Patton Boggs LLP

On February 9, 2012, the U.S. Food and Drug Administration (FDA) released draft guidelines regarding biosimilar product development. These draft guidelines supplement the abbreviated procedures for gaining FDA approval of…more

In This Issue: General Legislative On Monday, February 13, 2012, the House will meet at 1:00 p.m. in pro forma session. On Tuesday, the House will meet at 12:00 p.m. for morning hour and at 2:00 p.m. to consider…more

In This Issue: - DOMESTIC POLICY MATTERS Budget.  Next Monday, President Obama will release his Fiscal Year 2013 budget proposal.  On Wednesday, the House passed “The Expedited Legislative…more

In a slap at MSHA for back-door rulemaking, a judge has ruled that the agency cannot establish criteria for enforcing “repeated” flagrant violations through Procedure Instruction Letters (PILs) because the PILs…more

A custodial firm doing business at a mine incurred some $22,000 in legal expenses fighting an order MSHA issued, then vacated. A judge ruled the company is not entitled to compensation under the Equal Access to Justice Act…more

The Stop Trading on Congressional Knowledge Act (STOCK Act) was introduced in the House by Representative Louise Slaughter (D-NY) and Representative Tim Walz (D-MN) in March 2011 (H.R. 1148). Representative Slaughter had…more

DOL SEEKS UNPAID FINES Last month, the Labor Department (DOL) announced twice within three days that it had gone to court on behalf of MSHA to collect unpaid fines from quarry operators. DOL wants payment of $142,993…more

The 2012 Consolidated Appropriations Act (CAA) and the National Defense Authorization Act (NDAA) broaden the reach of the government’s suspension and debarment authority. The CAA prohibits covered federal agencies from…more

On Friday, February 3, 2012 the Internal Revenue Service and Department of the Treasury (Treasury) released a Notice of Proposed Rulemaking (NPRM) on the excise tax imposed on the sale of certain medical devices under…more

Mutual funds investing in commodity-linked notes or offshore corporations that deal in commodities may soon need to alter their trading strategies. On January 26, Senator Carl Levin (D-MI) called a Senate Investigation…more

OSHA’S MULTI-EMPLOYER POLICY The US DC Circuit Court of Appeals upheld OSHA’s multi-employer citation policy. Summit Contractors, Inc. had contested a citation for providing electrical equipment without…more

CSB ALLEGES FAILURE TO ACT BASED ON AN INSURANCE AUDIT Hoeganaes Corp. officials allegedly were aware of serious safety hazards at their Tennessee metal-powders plant, but did not eliminate the problems before a…more

Last week, the Senate held its first hearing on the Consumer Financial Protection Bureau (CFPB) following President Obama’s controversial recess appointment of former Ohio Attorney General Richard Cordray to lead the…more

OSHA threw the book at a Texas industrial employer after allegedly finding that Houston’s Piping Technology and Products, Inc. exposed its employees to amputation risks and other safety hazards. The fine was set at…more

OSHA has penalized a railroad and a trucking firm for allegedly retaliating against employees over safety issues, and has sued four other firms under the whistleblower statutes the agency enforces. Union Pacific…more