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User Fees

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.

May 01, 2012 | Daily News

As nearly half of the states pursue greater access to Medicare claims data as part of ongoing efforts to improve their care for dually eligible beneficiaries, state Medicaid directors issued a new white paper Tuesday calling on CMS to also give access to Medicare Advantage data and let states use Medicare claims data for efforts beyond care coordination purposes.

May 01, 2012 | Daily News

FDA has not taken any steps internally to address industry concerns over difficulty in leveraging outside experts to serve on advisory committees, according to a Government Accountability Office report, despite assertions by FDA Commissioner Margaret Hamburg earlier this year that a legislative fix is not needed to address conflict-of-interest policies that may be contributing to problems with filling vacant positions on advisory committees.

April 30, 2012 | Daily News

Economic incentives to spur manufacturing of drugs in shortage -- including federal reimbursement and exclusivity provisions being pushed by Sen. Orrin Hatch (R-UT) -- are not likely to be included in final legislation reauthorizing user fees, although the idea could still be explored outside the user fee bill, congressional sources and stakeholders said.

April 27, 2012 | Daily News

A bipartisan duo of senators are working toward a drug tracking compromise, which they hope to attach to FDA user fee legislation when it reaches the floor, with a proposal that draws heavily from an industry coalition's lot-level plan but adds some unit-level tracking requirements, including wholesale distributor verification, in a bid to assuage FDA and safety advocates' concerns with the lot-level approach. The Senate health committee marked up a user fee bill Wednesday (April 25) that includes other supply chain security provisions, and Sens.

April 26, 2012 | Daily News

Safety advocates' press to limit the use of recalled devices as predicates for new device clearances hit a snag after a proposed amendment was shot down by Senate health committee Chairman Tom Harkin (D-IA) at a user fee markup Wednesday (April 25), but the advocates still hope to get the measure attached to the user fee package when it hits the Senate floor.

April 26, 2012 | Daily News

The House Energy and Commerce Committee, after abruptly canceling a planned Thursday (April 26) markup of FDA user fee legislation, will resume its consideration of the bill in a little over a week, setting aside the week of May 7 for subcommittee and full committee markup, according to an updated schedule circulating among lobbyists. Committee Chairman Fred Upton (R-MI) then plans to take the bill to the floor "as soon as possible" under suspension of the rules, according to the schedule.

The following is the committee's updated schedule, according to the document:

April 26, 2012 | Daily News

The Senate health committee’s top lawmakers Wednesday (April 25) vowed to include biosimilars in the scope of a generic drug provision, included in the committee-passed user fee bill, that would prevent companies from using Risk Evaluation and Mitigation Strategies to restrict access to drugs used in bioequivalence studies.

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