency’s ability to fund the drug, biologic and device review programs. In some cases these fees account for a larger proportion of the FDA budget than the congressionally appropriated budget. For example, the report noted that user fees account for 68 percent of the FDA’s review budget for prescription drugs, while 58 percent of the review budget for generic drugs comes from user fees. The fees are touted as additional funding sources for the FDA to expedite the overall drug or device approval process.

For fiscal year (FY) 2017, the user fees rates are: $2,038,100 for applications requiring clinical data; $1,019,050 for applications not requiring clinical data or supplements requiring clinical data (one-half the amount of applications requiring clinical data rate); $512,200 for establishments; and $97,750 for products (see FY 2017 user fee rates issued for Rx and animal drugs, biosimilars, Health Law Daily, July 28, 2016).

Yet, Avalere analysis of data from FY 2013 suggests that the approval times are not improving; the standard prescription drug was reviewed and approved in 12 months with priority applications in almost 8 months. According to Avalere, there are significant amounts of unspent funds from the user fee programs, upwards of $300 million, that the FDA could use to “accelerate” product reviews, especially in light of public concern about rising drug costs.

Under the federal Food, Drug & Cosmetic Act (FDC Act) (21 U.S.C. §§379g and 379h), the FDA is authorized to set fees and schedules for these regulated areas. Prescription drug makers must account for three kinds of user fees: (1) product fees that are paid for each product being sold on the market; (2) establishment fees that are paid by all manufacturers annually; and (3) application review fees that are paid for every product application that is submitted. On September 30, 2017, all four FDA user fee programs will expire, including: Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Act (GDUFA), Medical Device Drug User Fee Act (MDUFA), and Biosimilar User Fee Act (BsUFA).