New York Times
By GARDINER HARRIS
September 7, 2007- WASHINGTON, Sept. 6 —
Makers of drugs and medical devices would be required to report publicly nearly all payments and gifts to doctors under legislation introduced Thursday in the Senate.
“Right now, the public has no way to know whether a doctor’s been given money that might affect prescribing habits,” said Senator Charles E. Grassley of Iowa, the ranking Republican on the Senate Finance Committee and one of the bill’s authors.
Senator Herb Kohl, Democrat of Wisconsin, said drug and medical device makers had long defended their payments and gifts to doctors as appropriate.
“If that is the case, full disclosure will only serve to prove them right,” Mr. Kohl said.
Ken Johnson, senior vice presi dent at the Pharmaceutical Research and Manufacturers of America, said, “A new law is not necessary when pharmaceutical marketing is already heavily regulated by the Food and Drug Administration.”
The F.D.A. does not regulate the gifts or consulting arrangements drug and device makers routinely provide doctors, and it reviews only a fraction of the scripted marketing talks doctors make on companies’ behalf.
The bill results from growing concerns that free meals and consulting payments — which in some cases have exceeded $100,000 annually — lead doctors to prescribe more expensive drugs and devices, increasing the costs of health care and sometimes endangering patients.
Minnesota and Vermont require disclosures, and the legislatures of Maine and West Virginia have passed measures that may soon require them. Other states are considering similar measures.
The bill introduced Thursday is more comprehensive than any state measure. It includes medical device c ompanies, not just drug makers, and has a more inclusive list of gifts and benefits that must be disclosed.
For instance, any payments or benefits made “directly, indirectly, through an agent, subsidiary or other third party” would have to be disclosed. That could include payments by universities and an array of small companies that, with industry financing, set up conferences for influential doctors at expensive hotels. Such payments have never been disclosed on a widespread basis.
The bill would also require the disclosure of financing for continuing medical education. Drug and device makers now underwrite much of the continuing education that is required of nearly all doctors.
Companies with at least $100 million in annual revenues would have to make quarterly disclosures of gifts or payments that exceed $25, and the reports would be posted on a Web site. Companies failing to make the disclosures — and many have not complied with the laws in Minnesota and Ve rmont — would be fined at least $10,000 per infraction.
Under the bill, the provision of free drug samples and financing for clinical trials would not have to be disclosed.
Rob Restuccia, executive director of the Prescription Project, a nonprofit group that works to eliminate conflicts of interest in medicine, said some academic medical centers already restricted gifts to faculty members. Greater disclosures would lead to more such restrictions, Mr. Restuccia said.
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