While 2012 has dawned everywhere else in the world, it’s still 1984 at the FDA. With its Bad Ad program, whistle-blower suits and spotters of conference crimespeak serving as its globalwise eyes and ears, the agency has adopted Big Brother (BB) tactics to promote goodspeak among drugmakers while crimestopping off-label promotion, bringing new life to George Orwell’s newspeak. In the newthink of the FDA, quality of life (QOL) is one of those doubleplusungood phrases that a biotech dare not utter – unless it has conducted a doubleplushuge, FDA-approved, randomized, controlled, double-blind pivotal study, including doubleplusvulnerable populations and diverse subpopulations, to...
Columbia Laboratories Inc. fought a losing battle Friday in a statistical throwdown with the FDA at an advisory committee meeting convened to consider whether data from the PREGNANT trial are enough to support a preterm birth indication for Columbia's Prochieve (progesterone gel 8 percent).
WASHINGTON – Even with all the Capitol Hill finger pointing over the continuing U.S. drug shortage crisis, one culprit has been largely overlooked – increased demand for commonly used cancer drugs such as cisplatin, doxorubicin and paclitaxel.
Columbia Laboratories Inc.'s attempt to find a niche for its Prochieve progesterone gel to reduce the risk of preterm birth may have raised more questions than answers, at least as far as the FDA is concerned.
WASHINGTON – In yet another signal that it's seriously considering drugmakers' use of social media, the FDA plans to survey health care professionals on the impact direct-to-consumer (DTC) drug promotion, whether online or in traditional media, has on their practice.
When it comes to getting social, biopharma has to get over itself, because being social is not about building a brand, promoting a drug or lecturing to the masses.
WASHINGTON – While biopharma is so hungry for social media guidance that it's taking any scraps it can get, the FDA's Office of Prescription Drug Promotion (OPDP) is serving up a research menu laden with print and broadcast issues.
Forma Therapeutics Inc. pulled another $700 million trick from its sleeve, just a few days after signing an $815 million deal with Boehringer Ingelheim GmbH.
WASHINGTON – Regulatory uncertainty at the FDA is often cited as a source of industry heartburn. But rather than turning down the heat, the agency is looking for ways to make that uncertainty less irritating, recognizing it as a natural part of the scientific process.
