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FDA User Fee Bill Approved

On August 3, the Senate passed legislation (H.R.2430) by a vote of 94-1 that extends for five years the FDA’s authority to collect user fees from drug- and medical-device makers for reviewing new products, sending it to President Trump for his signature. The House passed the bill in July.

The bill would reauthorize user fees for prescription drugs, medical devices, generic drugs, and biosimilar products from fiscal 2018 through 2022. They are set to expire on Sept. 30.

The FDA submits recommendations to Congress for each reauthorization cycle based on negotiations with industry over the framework for the fees and performance goals for the agency.

Under the bill, user fees would increase by about $400 million in fiscal 2018 compared with fiscal 2017. The following table shows base fee amounts in millions of dollars; fiscal 2017 numbers come from an Energy and Commerce Committee summary of the revised bill:

User Fee Program

Fiscal Year 2017

Fiscal Year 2018

Prescription Drugs

$718.7

$878.6

Generic Drugs

$299

$493.6

Medical Devices

$130.2

$183.3

Biosimilar Products

$20

$45

Medical Device Fees

Fees for medical device manufacturers would be reauthorized based on the agreement between FDA and industry. The total amount of revenue to be collected from medical device fees would be set at $183.3 million for fiscal 2018 and rise to $213.7 million by fiscal 2022.

The measure would increase the base fee amount for premarket applications to $294,000 for fiscal 2018, reaching $329,000 by fiscal 2022. Establishment registration fees would be increased to $4,375 for fiscal 2018 and would reach $4,978 by fiscal 2022.

The measure would add a fee for “de novo classification requests” -- new requests for device classifications -- which would equal 30 percent of the fee for a premarket application. Fees for premarket notification submissions would be increased to 3.4 percent of a premarket application fee, instead of 2 percent. The small business reduction to those fees would be 25 percent, instead of 50 percent. Small businesses are defined as those with $100 million or less in gross receipts or sales on its most recent federal tax return.

The measure also would increase the appropriation trigger amount required to allow the collection of user fees to $320.8 million, from $280.6 million.

The measure would establish a pilot program for labs that test medical devices to be accredited for meeting specified standards. HHS would have to initiate the program by Sept. 30, 2020, and the authority to accredit labs would expire on Oct. 1, 2022.

The measure would direct HHS to update its list of class I and class II devices eligible for review by an accredited person and to develop factors for the designation. It would remove certain restrictions in current law on eligibility of class II devices; class III devices also aren’t eligible.

Class I covers the least-invasive types of devices and includes items such as exam gloves, while class II devices are higher risk and require additional certifications and regulatory oversight. Class II devices include acupuncture needles, condoms, and powered wheelchairs. Class III represents the highest-risk category for devices and includes items such as pacemakers, other implantable equipment, and diagnostic tests for severe diseases.

Device manufacturers would have to submit their applications electronically.

By Patrick Cooney, The Federal Group, Inc.
Legislative Representative, Dental Trade Alliance