The District of Columbia moved closer today to becoming the first to require pharmaceutical sales representatives to obtain an official license, a move that may lead additional states to consider similar legislation.

The DC Council officially passed the SafeRx Act of 2007 by a vote of 7-6. Two novel components of the Act will be of particular interest to manufacturers of prescription drugs. First, the Act requires pharmaceutical "detailers," or representatives from drug manufacturers, to obtain a license from the DC Board of Pharmacy. Second, the Act requires physicians to obtain written informed consent from their patients before prescribing drugs for an off-label use.

The licensure provision requires all new sales representatives (including those with less than 12 months' experience) to have obtained at least a bachelor's degree in pharmacy or a chemical, physical or biological science. All sales representatives must also pay a licensure fee of at least $250 and participate in continuing education programs.

In addition to the new licensure and informed consent requirements, the SafeRx Act establishes a registry for the public disclosure of pharmaceutical company clinical trials and Food and Drug Administration correspondence and prohibits all gifts or remuneration from a pharmaceutical company to a member of a medication advisory committee, such as a state Medicaid board.

At the last minute, the Council voted to withdraw from the Act a proposed ban on all prescription "data mining" for commercial purposes. Similar data mining statutes passed recently in Maine, New Hampshire and Vermont are now being reviewed by federal courts. US District Courts in New Hampshire and Maine have overturned the laws on First Amendment grounds. New Hampshire has appealed the decision to the US Court of Appeals for the First Circuit and Maine is expected to do the same. Vermont has agreed to delay implementation of its law pending the outcome of the First Circuit appeals.

As amended, the SafeRx Act includes a provision that requires the District of Columbia to review the effectiveness of the Act approximately two years following its enactment. DC Mayor Adrian Fenty, who previously expressed support for the Act, now has 10 days to approve or veto the bill. Assuming Fenty signs the bill, the legislation will be subject to a 30-day congressional review period and will become law unless Congress takes action to overturn the District’s decision.

To discuss how this new policy may impact your business, please contact:

Larri Short
short.larri@arentfox.com
202.775.5786

Brian D. Schneider
schneider.brian@arentfox.com
202.715.8590