Open Congress : Blog Articles for H.R.1038 To amend the Public Health Service Act to provide for the licensing of comparable and interchangeable biological products, and for other purposes.

Patent Docs: Top Stories of 2008: #9 to #6

2009-01-04T19:00:00Z

... exclusivity and two years of market exclusivity), S. 1695 and H.R. 5629 (which provide four years of data exclusivity and eight years of market exclusivity), and S. 623 and H.R. 1038 (which do not address data/market exclusivity). ...

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Eye on FDA: Welcome 2009 - What's in Store for the Pharmaceutical ...

2008-12-30T19:00:00Z

H.R. 1038 - `Access to Life-Saving Medicine Act' · H.R. 1561 - Enhancing Drug Safety and Innovation Act of 2007 · H.R. 3 - Stem Cell Research Enhancement Act of 2007 · H.R. 331 - Drug Expiration Date Study ...

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Eye on FDA: New Prostate Cancer Treatment Approved by FDA

2008-12-28T19:00:00Z

Eye on FDA: Weekly Roundup - 12/19/08

2008-12-20T19:00:00Z

Eye on FDA: FDA Announces New Recommendations on Evaluating ...

2008-12-17T19:00:00Z

Eye on FDA: Weekly Roundup - 12/12/08

2008-12-11T19:00:00Z

Eye on FDA: Full Disclosure on Complete Response Letter by Targanta

2008-12-09T19:00:00Z

Eye on FDA: DTC in the Crosshairs of Congressman Waxman

2008-12-08T19:00:00Z

Eye on FDA: Weekly Roundup - 12/05/08

2008-12-04T19:00:00Z

Eye on FDA: The Tom Daschle Appointment for HHS - What's Inside?

2008-12-03T19:00:00Z

Eye on FDA: The Changing Policy and Communications Environment and ...

2008-12-02T19:00:00Z

Eye on FDA: Happy Thanksgiving Everyone

2008-11-26T19:00:00Z

Eye on FDA: Advice for the Obama FDA Commissioner, Part 2

2008-11-25T19:00:00Z

Eye on FDA: Advice for Obama's FDA Commissioner - Part 1

2008-11-23T19:00:00Z

Eye on FDA: American Health and Drug Benefits

2008-11-22T19:00:00Z

Eye on FDA: World AIDS Day

2008-11-21T19:00:00Z

Eye on FDA: Correction From Friday's Posting

2008-11-16T19:00:00Z

CQ Politics | Report: Increased Competition Will Produce Better ...

2008-09-24T20:00:00Z

The group favors legislation ( HR 1038 ) sponsored by Rep. Henry A. Waxman , D-Calif., that would provide an abbreviated pathway for the approval of follow-on biologic drugs. Biotechnology industry representatives disagreed with the ...

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CQ Politics | Less Is Better On Biologic Exclusivity, Candidates ...

2008-09-18T20:00:00Z

Makers of generic drugs favor legislation ( HR 1038 ) sponsored by Rep. Henry A. Waxman , D-Calif., that would provide an abbreviated pathway for the approval of follow-on biologic drugs and includes no period of data exclusivity for ...

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fop political bias extremely partisan

2008-07-11T20:00:00Z

hr 1038 (jackson, d-il) would impose a moratorium on the imposition of the death penalty at the federal level until a national commission on the death penalty reviews its fairness; * hr 1907 (norton, d-dc), the "racial profiling ...

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What should the US do about the millions of illegal immigrants now ...

2008-06-30T20:00:00Z

What should the US do about the millions of illegal immigrants now living in this country? The Republican incumbent Saxby Chambliss: Congress must make every effort to secure our borders and enforce our existing laws. ...

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MedWorm Query: cialis online (50 Ñ*Ð¾Ð¾Ð±Ñ‰ÐµÐ½Ð¸Ð¹)

2008-06-27T20:00:00Z

would allow for a 14-year period of data exclusivity, while another bill (HR 1038) by Rep. Henry Waxman (D-Calif.) contains no exclusivity period (McCarthy, CQ HealthBeat, 6/26). The report is available online. ...

