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Legislative Memo

Lev Ginsburg
Director of Government Afairs
T 518.465.7511 x207
www.bcnys.org

BILL:

S.3157 (Monserrate) /A.5201 (Brodsky)

Support

SUBJECT:

Subjects drug and medical device manufacturers which engage in direct-to-consumer advertising to liability

 

DATE:

June 15, 2009

 

The Business Council of New York State opposes this bill, as its impact would ultimately increase costs to businesses and consumers while potentially decreasing patient access to appropriate medication.

The bill eliminates the well-established legal defense of “learned intermediary” doctrine, which recognizes that the warnings which accompany medicines and medical devices are directed to physicians and other prescribers who have face-to-face interaction with patients and who are best able to evaluate the risks and benefits associated with prescription medication.

If drug and device manufacturers cannot rely on the “learned intermediary” doctrine, then the resulting required warnings for a prescription drug - the complete, complex, and highly technical statistical warnings currently provided to physicians – would need to reach and be reviewed by patients.  The bill is a direct and unwarranted intervention in the physician-patient relationship and places an incredible responsibility and burden on the patient to evaluate the contents of the required warnings and how that relates to the condition to be treated.

The “learned intermediary” doctrine has been sustained almost everywhere as it preserves the desirable relationship between physician and patient and respects the importance of having requisite training and experience in the use of medicines and how that relates to the patient's needs.  If this bill were passed into law, it would undoubtedly result in increased lawsuits which would drive up health care costs.  Additionally it would likely deter development or continued production of medicines. 

For these reasons, The Business Council of New York State respectfully opposes S. 3157/A.5201.