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User Fees

August 02, 2017 | Daily News

House Energy & Commerce Committee ranking Democrat Frank Pallone (NJ) is calling for cosmetics to be included in an over-the-counter (OTC) user fee program that is being discussed by FDA and Congress.

August 01, 2017 | Daily News

Senate Majority Leader Mitch McConnell (R-KY) announced Tuesday (August 1) that Republicans want to vote on the FDA user fee package before the August recess, but one industry source tells Inside Health Policy that while Republicans want to move on the legislation next week, Democratic and Republican leadership have not yet agreed on an amendment package.

August 01, 2017 | Daily News

Senate Majority Leader Mitch McConnell (R-KY) filed cloture late Tuesday (August 1) on the motion to proceed with the FDA user fee package, setting up a Senate vote on the motion early Thursday.

August 01, 2017 | Daily News

Sens. Orrin Hatch (R-UT) and Bob Menendez (D-NJ) are attempting to attach the Orphan Product Extensions Now Accelerating Cures and Treatments (OPEN) Act, which would extend exclusivity for orphan drugs by six months, to the user fee package expected to be taken up by the Senate this week, a Democratic lobbyist tells Inside Health Policy.

July 28, 2017 | Daily News

With the Senate's last-ditch effort to pass an Affordable Care Act repeal bill defeated, sources tell Inside Health Policy that the chamber has yet to settle on a date to consider must-pass FDA user fee reauthorization legislation, but point to the first week of September as a likely timeline.

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-- despite previous concerns that the rider could not be added due to jurisdictional issues -- if the tax is not repealed as part of health reform efforts.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 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-- despite previous concerns that the rider could not be added due to jurisdictional issues -- if the tax is not repealed as part of health reform efforts.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.

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