Science, Computers & Technology, Election & Politics Law, Health Law

Congress Drafts Compounding Legislation -- Defines Compounded Drugs as "New Drugs" Under the FFDCA and Creates Bright Line Between...

by Elinor Hart, Rachael G. Pontikes | Duane Morris LLP on 4/30/2013

In the wake of the New England Compounding Center meningitis outbreak, the federal government has actively pushed for greater legislative oversight over compounding pharmacies. On April 26, 2013, the U.S. Senate Committee on...more

Health Care Reform Implementation Update - April 26, 2013

by Mark Alderman | Cozen O'Connor on 4/26/2013

Marilyn Tavenner received bipartisan support from members of the Senate Committee on Finance in her confirmation hearing to lead the Centers for Medicare and Medicaid Services (CMS) though a full Senate vote is being held up,...more

White House Unveils BRAIN Initiative

by Donald Zuhn | McDonnell Boehnen Hulbert & Berghoff LLP on 4/10/2013

Last week, President Obama announced a new research initiative designed to advance our understanding of the human brain. It is hoped that the new initiative, dubbed the BRAIN (Brain Research through Advancing Innovative...more

Grassley Questions Hospital 340B Program Profits

by Ellyn L. Sternfield | Mintz Levin - Health Law on 4/5/2013

In a March 2013 article, I wrote about members of Congress calling for increased oversight of the 340B drug discount program and, in particular, hospital use of 340B drugs. This week, Senator Charles Grassley of Iowa...more

Alabama Legislative Update – Week 7: Medicaid Reform Takes the Stage as the Battle for Education Continues

by Denise Killebrew, Dennis Nabors | Baker, Donelson, Bearman, Caldwell &... on 3/26/2013

As the Alabama Legislature marked the halfway point of the 2013 Regular Session, progress continued to move at a slow pace where repercussions of the Alabama Accountability Act continue to linger in the halls of the...more

NIST Seeks Private Sector Information on Cybersecurity Framework Outlined in President’s Executive Order

by King & Spalding on 3/22/2013

On February 26, 2013, the National Institute of Standards and Technology (NIST) published a Request for Information (RFI) in the Federal Register soliciting views from both government and industry on developing the...more

Maryland Cybersecurity-Related Legislative Developments

by Michael Baader, Dismas Locaria, Anthony Rosso, Ryan Sweigard | Venable LLP on 2/21/2013

The Maryland State Senate is considering several cybersecurity-related bills to advance the state’s efforts to be the epicenter for cybersecurity. Maryland has already enacted several measures to foster cybersecurity...more

Capital Thinking Update - February 11, 2013

by Jennifer Cetta, Amy Davenport, Tanya DeRivi, Eugenia Edwards, Karen Kudelko, Matthew Kulkin, Amy Budner Smith, Scott Thompson, Joseph Urso, Sarah Vilms, Dana Weeks, Pam Welsh | Patton Boggs LLP on 2/14/2013

In This Issue: - General Legislative - Agriculture & Food - Budget, Appropriations, and Sequestration - Cybersecurity - Education - Energy - Environment - Financial Services -...more

Amendments to CLIA’s Proficiency Testing Provisions Passed by Congress

by Mintz Levin - Health Law on 11/19/2012

The Senate approved the previously House-passed Taking Essential Steps for Testing Act (also known as the “TEST Act”) this week, clearing the way for President Obama’s signature and enactment. The legislation, which amends...more

Federal Stem Cell Funding Approved by Appellate Court

by Foley & Lardner LLP on 8/28/2012

Good news for patients and stem cell researchers alike. On August 24th, the United States Courts of Appeals for the District of Columbia Circuit affirmed the District of Columbia court decision granting the government’s...more

President Obama Signs Bipartisan FDA User Fee Legislation

by McDermott Will & Emery on 7/11/2012

On July 9, 2012, President Obama signed legislation that reauthorizes the U.S. Food and Drug Administration (FDA) to assess user fees to support the agency’s review of marketing applications for drugs (including biologics)...more

President Signs Law Reauthorizing Drug and Device User Fees: Legislation Contains Several Important FDA Reforms

by Ropes & Gray LLP on 7/11/2012

On Monday, July 9, 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA). This statute reauthorizes the Prescription Drug User Fee Act (PDUFA) and the Medical Device User...more

