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Medical Devices

May 17, 2012 | Daily News

Senate Majority Leader Harry Reid (D-NV) is urging senators to be ready to quickly pass the FDA user fee legislation bill on Monday (May 21), warning that if he is forced to instead hold a cloture vote, debate on the bill could not begin until Wednesday (May 23). Reid encouraged senators to file amendments to the bill if they have problems with it, but not to hold up the legislation, citing the importance of the bill's drug shortage measures.

May 16, 2012 | Daily News

An updated Senate user fee bill unveiled late Tuesday adds provisions related to mobile medical applications guidance, rare diseases and patient participation in medical product discussions, with further changes expected in a manager's amendment before the legislation hits the Senate floor, a source close to the issue says. Senate Majority Leader Harry Reid (D-NV) said Tuesday that although he is lining the bill up for a cloture vote Thursday (May 17), he hopes to avoid a cloture vote and move directly to a floor vote Monday.

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 10, 2012 | Daily News

Industry's proposed alternative to the durable medical equipment competitive bidding program would fail because it would hold suppliers to their historical capacity, require that small suppliers get a bigger market share than they currently supply and take too long to implement, CMS Chronic Care Policy Group Director Laurence Wilson told Inside Health Policy. Industry countered that CMS misunderstands those measures and said industry welcomes the chance to discuss how they are designed to work.

May 10, 2012 | Daily News

FDA as part of a bid to encourage x-ray manufacturers to pursue pediatric indications that are currently not widely sought is calling for new x-rays to provide data to support pediatric indications or have labeling stating that the device should not be used in pediatric populations, according to draft guidance released by the agency. The agency also plans to hold a public meeting on pediatric x-ray imaging to obtain input on the guidance, testing criteria and the development of standards in this area.

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

The Government Accountability Office will release a report and testify on the first round of CMS' competitive bidding program for durable medical equipment (DME) at a Ways and Means health subcommittee hearing Wednesday (May 9), Rep. Aaron Schock (R-IL) told Inside Health Policy. Committee Chair Dave Camp (R-MI) said he disagrees with CMS' decision to make bids nonbinding and that committee Republicans likely will ask CMS officials about that aspect of the program.

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 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 07, 2012 | Daily News

CMS, facing criticism from key senators for delaying Sunshine Act data collection, has set up an internal work group and will also solicit stakeholders' help as it grapples with how to meet it latest plan to issue a final rule by the end of the year and require manufacturers to start collecting data on financial relationships between doctors and drug and device companies on Jan. 1, 2013.

May 04, 2012 | Daily News

Stakeholders who recently met with FDA and White House Office of Management and Budget officials said they fielded questions on how the upcoming Unique Device Identifier rule would affect recalls and patient safety, with one attendee saying administration officials appear to have moved beyond questions of whether the rule is needed and are now more focused on how it would work. The stakeholders said that they did not get a clear sense of when the delayed rule would be released from OMB.

May 03, 2012 | Daily News

The House Ways and Means health subcommittee plans to hold a hearing May 9 to review CMS' controversial competitive bidding program for durable medical equipment used in the home. The move is good news for medical equipment suppliers who believe the current bidding program is poorly designed and are pushing an alternative concept similar to auctions used in the private sector.

May 02, 2012 | Daily News

FDA is urging industry to develop device interoperability standards to help the agency decide if and how it should regulate such interactions, which have surged with the emergence of mobile health technology, an agency official said. Stakeholders already involved in the development of interoperability standards said FDA's involvement has increased the momentum of industry's efforts in the area.

May 02, 2012 | Daily News

A bipartisan group of senior Senate Finance Committee members is throwing out a broad solicitation for help from the entire health care community to come up with ideas to “better prevent and combat” waste, fraud and abuse in the Medicare and Medicaid programs.

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 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

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 25, 2012 | Daily News

The House Ways and Means oversight subcommittee is the latest congressional panel to launch an investigation into the success of CMS' myriad anti-fraud contractor programs, asking CMS on Wednesday (April 25) to provide details about its fraud-fighting efforts and how the agency gauges its contractors' success.

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.