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User Fees

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.