A hunter walks into a bar and says, “Did you hear the one about the FDA?” “You mean the time it shot itself in the foot?” the bartender responds. “The left foot or the right foot?” another hunter asks, wiping the beer froth from his mouth. “What difference does that make?” the first hunter asks. “I want to know if it’s the one I’ve heard before. Or if this is a new one.” The first rule of thumb for hunters is to know what they’re doing. Otherwise, they might shoot themselves in the foot – or worse. The second is...
WASHINGTON – While the Federal Circuit is still digesting the Supreme Court's ruling on patents involving laws of nature and natural correlations, the Patent and Trademark Office (PTO) has translated its Mayo Collaborative Services v. Prometheus Laboratories Inc. decision into temporary guidance for patent examiners.
If the FDA greenlights Vivus Inc.'s Qnexa next week, it won't just be giving the market go-ahead to a second obesity drug. It will be opening up a new lane for weight-loss drugs containing an anticonvulsant.
In the latest salvo against the growing problem of prescription drug abuse and misuse, the FDA approved a classwide risk evaluation and mitigation strategy (REMS) for extended-release and long-acting opioid drugs.
WASHINGTON – Although the SEC told Congress it was doing what it could to amp up the rulemaking process to implement the Jumpstart Our Business Startups (JOBS) Act, it didn't hit its first deadline.
The FTC seems to have come down with a bad case of star envy. Not content with its supporting role as implementer of laws duly passed by Congress, the agency is intent on rewriting the script, casting itself as headliner hero, executive producer, star-making director and congratulatory movie critic. (Bring up music intro.) In its colorized remake of the budget-busting melodrama How Government Functions, the FTC plays the white-hatted good guy come to cut down the gang of biopharma villains while the local sheriff (Congress) sits idly by, his pockets stuffed with Big Pharma bribes. The action climaxes as the...
In determining that the Affordable Care Act (ACA) was constitutional, the Supreme Court last week blew away a cloud of uncertainty that has been hanging over the biopharma industry for the past two years. But other clouds are gathering.
Stop waiting and start implementing. That's the message the Supreme Court sent to drugmakers Thursday when it ruled the Affordable Care Act (ACA) meets constitutional muster.
WASHINGTON – A week ahead of its self-imposed July 4 deadline, the Senate overwhelmingly passed the FDA Safety and Innovation Act (FDASIA) Tuesday, reauthorizing PDUFA for another five years. Now all the user-fee package needs is the president's signature so it can go into effect Oct. 1.