This article is reprinted from "The Gray Sheet" – December 10, 2007
Device lobbyists are joining a year-end push for an extension of a soon-to-expire tax credit for companies engaged in research and development, but opportunities are running out.
Continue reading this article on FDA Legislative Watch.
From the July 30, 2007, issue of "The Gray Sheet"
A rapidly moving Medicare bill puts imaging payments back in the crosshairs as the House looks for cost-saving measures to fund coverage of uninsured children and prevent massive cuts to physician payments.
H.R. 3162, The Children's Health and Medicare Protection Act, passed the House Ways and Means Committee early July 27. The Energy and Commerce Committee was unable to complete its separate markup of the bill later that day due to Republican stalling tactics and will likely send it to the House floor this week without a committee vote.
The activity is driven by a need to reauthorize the State Children's Health Insurance Program, or SCHIP, before it expires on Sept. 30. But the House legislation, first introduced by Energy and Commerce Chairman John Dingell, D-Mich., on July 24, goes much further.
Continue reading "House Bill Targets Imaging Payments To Help Fund Children's Insurance" »
From the June 11, 2007, issue of "The Gray Sheet"
A one-sentence provision tucked into draft legislation circulating in a House subcommittee seeks to weaken device and drug manufacturers' ability to claim FDA approval as a defense in state product liability lawsuits.
On June 6, the House Energy & Commerce Health Subcommittee released "discussion drafts" for nine FDA-related bills, including the reauthorization of medical device and drug user fee programs, and legislation relating to pediatric product development, drug safety, clinical trial registries and FDA advisory panel conflicts of interest.
Each of the drafts includes an identical section, entitled "Rule of Construction Regarding Federal Preemption." The section reads, "Nothing in this Act or the amendments made by this Act may be construed as having any legal effect on any cause of action for damages under the law of any State (including statutes, regulations, and common law)."
Continue reading "Federal Preemption Defense Under Fire In Draft House Bills" »
From the June 4, 2007, issue of "The Gray Sheet"
With legislation moving quickly in Congress, the device industry is stepping up its efforts to be heard in the long-running debate on reforming the U.S. patent system.
According to medical technology stakeholders, controversial provisions in the Patent Reform Act of 2007 - including limitations on damages that can be awarded for infringement and a new channel by which patents can be challenged long after they are granted - could weaken the value of patents and jeopardize firms' access to venture capital.
Identical bills introduced in the House and Senate April 18 (HR 1908 and S 1145) are backed by software giants like Microsoft, Cisco Systems and Intel. Sponsors say the legislation will prevent litigation abuses and increase patent quality.
Continue reading "Device Industry Intensifies Efforts To Protect IP, Modify Patent Reform Bills" »
From the May 21, 2007, issue of "The Gray Sheet"
The chairman of the House subcommittee overseeing reauthorization of medical device user fees is signaling that he might push to have a portion of industry-provided funds specifically allocated for FDA postmarket activities.
"Postmarket surveillance issues ... are equally as important" to achieving expedited premarket review, House Energy and Commerce Subcommittee on Health Chairman Frank Pallone, Jr., D-N.J., said during a May 16 hearing.
Under the Medical Device User Fee & Modernization Act, enacted in 2002 and set to expire Sept. 30, FDA collects fees from device manufacturers submitting applications for marketing approval. The fees are expressly intended to help FDA speed up the premarket review process.
Continue reading "Postmarket User Fees Floated At House Subcommittee Hearing" »
