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The FDA's approval of a prescription drug or biologic is the product of an often-delicate risk-benefit analysis of public benefit as opposed to individual safety. The therapeutic balance of these products must always be weighed against the risks inherent in their use. And there are always inherent risks associated with their use. Accordingly, while millions of Americans reap the benefits of prescription drugs every day, these same drugs may pose an unavoidable health hazard to a narrow, and often unidentifiable, subset of potential users. The American legal system currently regulates these risks by two means ' through the federal regulatory system as administered by the FDA, and through the common-law tort liability regime.

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Major pharmaceutical manufacturer AstraZeneca Pharmaceuticals LP pleaded guilty to a large-scale health care crime and agreed to pay $355 million to resolve the associated criminal charges and civil liabilities, according to an announcement released by the FDA Office of Criminal Investigations (FDA OCI) on June 20.

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The pharmaceutical industry has been heavily regulated for many years, starting with the original enactment of the Food and Drug Act in 1906. Over the years, a bewildering array of regulations has been established that affect the sale and consumption of drugs at both the federal and state levels. While many of these past regulations have been subsumed into the FDA's rules and regulations, one of the most difficult and currently pressing questions a pharmaceutical manufacturer must ask itself is whether to comply with California's Proposition 65. The manufacturer's decision to comply may have significant adverse affects on marketing and use of the drug; or conversely, imposition of stiff, costly penalties. This article provides a basic roadmap of the current landscape for compliance with Proposition 65 in the pharmaceutical context.

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The latest information for use in your practice, including rulings, draft guidances, seminars, and more.

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<b><i>Conducting Ex Parte Interviews with Plaintiff's Health Care Providers</i></b> The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a complex commercial statutory scheme aimed at regulating the health care industry's use and storage of electronic health information. In drafting this legislation, Congress expressed concern that health care entities must assure their "customers," including patients, "that the integrity, confidentiality, and availability of electronic protected health information they collect, maintain, use, or transmit is protected." 68 Fed. Reg. 8334 (Feb. 20, 2003). HIPAA (Pub. L. No. 104-191) is codified in myriad sections of 18, 26, 29, and 42 of the United States Code. Using the Public Law Number cite and referring to the most recent edition of the United States Code Annotated Tables periodical will permit the reader to pinpoint these scattered United States Code sections.

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Aside from promulgating regulations, imposing rigorous standards on myriad product manufacturers, and conducting research and studies on all such products, the FDA also takes an active role in participating in an array of product liability litigations both on the state and federal levels. Often, the FDA's position and "expertise" on an issue carry great weight with the courts and consequently can affect the outcome of litigation. Thus, defense counsel involved in product liability matters in which the FDA historically has had an interest should keep abreast of the FDA's positions on the relevant issues.