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User Fees

June 14, 2012 | Daily News

FDA proposed a drug pedigree system -- expected to start at the lot level but evolve to the unit level -- during a closed-door discussion with user fee negotiators Monday (June 11) aimed at coming up with a compromise drug track and trace proposal for inclusion in the final user fee package, sources said.

June 14, 2012 | Daily News

Groups in support of generic drug access are going public in their push for lawmakers to retain a Senate user fee provision that would prevent brand drug companies from using Risk Evaluation and Mitigation Strategies to impede generics' ability to access innovator drugs to support generic drug applications.

June 12, 2012 | Daily News

A bicamerical investigation into the pharmaceutical gray market has led two Democratic lawmakers to call on House and Senate leaders negotiating a final FDA user fee package to include a national pedigree system and stronger standards for pharmaceutical wholesale distributors, with the lawmakers arguing that an industry-crafted track and trace proposal may not stop unscrupulous companies from exploiting drug shortages to price gouge hospitals and other providers.

June 08, 2012 | Daily News

Stakeholders are pushing lawmakers to include biologics in the final user fee bill's drug shortage early notification requirements and to clarify that human plasma protein therapies and their recombinant analogs are subject to the requirement.

June 06, 2012 | Daily News

Lawmakers working to craft a user fee provision aimed at curbing illegal online pharmacies are now embracing toned-down language that calls for a Government Accountability Office report on the dangers of these websites, following concerns from telemedicine and physician groups that inclusion of a more-aggressive legislative proposal could have interfered with legitimate telehealth services and the doctor/patient relationship.

June 04, 2012 | Daily News

The Advancing Patient Safety Coalition is pushing lawmakers to include the Senate's more stringent language outlining the implementation of the Unique Device Identifier rule when they merge the House and Senate FDA user fee bills.

June 04, 2012 | Daily News

An FDA official said although the agency is not ready to create the kind of track and trace system for medical devices as stakeholders are currently developing for pharmaceuticals, there is a possibility that devices could be required to have serial numbers in the future.

June 01, 2012 | Daily News

Senate lawmakers stripped language authorizing funding for a new FDA nanotechnology program before tacking a provision creating the program onto the upper chamber's version of the user fee bill, a Senate aide said.

May 31, 2012 | Daily News

A provision included in the Senate user fee bill that would allow FDA to more easily reclassify devices is emerging as a possible point of contention as Congress prepares to resolve differences between the user fee bills passed by both chambers, sources said.

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.

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