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User Fees

June 15, 2012 | Daily News

Sen. Joe Manchin (D-WV) said he has support from Senate leaders to keep a hydrocodone-reclassification measure in the final FDA user fee bill, but he is also floating a potential compromise in light of growing opposition to the provision.

June 14, 2012 | Daily News

A diverse group of stakeholders appears to be making progress in its press for 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, with a pharmacy stakeholder saying congressional staff has signaled these drugs, along with older medicines, likely will be included in the final bill.

June 14, 2012 | Daily News

Groups opposed to the health reform law are weighing in on FDA user fee payfor mechanisms, saying that both House and Senate options should be included because some savings are dependent on the health reform-created biosimilar pathway and would be wiped out if the Supreme Court shoots down the health law later this month.

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).

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