Sweeping legislation known as “SafeRx” was enacted earlier this week by the District of Columbia Council.  The legislation was sponsored by D.C. Councilmember at Large David Catania, who is also Chair of the National Legislative Association on Prescription Drug Prices (NLARx).

The legislation includes a first-in-Nation provision establishing a licensing requirement for drug industry sales representatives known as “detailers.”  Such legislation has been hard fought in other states, including both West Virginia and Maine, where NLARx members Delegate Don Perdue and then-Senator Arthur Mayo sought to pass similar laws.  Nevada enacted a law in 2007 requiring detailers to adhere to a code of ethics, and Vermont passed legislation last year requiring detailers to provide evidence-based information when they provide marketing information to prescribers.  The lobbying was intense in D.C. as well, with one industry website going so far as to attack Councilmember Catania as “Pharma Enemy Number 1”.

“The passage of SafeRx is great news for patients and seniors.  It represents an important victory in the growing effort to address the problem of false and misleading advertising for prescription drugs,” said Councilmember Catania.   “As legislators, it is important that we recognize the role that detailers have come to play in our healthcare system.  Currently, we live under a regime that aggressively promotes the latest, most expensive drugs often at the expense of the best, most effective ones.  The passage of SafeRx is seminal event in the movement to fix this problem.”

The law has several other provisions of note, including establishing the Pharmaceutical Education Fund for the purpose of supporting the needs of the Board of Pharmacy and establishing and funding an academic detailing program within the Department of Health, provisions relating to providing patients with information about off-label use of medication, and prohibiting gifts or remuneration of any kind from a pharmaceutical company to a member of a medication advisory committee.

Vermont and Maine enacted academic detailing legislation in 2007, and Pennsylvania has the most well-established and funded program in the country.  The programs provide evidence-based information to physicians and other prescribers which is more comprehensive than that provided by drug detailers, who focus on the particular medications their companies sell.

The legislation was amended before final passage to remove the sections relating to datamining, although Councilmember Catania has asserted that he may reintroduce these provisions as separate legislation in the future. Similar provisions are in laws passed in New Hampshire, Maine and Vermont and all three are being challenged by the datamining industry in federal court.  A hearing was held earlier this week in the Federal Court of Appeals for the First Circuit in Boston in IMS v. Ayotte, the case challenging the New Hampshire law, which was enacted in 2006.

“The SafeRx Act is groundbreaking legislation nationally,” said Sharon Treat, NLARx Executive Director.  “Despite the personal attacks and heavy duty lobbying, Councilmember Catania was able to prevail because the public supports the very reasonable measures in SafeRx that promote safe prescribing of prescription drugs and reduce the influence of drug industry marketing and gifts.”

For more information on drug marketing and state policy, go to http://www.reducedrugprices.org/advertising.asp . As soon as the final version of the SafeRx Act is available it will be posted.

A number of articles provide more details.  See:

• Bill on School Firings Passes - Licensing of Drug Salespeople Is Approved in 7-6 Vote By Nikita Stewart and V. Dion Haynes, Washington Post, January 9, 2008
• DC Councilman: Why Reps Should Be Licensed [Interview with David Catania] By Ed Silverman, Pharmalot Blog, Posted: 10 Jan 2008 11:17 AM CST
• D.C. OKs new drug-sales regulations  By Gregory Lopes, Washington Times, January 9, 2008