If you are planning your medical convention or meeting in the District of Columbia you may want to consider the following information.
What would you think about a law that requires all pharmaceutical companies to register as sales reps; everyone who has contact with a physician or other prescriber who practices in the District of Columbia?
This past January the District of Columbia passed the Safe RX law. In August the DC Department of Health Rule issued – Safe RX rules. The rule was supposed to begin on October 1st but this week is when the department first posted their regulations and forms on-line.
Safe RX will require sales representatives of pharmaceutical companies to register with the District of Columbia, and take some courses. This sounds pretty much standard operating procedure for many professions but that is where the comparisons end.
Effective April 1, 2009, all persons providing pharmaceutical detailing services to health professionals in the District of Columbia should be licensed under the SafeRx Amendment Act of 2008 (Act) with the DC Board of Pharmacy.
According to the final rule, Safe RX defines sales reps as:
An individual who is employed by or is under contract to represent a manufacturer or labeler and engages in the marketing of pharmaceutical products in the District to any person or entity licensed to provide healthcare in the District of Columbia.
This broad definition could include:
• Sales Representatives
• District Managers
• Region Directors
• Managed Care Representatives
• National Accounts Managers
• Medical Science Liaisons
• Speakers bureau members lecturing in DC
• Medical convention booth personnel in DC
• Promotional Medical Education conducted in DC
• Home office ride-alongs in DC
• Market Research in DC
If this doesn’t discourage you, the reps, in their application form will have to show proof of college degree, or demonstrate twelve months tenure, disclose all schools they attended and number of hours completed, and list all jobs they have had since graduation from college (I am not sure the relevance of this information), sign an affidavit that they have not gotten in any trouble in the past and don’t owe the district government any money.
“Sales Reps” in DC will also have to include a notarized copy of the signed code of ethics:
A) A pharmaceutical detailer shall not engage in any deceptive or misleading marketing of a pharmaceutical product, including the knowing concealment, suppression, omission, misleading representation, or misstatement of any material fact. (I am sure this is exactly what the medical legal departments are telling the reps anyway)
B) A pharmaceutical detailer shall not use a title or designation that might lead a licensed health professional, or an employee or representative of a licensed health professional, to believe that the pharmaceutical detailer is licensed to practice medicine, nursing, dentistry, optometry, pharmacy, or any other similar health occupation, in the District of Columbia, unless the pharmaceutical detailer holds an active license to practice that health occupation (Be careful about what title you use)
C) A pharmaceutical detailer shall not attend patient examinations without the express, written consent of the patient. (So if you are a sales rep run from the room if a patient walks in)
D) A pharmaceutical detailer shall not willfully harass, intimidate, or coerce a licensed health professional, or an employee or representative of a licensed health professional through any form of communication, including through the sending of messages of disappointment for the failure to prescribe certain medications. (in this day I don’t think you will see much message sending about disappointments…. but let’s put it in anyway) the Board shall use a reasonable person standard to determine whether the conduct constitutes willful harassment, intimidation, or coercion (let’s hope the board is made up of reasonable people)
E) A pharmaceutical detailer shall not continue to make sales calls upon a health professional, or an employee or representative of a health professional after the health professional prescriber has requested in writing to the pharmaceutical detailer or the detailer’s employer not to receive any further sales calls (I suppose that the District will be providing physician’s offices with form letters to sign and making that part of their required CME in the future)
F) A pharmaceutical detailer shall not offer a gift or remuneration of any kind to a member of a medication advisory committee; except that a pharmaceutical detailer may give medication samples to a member of a medication advisory committee that is also a licensed physician engaged in the practice of medicine. (just so you know there is no list of these people anywhere, so be on the lookout for these folks)
G) A pharmaceutical detailer shall not employ any inducement or misleading statements to gain access to a healthcare professional (These are pharmaceutical reps, they are not saying from a corner – hey doc come here I have some really good stuff to sell you; those are the non-licensed illegal drug reps who operate freely in the District of Columbia – I think the District is confused)
H) A pharmaceutical detailer shall provide information to healthcare professionals that is accurate, fairly balanced, and consistent with FDA approved labeling (This is one of those ill defined clauses that means, if you do so much as give a journal article to a physician consistent with FDA rules, we will still fine you)
I) In additional to the regulations set forth under this section, any holder of a license under this chapter or any person authorized to practice pharmaceutical detailing functions under this chapter shall comply with the standards of ethical and professional conduct established by the Pharmaceutical Research and Manufacturers of America (PhRMA) in its publication entitled “PhRMA Code on Interactions with Healthcare Professionals” as it may be amended or republished form time to time. Where there is a conflict between this publication and the regulations set forth in this Chapter or the provisions of the Act, the regulations and/or Act shall control (You must abide by the PhRMA code, unless ours is more restrictive)
There is also a rule for re-licensure every even-numbered year and for re-licensure you must take 15 hours of coursework, and the courses have to be approved by the board, delivered by an accredited provider, pharmaceutical company or university, and include:
(a) General medical and pharmaceutical terminology and abbreviations;
(b) Food and Drug Administration laws and regulations pertaining to drug
marketing, labeling, and clinical trials;
(c) The cost-effectiveness of pharmacological treatments;
(d) Therapeutic drug classes and categories;
(e) Professional ethics;
(f) Properties and actions of drugs and drug delivery mechanisms;
(g) Etiologies, characteristics, and therapeutics of disease states;
(h) Pharmacology; and
(i) The anatomical and physiological effect of pharmaceuticals.
We expect this law to have a chilling effect on the convention and meetings businesses in the District of Columbia. Many conventions will have no choice but to move the location of their meetings to avoid registration and penalties for the sales reps brought in to handle exhibits. Or perhaps a simpler solution will be to put up a “DC Docs not allowed” sign in front of the exhibit hall and promotional meetings venues. Washington has been an anti-business city for quite some time, this regulation just adds to the many reasons to do business elsewhere. I am not sure how this will help the city, but then again it is DC.