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house commerce committee posts responses to its questions on ...

2008-06-18T20:00:00Z

henry waxman (d-ca), who is also a member of the subcommittee, introduced the access to life-saving medicine act (hr 1038). energy and commerce committee member jay inslee (d-wa) also introduced a bill in april 2007 â€“ the patient ...

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Patent Litigation Under a Future Biosimilars Act

2008-05-20T20:00:00Z

Henry Waxman introduced the first of the four biosimilars bills, the Access to Life-Saving Medicine Act (HR 1038), on February 14, 2007. The Waxman bill is regarded as the one most favorable to the generic drug industry. ...

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coalition releases letter in support of follow-on biologics

2008-04-10T20:00:00Z

follow-on biologic advocates support legislation (hr 1038) by house committee on oversight and government reform chair henry waxman (d-calif.) that would not provide brand-name biologics an exclusivity period. last year, the coalition ...

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follow-on biologics: intellectual property and innovation issues

2008-04-06T20:00:00Z

legislation has been introduced in the 110th congress that would create an expedited marketing approval pathway in the public health service act. the access to life-saving medicine act, introduced as hr 1038 and s. 623, would grant the ...

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NFIB.com - NFIB/Georgia News From the Gold Dome -- March 3, 2008

2008-03-05T19:00:00Z

HR 1038 allows for a repeal of inventory taxes levied specifically on retail furniture businesses. Because these resolutions propose to amend Georgia's Constitution, to be enacted they will require a two-thirds vote supermajority in the ...

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Lawmakers Push for Biosimilar Legislation in New Healthcare Initiative

2008-02-11T19:00:00Z

Access to Life-Saving Medicine Act, H.R. 1038, which would let the FDA approve biosimilars as interchangeable with the reference biologics, and Rep. Jay Insleeâ€™s (D-Wash.) Patient Protection and Innovative Biologic Medicines Act, ...

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Nelson Mullins | Newsletters

2008-01-29T19:00:00Z

HR 1038- Rep. Stephens (R-Savannah) Ad Valorem tax; inventories of retail furniture businesses; authorize exemption, is assigned to Ad valorem Sub Committee. HR 1056- Rep. Mills (R-Gainesville) Sales and use tax; educational purposes; ...

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Nelson Mullins | Newsletters

2008-01-18T19:00:00Z

HR 1038 â€“ Rep. Stephens (R-Savannah) proposed an amendment to the Constitution to exempt inventories of retail furniture businesses from ad valorem taxation. This proposal is inserted at Article VII, Section II. HR 1056 â€“ Rep. ...

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A Generic Delay....

2007-11-06T19:00:00Z

follow on (aka generic) biologics legislation (HR 1038). Many people living with MS and other diseases depend on biological drugs to sustain or improve their quality of life. This legislation would establish a ...

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lawmakers discuss bill that would allow fda to approve generic ...

2007-10-22T20:00:00Z

y.), and its house counterpart (hr 1038), sponsored by rep. henry waxman (d-calif.), would grant fda the authority to approve â€œfollow-on biologics,â€* or similar versions of brand-name biotech drugs (cq healthbeat, 3/8). ...

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Ask Your Representative to Support Affordable MS Therapies

2007-10-21T20:00:00Z

Ask them to move forward with the Access to Life-Saving Medicine Act (HR 1038). Congress can provide the FDA with a pathway for approving safe, effective, and lower-cost versions of biologic drugs. And give people living with MS and ...

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biogenerics legislation to be tabled in 2007

2007-09-13T20:00:00Z

in a speech before the generic pharmaceutical association on thursday said legislation (hr 1038) that would allow fda to approve generic versions of biotechnology drugs is unlikely to reach the house floor this year. ...

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Rep. Waxman Says Generic Biotech Drug Legislation Likely Will Not ...

