New Drugs

How often do you see the insurance industry petition the government to set up another federal agency? Well, in this case, this most unlikely of events has actually occurred. America's Health Insurance Plans (AHIP), the association representing health insurers, has asked Congress to create an agency dedicated to comparing the effectiveness of existing medical treatments, drugs and devices with new ones. (It would be intriguing to see whether some doctors' instincts are correct that snazzy …

> UnitedHealth has created a new claims submission website allowing physicians to file claims in real time. The health plan says the system can confirm patient costs within 10 seconds. Article

> A group of California lawmakers and consumer advocates are pushing for state regulation of medical insurance rates, similar to rules that already govern auto insurance. …

Doctors taking more than $50,000 from a drug or medical device company would be banned from voting on approval for that company's products if a new FDA rule becomes final. Physicians with such strong financial ties to a company whose products are under consideration--or ties to a competitor--would not be allowed to serve on the committees that make approval decisions. This represents a significant change from existing rules which, while they bar advisers holding $100,000 or more of stock …

Any practicing physician is familiar--perhaps too much so!--with the attractive, likeable marketers pharmaceutical companies send to their offices to pitch new products. Critics argue that far too much of the prescribing process is influenced by these so-called detailers, whose visits may push doctors to opt for expensive new drugs over older, cheaper meds which work just as well. Frustrated by the situation, these critics have begun to send out their own marketers, known by some as …

A case working its way through the legal system may end up forcing the FDA to give super-sick patients the right to buy and use unapproved experimental drugs. The case was spearheaded by a group called the Abigail Alliance, which works to break down barriers to accessing experimental drugs. Last year, a court ruled that dying patients have a constitutional right to purchase such drugs, at least if their doctors say there are no other options, but the FDA appealed. The ruling, if it …

Some Massachusetts lawmakers are complaining that members of the state's Health Insurance Connector agency--which oversees the state's health insurance law--should not be collecting relatively high salaries averaging $111,000 per year. Article

> The FDA is too slow to approve new drugs and …

Some time ago the FDA kicked off a program to speed the movement of new drugs through the FDA approval process. The project, called the Critical Path Initiative, proposes to streamline the process in several ways. For example, drug makers would now get permission to test a drug in ongoing trials for benefits they hadn't originally envisioned. The Critical Path process would also allow pharmaceutical companies to use predictive markers rather than testing results to evaluate new drugs. To …

A pair of cancer specialists in Arizona are developing what some say is the next, best model for delivering new cancer drugs to patients. While university researchers are aware of--and have access to--new drugs, they can wait months or more for their institutions to grant permission for human drug studies. But things are different for Scottsdale physicians Michael Gordon and David Mendelson. They specialize in running early-phase FDA research trials in their private practice, focusing …

Yesterday, we reported that Stanford University Medical Center has instated a policy prohibiting its physicians from receiving pharma and medical device industry gifts. Officials say it will prevent the industry from having any undue influence over doctors. But one FierceHealthcare reader objects to this line of thinking. "In a perfect world the policy made sense, but in the real …

An inquiry by Congressional researchers finds that the FDA approach to drug safety has changed little despite criticism from consumer advocates and prominent critics in medicine. The GAO looked at the agency's handling of safety issues and found little evidence that the agency has improved its oversight of drugs once they hit the market. The report concludes that the FDA should be given more power to compel drug companies to complete post-marketing studies. The authors also argue that …