Given OPM's call letter emphasis on controlling drug costs, I took note of two Reuters articles discussing comments made by a senior Food and Drug Administration official Janice Woodcock. In the first article, Ms. Woodcock announced that the pharmaceutical manufacturer pipeline is beginning to pump out more new drugs that the FDA has approved. In the other article, Ms. Woodcock projected that the FDA will issue guidance on a pathway for FDA approval of biosimilar drugs by the end of this year. The European Union already has created such a pathway. According to Reuters, "The worldwide market for copies of biotech medicines will grow to $3.7 billion by 2015 from just $243 million in 2010, according to a recent report from market analysis firm Datamonitor." Interestingly, Reuters quoted Ms. Woodcock as follows:
She said the U.S. agency has yet to receive any actual biosimilar applications, but there is a great deal of industry interest.Considering how aggressiveness of the generic manufacturers on the small molecule side of the playing field (who have had an FDA regulatory pathway for 25 years), it appears that the biosimilar manufacturers are taking a wait and see attitude in this country.
"We are open for business right now," Woodcock said.
The AMA News is all worked up this week about the new CMS Physician Compare website which evidently is suffering a case of garbage in, garbage out.
Finally, an article on a study concluding that colonoscopies may be overutilized caught the FEHBlog's attention. The study's findings, along with other research published today in Archives of Internal Medicine, suggest that doctors need to better target the tests to patients who are most likely to benefit, and conserve limited screening resources and prevent complications by sticking to recommendations more closely, researchers said." Is it possible that over-utilization for this uncomfortable and expensive but lifesaving procedure occurs due to scare tactics by the news media? The FEHBlog does not know. It does goes to show how difficult it is to bend the cost curve down.