2007-09-11T20:00:00Z

in a speech before the Generic Pharmaceutical Association on Thursday said legislation (HR 1038) that would allow FDA to approve generic versions of biotechnology drugs is unlikely to reach the House floor this year, [click link for ...

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Public Health Junk Science: Bill HR 1038

2007-09-08T20:00:00Z

In the interest of disclosure, I work for a pharmaceutical company. However, this post is purely my opinion and not that of my company. I heard about this bill and I was intrigued. View the bill here. I am all for bringing medicines to ...

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Generic Biotech Drug Legislation Likely Will Not Reach House Floor

2007-09-06T20:00:00Z

Generic Biotech Drug Legislation Likely Will Not Reach House Floor

2007-09-06T20:00:00Z

Generic Biologics Bill Still Has Good Chance For Enactment This ...

2007-09-06T20:00:00Z

Waxman, the sponsor of one generic biologics proposal, HR 1038, expressed disappointment that generic biologics is unlike to be tied to PDUFA reauthorization, which is a "must-pass" bill. - Jamie Hammon ...

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InsideKaty: Will talks with new Katy ISD superintendent bring ...

2007-08-13T20:00:00Z

Even the state legislature recognized his retirement (HR 1038). At age 62, all he would need to retire from TRS would be 18 years of service. He has much more than that. Regarding the tractor that you and others keep mentioning, ...

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does the congress get data exclusivity?

2007-06-26T20:00:00Z

... that said most if not all industry observers regard an eventual fda pathway for giosimilars as a political inevitability; and, (2) i did not find this provision in the corresponding legislation on the house side - (hr 1038). ...

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fighting childhood and young adult cancers with legislation: meet ...

2007-06-21T20:00:00Z

while we support the bill proposed by representative inslee, the candlelighters childhood cancer foundation is opposed to representative henry waxmanâ€™s bill, hr 1038, the â€*access to life-saving medicine actâ€*. ...

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Biologics in Perspective: Expanded Clinical Options amid Greater ...

2007-06-10T20:00:00Z

Legislation before the current (110th) Congress, H.R. 1038 and S. 623, would create an approval pathway within the FDA for generic biologics. As the FDA deputy commissioner testified in May, â€œThe science is going to continue to evolve, ...

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AARP Urges Congress to Act on Generic Biologic Drugs

2007-05-31T20:00:00Z

Congress is now considering the "Access to Life-Saving Medicine Act of 2007," (S. 623/H.R. 1038) a bill that would allow the FDA to establish a process to approve generic biologic drugs and potentially save patients and programs like ...

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Eye on FDA: Building the Case for Product Reimbursement - A ...

2007-05-14T20:00:00Z

Dollar Holds Near Low Vs. Euro (Cabin rental in pigeon forge tn ...

2007-05-10T20:00:00Z

The dollar index -- a measure of Forbes -two parties associated legislation (HR1038/S.623) defended of HouseGovernment and supervision committee preside Henry Waxman (D-Calif.),representative sincere Pallone (D-NJ), Jo Ann Emerson ...

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Keyword News: ["Hillary Rodham Clinton"]

2007-05-06T20:00:00Z

that would allow FDA to approve generic versions of biotechnology medications, CQ HealthBeat reports (Reichard, CQ HealthBeat, 5/2). Companion bills (HR 1038 and S 623) introduced earlier this year by Waxman and Sens. ...

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house subcommittee debates bill to allow fda to approve generic ...

2007-05-06T20:00:00Z

that would allow fda to approve generic versions of biotechnology medications, cq healthbeat reports (reichard, cq healthbeat, 5/2). companion bills (hr 1038 and s 623) introduced earlier this year by waxman and sens. ...

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federal focus on advocacy

2007-05-06T20:00:00Z

the access to life-saving medicine act (hr 1038 and s. 623) currently is being evaluated in congress and several hearings have been scheduled. as the bills move through the legislative process, we will be calling on ms activists to ...

