Life Sciences Law Blog : Class Action Lawyer & Attorney : Sheppard Mullin Law Firm : Antitrust, Securities, Wage & Hour, Consumer Fraud

By Peter Reichertz

FDA has at last began formal implementation of the Biologics Price Competition and Innovation Act of 2009 ("BPCI Act"), by announcing the proposal it will send to Congress to implement user fees for "generic" copies of biologics, called biosimilars in the BPCI Act. A biosimilar is a product approved under Section 351(k) of the Public Health Service Act ("PHSA"); approvals are not Federal Food, Drug and Cosmetic Act ("FFDCA") approvals. Under the proposal, the user fees for biosimilars - including the product application fee, the annual product fee and the annual establishment fee - would be identical to the fees established for human drug products approved under Section 505(b) of the FFDCA with one significant difference.[1]

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By Peter S. Reichertz

In a Federal Register notice of September 7, 2011,[1] the Office of Human Research Protection (“OHRP”) and the Food and Drug Administration have clarified that a waiver by an individual in an informed consent to compensation for use of his/her biospecimens is not “exculpatory”, and permissible, if worded properly. This Guidance – entitled “Guidance on Exculpatory Language in Informed Consent" – applies to research conducted for purposes of FDA approval, as well as research sponsored by the Department of Health and Human Services (“DHHS”).
 

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By Karie Rego

Obtaining reimbursement for new medical technologies and services can be complicated.  In 2010, the Centers for Medicare and Medicaid Services (CMS) published an Innovator's Guide to assist in the process. The Guide, however, is over fifty pages long so we summarized the key points.
 

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By Peter S. Reichertz and Allie Frumin

On March 22, the U.S. Supreme Court affirmed the Ninth Circuit’s ruling in Matrixx Initiatives, Inc. v. Siracusano, 09-1156. See our prior blog article from November 18, 2010.
 

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By Blaine Templeman and Sarah E. Aberg

1. You May Get What You Drafted.

Broad indemnification provisions, once played out, can sometimes result in surprising applications. For example, in Mass Transit Administration v. CSX Transportation, Inc., 708 A.2d 298 (Md. 1998), the court considered an indemnification clause in a procurement contract between the Maryland Transit Authority (MTA) and CSX Transportation, Inc. (CSX).  CSX had contracted with the MTA to operate a commuter rail service between Washington, D.C., and Baltimore. In the contract, the MTA agreed to “indemnify, save harmless, and defend CSX from any and all casualty losses, claims, suits, damages or liability of every kind arising out of the Contract Service.”  Ultimately, the court found that CSX, whose train had crashed into a piece of equipment belonging to CSX’s own subcontractor, could be indemnified against the subcontractor’s claims by virtue of the “any and all” language in the indemnification clause between CSX and the MTA. This was because the services the subcontractor was performing were part of the services CSX had contracted with the MTA to provide under the services contract.
 

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By Peter S. Reichertz

In a prior article dated May 25, 2010, we advised of a new excise tax on branded pharmaceutical manufacturers. We indicated that the Patient Protection and Affordable Care Act ("PPACA") required the Internal Revenue Service ("IRS") to publish guidance "necessary to carry out the purpose" of the section in which the tax is included. The IRS has now issued that guidance ("the Guidance"). 

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By Peter S. Reichertz

The U.S. Supreme Court has scheduled oral argument for January 10, 2011, in the case of Matrixx Initiatives et al v. Siracusano, Case Number 09-1156, on appeal from the decision of the Ninth Circuit in Siracusano v. Matrixx Initiatives, Inc., 585 F3d 1167 (9^th Cir. 2008).  The court granted certiorari on July 14, 2010.
 

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By Matthew Richardson

A bill was recently introduced in the House of Representatives that would provide significant tax incentives for life sciences research.

Under current law, a 20% tax credit is available for spending on qualified research in excess of a specified base amount, subject to a number of limitations and special rules. Under H.R. 6165, which was introduced last week, this research tax credit would be doubled (to 40%) in the case of "qualified life sciences research."  The bill also doubles the elective "alternative simplified credit" for qualified life sciences research (an alternative method of calculating the research tax credit).
 

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By Peter S. Reichertz

On August 9, 2010, the Food and Drug Administration (“FDA”) published a notice announcing a public meeting to be held September 17, 2010, “to gather stakeholder input on the development of a generic drug user fee program.” See 75 Fed. Reg. 47,820-21. FDA also requested submission of written comments on issues relating to assessment of user fees for generic drugs, which can be submitted by no later than October 17, 2010.
 

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By Peter Reichertz

On July 14, 2010, Congressman Edolphus Towns introduced legislation to provide for the mandatory recall of adulterated or misbranded drugs. The legislation, H.R. 5740, has been referred to the Committee on Energy Commerce. Congressman Towns was the chair of the subcommittee that held hearings about Johnson & Johnson/McNeil and its handling of adulterated children’s drug products (including Tylenol® and Motrin®) this past Spring. Johnson & Johnson was scrutinized for delaying the recall of the products and allegedly covering up the recall of some of the products. As a result, there has been increased publicity over the authority of the U.S. Food and Drug Administration (“FDA”) to require the recall of drug products.
 

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