“And those of us who manage the public’s dollars will be held to account — to spend wisely, reform bad habits, and do our business in the light of day —”
That call to transparency President Barack Obama issued in his inaugural address Tuesday seems to be answered, at least in part, by the reintroduction of the Physician Payments Sunshine Act today. The bill, co-sponsored by Sens. Charles Grassley (R-IA) and Herb Kohl (D-WI) would require prescription drug, medical device, biotech companies and their subsidiaries to disclose all payments that add up to more than $100 into a national and publicly accessible online database. It would capture not only small gifts, meals and conference payments, but the big-ticket consulting, advisory payments and honoraria that have landed some physicians in the hot seat and the headlines lately.
This two-part series in the Milwaukee Journal-Sentinel last week is a great case study in why a Sunshine law is important – it highlights some of the problems with the current patchwork system of self-reporting at some medical centers, which Robert Steinbrook eloquently lays out in this week’s New England Journal of Medicine.
“At present,” Steinbrook writes, “physicians and researchers often report industry payments confidentially to their medical school or medical center. Such reporting, however, may be voluntary and may not be subject to verification. There are wide variations in the level of detail, reporting procedures, and stringency of institutional policies and oversight. The information may be actively reviewed or merely collected.” He looks at the move of a few medical centers to make that information public online, and the prospect of the federal bill.
In FDA news, In Vivo blog wonders whether it’s Dr. Joshua Sharfstein for commissioner as the new administration looks closer to tapping someone to lead the FDA.
And Dr. Steve Nissen, one of those on the short list, is one of six scientists who penned public letters to the new President in Nature journal.
“Secrecy is antithetical to both science and good government, but much of what the FDA knows about drugs, it never publicly discloses,” Nissen writes, and says that secrecy is one of the reasons many consider the FDA “a failed agency”. “The Obama administration has the opportunity to reinvigorate the FDA, but only through major restructuring and policy changes that are designed to protect the agency from undue influence, and to promote transparency,” Nissen wrote.
The Bureau of National Affairs Health Care Daily Report (subscription required) has the roundest of all round-ups on what Congress plans to do on pharmaceuticals this session (including outtakes from our conference keynote speaker Rep. Henry Waxman.) Drug safety, marketing, off-label usage, biogenerics and reimportation: it’s all here.
The growing proportion of pharmaceutical ingredients made at uninspected overseas plants, particularly China, concerns those that think about U.S. drug supply and stockpiling efforts, according to the New York Times.
Acknowledging the ‘acting’ part of his title makes the job even tougher, Torti addresses consumers, Congress, academics, and industry, to which he offers this pledge: “We promise you that our deliberations will be completed with respect, diligence and speed, but always remembering the old, but wise admonition of Hippocrates, to first do no harm.”