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User Fees

May 11, 2017 | Daily News

The Senate health committee advanced Thursday (May 11) FDA user fee reauthorization to the Senate floor, and while the panel added two amendments aimed at increasing generic drug competition and expanding clinical trial eligibility for experimental treatments, committee Chair Lamar Alexander (R-TN) held strong on his pledge to block any controversial measures from being added during markup.

May 11, 2017 | Daily News

Sen. Orrin Hatch’s (R-UT) proposal to authorize the extension of exclusivity periods for orphan drugs by six months, require some drug sponsors show clinical superiority of their drugs and mandate the Government Accountability Office (GAO) report on whether the act's provisions are effective was not offered as an amendment during the Senate health committee’s user fee markup Thursday (May 11), despite the fact the amendment was filed earlier this week.

May 11, 2017 | Daily News

A bipartisan Senate duo succeeded Thursday (May 11) in attaching to pending FDA user fee legislation a new version of a bill to prioritize generic drug competition that eliminates multiple controversial provisions, including the award of lucrative priority review vouchers for first generic sponsors, a requirement for a study on Risk Evaluation and Mitigation Strategies, and a mandate that FDA review prioritized generic applications within 150 days.

May 11, 2017 | Daily News

During Thursday's Senate health committee user fee markup, Sen. Johnny Isakson (R-GA) plugged his bipartisan over-the-counter (OTC) monograph reform discussion draft, which would authorize a new FDA user fee program for OTC drugs and provide two years of exclusivity for a drug developer that submits original human data on its drug.

May 11, 2017 | Daily News

Senate health committee Chair Lamar Alexander (R-TN)'s deal to hold a hearing on drug pricing partially succeeded Thursday (May 11) in delinking the hot-button issue of drug pricing from reauthorization of user fees.

May 10, 2017 | Daily News

Sen. Michael Bennet (D-CO) hopes to wrap into FDA user fee legislation an updated version of his bill aimed at spurring new research on pediatric cancer drugs.

May 10, 2017 | Daily News

Senate health committee member Orrin Hatch (R-UT) has filed an amendment to authorize the extension of exclusivity periods for orphan drugs by six months, require some drug sponsors show clinical superiority of their drugs and mandate the Government Accountability Office (GAO) report on whether the act's provisions are effective.

May 10, 2017 | Daily News

A bipartisan group of senators hopes to wrap into the FDA user fee package an FDA-centric alternative to state Right to Try laws that aims to expand patients' access to experimental treatments within the current regulatory structure.

May 10, 2017 | Daily News

Despite Senate health committee Chair Lamar Alexander's attempt to keep controversial drug-pricing measures out of the FDA user fee debate, Sen. Bernie Sanders (I-VT) notified the panel he will push two drug reimportation amendments at a user fee markup, rescheduled for Thursday (May 11).

May 10, 2017 | Daily News

A bipartisan Senate discussion draft obtained by Inside Health Policy would authorize a new FDA user fee program for over-the-counter (OTC) drugs while seemingly not including any incentives or a period of exclusivity as the OTC industry had hoped.

May 10, 2017 | Daily News

A bipartisan Senate discussion draft obtained by Inside Health Policy would authorize a new FDA user fee program for over-the-counter (OTC) drugs and provide two years of exclusivity for a drug developer that submits original human data on its drug.

May 10, 2017 | Daily News

Senate health committee Chairman Lamar Alexander (R-TN) delayed Wednesday's markup of FDA user fee legislation because of an all-caucus meeting being held by Democrats in the wake of President Donald Trump's firing of FBI Director James Comey.

May 10, 2017 | Daily News

Senate health committee Chairman Lamar Alexander (R-TN) abruptly delayed Wednesday's markup of FDA user fee legislation because of an all-caucus meeting being held by Democrats in the wake of President Donald Trump's firing of FBI Director James Comey.

May 09, 2017 | Daily News

Senate health committee Chair Lamar Alexander's (R-TN) agreement Tuesday (May 9) to a bipartisan request to schedule a drug-pricing hearing appears to have delinked the hot-button issue from Wednesday's FDA user fee markup.

May 08, 2017 | Daily News

The FDA user fee package heading to a Senate committee vote this week includes riders on drug importation and counterfeiting, over-the-counter hearing aids, risk-based device inspections, real-world evidence and pediatric drug development, among others, according to a manager’s amendment released Monday (May 8).

May 08, 2017 | Daily News

The Senate health committee answered the calls of pediatric research advocates by including a number of riders in user fee reauthorization legislation, released Monday (May 8), meant to facilitate pediatric drug and device development, including requiring FDA: analyze real-world evidence on off-label uses of medical devices in children; issue guidance on pediatric drug development; and create an internal pediatrics team.

May 08, 2017 | Daily News

The Senate user fee package unveiled Monday (May 8) sets up a process for device makers to request FDA reclassify based on their intended use accessories that were previously linked to the higher-risk classification of their parent device.

May 05, 2017 | Daily News

Stakeholders clashed over a bipartisan bill that would require third-party device servicers to register with FDA and submit adverse event reports, causing lawmakers to think twice about their idea of attaching the bill to FDA user fee reauthorization legislation.

April 28, 2017 | Daily News

The Association For Accessible Medicines is urging heads of two key congressional committees to include Risk Evaluation Mitigation Strategies (REMS) reform in the FDA user fee reauthorization package, as well as provisions to ensure companies do not use self-imposed restricted distribution systems to block generics from coming to market.

April 26, 2017 | Daily News

A group of Democratic lawmakers is asking FDA Commissioner-nominee Scott Gottlieb to expand on how, if confirmed, he would ensure FDA is sufficiently staffed and funded, how a hiring freeze would affect his ability to lead the agency and how he would implement hiring provisions under 21st Century Cures.

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