-
March 2013
Publications
-
This special edition of the FDA Monitor provides an analysis on the recent Friedman v. Sebelius decision that effectively expands the Park Doctrine’s reach by authorizing exclusion from federal healthcare programs based on “Responsible Corporate Officer” misdemeanor convictions for violations of the FDCA.
December 2012
Publications
-
This edition of the FDA Monitor provides a summary of FDA’s first food facility registration suspension and potential future implications.
December 2012
Publications
-
California's Safer Consumer Products regulations, currently in draft form and set for implementation in early 2013, pose a serious challenge to US over-the-counter (OTC) drug manufacturers by imposing a new layer of bureaucratic oversight on top of what already exists through federal statutes. There is a high potential for contradictory labeling and information requirements as well as greater liability exposures—even an outright ban on sale of OTCs in the state. Nevertheless, there is little awareness of the extent of the threat. To date the pharmaceutical industry has been largely missing from the dialogue.
November 1, 2012
Publications
-
This advisory discusses the California Department of Toxic Substances Control’s (DTSC) recent issuance of the fourth iteration of its Safer Consumer Products draft regulations. These stringent regulations, implementing California’s Green Chemistry program, have a broad reach and impact across the industrial spectrum. Although concern is widespread across industries that make consumer products sold in California, the pharmaceutical industry is largely missing from the dialog. On first blush, the regulations, like the federal Toxic Substance Control Act (TSCA), appear to exempt drug, devices and food—products regulated by the United States Food and Drug Administration (FDA). However, the regulations only exempt “dangerous drugs,” a term defined to include prescription (Rx) drugs, but not over-the-counter (OTC) drugs. Therefore, the entire gamut of OTC drug products and their packaging—from aspirin to sunscreen—is susceptible to regulation. Although the pharmaceutical industry has a strong argument that the Safer Consumer Product regulations, as they apply to OTC drugs, are preempted by FDA regulations, it should act quickly to raise these concerns by October 11, 2012, the close of the public comment period.
September 10, 2012
Advisories
-
“Medical Devices Law and Regulation Answer Book,” co-author Chapter 19, Practising Law Institute, 2011-2012.
2011-2012
Publications
-
"Strategic Enterprise Risk Management and Pharmaceuticals," Chapter 8 of Product Liability, January 2011.
January 2011
Publications
-
"FDA Debars Food Importer as Tougher Food Safety Legislation Looms," Product Risk Management Alert, December 29, 2009.
December 29, 2009
Publications
-
"UK and US Focus Efforts on Food Safety," Product Risk Management Alert, December 16, 2009.
December 16, 2009
Publications
-
"Recent Eighth Circuit Ruling Imposes Affirmative Duty On Generic Drug Manufacturers To Propose Label Changes Or Risk 'Failure To Warn' Lawsuits: Mensing v. Wyeth, Inc., et al.," Product Risk Management Alert, December 4, 2009.
December 4, 2009
Publications
-
"Unauthorized H1N1 Product Claims Targeted by Federal Agencies," Product Risk Management Alert, November 11, 2009.
November 11, 2009
Publications
-
"Legal Risks Affecting Blood Banks," GxP Lifeline, 2009.
2009
-
"Enterprise Risk Management and Pharmaceuticals," John Liner Review, Vol. 23, No. 2, Summer 2009.
Summer 2009
-
"Congress Moving Quickly On Food Safety Legislation," Product Risk Management Alert, June 5, 2009.
June 5, 2009
-
"For Life Science Companies: Good and Bad Responses to 483s," Master Control Online Newsletter, May 2009.
May 2009
-
"House Introduces Legislation on Generic Biologics Approval Process," Life Sciences/Public Policy Alert, March 12, 2009.
March 12, 2009
-
"In Wake of Wyeth Pharma Decision, Congressional Democrats Introduce Bills to Nullify Supreme Court's Riegel Medical Device Preemption Ruling," Life Sciences & Torts Alert, March 6, 2009.
March 6, 2009
-
"Senate Responds to Peanut Recalls with Bipartisan Food Safety Reforms," Product Risk Management Alert, March 4, 2009.
March 4, 2009
-
"The Obama Administration Stakes Out Positions on Generic Biologics, Hatch-Waxman Settlements and Evergreening in Its First Budget," Life Sciences & Torts Alert, March 4, 2009.
March 4, 2009
-
"Wyeth v. Levine: U.S. Supreme Court Rules FDA Approval of Label Does Not Provide Pharmaceutical Manufacturer with Complete Preemption Defense to State Failure-to-Warn Claims," Life Sciences Alert, March 4, 2009.
March 4, 2009
-
"California Appeals Court Ruling May Lead to Direct Liability for Pioneer Drug Manufacturers in Suits Involving Generic Products," The Federal Lawyer, February 2009.
February 2009
-
"Recent California Appeals Court Ruling May Lead To Direct Liability For Pioneer Manufacturers In Suits Involving Generic Drugs: Conte v. Wyeth, Inc., et al.," Life Sciences & Torts Alert, November 11, 2008.
November 11, 2008
-
"Supreme Court Asked To Consider Congressional Staff Report on Eve of Oral Argument in Wyeth v. Levine," Life Sciences & Torts Alert, November 5, 2008.
November 5, 2008
-
"Watching for Wyeth: High Court Decision Could Have Strong Implications for Medical Device Manufacturers," MX: Business Strategies for Medical Technology Executives, November 2008.
November 2008