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User 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.

April 19, 2012 | Daily News

Updated Story

The generic drug industry's plan to help combat drug shortages could be fully operational in the next three months pending advice from the Federal Trade Commission on anti-trust issues, according to officials from the Generic Pharmaceutical Association. The group has also chosen IMS Health to act as an independent third-party for the industry's so-called Accelerated Recovery Initiative, with the consulting firm collecting production data from manufacturers and working with industry and FDA to mitigate the shortages.

April 19, 2012 | Daily News

The chances of drug tracking measures being included in the broader FDA user fee/reform package appeared to wane this week in both chambers of Congress. A House Energy and Commerce lawmaker who backs drug tracking initiatives, including an industry-backed drug proposal, clashed with FDA's top drug official who said the industry plan would not prevent counterfeit and adulterated drugs from reaching patients and therefore would not solve the problem stakeholders are trying to address.

April 18, 2012 | Daily News

The House Energy and Commerce Committee unveiled an updated draft user fee bill Tuesday (April 17) that makes some changes to the version released last month -- including new language permanently reauthorizing two pediatric statutes and adding new requirements to drug shortage provisions -- but largely leaves unchanged much of the first draft, including contentious measures revamping FDA's mission and reforming medical device approvals.

April 13, 2012 | Daily News

Infectious disease experts believe their best chance of getting a recently proposed limited population approval mechanism into FDA user fee legislation is to focus on the plan's benefits in spurring new antibiotics, even though the idea has been discussed for broader uses such as obesity drugs. The Infectious Diseases Society of America is touting support from a slew of drug companies and public health groups as it ramps up lobby efforts in support of the limited approval proposal.

April 13, 2012 | Daily News

Efforts by the National Community Pharmacists Association to include reimbursement changes for outpatient prescription drugs as a solution to stem drug shortages comes as lawmakers also consider other economic incentives to combat the drug dearths and highlights the larger problem with reimbursement under Medicare Part D, although the plan -- or other proposed reimbursement changes -- will not likely make it into a bill reauthorizing user fees, a pharmacy source said.

April 12, 2012 | Daily News

Congressional committees working on the reauthorization of FDA user fees, including a fee for the health reform-created biosimilars review pathway, could begin marking up bills the last week in April, sources said, with the Senate health committee planning to convene a markup the week of April 23. A bipartisan draft is expected from the House Energy and Commerce Committee in the coming weeks, a source said, noting that both chambers still have to address gaps in their legislative measures.

April 04, 2012 | Daily News

Draft drug reform legislation released by the Senate health committee Wednesday (April 4) instructs FDA to release long-awaited social media guidance, with the bill also including previously introduced measures codifying the accelerated approval process, creating a new breakthrough drug designation to speed up development of promising medications and expanding the agency's use of experts for advice on rare diseases.

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