FDA's New Quality System Guidance: Minimizing a Pharmaceutical Company's Risk
February 27, 2007
On Sept. 29, 2006, the Food and Drug Administration ('FDA') issued a final guidance on quality systems for pharmaceutical companies: formalized business practices that define management responsibilities for organizational structure, processes, procedures, and resources needed to fulfill product and service requirements, improve customer satisfaction, and ensure continual improvement. The 'Quality Systems Approaches to Pharmaceutical Current Good Manu-facturing Practice Regulations' (the 'Guidance Document') is intended to help companies comply with the FDA's current Good Manufacturing Practices ('cGMP') regulations. The Guidance Document is part of the FDA's Pharmaceutical cGMPs for the 21st Century Initiative, a program that seeks to integrate quality systems and risk management approaches into existing manufacturing programs with the goal of encouraging industry to adopt modern and innovative manufacturing technologies.
The Changing Face of FDA Consent Decrees
February 27, 2007
Historically, when a health care company had a compliance failure, counsel could help it remain in business by negotiating with the relevant agency. If the problem involved sales, marketing or pricing, the company could seek a Corporate Integrity Agreement (CIA) with the Office of Inspector General (OIG) at Health and Human Services (HHS). If the problems related to manufacturing, counsel could obtain a consent decree of permanent injunction ('consent decree') with the Food and Drug Administration (FDA) under the Food Drug and Cosmetic Act (FDCA). Consent decrees and CIAs each had their particular burdens and benefits, which health care practitioners had learned to navigate. Now this tidy distinction has become blurred as the FDA has borrowed features from HHS's CIAs.
Predicting Bondholder Activism
February 26, 2007
The image of bondholder activism in many quarters is one of rapacious bondholders aggressively pursuing a ruthless quest for returns. The reality is far more complex, but the outcome of particular cases may be surprisingly predictable for the astute analyst.
A Rational Basis for Setting Hourly Rates
February 01, 2007
For the past 20 years, law firms have annually increased their hourly rates on the basis of various ad hoc criteria ' what the market will bear, matching the competition, cost-plus, maintaining profit margins ' that neither firm members nor clients find satisfactory. Alternative pricing methods (fixed fees, percentage of the deal, etc.) have long been advocated as a solution to hourly billing discontents, but in practice, for a large majority of firms they remain limited in application. Firms whose clients expect fees to be charged on an hourly rate basis therefore require a rational means of constructing an hourly rate schedule that is transparent and acceptable to clients as well as defensible within the firm.
Challenges to Law Firm Mandatory-Retirement Policies
February 01, 2007
A 2006 survey report indicated that 57% of law firms with 100 or more attorneys have mandatory retirement age policies. See L. Jones 'Pitfalls of Mandatory Law Firm Retirement,' <i>National Law Journal</i>, May 24, 2006. But legal challenges to mandatory retirement policies at law firms are likely to become more common as baby boomers reach retirement age.
Trends in Financial Services Patents
January 31, 2007
Armed with a well-stocked patent portfolio, a company can effectively corner valuable markets for a limited amount of time. While this concept is second nature for most makers of tangible products, pharmaceuticals, or even software, it is only now becoming widely accepted in the financial services sector. As a result, another battlefield is emerging in which patents are becoming the weapon of choice, and trading floors and back-office processing centers have become the new settings for patent disputes.
Supreme Court Revisits Test for Deciding Obviousness
January 31, 2007
The U.S. Supreme Court has recently shown an interest in intellectual property in general and patents in particular. Most prominent among the recent cases is <i>KSR International Co. v. Teleflex Inc.</i>, which presents perhaps the most difficult question in substantive patent law: When is the subject of a patent application a true 'invention' ' that is, something that promotes the progress of a useful art sufficient to warrant giving the applicant exclusive rights to the technology claimed for the next 20 years. Conversely, when is the invention 'obvious' ' merely taking a step that anyone of ordinary skill would take, confronted with the same problem and possessing all the knowledge already known to the field?
News Briefs
January 31, 2007
Highlights of the latest franchising news from around the country.
