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:
- It gives the DOH authority to set and enforce a code of "ethical" conduct and practice on pharmaceutical detailers. However, the bill imposes no substantive limits as to the scope of this "code," or of the qualifications the DOH can impose for the registration of detailers.
- It prohibits - and provides DOH with enforcement authority related to - concealment of a "material fact." However, it provides no definition or criteria for what constitutes a "material fact" for the purpose of this law; it doesn't even require such "material fact" be specifically related to the pharmaceutical product being discussed. Also, it is unclear what is meant by concealing or suppressing a "material fact." Does this require the representative to discuss all research and reports regarding a product, including non-peer reviewed studies and/or studies questioned by the manufacturer? Finally, this section would make it illegal to make a "misstatement" (intentional or not) regarding a material fact. This vague requirement coupled with broad enforcement authority would make it difficult for a registered employee to assure compliance.
- It gives the DOH the authority to impose a registration fee of any amount over $500, with no limit on the level of this assessment, no criteria for how registration fees should be established, and no indication of how the revenues are to be used.
- It gives the DOH unfettered ability to require that detailers submit "information" regarding communications with medical professionals. Again, the bill contains no criteria as to what information can be required, and to what purpose this mandated disclosure is to serve.
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.