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User Fees

July 25, 2017 | Daily News

The medical device lobby will seek to add a rider permanently repealing the medical device tax to the Senate user fee package -- despite previous concerns that the rider could not be added due to jurisdictional issues -- if the tax is not repealed as part of health reform efforts.

July 24, 2017 | Daily News

FDA Commissioner Scott Gottlieb wrote to FDA staff Monday (July 24) that the agency will not issue layoff notices to user fee-funded employees until Sept. 30, buoyed by confidence that the user fee package will be signed into law before the existing authorizations lapse.

July 24, 2017 | Daily News

The Senate is still “hopeful” over-the-counter (OTC) monograph reform language could be added to the FDA user fee reauthorization bill, a spokesperson for Sen. Johnny Isakson (R-GA) told Inside Health Policy.

July 24, 2017 | Daily News

A leading cancer research advocacy organization is urging the Senate to include in its user fee package a bill that aims to increase development of therapies for childhood cancer.

July 17, 2017 | Daily News

Senate Majority Leader Mitch McConnell (R-KY) used Rule XIV to place the House-passed user fee package on the Senate calendar Monday (July 17).

July 12, 2017 | Daily News

The House passed FDA user fee legislation Wednesday afternoon (July 12) by voice vote, and lawmakers pressed the Senate to act quickly on the must-pass reauthorization package to avoid pink slips being sent to FDA employees at the end of the month.

July 10, 2017 | Daily News

A pre-conferenced FDA Reauthorization Act (FDARA), which is expected to face a House vote Wednesday afternoon, includes portions of a bill aimed at increasing development of childhood cancer drugs.

July 10, 2017 | Daily News

A revised FDA user fee package set to face a House vote Wednesday afternoon under suspension of the rules largely combines the marked up House and Senate bills, and leaves out legislation crafted by industry and FDA to create an over-the-counter monograph user fee program.

July 10, 2017 | Daily News

The House is set to send a pre-conferenced FDA Reauthorization Act to the floor Wednesday afternoon for a vote on the user fee package under suspension of the rules, sources tell Inside Health Policy.

July 03, 2017 | Daily News

A House FDA user fee measure that would use market incentives to boost generic competition for sole-source drugs could be bolstered by FDA chief Scott Gottlieb's newly unveiled list of off-patent drugs that lack competition.

June 30, 2017 | Daily News

Despite dodging a proposal for much more stringent oversight, one third-party medical device servicers organization is again calling on Congress to further revise a bill that would require FDA to submit a report on how it will ensure the quality and safety of medical devices that have been repaired “by a person other than the manufacturer.”

June 23, 2017 | Daily News

A draft document obtained by Inside Health Policy sets out expected performance goals for an over-the-counter monograph user fee program (OMUFA) under which FDA would see improved review timelines and more efficient review capacity by year four of the program.

June 23, 2017 | Daily News

The Consumer Healthcare Products Association (CHPA), Pew Charitable Trusts and American Academy of Pediatrics along with four other health-focused groups recently penned a letter to Sens. Johnny Isakson (R-GA) and Bob Casey (D-PA) showing support for the senators' revised draft of their bill intended to reform FDA's over-the-counter (OTC) drug monograph system.

June 23, 2017 | Daily News

Recently unveiled over-the-counter (OTC) monograph legislation is all the more important to reducing the monograph backlog given that FDA's fiscal 2018 budget justification maintains fiscal 2017 funding levels for the agency's OTC review processes, the Pew Charitable Trusts recently recently told Inside Health Policy.

June 21, 2017 | Daily News

FDA isn't waiting for the generic drug user fee reauthorization measure to move through Congress to move forward with one of the package's commitments: A new draft guidance issued this week sets up a new pre-submission process for certain generic drug applications, which FDA chief Scott Gottlieb says could cut two months off review times and increase access to affordable drugs.

June 07, 2017 | Daily News

The House Energy & Commerce Committee sent its user fee package to the floor, 54-0, Wednesday (June 7), tacking on several new amendments that deal with medical imaging, device servicing, accessory classification, a medical device safety pilot program and a sense of Congress urging the HHS secretary to take administrative actions to lower drug costs.

June 07, 2017 | Daily News

The House Energy & Commerce Committee attached a watered-down version of Rep. Ryan Costello's (R-PA) medical device imaging servicers bill to FDA user fee legislation Wednesday (May 7).

June 07, 2017 | Daily News

A measure that would require drug developers conduct pediatric studies on cancer drugs made for adults if the molecular target is the same as in children was withdrawn from discussions during the House Energy & Commerce Committee user fee markup Wednesday (June 7).

June 07, 2017 | Daily News

Drug importation from Canada, a sense of Congress on drug pricing and off-label communication with payers are the subjects of hot-button amendments that lawmakers signaled they plan to bring up at today's House Energy & Commerce markup of FDA user fee legislation.

June 07, 2017 | Daily News

Rep. David McKinley (R-WV) told fellow House Energy & Commerce Committee members that he and Rep. Peter Welch (D-VT) plan to offer their bipartisan Risk Evaluation and Mitigation Strategy (REMS) bill during the committee’s markup of the FDA user fee package, saying concerns that the bill would endanger patient safety are unfounded.

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