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User Fees

May 31, 2012 | Daily News

Key pharmacist groups are pushing back against a provision added to the Senate user fee bill during floor debate that would reclassify hydrocodone-containing pain medications to a more restrictive class, saying the change would result in barriers for patients who have a legitimate need for these products and increase health care costs by placing additional burdens on pharmacists without assurances that the move would reduce diversion and abuse.

May 31, 2012 | Daily News

Lawmakers must now resolve a wide range of discrepancies between House and Senate FDA user fee legislation that include differences in the generic drug pay-fors, drug track and trace language and several medical device provisions following the House's overwhelming passage of FDA user fee bill Wednesday.

May 30, 2012 | Daily News

As the House prepared to vote on FDA user fee legislation Wednesday afternoon, a key consumer advocacy group geared up to lobby lawmakers to endorse the Senate bill's stricter provisions on a handful of items when they merge the chambers' bills. Consumers Union is pushing for Senate-passed user fee language on medical device reclassification, Unique Device Identifier implementation and postmarket studies.

May 30, 2012 | Daily News

Government watchdog groups are urging House lawmakers to remove or substantially narrow a user fee provision that allows FDA to withhold from the public drug inspection data it obtains from foreign and domestic regulators, with the push emerging before FDA user fee legislation comes to a vote Wednesday (May 30).

May 29, 2012 | Daily News

A new Congressional Budget Office score of the House FDA user fee bill outlines additional savings over a previous analysis, according to documents obtained by Inside Health Policy.

May 29, 2012 | Daily News

FDA officials said they will continue developing drug authentication and pedigree systems if a federal drug track and trace mandate does not end up in final user fee legislation, but acknowledged there are legal limitations that prevent the agency from converging differing state laws into a national standard.

May 25, 2012 | Daily News

House lawmakers tweaked their FDA user fee legislation to expand a citizen petition response mandate to include biosimilars, a technical change they expect will reduce the bill's spending by $350 million over 10 years and make it compliant with pay-as-you-go rules, according to documents obtained by Inside Health Policy.

May 25, 2012 | Daily News

The House will vote as early as the week of June 4 on bills to repeal the health reform law's tax on medical devices and its ban on using HSAs and FSAs to purchase over-the-counter drugs, according to a May 25 internal memo from House Majority Leader Eric Cantor (R-VA).

May 25, 2012 | Daily News

The House is slated to take up FDA user fee legislation Wednesday under suspension of the rules, followed by an informal conference between lawmakers in both chambers and a possible “ping pong” back and forth to pass a final bill that lawmakers hope to send to the president by July 4, according to sources and an internal GOP leadership memo.

May 24, 2012 | Daily News

The Senate Thursday (May 24) overwhelming passed the FDA user fee bill after rejecting highly controversial amendments aimed at limiting drug patent settlements and allowing certain drug imports from Canada. Stakeholders are now setting their sights on the House, which is expected to take up its version of the bill next week, followed by an informal conference to sort out the differences between the two bills.

May 24, 2012 | Daily News

Prior to voting in favor of FDA user fee legislation Thursday (May 24), the Senate took up nearly 20 amendments, with several passing by unanimous consent and the remainder either tabled, withdrawn or rejected. The following is a quick snapshot of the Senate votes leading up to final passage of the bill.

May 24, 2012 | Daily News

Senators on Thursday (May 24) morning voted down an amendment to the FDA user fee bill aimed at curbing drug patent settlements, rejecting by a wide margin a measure backed by a bipartisan duo of senators but that drew strong opposition from the generic drug industry. The upper chamber also rejected an amendment delaying FDA approval of genetically engineered fish to complete environmental and economic analysis, but approved by unanimous consent a handful of less controversial measures.

May 23, 2012 | Daily News

The Union of Concerned Scientists is already taking steps to recruit its own members to serve on FDA advisory committees in anticipation that regulated industry may try to increase its presence on the panels as a result of user fee provisions moving through Congress that lift caps on the number of conflicted experts that can participate. Consumer and safety advocates opposed lifting the caps, but were successful in adding provisions to the user fee bills that would require financial disclosure of these experts and increase recruitment efforts.

May 23, 2012 | Daily News

Senate leaders have reached an agreement that will allow the chamber to vote on FDA user fee legislation Thursday, a move averting earlier industry stakeholder concerns the vote might be delayed until June as lawmakers from both sides of the aisle filed more than 30 amendments, some of them non-germane to the must-pass user fee measure, over the past couple of days.

May 23, 2012 | Daily News

Senate Majority Leader Harry Reid (D-NV) delayed proceeding with the FDA user fee bill again Wednesday (May 23) saying there is a dispute on a Republican amendment. Sources said the more than 30 amendments filed in recent days will be whittled down, with votes expected on Sen. John McCain's (R-AZ) amendment on drug reimportation and Sen. Jeff Bingaman's (D-NM) proposal to curb drug patent settlements, among a few others.

May 23, 2012 | Daily News

Senators from both sides of the aisle floated a slew of amendments ranging from a drug shortage critical reinforcement program to a repeal of the health reform-created medical device tax as concerns emerged that the upper chamber might not pass user fee legislation ahead of a week-long recess, with Senate leaders Tuesday afternoon delaying a motion to proceed and threatening to file cloture.

May 22, 2012 | Daily News

Top lawmakers on the Senate health committee Tuesday (May 22) sought to alleviate concerns from California stakeholders and lawmakers about the potential creation of a drug track and trace system with weaker standards than the California pedigree law, saying a newly added user fee provision offering a drug tracking framework is nothing more than a placeholder as it would not preempt state law if left unchanged.

May 21, 2012 | Daily News

Senate health committee Chairman Tom Harkin (D-IA) and ranking Republican Mike Enzi (WY) reached agreement late Monday on a revised FDA user fee bill that includes a detailed framework for a drug trace and track system to be negotiated by FDA, lawmakers and stakeholders, and the lawmakers said they hope the bill will sail through the Senate this week with few amendments and reach the president's desk by the end of June.

May 21, 2012 | Daily News

Senators are pushing user fee amendments that would limit pay-for-delay settlements and drug exclusivity, allow importation of drugs from Canada, curb approval of genetically engineered fish and increase financial disclosure by drug applicants, but sources don't expect any of the amendments to make it into the final bill moving through the Senate floor Monday.

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