Login

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

User Fees

May 18, 2012 | Daily News

Companies developing mobile medical applications, FDA and other stakeholders have come out against a last-minute addition to the Senate user fee bill that would require an outside working group report to Congress on a proposed regulatory framework for health information technologies before FDA could issue final mobile medical application guidance.

May 17, 2012 | Daily News

As FDA user fee bills head to the full House and Senate, consumer and safety advocates are focusing their lobbying efforts on convincing lawmakers to add provisions that would institute additional safeguards for implantable medical devices, including measures that would reduce the number of products cleared through the 510(k) process, while acknowledging that limiting the use of recalled devices as predicates for new device clearances is not likely to be included in user fee legislation. The groups are hopeful, however, that FDA might address predicate nullification administratively.

May 17, 2012 | Daily News

The Generic Pharmaceutical Association is urging Sens. Jeff Bingaman (D-NM) and David Vitter (R-LA) to scrap a an amendment curbing so-called pay-for-delay drug patent settlements, saying the group would no longer support the FDA user fee bill if the provision is added. The move comes as senators prepare to offer amendments to the user fee bill that is set to hit the floor on Monday, with sources saying the patent measure could be offered but is unlikely to be included in the final package (see related story).

May 17, 2012 | Daily News

Senate Majority Leader Harry Reid (D-NV) is urging senators to be ready to quickly pass the FDA user fee legislation bill on Monday (May 21), warning that if he is forced to instead hold a cloture vote, debate on the bill could not begin until Wednesday (May 23). Reid encouraged senators to file amendments to the bill if they have problems with it, but not to hold up the legislation, citing the importance of the bill's drug shortage measures.

May 16, 2012 | Daily News

A key telemedicine industry official said lawmakers are making progress in revamping legislation aimed at curbing illegal online pharmacies to ensure the bill does not affect legitimate telehealth services and online pharmacies' role in medical homes, but cautioned the industry remains concerned that the potential user fee rider could interfere with the doctor/patient relationship. The industry is particularly upset by language that would restrict patients to one online visit before requiring proof of an in-person physician for subsequent visits

May 16, 2012 | Daily News

An updated Senate user fee bill unveiled late Tuesday adds provisions related to mobile medical applications guidance, rare diseases and patient participation in medical product discussions, with further changes expected in a manager's amendment before the legislation hits the Senate floor, a source close to the issue says. Senate Majority Leader Harry Reid (D-NV) said Tuesday that although he is lining the bill up for a cloture vote Thursday (May 17), he hopes to avoid a cloture vote and move directly to a floor vote Monday.

May 15, 2012 | Daily News

Lawmakers and stakeholders continue to debate issues related to valid prescriptions and track and trace provisions included in FDA user fee legislation in anticipation that the Senate bill could come to the floor as early as this week and the House could schedule floor action in the next two weeks, but it remains a long shot that the bills will be changed prior to conference, sources say.

May 15, 2012 | Daily News

There are unlikely to be any major changes to drug shortage measures included in user fee legislation moving through the House and Senate -- such as the addition of civil monetary penalties for companies that fail to comply with new mandatory reporting requirements -- but lawmakers will have to hammer out a few differences between the two bills including whether to add biologics to the reporting requirements, require FDA to maintain a list of drugs in shortage and allow hospital systems to repackage medications in shortage situations, a key source says.

May 15, 2012 | Daily News

Provisions included in the Senate FDA user fee bill providing exclusivity for new antibiotics and pediatric drugs would increase direct spending by CMS and other federal health care programs, and increase subsidies for enrollees in health insurance exchanges, but would be offset by other measures, including a provision that would facilitate acquisition of drug samples by generic and biosimilar companies, leading to earlier entry of these products onto the market and thereby reducing spending by federal healthcare programs, according to the Congressional Budget Office.

