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User Fees

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the Senate took up nearly 20 amendments, with several passing by unanimous consent and the remainder either tabled, withdrawn or rejected.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.

May 18, 2012 | Daily News

Companies developing mobile medical applications, FDA and other stakeholders have come out against a last-minute addition to the Senate user fee bill that would require an outside working group report to Congress on a proposed regulatory framework for health information technologies before FDA could issue final mobile medical application guidance.

May 17, 2012 | Daily News

As FDA user fee bills head to the full House and Senate, consumer and safety advocates are focusing their lobbying efforts on convincing lawmakers to add provisions that would institute additional safeguards for implantable medical devices, including measures that would reduce the number of products cleared through the 510(k) process, while acknowledging that limiting the use of recalled devices as predicates for new device clearances is not likely to be included in user fee legislation. The groups are hopeful, however, that FDA might address predicate nullification administratively.

May 17, 2012 | Daily News

The Generic Pharmaceutical Association is urging Sens. Jeff Bingaman (D-NM) and David Vitter (R-LA) to scrap a an amendment curbing so-called pay-for-delay drug patent settlements, saying the group would no longer support the FDA user fee bill if the provision is added. The move comes as senators prepare to offer amendments to the user fee bill that is set to hit the floor on Monday, with sources saying the patent measure could be offered but is unlikely to be included in the final package (see related story).

May 17, 2012 | Daily News

Senate Majority Leader Harry Reid (D-NV) is urging senators to be ready to quickly pass the FDA user fee legislation bill on Monday (May 21), warning that if he is forced to instead hold a cloture vote, debate on the bill could not begin until Wednesday (May 23). Reid encouraged senators to file amendments to the bill if they have problems with it, but not to hold up the legislation, citing the importance of the bill's drug shortage measures.

May 16, 2012 | Daily News

A key telemedicine industry official said lawmakers are making progress in revamping legislation aimed at curbing illegal online pharmacies to ensure the bill does not affect legitimate telehealth services and online pharmacies' role in medical homes, but cautioned the industry remains concerned that the potential user fee rider could interfere with the doctor/patient relationship. The industry is particularly upset by language that would restrict patients to one online visit before requiring proof of an in-person physician for subsequent visits

May 16, 2012 | Daily News

An updated Senate user fee bill unveiled late Tuesday adds provisions related to mobile medical applications guidance, rare diseases and patient participation in medical product discussions, with further changes expected in a manager's amendment before the legislation hits the Senate floor, a source close to the issue says. Senate Majority Leader Harry Reid (D-NV) said Tuesday that although he is lining the bill up for a cloture vote Thursday (May 17), he hopes to avoid a cloture vote and move directly to a floor vote Monday.

May 15, 2012 | Daily News

Lawmakers and stakeholders continue to debate issues related to valid prescriptions and track and trace provisions included in FDA user fee legislation in anticipation that the Senate bill could come to the floor as early as this week and the House could schedule floor action in the next two weeks, but it remains a long shot that the bills will be changed prior to conference, sources say.

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