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DHS Chemical Facilities Take Note GAO Suggested Need For Enhanced Enforcement

The U.S. Government Accountability Office (GAO) has just issued a report on Critical Infrastructure Protection with a finding that Department of Homeland Security (DHS) action is needed to verify chemical facility information...more

Pharmacy Benefit Manager Group Opposes 21st Century Cures Act’s Cost Offset

The trade coalition representing pharmacy benefit managers is raising concerns about major bipartisan legislation aimed at streamlining the approval of new medicines and medical devices. However, the Pharmaceutical Care...more

TSCA Reform: Detailed Review of the TSCA Modernization Act of 2015 Considered in Markup by the House Energy and Commerce Committee

The House Energy and Commerce Committee convened a markup session on June 2 and 3, 2015, to consider a slightly revised version of the TSCA Modernization Act of 2015 as H.R. 2576. As reported in our June 3, 2015, memorandum,...more

A Sea Change for IPRs? -- Part II

Yesterday, we reported on the inter partes review (IPR)-specific provisions of the Managers Amendment to the PATENT ACT bil, which was passed last week by the Senate Judiciary Committee (see also "Senate Judiciary Committee...more

Patent Reform Heads to the Senate Floor

Yesterday, the Senate Judiciary Committee voted 16-4 to send an amended version of S. 1137, the Protecting American Talent and Entrepreneurship (PATENT) Act, to the full Senate for debate. The PATENT Act is this year’s...more

Patent Litigation Reform Legislation: State of Play

On April 29, Senate Judiciary Committee Chairman Charles Grassley (R-IA), along with fellow Committee members Orrin Hatch (R-UT), John Cornyn (R-TX), Mike Lee (R-UT), Patrick Leahy (D-VT), Chuck Schumer (D-NY), and Amy...more

Long-Term Care Legislation in Florida - Regulatory Compliance Impacts Retirement Communities, ALFs and Nursing Homes

Long-term care companies in Florida need to dust off their regulatory compliance plans to see if updates are needed in light of several bills that passed during the regular legislative session of 2015. If they are signed by...more

Congress Could Be Coming For Dietary Supplements Soon

The next chapter in the saga of New York State Attorney General Eric T. Schneiderman's investigation of the dietary supplements industry may take place on Capitol Hill. On April 2, Schneiderman and the state attorneys general...more

Senators Send Letter on Biosimilars to FDA

A group of Senators led by Sen. Lamar Alexander (R-TN), the Chairman of the Senate Committee on Health, Education, Labor, and Pensions, sent a letter last month to Dr. Stephen Ostroff, the Acting Commissioner of the U.S. Food...more

Medical Innovation: Congressional Committees Support Accelerated Research and Development for New Drugs, Devices and Biologics

Recent hearings by Senate and House committees and a scheduled markup underscore Congress' continued commitment to eliminating barriers that are slowing the development of effective drugs, devices, and biologics so that...more

TSCA Reform: Detailed Analysis of Substitute Version of Frank R. Lautenberg Chemical Safety for the 21st Century Act

A new version of the Frank R. Lautenberg Chemical Safety for the 21st Century Act was considered for markup by the Senate Environment and Public Works (EPW) Committee on April 28, 2015. ...more

Progressing Toward a Cure: House Committee Unveils Revised, Streamlined 21st Century Cures Discussion Draft

On April 29, 2015, the House Energy & Commerce Committee (“E&C Committee”) released a revised discussion draft of the medical innovation reform legislation that has been in the works for over a year as part of the 21st...more

Latest Spike in Prescription Drug Spending Prompts OIG Investigation

A new report released by the IMS Institute for Healthcare Informatics shows that U.S. spending on pharmaceuticals increased in 2014 by 13.1 percent, reaching $373.9 billion. This is the highest increase since 2001 when drug...more

Generic Drug Manufacturers to be Investigated by HHS for Recent Price Hikes

On April 13, 2015, the Inspector General (IG) of the Department of Health and Human Services announced in a letter to Senator Bernard Sanders (I. VT), that it would investigate recent price hikes for generic drugs. Generic...more

Toxic Tort and Environmental Litigation: Toxic Substances Control Act - Reform at Last? (4/15)

Efforts to reform the Toxic Substances Control Act (TSCA), 15 U.S.C. § 2601 et seq., have been underway for several years, but to date, none have succeeded in modifying how this often criticized law regulates chemicals in...more

Washington Healthcare Update

This Week: CMS Releases Three Documents on Biosimilar Reimbursement... SCOTUS: Agencies, Not State Courts, in Charge of Medicaid Rate Setting... HHS OIG and Treasury IG Release Report on ACA’s Advanced Premium Tax Credits....more

Congress Holds Hearing on 340B Program

The U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Health held a hearing on March 24, 2015 to review the functionality of the 340B Drug Pricing Program to understand how it impacts patients,...more

Bringing Predictability and Speed to DEA’s Scheduling of New Drugs

A bipartisan bill working its way through Congress could have a major effect on how the Drug Enforcement Agency (DEA) classifies drugs under the Controlled Substances Act (CSA). The Improving Regulatory Transparency for New...more

Washington Healthcare Update

This Week: Bipartisan, Bicameral Permanent SGR Fix Introduced... House Budget Committee Advances FY2016 Budget Proposal... National Coverage Determinations Proposed for Removal... HHS Releases Proposed Rules on EHR Incentive...more

Washington Healthcare Update

This Week: Senate HELP Committee Hosts Hearing on Medical Innovation... HHS Announces Next Generation Accountable Care Organization (ACO) Model... CBO Releases New Long-range Cost Estimates for ACA....more

TSCA Reform: Detailed Analysis of Frank R. Lautenberg Chemical Safety for the 21st Century Act: Significant Changes Made to...

The Senate over the past several years has considered a number of legislative texts to amend the Toxic Substances Control Act (TSCA). These include the Safer Chemicals Act, several versions of which were introduced by Senator...more

Health Care Update - March 2015 #2

In This Issue: - Senate HELP Begins Innovation for Healthier Americans Hearings - 340B Hearing Postponed; Written Testimonies Shed Light on Agenda - Implementation of the Affordable Care Act -...more

White House Releases Cyber Threat Intelligence Integration Center Fact Sheet

On February 25, the White House issued a fact sheet regarding the establishment of the Cyber Threat Intelligence Integration Center (CTIIC), which outlines the purpose, authority, organizational structure, and how the CTIIC...more

New Cyber Agency to Combat Cyber Threats

The Obama administration, on February 10, announced its intention to create a new federal agency to combat cyber threats and coordinate digital intelligence among all federal agencies....more

Washington Healthcare Update

This Week: Ways and Means Advances Four Health-Related Measures... Senate Commerce Committee Clears Legislation on E-Cigarette Packaging... CMS Pushes Back Deadline on Meaningful Use for Physicians....more

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