Washington DC Passes Bill To License Reps
7 CommentsBy Ed Silverman // January 8th, 2008 // 5:11 pm
It was a close call, but the initiative made it by a 7-6 vote. And now the city is the first in the country to license sales reps, whose licenses can be revoked if their activities are deemed fraudulent, the Washington Business Journal notes.
The bill’s supporters say this is a way to force and enforce good business practices on people who have undue influence over docs, and therefore patients. “I don’t understand the logic that says we shouldn’t have these additional protections for patients,” says councilwoman Mary Cheh, who voted in favor of the bill. “The dangers are real, and the enforcement to date by the federal government is ineffectual.”
But the pharmaceutical industry and other opponents consider the new local oversight unnecessary, impossible to execute and redundant with already existing federal oversight. They also worry about the precedent such regulation would set for other sales positions, as well as the effects of promising to police an industry better than the federal government can. “Overregulation, misguided regulation, bad regulation affects everybody,” councilwoman Muriel Bowser, who voted against the bill, tells the paper. “I know it won’t do what it claims to do.”
The bill, dubbed SafeRx, also mandates that drug reps have a bachelor’s degree, adhere to a code of ethics and refrain from giving gifts to docs. Further, it requires docs to tell their patients when they’re prescribing meds for a treatment not specifically authorized by the FDA. Finally, it sets the framework for a new city-funded system of educating area physicians about new drugs on the market.
The bill boasted the same supporters and opponents as in its first reading on Dec. 11, when it also passed by a 7-6 vote.
But the bill’s sponsor, councilman David Catania, amended the bill since then, eliminating a passage that would have forbid reps from data mining, or using area prescribing data and trends as a marketing tool to target specific docs. He said that measure has been challenged in the New England courts so far and depending on a decision expected as early as Wednesday, he may renew efforts this fall to prohibit such data mining, the paper writes.
Instead, the bill approved today adds a requirement for docs to include new drug and trend info in their continuing education mandates to learn more about the industry, as well as new instructions for the DC Health Department to track the effectiveness of the bill - from fines collected to number of licensed salespeople - after the end of 2010.
Bob Freeman
A great first step in controlling excessive promotion and addressing abuses that pharma is unwilling or unable to remedy. The next step is to impose a licensing fee of $2500 per rep.
Sea
Slippery slope argument. Who defines “excessive” promotion? You’re just breeding more bureaucrats. And a $2500 “license fee”? please… these punative costs are just going to be passed on to the consumer.
Doc
Its about time additional steps were taken to control the promotional wastes and abuses of the pharma industry. Hopefully this is the first step in reigning in the marketing and sales departments. They are selling medicine, not cars.
Atlex
This is nothing but a shakedown for money under the guise of protecting public health. What can they require for licensure? A college degree? A couple of hours in a class room? What agency is going to enforce anything once the license is issued? There’s no tie to marketing restictions, use of data, or anything else that would impede a reps interaction with a physician.
James
Doc, how is this the “first” step in controlling “promotional wastes and abuses of the pharma industry”? Numerous states, as well as the Feds, have imposed dozens of different laws and spent billions of taxpayer dollars going after companies allegedly engaged in off-label promotion, FCA violations, etc. They’ve even jailed at least one doctor for engaging in off-label promotion (which, last I checked, was still legal for doctors to do).
How about someone take the first step in reigning in government waste? They’re using our money, not theirs.
And Nathan, you’re spot-on right. I live in the D.C. area, and even Councilman Marion Barry disagreed with this one–he believes the money to administer the new licensing program could be better spent on AIDS prevention and healthcare. But, I guess if they can turn it into a revenue generator, it can replace the red-light cameras they rigged to short-time to generate extra cash.
Jack2
QUOTE: Further, it requires docs to tell their patients when they’re prescribing meds for a treatment not specifically authorized by the FDA.
Is that actually true? Am I the only one who sees that as a big deal? I’m surprised the AMA doesn’t care about this one. And what if someone arrives at an ER unconcious/psychotic? Do they need to get consent forms signed to use a med off-label (IV Haldol is technically off-label). Do doctors actually know which uses are off-label and which are on-label? Will pediatricians, who routinely prescribe off-label because of their patient population, who practice in DC now need to alert parents when going off-label, sometimes for drugs that are 30 years old? Is every antibiotic routinely used in kids approved for kids?
Cheryl-Anne
TO Jack 2 -
There are already provisions in the bio ethics code on how to deal with the scenarios you present in your comments. patients unable to speak for themselves or arriving at the hospital without a representative are treated as per the code of ethics. So, this is no concern.
I like the idea of doctors informing patients when they are being treated off label. Most patients are smart enough to understand the situation. I think making it part of the information just provides another topic to promote good dialog between the patient and the doctor - nothing wrong with that….However, the new bill also ” adds a requirement for docs to include new drug and trend info in their continuing education mandates to learn more about the industry, as well as new instructions for the DC Health Department to track the effectiveness of the bill - from fines collected to number of licensed salespeople - after the end of 2010″. So, this should answer your concern of what the doctors know or might not know. This should certainly keep CME accreditation agencies quite busy….
As a former sales rep myself I think this is good thing. If implemented properly it should help to improve service and information to health care professionals.