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Until now, most small tax-exempt organizations, defined as those with gross receipts of $25,000 or less per year, have not been required to file an annual information return with the Internal Revenue Service (the “IRS”). 

However, small tax-exempt organizations must now file an annual electronic information return – the Form 990-N, also known as the e-Postcard. This requirement covers all tax periods beginning after December 31, 2006. The e-Postcard must be filed no later than the 15th day of the 5th month following the end of the organization’s tax year. For example, an organization whose tax year ends December 31 must submit the e-Postcard by the following May 15.

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The Prescription Drug Marketing Act was enacted in 1988 to establish, among other things, a system for tracking drugs through the manufacturing and marketing processes. implementing regulations regarding these pedigree provisions for prescription drugs have been delayed for years. The Food and Drug Administration has issued it’s own stay on implementation, and a recent lawsuit by prescription drug distributors over the scope of the pedigree requirements has contributed to the delay as well.

The resulting lack of clear of federal criteria for prescription drug pedigrees has created an opportunity for states to pass their own pedigree laws, leading to a patchwork of diverse, often conflicting, state standards. Prescription drug distributors find it increasingly difficult to comply with the multitude of state laws, thus the time is ripe for federal action to create uniform pedigree requirements.

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Included In This Update:

• United States Supreme Court Holds Food, Drug and Cosmetic Act Preempts State Law Claims Against Medical Device that Received Premarket Approval from Food and Drug Administration
• Massachusetts Appeals Court Decertifies Class of Mouthwash Purchasers Due to Differences Among Purchasers’ Exposure to, and Reliance on, Allegedly Deceptive Advertisements
• Massachusetts Superior Court Refuses to Certify Class of Buyers/Lessees of Vehicles that Included Twenty-Three Distinct Jacks, Finding Lack of Common Factual Issues, Predominance of Common Over Individual Issues and Superiority of Class Action Method of Adjudication Over Individual Claims
• Massachusetts Appeals Court Holds Alleged Failure to Warn Was Not Proximate Cause of Injury Because Plaintiff Did Not Read and Heed the Warnings that Were Provided
• Massachusetts Appeals Court Holds Failure to Move for Dismissal Within Reasonable Time Waives Pleaded Defense of Insufficient Service of Process

For more information about the Product Liability and Complex Tort Practice Group, please contact Dave Geiger.

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Health Canada released a draft guidance this week which would allow approval of “subsequent entry biologics” (SEB) based on an abbreviated complement of clinical data, provided the SEB is shown to be “similar” to a reference, approved biologic product.[1] While the U.S. continues to heatedly debate legislation which would create a pathway for abbreviated approval of biosimilars, or follow-on biologics, by the U.S. Food and Drug Administration (FDA), Canada is advancing its implementation of such a pathway with the release of the SEB draft guidance. The European Union has permitted approval of biosimilar products since 2005.

Like FDA guidance documents in the U.S., Health Canada guidance documents do not have the force of law in Canada. However, the draft guidance indicates that the Canadian Food and Drug Regulations will be amended to provide “a comprehensive legal basis” for the regulation of SEBs and that in the interim, the draft guidance will provide a flexible SEB regulatory framework. The Canadian Minister of Health also plans to publish additional guidance documents that will further elaborate information and data requirements for specific classes of SEBs. Public comments on the SEB draft guidance are due April 16. 

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On February 11, 2008, the U.S. Department of Labor (“DOL”) proposed significant changes to its regulations regarding the Family and Medical Leave Act (“FMLA”). These proposed changes -- the first regulatory revisions in over a decade -- reflect the DOL’s experience in administering the law since its enactment and public comments about the current regulations. The following represents a summary of some of the more notable proposed changes. The proposed regulations and explanatory materials consist of more than 125 pages, and thus this summary should not be viewed as comprehensive.