Tag Archives: drug safety
"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 [...]
Posted in Guest Blog, Op-Ed, Regulatory, Safety, Strategy, healthcare, pricing Also tagged Obamacare, regulatory affairs, Sunshine Act, transparency 1 Comment
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 CEO, CEOs, Eli Lilly, Financial Times, Global, healthcare reform, innovation, IP, IPAB, Lilly, PhRMA, policy, R&D 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 FDA, new molecular entities, opioids 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 [...]
Posted in Regulatory Also tagged FDA, information technology, Obama, Peter Pitts, president, regulation Leave a comment

Safety Trumps Access to Pain Meds for FDA