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User Fees

Friday, 18 August 2017

President Donald Trump signed Friday (Aug. 18) the FDA Reauthorization Act of 2017, a White House spokesperson tells Inside Health Policy.

Thursday, 10 August 2017

An over-the-counter (OTC) industry source expressed concern over calls that OTC monograph reform legislation include cosmetics regulations, saying that could slow things down and detract from the goal of getting the legislation passed as soon as possible.

Tuesday, 08 August 2017

FDA will hold a public meeting Sept. 18 to examine the experiences of the agency and stakeholders with structured benefit-risk assessments and approaches to incorporating patient perspectives in these assessments, according to a Tuesday (Aug. 8) agency notice.

Friday, 04 August 2017

A Democratic senator is redoubling calls for Congress to pass her bill granting FDA recall authority over cosmetics.

Thursday, 03 August 2017

Public Citizen is claiming victory after Sens. Orrin Hatch (R-UT) and Bob Menendez (D-NJ)'s Orphan Product Extensions Now Accelerating Cures and Treatments (OPEN) Act, which would extend exclusivity for orphan drugs by six months, was not brought up as part of the FDA user fee package passed by the Senate Thursday (Aug. 3).

Thursday, 03 August 2017

The Senate passed 94-1 Thursday (Aug. 3) the FDA Reauthorization Act, sending the user fee legislation to the president’s desk.

Wednesday, 02 August 2017

A bipartisan Senate bill requiring HHS to develop standards for hospitals and physicians to denote a patient's history of opioid addiction in medical records if a patient provides the information is expected to be passed by unanimous consent Thursday (Aug. 3) morning, a spokesperson for bill sponsor Sen. Joe Manchin (D-WV) tells Inside Health Policy.

Wednesday, 02 August 2017

The Senate hotlined a bill Wednesday (Aug. 2) afternoon from Sens. Roger Wicker (R-MS) and Amy Klobuchar (D-MN) that seeks to increase the patient's role in FDA's risk-benefit determination for drug approvals.

Wednesday, 02 August 2017

Sen. Ron Johnson (R-WI) has agreed to pull back his threat to hold up the FDA user fee package in exchange for a commitment that an amended version of his Right to Try legislation will be taken up by unanimous consent as the Senate moves to pass the user fee package Thursday (Aug. 3), sources tell Inside Health Policy.

Wednesday, 02 August 2017

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.

Tuesday, 01 August 2017

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.

Tuesday, 01 August 2017

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.

Tuesday, 01 August 2017

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.

Friday, 28 July 2017

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.

Tuesday, 25 July 2017

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.

Tuesday, 25 July 2017

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.

Monday, 24 July 2017

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.

Monday, 24 July 2017

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.

Monday, 24 July 2017

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.

Monday, 17 July 2017

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).

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