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User Fees

September 14, 2017 | Daily News

Lawmakers may need to tweak provisions in the recently released over-the-counter monograph reform discussion draft that give FDA authority to issue administrative orders on packaging requirements for OTC drugs and to award two years of exclusivity to OTC drug manufacturers. FDA and stakeholders pointed to both provisions as issues that require a second look from Congress during the House Energy & Commerce health subcommittee’s Wednesday (Sept. 13) hearing on the bill.

September 14, 2017 | Daily News

House Energy & Commerce Committee Democrats Frank Pallone (NJ), Debbie Dingell (MI) and Jan Schakowsky (IL) said they hope the committee will consider setting up an FDA user fee program for cosmetics, noting that reforming the agency's oversight of cosmetics is on their priority lists.

September 11, 2017 | Daily News

House lawmakers released Monday (Sept. 11) a bipartisan discussion draft of their proposed over-the-counter monograph user fee program (OMUFA), coming two days ahead of an Energy & Commerce health subcommittee hearing on ways to reform the OTC monograph process.

September 05, 2017 | Daily News

The House Energy & Commerce Committee will hold a hearing on over-the-counter (OTC) monograph user fees Sept. 13, a congressional aide tells Inside Health Policy.

August 18, 2017 | Daily News

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

August 10, 2017 | Daily News

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.

August 08, 2017 | Daily News

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.

August 04, 2017 | Daily News

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

August 03, 2017 | Daily News

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).

August 03, 2017 | Daily News

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

August 02, 2017 | Daily News

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.

August 02, 2017 | Daily News

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.

August 02, 2017 | Daily News

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.

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.

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