As pharmacies began dispensing Zogenix's powerful new painkiller Zohydro this week, FDA Commissioner Margaret Hamburg found herself under increasing pressure to revoke her agency's approval of the drug and yank it off the market. But she's not about to cave in to the pressure, she told the U.S. Senate's Health, Education, Labor and Pensions Committee during a hearing on Thursday, according to Reuters.
As the commercial release of Zogenix's hydrocodone bitartrate pain drug Zohydro spawns headlines from coast-to-coast warning of a potential epidemic of abuse similar to what was seen with OxyContin, the rival Purdue Pharma says it has successfully wrapped a Phase III trial of its abuse-resistant competitor. And the data sets the stage for an FDA filing later this year as Zogenix labors at its own early-stage efforts at making a pain pill that's harder to abuse.
Purdue Pharma will invest nearly $60 million in a new plant in the Raleigh/Durham, NC, area with a little help from its friends there.
Which doctors to flag for reckless OxyContin prescribing may soon be a decision that's out of maker Purdue Pharma's hands, at least in California. Thursday, a spokesman from Purdue Pharma confirmed that the company had turned over a list of 49 California doctors it suspected of risky script-writing to the Medical Board of California.
California is pushing some new legislation that drugmakers and physicians were none too happy with in its original form. But after some amendments, a slate of reforms to increase authorities' powers to crack down on risky narcotics prescribers has made its way to the desk of Gov. Jerry Brown. The three bills now await his signature to make them law.
Wednesday, the pharmacy chain said it had stopped filling prescriptions for doctors who prescribe the addictive drugs at remarkably high rates. And it's hinting that other pharmacies should do the same.
Now that Purdue Pharma has acknowledged news reports that it compiled a list of 1,800 doctors suspected of churning out OxyContin prescriptions for addicts and drug dealers, the political fallout has begun.
Purdue Pharma has a database of doctors who prescribe a lot of its painkiller OxyContin. On the face of it, that's not much of a statement, but in this case, the list of more than 1,800 comprises doctors suspected of recklessly writing scripts for addicts and drug dealers, the Los Angeles Times reports.
The FDA has fueled a pharmaceutical arms race in the painkiller market with the agency's decision last month to bar the sale and production of generic OxyContin, which has become one of the most widely abused opioids among Americans.
The life sciences industry is warming up to cloud computing, or so Medidata Solutions' first quarter financial results would seem to indicate.