August 2010 Client Bulletins

September 21, 2010

Authored by: Jeannie Osborne

SEC Adopts Rules Allowing Shareholders Access to Company Proxy Materials

On August 25, 2010, the Securities and Exchange Commission voted to adopt new rules that will require companies to include in their proxy materials nominations for election as directors submitted by eligible shareholders, subject to certain conditions.  For more information, please see the Client Alert published by the Corporate Finance and Securities Client Service Group August 26, 2010.  

Enforcement Landmines for Private Funds in Dodd-Frank

By now, most “private” or “hedge” fund managers know that the Dodd-Frank Wall Street Reform and Consumer Protection Act requires SEC registration of most advisers to private funds, effective July 2011. But SEC registration is not the only aspect of the new law that fund managers need to be aware of. Other provisions of the law will have significant effects on funds.  For more information, please see the Client Alert published by Securities Litigation and Enforcement Alternative Investments Team.

Regulations Issued Under Health Care Reform on Preventive Services and Internal claims and Appeals, and Extended Review Procedures

The Departments of Treasury, Labor and Health & Human Services (the “Departments”) recently issued two more batches of interim final regulations under the Patient Protection and Affordable Care Act as amended (the “Act”).  This new guidance addresses (i) the preventive services coverage mandate, and (ii) the new internal claims and appeals and external review processes.  For more information, please see the Client Alert published by the Employee Benefits and Executive Compensation Group August 5, 2010

USDA to Hold Meeting for Public Input on Codex Processed Fruits and Vegetables Standards

On August 18, 2010, USDA announced a public meeting to provide information and receive comments on agenda items and draft U.S. positions that will be discussed at the 25th Session of the Codex Committee on Processed Fruits and Vegetables.  For more information, please see the August 19, 2010 Food Regulatory and Policy Bulletin published by the Food and Drug Administration Practice

During China Visit, FDA Commissioner’s Focus Not on Heparin Investigation

FDA Commissioner Margaret Hamburg’s recent trip to China focused primarily on avenues of collaboration and cooperation between the FDA and Chinese regulators rather than on the current investigation into the contaminaiton of heparin.  For information on this and other issues, please see the August 27, 2010 Drugs and Devices Regulatory and Policy Bulletin published by the Food and Drug Administration Practice.   

FDA Issues Guidance on Menu Labeling Requirements

On August 24, 2010, FDA released two guidance documents that outline steps to help certain chain restaurants and vending machine companies comply with new federal nutrition labeling requirements (which were included in the new health care reform law passed in March.  For more information, please see the August 27, 2010 Food Regulatory and Policy Bulletin published by the Food and Drug Administration Practice. 

U.S. Widens Investigation into Drug Makers and Overseas Bribery

A report in the New York Times has found that the Department of Justice and the Securities and Exchange Commission have indicated that they were widening their investigation into payments made by drug and device manufacturers by physicians overseas to include the activities of more than a dozen companies.  For more information on this and other issues, please see the Drugs and Devices Regulatory and Policy Bulletin published August 17, 2010 by the Food and Drug Administration Practice.  

Device Industry Begins Preparation for Excise Tax as Some Call for Repeal

Although the excise tax on medical devices that was part of the health reform bill does not take effect until 2013, members of the device industry have already begun preparing for its imposition, and have indicated that they will continue to call for the repeal or revision of the tax. For more information, please see the Drugs and Devices Regulatory and Policy Bulletin published August 11, 2010 by the Food and Drug Administration Practice.

Senate Strikes Deal on Food Safety Manager’s Package

On August 12, 2010, Senate Health Education Labor and Pensions Committee Chairman Tom Harkin announced that Senators had reached a deal on the Manager’s Package for the FDA Food Safety Modernization Act.  For more information, please see the August 13, 2010 Food Regulatory and Policy Bulletin published by the Food and Drug Administration Practice. 

Most Oil Cleaned Up, Little Risk Remains

The Administration released a report this week claiming that seventy-five percent of the oil from the BP spill has been removed, burned off, or evaporated, and the remainder is so thinly spread throughout the region that it is unlikely to cause more significant harm.  For more information and other energy-related issues, please see the Bryan Cave Energy Update, Issue 51, published August 1, 2010 by the Energy Industry Team.

FDA Boasts Reportable Food Registry Successes

In an August 3, 2010 Constituent Update, FDA boasts that its new reportable food electronic portal speeds identification and investigation of potential health hazards in human food, animal feed, and pet food industries.  For more information, please see the August 4, 2010 Food Regulatory and Policy Bulletin published by the Food and Drug Administration Practice.

FDA Releases Recommendations Regarding Device Approvals

The FDA has released a set of proposed recommendations regarding device approvals and its 510(k) process.  For more information, see the Food Regulatory and Policy Bulletin published by the Food and Drug Administration August 4, 2010.