Off the labeled path
Late last week, the FDA proposed new guidelines on off-label marketing, a follow up to a more nebulous ‘guidance’ it issued in December. The rule change-up would allow drug companies to begin distributing medical journal articles on drugs for off-label uses, providing they are peer-reviewed publications with a legit editorial board.
Under current (but lapsed) FDA rules, manufacturers are not permitted to promote drugs for off-label indications, those for which the drug has not been approved. Critics of the move say it will give drug reps the green light to do more marketing with less therapeutic evidence.
Now the FDA is soliciting public comment on the proposed guidelines, and plans to make a formal ruling in 60 days.
PostScript previously considered last year’s guidance here.
Up, up, and away
In other cheery drug news, pharmaceutical makers have raised the wholesale price of the 50 top-selling brand name drugs at roughly twice the rate of inflation in 2007.
The Wall Street Journal reported it, but the Wall Street Journal Healthblog did too (and it’s free.)
This story has it all. As part of a comprehensive feature on the medical school’s new policies, RxP associate director David Rothman talks to PittMed, the magazine of University of Pittsburgh School of Medicine, calling Pitt’s new policies on medical conflict of interest “outstanding.”
The reporting in this piece is as layered as the towering sandwich on the first page, canvassing students, researchers like Rothman, medical school faculty, and surveying work being done at the state and federal level to limit the influence of pharmaceutical marketing on prescribing and medical education.
Be sure to read the interview with UPSM Dean Arthur Levine at the end of the feature story with the intriguing subhead, “The Dean Contemplates Tchotchkes…”
Washington state senate passes prescription privacy bill
This week, Washington State Senate passed a bill that would ban the sale of prescription data for marketing purposes. SB 6241, which would limit the practice commonly called data-mining, passed 26-22, and now faces the House vote, which must happen before March 8.
“This vote today tells me that our legislators agree that the doctor-patient relationship should be private and that includes prescriptions,” said Rupin Thakkar, an Edmonds-based pediatrician and co-chair of the Washington Coalition for Prescribing Integrity.
Check out this news release from the Healthy Washington Coalition, a member group of the WCPI, which includes the Washington State Medical Association and the King County Medical Society.
Here’s a trio of opinion pieces in the Tennessean by the editorial board, a University ofTennessee business ethicist, and Steven Gabbe MD, dean of medicine at Vanderbilt on the conflict of interest guidelines the medical school introduced earlier this year.
“If we are going to teach medical students…about their obligations as a professional,” writes Gabbe, “we must make sure their teachers are modeling the behavior we are teaching.”
Some students at Des Moines University balked at a recent visit by PhRMA prez Bill Tauzin, who took the podium on campus this week the Partnership to Fight Chronic Disease.
The students smelled a fox-henhouse arrangement, since pharmaceutical companies are often major sources of financial backing for patient advocacy and disease groups.
Here’s a slightly-belated think piece by writer Dan Greenberg, author of “Science for Sale: The Perils, Rewards, and Delusions of Campus Capitalism.”
Greenberg, who has spent a good deal of pages on the issue of corporate funding in academic research, looks at the recent JAMA survey of academic medical centers we posted on here, and he pulls few to zero punches.