|Louisiana Senate Committee Passes IACP Supported Legislation|
This afternoon, June 2, 2015, the Louisiana Senate Health and Welfare Committee unanimously passed House Bill 568 with amendments, legislation that has been identified by the IACP Board of Directors as a priority state initiative for the Academy. The bill was introduced in early May by state Representative Ledricka Thierry who personally experienced questionable marketing of compounded preparations to herself and her constituents and was passed unanimously by the House Health and Welfare Committee on May 6, followed by full House approval a week later.
As introduced, HB 568 provides the state Board of Pharmacy with statutory authority to investigate complaints about marketing of prescriptions drugs by individuals affiliated with or employed by a pharmacy. Unlike pharmaceutical manufacturers' sales representatives and marketers, which are heavily regulated by the Food and Drug Administration, little or no oversight is provided for at the state level for the promotion and sales of prescription drugs, including compounds. As many IACP members have seen and shared with the Academy leadership, marketers are engaging in all sorts of "schemes" to induce the writing of prescriptions by doctors, including direct payment or other types of remuneration, establishing "studies" which pay doctors for the number of prescriptions they generate for a particular pharmacy, and even instances of cold-call telemarketing to patients' homes to obtain personal health and insurance information.
"This past weekend, yesterday, and this morning before the hearing, IACP worked with the Louisiana Medical Society, physician groups, the state Board of Pharmacy, and our members in Louisiana to craft amendments and clarify language that would help protect a patient's right to choose the pharmacy and pharmacist from whom they wish to receive compounding services while at the same time making sure that existing physician/pharmacist/patient relationships aren't disrupted," said IACP Executive Vice President David Miller from Baton Rouge, LA. "We were able to bring all the parties together to make sure that this consumer protection bill was good for our members as well as the physicians with whom they work."
Unfortunately, the vast majority of compounders are being mischaracterized by the actions of a very, very small percentage of companies that engage in questionable marketing tactics. With the recent CBS investigative reports, ongoing scrutiny by law enforcement of compounders and marketing schemes, significant multi-million dollar settlements for closed-shop referral arrangements which violate the federal False Claims Act, IACP's Board of Directors saw this bill as a potential model for other states to adopt. "Compounding is and must remain regulated by states. It is part of the core of what pharmacy is," said IACP President Dale Coker. "By supporting legislation like the Louisiana legislation, we can prevent further federal incursion into each state's determination of what is and is not best for consumers and patients."
House Bill 568 has three major components:
-- It provides the state Board of Pharmacy with statutory authority to investigate and take disciplinary action, where warranted, for complaints about misleading or false marketing by non-licensed individuals engaged by or working for a licensed pharmacy.
-- It applies existing state law governing the types and appropriateness of physician/pharmacist financial arrangements -- including ownership and investment by a prescriber in a pharmacy -- to provide for transparency, notification, and investigative action by the state Board of Pharmacy whenever consumer freedom-of-choice may be compromised.
-- It enables the Board of Pharmacy to develop regulations for the oversight of marketing and financial arrangements between pharmacies and prescribers that build upon existing regulations that address direct or indirect remuneration for prescriptions.
The full Louisiana Senate is expected to vote on House Bill 568 as soon as Thursday of this week. Once the Senate has finished compiling the amendments developed by IACP and its lobbying team, we'll post a full copy of the bill on our "Breaking News" site.
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