Healthy Skepticism Library item: 16841
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Electronic Source
Silverman E
NJ AG: Clampdown On Pharma Influence On Docs
Pharmalot 2009 Dec 4
http://www.pharmalot.com/2009/12/nj-ag-clampdown-on-pharma-influence-on-docs/
Notes:
Link to report:
http://www.nj.gov/oag/newsreleases09/pr20091203b-ReportOnPhysicianCompensationArrangements.pdf
Full text:
In a long-promised move, New Jersey Attorney General Anne Milgram released a report from the state’s Division of Consumer Affairs recommending new regs to curtail the potential for conflicts of interest between docs, and drug and device makers. The move comes two years after Milgram formed a task force (see here and interview with Milgram here).
“It is critical to minimize the potential for conflicts and it is critical that patients are made aware of any financial relationship between a physician and a pharmaceutical company or medical device manufacturer. Such relationships could bias medical decision-making,” she says in a statement. The report addresses a host of familiar issues – data mining, CME, payments to docs, food and other freebies.
On gifts, the AG wants the state’s Board of Medical Examiners to require docs to disclose whether they take more than $200 during the preceding two years, whether in cash, food, travel, consulting fees, research funding, or anything else. Samples wouldn’t count. The disclosure should include the company name; value, date and nature of the payment; product name, and whether payment is related to marketing, education or research pertaining to a specific product. A searchable, “user-friendly database” to make disclosure info pubicly available is also recommended.
When it comes to data mining, docs must know about the American Medical Association’s data mining opt-out program; the state’s Board of Pharmacy regulations be amended to require pharmacies to maintain documentation confirming that prescribers have consented to the sale of their prescribing information; and the state should enact legislation to restrict the transfer, use or sale of prescriber-identifiable prescription information for commercial purposes. Vermont has a law that is currently being appealed (see here).
Next up – forbidding payments, including tuition, fees, travel, lodging or other incidental expenses, to support attendance as a participant at an accredited CME program; fees, travel, or lodging reimbursement for non-faculty or non-consultant attendees at company-sponsored meetings; items intended for a doc’s personal benefit, such as flowers, artwork, CDs, DVDs or tickets to a sporting event; cash or gift certificates unless it’s for bona fide services such as consulting or participating in research; and company-funded entertainment or recreational items. Lilly and Merck have already agreed to disclose payments. Here is the proposed federal legislation about payments to docs.
What about food? Drug and device makers wouldn’t be allowed to provide docs and their staffs with free food in any venue and docs would be required to pay the fair market value of their meals whenattending unaccredited educational or promotional sessions organized by drugmakers.
Then there’s CME. The report recommends that BME regulations be amended to provide credit only for those CME courses that meet Accreditation Council for Continuing Medical Education or American Osteopathic Association standards that specifically bar the CME provider from obtaining advice from a subsidizing company as to faculty or content; impose an obligation on physicians who are engaged as CME speakers to directly disclose to physician-learners, at the beginning of the presentation, the receipt of reportable compensation from manufacturers; and direct that a phase-in begin to require 25 percent of CME to be obtained in evidence-based educational programs or through academic detailing.
Hat tip to the WSJ Health blog
