Tag Archives: drug safety

Safety Trumps Access to Pain Meds for FDA

By Jill Wechsler, Washington Correspondent. The Food and Drug Administration has come down on the side of reducing abuse of opoid medications, over encouraging wider availability of low-cost painkiller meds. The agency decided to block generic versions of the original OxyContin formulation, which is fairly easy to manipulate by illegal users. The aim is to help [...]
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"Sunshine" Just the Tip of the Iceberg: Pharma and Full Disclosure

“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 [...]
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Fixing Innovation: Lilly's CEO Says Why, and How

Following his keynote address last week at the Financial Times US Healthcare and Life Sciences Conference in New York, Eli Lilly CEO John Lechleiter huddled into a corridor to speak with PharmExec about his agenda as incoming chairman of PhRMA, and how to fix innovation.
Posted in Europe, Events, FDA, Global, IP, Legal, Market Access, Meetings, People, R&D, Regulatory, Safety, Strategy, Technology, healthcare, leadership, pricing | Also tagged , , , , , , , , , , , , | 1 Comment

Combating Opioid Abuse With Science

So far, the creative approaches industry has taken to develop tamper-resistant and abuse-deterrent opioid drugs have been largely matched by the ingenuity of those users who manage to tamper with and abuse those same formulations.
Posted in FDA, R&D, Regulatory, Safety, Strategy, Technology | Also tagged , , | 3 Comments

Memo to President Obama on Reforming FDA

In recent weeks, the incoming Obama administration has solicited input from across the policy community as it begins to shape priorities for its forthcoming term. As a former FDA official, I was honored to be asked for my advice on the pharma industry. Demand for drugs is on the rise, yet FDA remains undermanned, underfunded, and [...]
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