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User Fees

February 28, 2013 | Daily News

Implementation of the new generic drug user fee act is complicated by uncertainty over the budget and the looming cuts mandated by sequestration, according to FDA Commissioner Margaret Hamburg, who acknowledged at a recent meeting with generic drug industry executives that the agency was off to a slow start in reducing the backlog of abbreviated new drug applications.

February 27, 2013 | Daily News

The Obama administration is asking appropriators to include in upcoming funding legislation a provision allowing FDA to fully collect user fees associated with medical devices, generic drugs, biosimilars, animal drugs and tobacco products, according to a document obtained by Inside Health Policy that lists “anomalies” the White House Office of Management and Budget recently sent to lawmakers.

September 24, 2012 | Daily News

The Senate early Saturday morning approved a six-month continuing resolution and a bill allowing FDA to collect all generic drug user fees, sending both measures to the president for his signature.

September 21, 2012 | Daily News

FDA officials said Friday (Sept. 21) they plan to start the generic drug user fee program regardless of the outcome of congressional efforts to allow fee collection, as the lack of an appropriations measure affects when -- not if -- the fees will be collected.

September 20, 2012 | Daily News

The pharmaceutical industry is concerned that the administration's inclusion of FDA user fees among programs to be hit by the upcoming budget sequestration could permanently divert the industry-paid funding away from FDA, the head of the drug industry's trade group said Thursday (Sept. 20), a view echoed by the Biotechnology Industry Organization.

September 20, 2012 | Daily News

The House passed by unanimous consent late Wednesday (Sept. 19) a measure that would allow FDA to collect all of the generic drug user fees authorized in the recently enacted FDA Safety and Innovation Act, but the bill does not address other user fees, including for medical devices and biosimilars.

September 04, 2012 | Daily News

Mandatory across-the-board government funding cuts might apply to FDA user fees and as a result lead to a bigger agency impact that initially thought, FDA funding advocates said in advance of an administration report set for release this week that will detail cuts to occur under the budget act's sequestration.

July 26, 2012 | Daily News

An agreement on a federal drug track and trace measure is not likely to come before the August recess as initially hoped, but discussions among stakeholders, lawmakers and FDA are ongoing and will likely continue in September, with negotiators now hoping to conclude talks by the end of the year, according to a key stakeholder group.

July 19, 2012 | Daily News

FDA is continuing to move forward in developing a national post-market medical device surveillance system by seeking outside help to craft a roadmap for development and maintenance of device registries, with the move coming as the agency also works to implement the Unique Device Identifier system to track devices.

July 13, 2012 | Daily News

Key FDA reforms -- such as tools to prevent drug shortages and antibiotic exclusivity incentives -- are immediately available following the July 9 enactment of the FDA Safety and Innovation Act mans, but the agency must also develop several policies in the coming years on a slew of hot-button issues ranging from social media regulation to antibiotic development.

July 12, 2012 | Daily News

Lawmakers and congressional staff are regenerating efforts to establish a national drug track and trace system and started meeting to discuss the topic this week, including discussions with FDA, several sources said.

July 12, 2012 | Daily News

Stakeholders watching the reauthorization of the Pandemic and All-Hazards Preparedness Act expressed concern this week that the bipartisan bill reauthorizing HHS medical countermeasure programs could become a Christmas tree for other provisions that failed to make it into the final FDA user fee bill, including a drug track and trace measure.

July 09, 2012 | Daily News

FDA is laying the groundwork to track its revamped review program for new molecular entity new drug applications and biologics license applications, a program outlined in the industry-agency negotiated user fee pact that both parties hope will increase first cycle reviews.

July 09, 2012 | Daily News

Lawmakers are continuing to push legislation to address the drug shortage problem that did not make it into FDA Safety and Innovation Act, but sources said outstanding proposals to curb the gray market and change reimbursement for some medications are not likely to gain much traction in the coming months.

July 05, 2012 | Daily News

Once pending user fee legislation is signed into law FDA will need to speed up by one year its proposed timeline for applying the Unique Device Identifier system to some implantable devices to follow the new law's requirements, agency device center officials said Tuesday (July 3) as they rolled out a long-awaited UDI proposed rule.

July 03, 2012 | Daily News

A citizen petition payfor in the recently passed FDA Safety and Innovation Act will likely do little to cut down on the number of citizen petitions filed by brand pharmaceutical companies targeting generic drugs, according to a law professor who recently published a study that found legislation enacted in 2007 to curb these petitions has not been successful.

June 27, 2012 | Daily News

BOSTON -- FDA and drug company officials said they are optimistic the agency will meet drug performance goals this time around despite the user fee bill's significant changes to the review process and the slew of reforms attached.

June 27, 2012 | Daily News

The FDA Safety and Innovation Act cleared Congress with a 92 to 4 Senate vote Tuesday (June 26) after Sen. Richard Burr (R-NC) spoke for hours on the Senate floor pointing out shortfalls of the bill, which he said was unnecessarily rushed through Congress ahead of the Supreme Court ruling on health reform and, given extra time, could have resolved several issues, including the creation of a federal track and trace system.

June 26, 2012 | Daily News

The authors of a new study that reveals metal-on-metal hip implant manufacturers initiated FDA-mandated post-market studies for only 24 of 104 products last year are hopeful that device reforms moving through Congress will avert such lags in the future, but also urge FDA to go a step further and pursue a comprehensive national device postmarket safety registry.

June 25, 2012 | Daily News

The final user fee bill on the Senate floor Monday (June 25) gives FDA discretion to include biologics in the legislation's drug shortage early notification requirements -- a move applauded by a coalition of pharmacists, providers, hospitals and patient groups that was upset the original House version of the bill didn't address the issue.