May 14, 2012 | Daily News

A measure included in the House user fee bill requiring FDA to notify Congress 60 days before issuing guidance regulating laboratory developed tests could provide the impetus needed to move a stand-alone bill expanding CMS oversight of these tests that the clinical laboratory industry was unable to get into the user fee package, an industry source said. However, the source said it is unlikely the last-minute House notification measure will wind up in the Senate user fee bill set to hit the floor soon and it will be up to conferees if the provision is part of the final legislation.

May 11, 2012 | Daily News

The generic drug industry is gearing up to oppose a possible user fee floor amendment by Senate Judiciary Committee Chairman Patrick Leahy (D-VT) that would permit generic generic manufacturers to change the warning information on their products and as a result increase generic makers' liability exposure. But the industry may have to turn its focus to the administration, as Leahy and other key Democrats on Wednesday (May 9) sent a letter to FDA asking for the change to be made administratively.

May 10, 2012 | Daily News

A bipartisan trio of House lawmakers said they will continue efforts to reach an agreement with FDA and industry on a national standard for drug track and trace that could be modeled after a California law that tracks pharmaceutical drugs through the supply chain on the unit level, after the House Energy & Commerce Committee swiftly passed a user fee bill Thursday (May 10) without language on the issue.

May 10, 2012 | Daily News

As FDA user fee legislation heads to the House floor, a key Democratic lawmaker called for antibiotic incentive to be focused on serious and life-threatening infections and an HHS directive to work on stewardship programs while the lead sponsor of antibiotic incentives pushed back against attempts to change the incentive structure outlined in the Generating Antibiotic Incentives Now section of the bill.

May 09, 2012 | Daily News

Changes to the Generating Antibiotic Incentives Now (GAIN) provision in the House user fee bill are not expected at the full House Energy and Commerce Committee markup Thursday (May 10), a committee aide said, as lawmakers continue efforts to tweak the provision. The antibiotic incentives were one of two areas flagged as needing work in an otherwise smooth health subcommittee markup, the other being a provision on valid prescriptions.

May 08, 2012 | Daily News

House lawmakers said they will continue efforts to narrowly tailor antibiotic incentives and clarify an online pharmacy measure before the full Energy and Commerce Committee takes up FDA user fee legislation that gained bipartisan subcommittee backing Tuesday morning, with stakeholders also continuing to push for changes to drug shortage and medical device measures.

May 08, 2012 | Daily News

A bipartisan group of House Energy and Commerce Committee lawmakers lobbied unsuccessfully for the inclusion of drug tracking language in the committee's updated version of FDA user fee legislation, according to a letter obtained by Inside Health Policy, as the committee recently unveiled long-awaited drug supply chain language that largely mirrors the Senate committee-passed version and does not include a track and track mandate.

May 07, 2012 | Daily News

A bipartisan duo on the Senate Judiciary Committee has asked the Government Accountability Office to study whether Drug Enforcement Administration quotas designed to curb prescription painkiller abuse are contributing to drug shortages, while also asking GAO to examine if sharing products between agencies, using expired products, implementing shelf-life extension programs and repackaging drugs in short supply could help mitigate drug dearths. The lawmakers said the quota issue, which is addressed in House FDA user feel legislation, falls under the Judiciary Committee's jurisdiction.

May 07, 2012 | Daily News

The House Energy and Commerce Committee unveiled a markedly different user fee draft with several additions over past versions, while keeping several controversial medical device provisions such as clarification of the least burdensome standard for product approvals and investigational device exemptions, although scaled back.

May 03, 2012 | Daily News

FDA plans to provide guidance clarifying the agency's drug repackaging policy for hospital system pharmacies that transfer medications in shortage to affiliated hospitals, according to an agency letter obtained by FDA Week that came in response to an Ohio senator's concerns that such repackaging could be viewed as manufacturing under the agency's compliance guide.A repackaging provision instructin

May 01, 2012 | Daily News

New Institute of Medicine findings that FDA does not consistently monitor drugs throughout the product's life cycle and that the use of surrogate endpoints has resulted in high-profile drug safety problems underscore consumer advocates' concerns about a proposed expansions of the accelerated approval pathway, a drug safety advocate said, referring to user fee legislation pending before Congress.

Pages