NJ AG: Clampdown On Pharma Influence On Docs
16 CommentsBy Ed Silverman // December 4th, 2009 // 10:25 am
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
Carey
Doctors might have to pay for their own food?! The horror.
Confucius
I’m confused about how the state laws/regs will work with the pending federal law/regs. What’s the point of all these state laws if they are trumped by a federal standard? I’m sure every state law with be appealed endless times. Any ideas on how true pharma/doc disclosure could actaually play out? Bit frustrating to keep talking about it, with little progress.
Lisa Van Syckel
How about the new Governor-Elect Christie, oh thats right, he just signs Bills into law!!!
Lisa Van Syckel
Ed, how about the docs that testify before state committee hearings?
pharmavet
Christie just hired an ex-Pfizer big to run the budget. This will die a quick political death.
Jim S
I would like to see a website that lists every lawmaker and the meetings / junkets they attend and with whom. An itinerary would suffice so the public can see how they are spending taxpayer money.
anonymous
I don’t think you get it Jim S. I know who gives legislators money- they have to list it in their campaign filings and PAC filings. As well the lobbyists have to register who they give money to and who they are working on behalf of…Physicians are the first line of prescribers- and unlike my insurer were you have to turn over a formulary to me so I know you got a deal on numbers 1, 2 and 3 and those are the drugs you are pushing… as my doctor, I have no idea that you only prescribe Seroquel because you like the AZ rep, you are on their speaker to speaker and you do their Doc to Doc live video chat… or it may be that you believe that is the best drug out there regardless- either way the conflicts should be there for me to see and decide. No one said you can’t do the train the trainer or a gizillion CMEs for AstraZeneca but your patients should be able to access the information. The physician has all the education and writes the prescription but the patient gets the side effects and takes all the risk.
Evelyn Pringle
I predict that this AG will soon be offered a “promotion” to a high position in the Justice Department to get her out of Pharma’s hair in New Jersey.
Elaine
What about transparency from the nonprofits? You know, the tax-exempts industry funds to lobby, write policy and bless products?
Anonymous
I will be for this if the same rules are put in place at the federal and state level for lobbyists which we all know will never happen since politicans are all hypocrites.
Paul
I am all for transparency but has to be everyone. It´s good that they are asking doctors to also disclose. We also need for politicians, industry critics, and editors of medical journals to disclose.
Paul
And how about Bauchus, the champion senator of disclosure who did not disclose that he was dating a woman he recommended for a big appointment?
Talk about hypocrisy.
doc
After 30+ years on the promotional/selling side of pharma, it is obvious to me that the model is broken.
The dollars spent on food, honorarium all targeted by IMS Rx data to high prescribers has the business corrupted.
Remember, your average sales rep is a business major or communications major with virtually no science background other than what their company provides. If you think the training departments of big pharma are unbiased or have well qualified people doing the training, you’re asleep. Most of the training department are staffed by reps that were willing to move to their home office.
I hope all states adopt something like the NJ proposed model. Doctors are much more influenced than they think by reps.
Lisa Van Syckel
Paul,… Id like to see Senator Baucus lose his Chairmanship.Where is the outrage, oh I forgot hes not a Republican. What he did was worse then Clinton’s oral sex escapade!!
harpy
@ Confucius - the federal bill keeps changing as it gets passed around. The last time I was really paying attention, they said it would preempt state law for similar provisions, but not where states are stricter.
Anyone know if that’s still the case?
harpy
I just realized this proposal puts the onus of reporting on the doctor rather than on industry. Nice.