This article is more than 5 years old. Information may no longer be current.
California enacts law modeled after PhRMA guidelines
On July 1, a new California law took effect, requiring that pharmaceutical companies adopt Comprehensive Compliance Programs (CCP) for their dealings with medical professionals.
SB 1765, which was signed into law by Gov. Arnold Schwarzenegger, requires that these CCPs be “in accordance” with the guidelines released by the Pharmaceutical Research and Manufacturer’s Association (PhRMA) and the recommendations of the Office of the Inspector General.
The PhRMA guidelines, along with a draft of compliance programs promulgated by the OIG in 2003, have resulted in increased scrutiny of pharmaceutical company ethics. The guidelines have also served as the catalyst for an ongoing dialogue about the role of industry in medical practice and education.
Details of the legislation
The new law applies to pharmaceutical companies engaging in pharmaceutical dealing, promotional activities or other prescription drug marketing in California. The law also covers companies participating in the same activities for medical devices requiring a prescription, but it does not explicitly refer to medical device industry compliance guidance.
“In California, we were not allowed to dispense sample medications out of our offices because of a restriction in the state law,” said David P. Sendrowski, OD, FAAO, an associate professor at Southern California School of Optometry who practices in Fullerton, Calif.
Dr. Sendrowski called the bill a “cleanup bill.”
“It basically allows optometrists to sample medications that they were not previously allowed to provide to their patients in their offices,” he told Primary Care Optometry News. “But it also prevents practitioners from being incentivized by outside entities to exclusively supply their products in the doctor’s office.”
Medical device language
There has been some discussion among optometrists regarding the reference to medical devices in the language of the bill.
“The only medical devices that optometrists would sample would be contact lenses and, indirectly, contact lens solutions,” Dr. Sendrowski said. “That would take away the incentive for a company to come in and say, ‘I’ll give you 1,000 free contact lenses if you exclusively promote our contact lenses.’”
Dr. Sendrowski said he believes the legislation will promote improved patient care. “It basically allows an optometrist to make a professional judgment without being hindered or having his or her decision altered by some outside contract or alliance he or she might have with a pharmaceutical or device company,” he said. “I think it will be beneficial. It provides better care to the patient, because the doctor bases treatments and products on clinical decisions, as opposed to corporate pressure.”
For Your Information:
- David P. Sendrowski, OD, FAAO, is an associate professor at Southern California College of Optometry. He can be reached at 2575 Yorba Linda Blvd., Fullerton, CA 92831; (714) 449-7414; fax: (714) 992-7848; e-mail: dsendrowski@scco.edu.