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House Subcommittee Debates Bill To Allow FDA To Approve Generic ...

2007-05-06T20:00:00Z

that would concede nullity pother esteem generic specifically biotechnology medications, CQ HealthBeat reports (Reichard, HealthBeat, 5/2). zilch comrade bills (HR 1038 and S 623) introduced earlier siesta year close Waxman furthermore ...

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ccagw supports abbreviated pathway to generic biotech drugs

2007-04-26T20:00:00Z

y.), hr 1038 and s. 623 respectively, are good avenues to create such an abbreviated pathway. ccagw will soon release a research paper on the importance of creating an abbreviated pathway for generic biotech drugs and the potential ...

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Another Drug Trade Group Opposes Legislation on Biogenerics

2007-04-24T20:00:00Z

The “Access to Life-Saving Medicine Act” (S.623 and HR1038) does not require clinical trials to prove the safety and efficacy of follow-on biologics, PhRMA Senior Vice President Caroline Loew said. The trials are necessary because even ...

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Support Generic Alternatives to Expensive Biologic Drugs

2007-04-22T20:00:00Z

Write your Representative today and ask them to support bio-generic drugs by including the Access to Life-Saving Medicine Act (HR 1038) with the re-authorization of PDUFA. Click above to take action. Many people living with MS depend on ...

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Another Drug Trade Group Opposes Legislation on Biogenerics

2007-04-19T20:00:00Z

keyword news: ["hillary rodham clinton"]

2007-04-17T20:00:00Z

... which they argue are too complex to approve without first conducting clinical trials, the boston globe reports (henderson, boston globe, 4/16). companion bills (hr 1038 and s 623) introduced earlier this year by rep. ...

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Lobbyists Seek To Slow Legislation That Would Allow Generic ...

2007-04-17T20:00:00Z

... to pan without pristine conducting antiseptic rehearsal the waders Globe reports (Henderson, boot Globe, 4/16). Companion bills (HR 1038 and 623) glamorous earlier this year feasible Henry Waxman (D-Calif. link for imbued article]

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Another Drug Trade Group Opposes Legislation on Biogenerics

2007-04-17T20:00:00Z

The “Access to Life-Saving Medicine Act,” (S.623 and HR1038) does not require clinical trials to prove the safety and efficacy of follow-on biologics, PhRMA Senior Vice President Caroline Loew said. The trials are necessary because even ...

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Lobbyists Seek To Slow Legislation That Would Allow Generic ...

2007-04-17T20:00:00Z

... which they argue are too complex to approve without first conducting clinical trials, the Boston Globe reports (Henderson, Boston Globe, 4/16). Companion bills (HR 1038 and S 623) introduced earlier this year by Rep. ...

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Lobbyists Seek To Slow Legislation That Would Allow Generic ...

2007-04-17T20:00:00Z

... biotechnology drugs, which they argue are too complex to approve without first conducting clinical trials, the Boston Globe reports (Henderson, Boston Globe, 4/16). Companion bills (HR 1038 and S 623) introduced earlier this year [. ...

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HR 1038 Enrolled

2007-04-11T20:00:00Z

Honoring Katy ISD Superintendent Dr. Leonard Merrell on the occasion of his retirement.

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FACES COSMETICS PLC - Notice of Results & London Presentation

2007-04-11T20:00:00Z

Companion bills (HR 1038 and S 623) introduced earlier this year by Rep. Henry Waxman (D-Calif.) and Sens. [click link for full article] Thu, 12 Apr 2007 02:00:00 PDT PR Inside - FOR RELEASE 7.00 AM 12April 2007 Faces Cosmetics plc (? ...

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Leading Lawmakers From Both Parties Working To Reach Agreement On ...

2007-04-11T20:00:00Z

... to lower45cost copies of biotechnology drugs that now cost tens or hundreds of thousands of dollars a year, the New York Times reports Pear, New York Times, 48. Companion bills HR 1038 and S 623 introduced earlier this year by Rep. ...

