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Pharmaceutical Executive August 1, 2011 Jill Wechsler |
The Supremes Shape Pharma A number of important decisions from the Supreme Court will affect drug marketing, research, and regulation  |
BusinessWeek June 10, 2009 Arlene Weintraub |
The Fight Over Drug Data Mining Prescription-data collector IMS's legal drama unfolds in a battle over privacy and free speech, and could be headed to the Supreme Court  |
Chemistry World May 14, 2015 Rebecca Trager |
FDA accused of violating drug company's freedom of speech The US Food and Drug Administration is under pressure to reconsider its policy prohibiting pharmaceutical companies from promoting 'off-label' uses of their products.  |
Pharmaceutical Executive May 1, 2011 John F. Brenner |
Expanded Liability for Generic, Brand Manufacturers Ahead? To what extent are generics companies obligated by law to request labeling changes with FDA?  |
Reason July 2005 |
Who Should Reign Supreme? Libertarian legal experts weigh in on who their favorites are--past, present, and future--on the nation's highest court.  |
The Motley Fool December 22, 2006 Stephen Albainy-Jenei |
Is Off-Label Off-Base? Off-label prescriptions for uses lacking scientific support account for billions in drug revenue for Eli Lilly. If the FDA takes an aggressive stance on off-label-use marketing, it could significantly shrink drug sales for companies whose revenues are derived largely from such off-label use.  |
Pharmaceutical Executive June 1, 2014 dos Santos & Leskin |
Social Media and the In-House Counsel Social media poses a regulatory and litigation maze that must be carefully navigated by pharmaceutical companies.  |
Pharmaceutical Executive April 1, 2011 |
Off-Label But On Point? Use of off-label drugs is a balancing act for physicians, and poses even more problems for pharma. The FDA is moving slowly to help.  |
Reason December 2008 Brian Doherty |
How the Second Amendment Was Restored The inside story of how a gang of libertarian lawyers made constitutional history, declaring by a 5-4 decision that yes, the Second Amendment does secure an individual right to keep and bear arms.  |
Home Theater June 29, 2007 |
Supreme Court Reconsiders Price Fixing The Supreme Court adopted a looser standard for price fixing yesterday, ruling that manufacturers may sometimes set minimum prices for products without violating antitrust statutes.  |
Salon.com October 31, 2002 Arianna Huffington |
Drugging our children the legal way America's legal drug pushers are free to offer kids their potent concoctions without having to prove they're safe or effective.  |
Salon.com November 7, 2000 Stephen Cohen |
Shameful emissions The Supreme Court weighs whether the EPA overstepped its authority -- and public health hangs in the balance...  |
The Motley Fool November 4, 2008 Brian Orelli |
Does the Supreme Court Control Your Investment? The Supreme Court is about to make a decision that could affect drug company investors.  |
InternetNews June 29, 2004 Roy Mark |
Supreme Court Upholds COPA Ban Justices suggest filtering software superior alternative to content-based restrictions on free speech.  |
Pharmaceutical Executive January 1, 2007 Jill Wechsler |
Washington Report: A Full Plate It's going to be a busy year in Washington for the pharmaceutical industry. Drug safety, unapproved uses, e-data requirements, and a shift to personalized medicine are just a few of the hot issues on tap for 2007.  |
Reason August 2002 Jacob Sullum |
Second Thoughts John Ashcroft's Second Amendment position, even if adopted by the U.S. Supreme Court, is not likely to have practical consequences anytime soon.  |
The Motley Fool March 5, 2009 Brian Orelli |
The Dilemma for Drugmakers There's no safe place to hide.  |
The Motley Fool November 22, 2006 Brian Lawler |
How to Market a Drug Too Well Cephalon's promotion of its pain drug Actiq might have crossed the line.  |
Managed Care August 2006 Martin Sipkoff |
Off-Label Use Often Presents Conundrum for Health Plans Insurers recognize the clinical importance of off-label prescribing, but criteria are needed to avoid over-utilization.  |
Chemistry World June 6, 2013 Phillip Broadwith |
Big data to sniff out drug marketing fraud The US Food and Drug Administration is offering a contract for a company to collect and analyze data on pharma companies' promotional activities. The aim is to use this big data approach to spot off-label marketing and other forms of marketing fraud.  |
The Motley Fool February 22, 2008 Brian Orelli |
Supreme Court Gives Health-Care Companies a Boost Medical device maker Medtronic celebrates a Supreme Court ruling in its favor; industry and investors will win in the long term.  |
American History December 14, 2004 David J. Garrow |
The Once and Future Supreme Court The last four decades have witnessed a fundamental transformation in the types of men, and now women, who exercise the broad and untrammeled judicial power of the U.S. Supreme Court.  |
BusinessWeek October 18, 2004 John Carey |
"Off-Label" -- And Out Of Bounds? When drugmakers promote products for unproven uses, they may be courting trouble. How restrictive should the regulations be?  |
Pharmaceutical Executive July 1, 2014 Jill Wechsler |
Pre-emption and States' Rights Pharma backs federal standards for compassionate use, drug importing, data transparency, and track-and-trace.  |
Pharmaceutical Executive January 1, 2006 Cinquegrana & Lloyd |
