WASHINGTON – After coming under fire for delaying rulemaking on prescription drug reimbursement, the Centers for Medicare & Medicaid Services (CMS) has proposed a rule to implement provisions of the 2010 Affordable Care Act (ACA) relating to manufacturer rebates and alignment of pharmacy reimbursement rates for covered outpatient prescription drugs.

WASHINGTON – All those drug ads on TV may eventually be required to include side-effect and contraindication information in superimposed text as well as audio.

In an economy gasping for air, patents are increasingly becoming the oxygen of biopharma, fueling a litigation process that fans their value even more.

WASHINGTON – If a mention in two guidances is enough to establish a trend, social media is definitely trending at the FDA.

Legislation to broaden the accelerated approval path is being gussied up for its Senate debut within the next few months.

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.