Category Archives: Regulatory

"Sunshine" Just the Tip of the Iceberg: Pharma and Full Disclosure

By Jill Wechsler | Published: April 10, 2013
“Sunshine” Just the Tip of the Iceberg: Full Disclosure for Pharma:??There seems no end to demands for data on clinical research, conflicts of interest, company payments, and drug prices, writes Jill Wechsler. Although recent legislation and regulations have greatly expanded the range of information that pharmaceutical companies have to unveil to the public, there’s an escalating [...]
Also posted in Guest Blog, Op-Ed, Safety, Strategy, healthcare, pricing | Tagged , , , , | 1 Comment

The FTC's Beef with Pay For Delay: What's the Fuss?

By Clark Herman | Published: March 26, 2013
Yesterday, the Supreme Court heard arguments on the matter of pay-for-delay settlements between patent holders and generic firms. The Federal Trade Commission (FTC) hopes to overturn the 11th federal circuit’s ruling that such settlements are not anti-competitive on the grounds that these settlements amount to a restraint of trade under the commerce clause of the [...]
Also posted in IP, Legal, Market Access | Tagged , , , , | 1 Comment

FTC v. Actavis: The Wrong End of the Telescope

By Guest Blogger | Published: March 25, 2013
by Traci Medford-Rosow and Peter C. Richardson On December 8, 2012, the Supreme Court agreed to hear the Federal Trade Commission (FTC) v. Actavis, Inc. case. The court’s grant of certiorari marked the latest chapter in a decade-long effort by the FTC to have the court rule on the festering issue of whether pay-for-delay provisions in [...]
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Refilling the Antibiotic Pipeline: How to Lead the Horse to Water?

By Clark Herman | Published: March 15, 2013
Last week, the United States Center for Disease Control (CDC) and Britain’s Chief Medical Officer issued separate warnings about the urgent problem of antibiotic resistance in infectious diseases. Given industry’s general lack of interest in developing new antibiotics to address this problem, the warnings indicate that a discussion is needed around which incentives and regulatory [...]
Also posted in FDA, Global, Market Access, R&D, Safety, Strategy, pricing | Tagged , , , , | 1 Comment

Congress, FDA Should Consider Tech Solutions for Safer Compounding

By Guest Blogger | Published: March 14, 2013
By Niels Erik Hansen Last fall’s deadly meningitis outbreak linked to contaminated steroid injections is a tragic reminder of the risk of errors inherent in manual pharmacy medication compounding. Unsanitary conditions at the Massachusetts compounding pharmacy that made the injections resulted in fungal contamination of the drugs. The resulting outbreak sickened nearly 700 people in [...]
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