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User Fees

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.

April 26, 2012 | Daily News

Senators said they will continue to work on the development of a drug tracking system, a measure limiting drug patent settlements, penalties related to drug shortages and due process concerns related new FDA authorities for destroying unsafe drugs before the health committee-passed user fee bill moves to the full Senate. The committee's top Democrat also appeared to close the door on inclusion of a device predicate nullification as Chair Tom Harkin (D-IA) said he favors the idea but there is not bipartisan support for it and new reclassification authorities could help address the issue.

April 26, 2012 | Daily News

A cosmetics placeholder was dropped from the latest version of House Energy and Commerce Committee user fee legislation released late Tuesday (April 24), just prior to the panel's decision to delay a markup scheduled for Thursday, as lawmakers continued to disagree over proposals to beef up FDA's oversight. Democrats have raised concerns over GOP cosmetic proposals that do not include cosmetic fees.

April 25, 2012 | Daily News

House Energy and Commerce Chairman Fred Upton's decision Wednesday to abruptly postpone markup of FDA user fee legislation came after the panel's top Democrats pushed for a delay to resolve outstanding policy issues, sources say. Upton (R-MI) postponed the E&C health subcommittee's markup until May 8, but he didn't explain why in remarks to lawmakers during the committee's budget reconciliation markup Wednesday morning.

April 25, 2012 | Daily News

Device safety advocates on Tuesday (April 24) voiced support for a proposed amendment to the Senate user fee bill that would limit the use of recalled devices as predicates, with the amendment tweaking a House Democrat's proposal by clarifying that the measure would only apply to predicates that have been recalled based on a design flaw. The narrowed scope could also draw FDA backing as an agency official recently called for a less-expansive predicate nullification approach than that proposed in the House.

April 25, 2012 | Daily News

The Senate Appropriations Committee will mark up the FDA funding bill Thursday (April 26), the committee announced Tuesday, with funding advocates also anticipating a markup of the House appropriations bill within the next few weeks.

April 24, 2012 | Daily News

Senators will seek to include a drug tracking system, civil monetary penalties for failing to notify FDA of drug shortages and limits on drug patent settlements, among other proposals included in 27 user fee amendments, obtained by Inside Health Policy, filed by lawmakers in preparation for Wednesday's health committee markup.

April 24, 2012 | Daily News

The lead sponsor of antibiotic incentive legislation Tuesday (April 24) is raising concerns to FDA about a separate proposal floating on Capitol Hill for a limited population antibiotic drug approval measure, saying the limited approval idea could damage the incentives in his broader bill and discourage antibiotic development, although committing to further vetting the idea, according to a letter obtained by FDA Week. In the letter Rep.

April 23, 2012 | Daily News

A manager's amendment to the Senate health committee user fee bill released Monday (April 23) includes provisions backed by a duo of Senate Republicans addressing customized devices, 510(k) modifications, the drug approval risk-benefit framework, global clinical trials, regulatory science, information technology, reporting requirements and FDA's integrated management plans.

April 20, 2012 | Daily News

Following technical input from FDA, including the addition of language that could effectively curb broader and off-label uses, the Infectious Diseases Society of America is touting support for its limited population antibiotic drug (LPAD) pathway from the agency and Energy and Commerce's top Democrat, although Rep. Henry Waxman (D-CA) is still seeking assurances that off-label prescribing would be limited and FDA has yet to officially endorse the idea.

April 20, 2012 | Daily News

Rep. Michael Burgess (R-TX) signaled support for ensuring FDA can reject medical device 510(k) clearances based on a recalled predicate, with the lawmaker being the first Republican to publicly express interest in the idea for which Democrats in Congress and safety advocates have working to build support. The lawmaker, however, questioned at a House hearing Wednesday whether FDA could implement the approach using its current authorities and requested specific examples of when unsafe medical devices have cleared the agency.

April 20, 2012 | Daily News

It could be difficult to translate a narrowly written device predicate nullification proposal into legislative language with undefined legal terms like "design flaws" that could create subjective legal areas for FDA, an industry source said, adding that this could pose hurdles for those seeking the proposal's inclusion in user fee legislation. Safety advocates counter that the bill should not be so narrowly written to prevent FDA from having authority to take action, as they continued lobby efforts with letters to congressional committees citing the predicate issue as a top priority.

April 20, 2012 | Daily News

Public Citizen this week sharply criticized House Energy and Commerce draft user fee legislation on the grounds that it would weaken oversight of medical products and fails to include proposals aimed at improving patient safety, such as a predicate nullification measure pushed by safety advocates. The group outlined its concerns in a letter to the health subcommittee, which released a new user fee discussion draft on Tuesday (April 17).

April 19, 2012 | Daily News

Sen. Orrin Hatch (R-UT) is working with Finance Committee members on drug shortage legislation that would change federal reimbursement for some sterile injectable drugs that are susceptible to shortages and would grant five years of exclusivity to manufacturers that produce drugs to alleviate a shortage, according to a discussion draft of the bill and an internal email obtained by Inside Health Policy.

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