Legislative Memo

T 518.465.7511


A. 10877 (Gottfried)



Registration of Pharmaceutical "Detailers"



May 29, 2008


The Business Council opposes this bill that would allow the state Department of Health to register and adopt broad regulations governing pharmaceutical company "detailers," which are defined as an employee, agent or representative of a pharmaceutical manufacturer who communicates with licensed health care professionals for the purpose of selling, providing information about, or in any way promoting a prescription drug.

The Business Council opposes this legislation for a number of reasons.

First and foremost, communications by pharmaceutical representatives with health care professionals and health care entities are already strictly regulated by the federal Food and Drug Administration. As such, this bill would impose a second, unnecessary layer of regulation on this component of the pharmaceutical industry.

Moreover, this bill would give the Department of Health excessively broad, almost unlimited authority to regulate and impose fees on pharmaceutical representatives. For example:

This bill contains open-ended regulatory and fee assessment authority, with virtually no indication as to the purpose of, or limits on, these new regulatory and enforcement provisions. Considering that this bill would apply a second level of state regulation on economic activity already regulated at the federal level, we see no compelling need for this broad new regulatory authority.

Finally, this bill is an unnecessary regulation that will cost the pharmaceutical industry millions to implement and will only increase the already high cost of doing business in New York State . The biopharmaceutical industry is an important industry in New York State . We should encourage its growth. Biopharmaceutical companies need a legislative and regulatory environment that fosters innovation, that encourages open access to state of the art medicines and that does not discourage or harm the business in New York State.

For these reasons, The Business Council opposes approval of A.10877.