The Regulatory Future of mHealth: FCC, FDA and the United States Congress

by Fenwick & West Life Sciences Group on 6/19/2012

As a general matter FDA regulates all medical devices and FCC regulates devices that utilize electromagnetic spectrum - i.e. broadcast devices. So with regard to mobile health devices - sensors, applications, systems - FDA...more

House Passes FDA User Fee Bill; Congress on Track to Pass Reconciled Bill by Beginning of July

by McDermott Will & Emery on 6/7/2012

On May 30, 2012, the U.S. House of Representatives passed the Food and Drug Administration Reform Act of 2012—the chamber’s FDA user fee authorization bill—by a 387–5 margin. With regard to user fees, the bill is very similar...more

Senate Easily Passes FDA User Fee Bill, Reconciliation with House Version Looms

by McDermott Will & Emery on 5/30/2012

In a nearly unanimous decision, the U.S. Senate passed the Food and Drug Administration Safety and Innovation Act on May 24, 2012. The bill would reauthorize the drug and device user fee programs and, for the first time,...more

Capital Thinking Update - May 14, 2012

by Patton Boggs LLP on 5/15/2012

General Legislative The House is not in session on Monday, May 14, 2012. The House will meet at 12:00 p.m. on Tuesday, May 15, for morning hour and 2:00 p.m. for legislative business. On Tuesday the House will consider...more

Massachusetts House Votes to Repeal Gift Ban Law

by Mintz Levin - Health Law on 4/30/2012

Earlier this week the Massachusetts House of Representatives voted 128-22 to repeal the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct (often called the “gift ban” law). The gift ban law...more

Conflict of Interest Strikes Again at the FDA

by Patrick Malone & Associates P.C. | DC Injury... on 1/25/2012

On his GoozNews website, journalist Merrill Goozner recently tackled the decision by Health and Human Services Secretary Kathleen Sebelius to overrule FDA scientists and ban the sale to minors of the over-the counter...more

Victims of Rare Diseases See New Focus on "Orphan Drug" Research

by Patrick Malone & Associates P.C. | DC Injury... on 1/17/2012

A recently introduced bill in the House of Representatives seeks to update legislation for “orphan” diseases and drugs. “Orphan” status denotes disorders that are extremely rare—generally afflicting 6,000 or fewer...more

Acquisition Price Metric Proposed for Medi-Cal Rx Reimbursement

by King & Spalding on 2/22/2011

Plan Would Impose California Price Reporting Obligations on Drug and Biologics Manufacturers California Governor Jerry Brown has released a draft set of amendments to the state’s Medi-Cal code that would add “average...more

Recent Congressional Activity Presents Opportunity for Medical Device Industry

by King & Spalding on 2/22/2011

Focusing on burdensome regulatory issues and the imposition of a new medical device tax under the health care reform law, Congress has begun to examine specific changes to medical device regulations in the United States. As...more

President Obama's FY 2012 Budget Plan Includes Provisions that Impact Pharmaceutical and Device Manufacturers

by King & Spalding on 2/15/2011

On February 14, 2011, the White House released its proposed budget for Fiscal Year 2012. The budget projects a $1.1 trillion reduction in the federal deficit over the next ten years, with two-thirds of the savings expected to...more

Ralph Nader and EPIC Urge Senate Hearings on Airport Body Scanners; Letter to Senator Lieberman

by Electronic Privacy Information Center on 9/8/2010

In letters to Senator Lieberman and Senator Collins, EPIC President Marc Rotenberg and consumer advocate Ralph Nader urged the Senate Committee on Homeland Security and Governmental Affairs to "convene a public hearing to...more

Ralph Nader and EPIC Urge Senate Hearings on Airport Body Scanners; Letter to Senator Collins

by Electronic Privacy Information Center on 9/8/2010

In letters to Senator Lieberman and Senator Collins, EPIC President Marc Rotenberg and consumer advocate Ralph Nader urged the Senate Committee on Homeland Security and Governmental Affairs to "convene a public hearing to...more

Medical Device Tax Provisions in Health Care Reform Legislation

by Foley Hoag LLP on 3/26/2010

The Patient Protection and Affordable Care Act of 2009 (Pub. L. No. 111-148),1 which President Obama signed into law on March 23, 2010 imposes an annual fee on medical device manufacturers and importers. The “Health Care and...more

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Science, Computers & Technology › Election & Politics Law › Health Law