Government’s Burden to Prove Facts Underlying Criminal Fines Is Heightened
June 25, 2012
The Supreme Court provided corporations and their officers and directors an important new tool in responding to criminal charges by holding that juries, not judges,...
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U.S. House of Representatives Passes FDA User Fees Bill
June 25, 2012
On June 20, 2012, the U.S. House of Representatives passed by a voice vote a revised and purported final version of the Food and Drug Administration ("FDA")...
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NLRB Acting General Counsel Publishes 'Safe Harbor' Social Media Policy
June 21, 2012
As we have previously advised, the Office of the General Counsel of the National Labor Relations Board (NLRB) currently is focused on employer efforts to regulate...
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M&A in 2012: Reverse Break-Up Fees
June 21, 2012
A key consideration in M&A deals is what happens if the deal fails to close. Specific performance and reverse break-up fees are central to this topic.
Review...
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Pay-for-Delay: Still a Critical Antitrust Enforcement Priority
June 21, 2012
On Monday, June 11, 2012, the Federal Trade Commission continued its lengthy and aggressive challenge to pay-for-delay settlement agreements by petitioning the Eleventh...
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SEC Adopts Rule Requiring Listing Standards for Compensation Committees
June 21, 2012
As required by Dodd-Frank, and building upon the independence requirements of audit committees, the Securities and Exchange Commission has approved a rule that...
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AHA Seeks Renewal of Expiring Medicare Reimbursement Provisions
June 21, 2012
The American Hospital Association ("AHA") has asked Congress to renew several Medicare reimbursement policies that either have expired or will soon expire. ...
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U.S. Senate Finance Committee Examines Physician Payment System
June 20, 2012
On June 14, 2012, the U.S. Senate Committee on Finance held a hearing entitled "Roundtable Discussion on Medicare Physician Payment Policy: Lessons from the...
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Supreme Court Rejects DOL’s Attempt to Narrow Outside Salesperson Exemption
June 19, 2012
U.S. Supreme Court Holds Pharmaceutical Reps Are Exempt from Overtime
In one of its most highly anticipated decisions this term, the United States Supreme...
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Rule Gives State Medicaid Programs a Year to Return Federal Portion of Overpayments
June 19, 2012
On May 29, 2012, the Centers for Medicare & Medicaid Services ("CMS") published a final rule providing state Medicaid programs one year from the discovery...
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House Ways and Means Committee Chairman Requests Information on CMMI Innovation Grants
June 18, 2012
On June 13, 2012, Charles Boustany Jr. (R-La.), chairman of the House Ways and Means Subcommittee on Oversight, issued a letter seeking documentation from the Center for...
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EPA Proposes More Stringent NAAQS for Fine Particulate Matter and Visibility Impairment
June 18, 2012
On June 15, 2012, the United States Environmental Protection Agency (EPA) announced a proposed rule that would increase the stringency of the primary annual National...
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The Long Road Ahead: Burdens on the Industry
June 18, 2012
The Long Road Ahead: Burdens on the Industry
The Sunshine Act represents an enormous regulatory burden on the drug, biological, device, and supply industry and its...
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Texas Supreme Court Refuses to Apply Direct-to-Consumer Advertising Exception to the Learned Intermediary Doctrine
June 18, 2012
Introduction
The learned intermediary doctrine remains alive and well in Texas. In an important decision for the pharmaceutical industry, the Texas Supreme Court...
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Clearing the Air: Issues Around Your Power Project, Challenges for Generation Projects
June 12, 2012
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The Power Practice Group at Fulbright presents an interactive web seminar that provides insight and analysis on the EPA air emission regulations with the...
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