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leading lawmakers from both parties working to reach agreement on ...

2007-04-10T20:00:00Z

companion bills (hr 1038 and s 623) introduced earlier this year by rep. henry waxman (d-calif.) and sens. [click link for full article]. original post by health news from medical news today.

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generic biologics debated in congressional hearing

2007-03-26T20:00:00Z

"we strongly oppose hr 1038 as it fails to do either. hr 1038 would permit the approval of follow-on biologics that do not meet the same rigorous standards of safety, purity, and potency that innovator products must meet; would restrict ...

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BIO Restates Opposition to HR 1038

2007-03-25T20:00:00Z

Keywords: [intellectual property] [patent] [property] ; Phrases: The legislation also eviscerates incentives to develop new therapies through its one-sided alteration of long-standing patent law in ways that favor follow-on biologics ...

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Man arrested after allegedly holding children at knifepoint WCAX 3 ...

2007-03-25T20:00:00Z

BIO Restates Opposition to HR 1038 [Press Release] BIO - Mar 26 7:04 AM Any legislative discussion of creating a pathway for follow-on biologics must ensure patient safety and preserve incentives for biomedical research and innovation. ...

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Should Lexecon be overruled?

2007-03-10T19:00:00Z

(1999); Multidistrict Litigation Restoration Act of 2005, HR 1038, 109th Cong., 1st Sess. (2005). Here's today's question: Should that law be passed? Should Lexecon be overruled by statute? We're of two minds on this issue. ...

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Follow-On Biologics: Intellectual Property and Innovation Issues ...

2007-03-08T19:00:00Z

Several bills introduced in the first session of the110th Congress, including H.R. 1038, S. 623, H.R. 1956, S. 1505, S. 1695 (ordered to be reported, with amendments in the nature of a substitute), and H.R. 5629 would create an ...

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Options Exist For Offsetting the Cost of Extending Health Coverage ...

2007-03-07T19:00:00Z

Legislation to establish an FDA process for approving generic versions of biological drugs has recently been introduced by Representative Henry Waxman (H.R. 1038) and Senator Charles Schumer (S. 623). ...

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advocates get behind genetic 'biologics' bill

2007-03-07T19:00:00Z

aarp says it has endorsed the "access to life-saving medicine act of 2007" (s. 623/hr 1038). under current law, after the patent of a brand-name prescription drug expires, a generic manufacturer can market a generic version of the drug. ...

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Generic Biologics Could Save $71 Billion Over 10 Years, Report Says

2007-03-06T19:00:00Z

The following article was recently published which outlines the potential savings that pending legislation (HR1038, the "Access to Life-Saving Medicine Act of 2007") for creating and marketing generic biologic medicines could have on ...

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house legislation: health

2007-02-25T19:00:00Z

hr 1038 - rep. henry waxman [d-ca] to amend the public health service act to provide for the licensing of comparable and interchangeable biological products, and for other purposes. hr 1072 - rep. carolyn maloney [d-ny] ...

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Patent Baristas Â» Bill Re-Introduced to Create Path for Biogenerics

2007-02-23T19:00:00Z

Representatives Waxman, Emerson, and Pallone, along with Senators Schumer and Clinton, have re-introduced H.R. 1038, the â€œAccess to Life-Saving Medicine Act,â€* which will establish a process through which the FDA will be able to approve ...

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Bill Action: Introduced: HR 1038: To amend the Public Health ...

2007-02-12T19:00:00Z

Henry Waxman [D-CA] introduced HR 1038: To amend the Public Health Service Act to provide for the licensing of comparable and interchangeable biological products, and for other purposes.. [This event matched these monitors: Active ...

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HR 1038, To amend the Public Health Service Act to provide for the ...

2007-02-12T19:00:00Z

HR 1038 would amend the Public Health Service Act to provide for the licensing of comparable and interchangeable biological products....

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