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Medical Devices

April 13, 2012 | Daily News

FDA should have the authority to share information with international regulatory agencies and adopt a medical product track and trace system that centers on interactions with trading partners, known as a one-up-one-back system, according to a recent Institute of Medicine report on the safety of imported food and drugs. The report emerges as lawmakers debate supply chain security measures that could be attached to FDA user fee legislation, with information sharing and drug tracking two of the more contentious components.

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

Safety advocates continue to push for stronger conflict-of-interest requirements as part of legislation reauthorizing user fees as draft bills in the House and Senate remove caps on the number of waivers FDA can grant and they are also working to pass a law reforming federal advisory committees that could also apply to FDA panels if repeal efforts succeed. However, a congressional aide said any changes to the conflict-of-interest measure in the draft Senate bill are unlikely and sources expressed apprehension over the Federal Advisory Committee Reform Act becoming law soon.

April 04, 2012 | Daily News

House Energy and Commerce Republicans are pushing FDA to justify several policy changes they say the agency is proposing in a draft guidance on in vitro diagnostics for research and investigational use, largely echoing concerns raised by industry over the agency's definition of intended use, regulation of clinical laboratories and a requirement that manufacturers must ensure end users are compliant with regulations.

April 04, 2012 | Daily News

As part of a sizeable stakeholder effort to improve health care quality and reduce patient harm and waste, nine physician specialty societies -- including the American Academy of Family Physicians, the American College of Radiology and the American Society of Clinical Oncology -- have identified 45 commonly-used tests that they say are often unnecessary and whose use physicians and patients should question.

April 02, 2012 | Daily News

FDA's top device official on Thursday (March 29) signaled support for a measure to narrowly prohibit devices recalled for safety design flaws from being used as predicates -- similar to a measure being pushed by a Democratic lawmaker. At least one Democratic Senator expressed support for including this predicate nullification measure in legislation reauthorizing FDA user fees during a Senate health committee hearing on the issue.

March 28, 2012 | Daily News

FDA's top device official said he will raise issues with guidance, tracking and third-party review legislative proposals among others, and hone in on reforms included in a House draft of FDA user fee reauthorization, previewing for FDA Week what he may tell lawmakers as the legislative process continues. FDA will soon transmit the medical device user fee agreement to Congress and device center chief Jeffrey Shuren said the agency has concerns that other pending reforms could conflict with what FDA negotiated with industry in the agreement.

March 26, 2012 | Daily News

A vote on legislation to repeal the health reform law's medical device tax could possibly come this spring or summer, according to the Advanced Medical Technology Association, which on Monday (March 26) continued its push for repeal of the tax with the release of a report showing that the decline in revenue associated with the tax would result in the loss of nearly 39,000 jobs and more than $8 billion in economic output, figures that are part of the group's strategy to frame the tax as a job killer in an effort to garner bipartisan support for repeal.

March 23, 2012 | Daily News

A federal appeals court decision to block FDA's requirement that tobacco ads appear only in black and white, part of a larger ruling this week that otherwise upheld the agency's graphic warning labels for cigarettes, is hailed by a free speech advocate as putting a check on blanket bans on speech, such as off-label marketing restrictions, and a move that could require FDA to more narrowly tailor such restrictions.

March 23, 2012 | Daily News

A measure expanding CMS oversight of laboratory developed tests was excluded from a draft House user fee bill, signaling the proposal, which is opposed by a key device industry trade group, might not make it into the final user fee legislation, although lobbying efforts are heating up and some sources predicted the proposal could still move through user fees or other legislation.

March 23, 2012 | Daily News

Rep. Ed Markey (D-MA) is pushing to build bipartisan support and user fee inclusion of a bill that would give FDA the authority to reject 510(k) medical device clearances based on recalled predicates, with the lawmaker releasing a report Thursday (March 22) outlining what he is calling a loophole in the FDA clearance process.

March 17, 2012 | Daily News

A draft Senate medical device reform bill being circulated for comment addresses some issues raised by stakeholders and included in previously introduced legislation -- including reform of the de novo pathway, humanitarian use device profits and conflict-of-interest rules -- while also introducing other concepts, including reform of the supervisory review process, a recall evaluation program and the ability of FDA to put a clinical hold on investigational devices.

March 17, 2012 | Daily News

Stakeholders have forged an agreement on humanitarian device reform that embraces a proposal by Sen. Al Franken (D-MN) to allow profits for humanitarian use devices in limited situations -- a deal that comes after pediatricians expressed concern that other proposals would eliminate incentives for pediatric devices with the designation.

March 15, 2012 | Daily News

A bipartisan group of senators on Thursday (March 15) introduced a medical device safety bill aimed at improving post-market surveillance, with the measure adding devices to FDA's Sentinel system and requiring the agency to issue its long-awaited Unique Device Identification rule by the end of the year.

March 13, 2012 | Daily News

The House Energy and Commerce Committee will push accelerated approval changes, antibiotics incentives, drug shortage solutions, a slew of device reforms, changes to the agency's mission statement, mandates for public participation in guidance development and a complete repeal of FDA's conflict-of-interest policies, according to a discussion draft of the committee's user fee package, obtained by FDA Week.The document offers an initial glimpse into the committee's FDA reform priorities and sets up likely debates to occur in the coming months as Democrats prepare to push competing re

March 13, 2012 | Daily News

The American Academy of Family Physicians decided Tuesday (March 13) to stay in a key American Medical Association panel that helps drive CMS physician payment rates after AMA recently conceded to take some steps to increase primary care physicians' role, but AAFP remains concerned the so-called RUC panel is weighted towards specialty physicians.

March 12, 2012 | Daily News

A measure that would create a temporary code for some diagnostics could be dropped from pending legislation if the Obama administration and the American Medical Association address the issue administratively, according to a patient advocate pushing the bill, who says that AMA and CMS have looked into whether the current coding system unnecessarily delays reimbursement and access to diagnostics. Stakeholders have highlighted the coding system for diagnostic tests as an area for reform, saying coding changes could spur access to personalized medicine therapies.

March 02, 2012 | Daily News

Industry and FDA have agreed to a draft commitment letter and legislative language for medical device user fees following the inclusion of a waiver system to exclude laboratory developed tests from the fees, and the agreement is being vetted internally before being released for public comment and sent to Capitol Hill, sources say. The waivers satisfy concerns the American Clinical Laboratory Association had about laboratory developed tests being subject to the fees, but the group will continue to lobby for expanded CMS oversight of these tests in lieu of expected FDA regulation.

March 01, 2012 | Daily News

Industry lobbying groups are bringing state device and bioscience associations to Capitol Hill over the coming months to bolster their push for lawmakers to repeal the medical device tax, ease product approval hurdles and reauthorize FDA user fees, while watchdog groups that oppose the tax repeal and seek tighter approval standards highlight the stepped-up lobbying by medical device companies and their financial contributions to lawmakers.

February 28, 2012 | Daily News

Industry lawyers are bristling at a top FDA official's recent call for companies to back up health economic claims with substantial evidence, with one lawyer saying a requirement for adequate and well-controlled clinical studies may go beyond the statute's less stringent "competent and reliable evidence" benchmark. Industry speakers at a recent marketing conference said the FDA official's statement confirms what they have seen in agency enforcement actions.

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