Login

Forgot password?
Sign up today and your first download is free.
REGISTER

User Fees

Friday, 23 June 2017

A draft document obtained by Inside Health Policy sets out expected performance goals for an over-the-counter monograph user fee program (OMUFA) under which FDA would see improved review timelines and more efficient review capacity by year four of the program.

Friday, 23 June 2017

The Consumer Healthcare Products Association (CHPA), Pew Charitable Trusts and American Academy of Pediatrics along with four other health-focused groups recently penned a letter to Sens. Johnny Isakson (R-GA) and Bob Casey (D-PA) showing support for the senators' revised draft of their bill intended to reform FDA's over-the-counter (OTC) drug monograph system.

Friday, 23 June 2017

Recently unveiled over-the-counter (OTC) monograph legislation is all the more important to reducing the monograph backlog given that FDA's fiscal 2018 budget justification maintains fiscal 2017 funding levels for the agency's OTC review processes, the Pew Charitable Trusts recently recently told Inside Health Policy.

Wednesday, 21 June 2017

FDA isn't waiting for the generic drug user fee reauthorization measure to move through Congress to move forward with one of the package's commitments: A new draft guidance issued this week sets up a new pre-submission process for certain generic drug applications, which FDA chief Scott Gottlieb says could cut two months off review times and increase access to affordable drugs.

Wednesday, 07 June 2017

The House Energy & Commerce Committee sent its user fee package to the floor, 54-0, Wednesday (June 7), tacking on several new amendments that deal with medical imaging, device servicing, accessory classification, a medical device safety pilot program and a sense of Congress urging the HHS secretary to take administrative actions to lower drug costs.

Wednesday, 07 June 2017

The House Energy & Commerce Committee attached a watered-down version of Rep. Ryan Costello's (R-PA) medical device imaging servicers bill to FDA user fee legislation Wednesday (May 7).

Wednesday, 07 June 2017

A measure that would require drug developers conduct pediatric studies on cancer drugs made for adults if the molecular target is the same as in children was withdrawn from discussions during the House Energy & Commerce Committee user fee markup Wednesday (June 7).

Wednesday, 07 June 2017

Drug importation from Canada, a sense of Congress on drug pricing and off-label communication with payers are the subjects of hot-button amendments that lawmakers signaled they plan to bring up at today's House Energy & Commerce markup of FDA user fee legislation.

Wednesday, 07 June 2017

Rep. David McKinley (R-WV) told fellow House Energy & Commerce Committee members that he and Rep. Peter Welch (D-VT) plan to offer their bipartisan Risk Evaluation and Mitigation Strategy (REMS) bill during the committee’s markup of the FDA user fee package, saying concerns that the bill would endanger patient safety are unfounded.

Wednesday, 07 June 2017

House Energy & Commerce members discussed but ended up not voting on a bill to close loopholes in the Risk Evaluation Mitigation Strategy program at Wednesday's markup of FDA user fee legislation.

Tuesday, 06 June 2017

On the eve of the House Energy & Commerce Committee's Wednesday (June 7) FDA user fee markup, health subcommittee member Rep. Diana DeGette (D-CO) spoke out publicly against GOP attempts to add controversial off-label amendments to the user fee reauthorization package.

Monday, 05 June 2017

With an FDA user fee markup slated for Wednesday (June 7), mixed signals are coming from Energy & Commerce GOP and Democratic staff on whether a bipartisan amendment is in the works that would ease FDA limits on off-label communication.

Friday, 02 June 2017

The House Energy & Commerce Committee has tentatively scheduled markup of FDA user fee legislation for Wednesday (June 7), as talks continue on potential riders, including off-label amendments that Democrats have warned could derail their support for what so far has been a bipartisan user fee reauthorization effort.

Wednesday, 24 May 2017

Objections from the brand-drug and biotechnology lobbies prompted lawmakers to twice remove a bipartisan bill aimed at spurring pediatric cancer research from the user fee reauthorization package moving through Congress, the architect of the pediatric bill told Inside Health Policy.

Wednesday, 24 May 2017

Objections from the brand-drug and biotechnology lobbies prompted lawmakers to leave out for now from the user fee reauthorization package moving through Congress a bipartisan bill aimed at spurring pediatric cancer research, the architect of the pediatric bill told Inside Health Policy.

Friday, 19 May 2017

House Energy & Commerce Democrats are threatening to vote against FDA user fee reauthorization if Rep. Morgan Griffith (R-VA)’s off-label communication bill is included in the package, a source close to the negotiations tells Inside Health Policy.

Thursday, 18 May 2017

A House subcommittee easily passed FDA user fee legislation Thursday (May 18) with riders allowing over-the-counter hearings aids, requiring risk-based device inspections, offering new exclusivity for a new class of competitive generic drugs and restricting drug imports, and in the process brushed off the Trump administration's call for a doubling of the user fee levels FDA negotiated with industry.

Thursday, 18 May 2017

House Energy & Commerce health subcommittee lawmakers provided a preview Thursday (May 18) of legislation that could be added to user fee reauthorization either during the full committee markup or when the legislation hits the floor, including bills related to off-label communication, pediatric cancer research, orphan drug exclusivity, regulation of medical device servicers and over-the-counter monograph reform.

Wednesday, 17 May 2017

A group of House Democrats wrote to President Donald Trump Monday (May 15) urging him to work with them to attach drug pricing measures to FDA user fee reauthorization legislation, naming Medicare price negotiation, drug maker transparency, a pay-for-delay crackdown, Risk Evaluation and Mitigation Strategies (REMS) reform, and Medicare rebates as possible policies that could be included.

Tuesday, 16 May 2017

Just days before the House plans to mark up its FDA user fee reauthorization bill, HHS Secretary Tom Price is pushing lawmakers to increase the fees payed by industry to cover 100 percent of medical product reviews, as proposed in President Donald Trump's skinny budget.

Pages