Legal: Shifting Perspective on Off-Label Promotion A recent court case points to the government's shifting perspective on how it prosecutes companies for promoting off-label. Instead of criminal charges, hefty corporate integrity agreements might be in store.  |
Salon.com December 11, 2000 |
Florida Supreme Court clarifies As the U.S. high court hears oral arguments, the Florida court says its ruling was based on state law...  |
Reason April 2004 Todd Seavey |
Regulation for Dummies A book about the FDA.  |
Salon.com December 13, 2000 |
Split over the decision Two law professors offer two views of the Supreme Court ruling. Rotunda: The Florida court was acting like a psychic hot line; Raskin: The Supreme Court has disgraced itself...  |
The Motley Fool December 4, 2007 Brian Orelli |
An Early Gift to Drugmakers Drugmakers could be allowed to market for drugs' off-label indications.  |
Pharmaceutical Executive April 1, 2009 Patrick Clinton |
Dear Commissioner... Unsolicited advice for FDA's next leader: Keep it real, fight popular delusions, and somehow, please, defend the agency.  |
Pharmaceutical Executive August 1, 2012 Jill Wechsler |
Fleshing Out FDASIA Medical apps, e-submissions, counterfeit drugs, and imports tucked into fairly "clean" user-fee renewal legislation. In late June leading legislators reached across party lines to quickly approve the Food and Drug Administration Safety and Innovation Act.  |
Pharmaceutical Executive March 1, 2006 Jill Wechsler |
Washington Report: Labels and Liability New FDA guidance aims at better communication of risks. But it creates some, too.  |
Food Processing August 2013 Eric Lindstrom |
FDA Paints Itself Into a Corner with FSMA A federal judge orders the agency to issue overdue food safety rules by November ... which looks unrealistic.  |
BusinessWeek December 11, 2006 Michael Arndt |
Kills Pain, Cures Rabies, And Grows Hair The prescription drug market is one part Big Brother and one part Wild West.  |
Reason April 2008 Ronald Bailey |
Medical Speech As a 1997 law expires, the FDA is mulling a plan allowing companies to disseminate unabridged reprints of "truthful and non-misleading" medical journal articles describing "off-label" uses of approved medications to physicians.  |
Reason Aug/Sep 2009 Radley Balko |
Just Compensation?: Testing the Takings Clause The Takings Clause in the Fifth Amendment forbids the state from seizing private property for public use without just compensation.  |
Bio-IT World August 13, 2003 Brian Reid |
Remaking the FDA New commissioner is pushing for greater use of technology and innovation to speed the flow of drugs to market.  |
Pharmaceutical Executive December 1, 2006 Richard A. Epstein |
FDA vs. the Individual In this excerpt from his important new book Overdose, an ever controversial legal scholar argues that the current system overvalues risk, ignores individual differences, and deprives patients of valuable treatments.  |
Pharmaceutical Executive December 1, 2013 |
FDA Pursues Delicate Balancing Act The Agency struggles to ensure access to needed medicines while minimizing potential risks, writes Jill Wechsler.  |
Pharmaceutical Executive November 1, 2011 Jill Wechsler |
The Drug Shortages Struggle Clamor for critical therapies prompts probes of prices, production practices.  |
The Motley Fool January 31, 2007 Brian Lawler |
FDA Says Hurray for More Drug Safety The FDA outlines its proposal to increase drug safety. Whatever the FDA does, pharmaceutical investors should hope that its renewed interest in drug safety doesn't make the already lengthy process of bringing drugs to market any longer.  |
Pharmaceutical Executive January 1, 2014 Jill Wechsler |
Pharma Challenges for 2014 Pricing and personalized medicine are key themes shaping drug development and marketing  |
Pharmaceutical Executive June 1, 2007 Clinton & Wechsler |
The View From Inside Commissioner Andrew von Eschenbach on drug safety, DTC advertising, FDA's culture, and how the agency plans to bring itself into the age of molecular medicine.  |
Pharmaceutical Executive January 1, 2012 Jill Wechsler |
New Year, New Issues Look for action in 2012 on drug access, shortages, innovation, and transparency. The 800-pound gorilla in the room is the looming Supreme Court decision on the constitutionality of the Obama health reform legislation.  |
Pharmaceutical Executive January 1, 2011 Jill Wechsler |
Politics & PDUFA Pharma companies will assess health reform, negotiate user fees and keep an eye on federal prosecutors in the year ahead.  |
Pharmaceutical Executive March 1, 2012 Jill Wechsler |
When Talk is Not So Cheap FDA and industry are pushing user fees, while they struggle with curbs on communications.  |
Salon.com June 16, 2000 Damien Cave |
Did Judge Jackson goof? By forcing Microsoft to comply with conduct remedies in 90 days, Jackson may have put the case exactly where he doesn't want it -- in the Court of Appeals.  |
Pharmaceutical Executive October 1, 2006 Jill Wechsler |
Washington Report: After Plan B: Out of the Quagmire, into the Data The morning-after pill goes OTC, with some special requirements. But is FDA's drug information system up to the task of tracking how it is used?  |
Pharmaceutical Executive March 1, 2013 Jill Wechsler |
Another Round of FDA Legislation? Pressure for action on key enforcement and regulatory issues may prompt congressional action this year.  |
Chemistry World May 27, 2015 Phillip Broadwith |
Label laundry It's been an interesting month in the world of off-label pharmaceuticals.  |