Archive for the ‘ FDA ’ Category
According to an editorial in The New York Times, “A prime driver of our escalating health care costs is the advance of medical technology …” Indeed. The driver of the Gray Lady’s oration is the decision by Medicare to pay for both Provenge (advanced prostate cancer) and Avastin (for breast cancer – even if the [...]
Never express yourself more clearly than you are able to think. –Niels Bohr Think regulatory headaches about Facebook is a hot topic? Here are some communications issues that make social media guidance pale in comparison. Yesterday Eli Lilly, Johnson & Johnson, Novartis, Novo Nordisk, Pfizer and sanofi-aventis will file a Citizen Petition with the U.S. [...]
I’ve just returned from the big BIO bash, where I was honored to moderate the panel discussion, “Lessons From In-Licensing Partnership: Biotech Company Partners with Global Pharma to Deliver Cutting-Edge Follow-On Biologics.” I was joined on the podium by joined by Arun Chandavarkar, chief operating officer of Biocon Ltd.; Stephen Hoge, principal at McKinsey & [...]
Back in February, Peggy Hamburg, M.D., Commissioner of The Food & Drug Administration, made some interesting comments at the Council on Foreign Relations: * The new reality of food and drug regulation is that it’s global. In fact, it should be a topic for conversation at the next meeting of the G20. * The recent [...]
Ah, the brief summary. Inside the FDA many joke that it is like the Holy Roman Empire – neither brief nor a summary. And if you want to throw in “fair balance and adequate provision,” well, go right ahead. Same issue – too much information equals not enough comprehension. It’s not a new [...]
What’s the difference between “advertising” and “information?” Consider the interesting (but somewhat byzantine) decision from the Court of Justice of the European Union (CJEU) on the “advertising” of medicines. The ruling in MSD Sharp & Dohme GmbH v. Merckle GmbH, handed down on May 5, seeks to define the boundaries of acceptable information provision so [...]
The use of social media by regulated industry is faltering because of fear, timidity, and misunderstanding. I’d like to make five main points that are often overlooked or misconstrued when we discuss social media in the context of regulated speech: 1. There is a difference between online advertising and social media When the FDA sent [...]
As the weather turns warmer and you’re looking for some beach reading, may I recommend FDA’s, “Strategic Priorities 2011-2015: Responding to the Public Health Challenges of the 21st Century.” And therein the first issue. If the FDA views it’s job as only responding to challenges, which needs to change. The FDA needs to be a [...]
To paraphrase the late Dr. Martin Luther King, Jr., “There comes a time when people get tired … and we have no alternative but to protest.” There has been a lot of moaning and groaning about the FDA’s continued delay in releasing social media guidance. As if it matters. Various DDMAC big wigs have consistently [...]