Third Florida Development Paints a Clear Target on Pharma Pricing
Three major regulatory developments in Florida in the past six months paint a frightening picture of the evolving regulatory framework on pricing for brand drug manufacturers. With Florida having led the regulatory charge previously, (e.g. supply chain pedigree requirements, DR testing/ licensing, etc.), we can expect the rest of the states to follow suit if they prove successful.
Quick sidebar and shameless plug: this article is courtesy of the new Selective Notifications capability of LighthouseAI Intelligence. LighthouseAI Intelligence provides dynamically updated 50-state assessments that are tailored to the 100+ business activity, product portfolio, and jurisdiction attributes that drive compliance for drug supply chain and pharmacy. Selective Notifications extends that capability by keeping companies updated on rule and legislation making, in addition to Intelligence’s currently enforced requirements, that directly affect our customers at the facility and company level.
January 2024: Florida Introduces Expansion to International Price Reporting
It seems like Florida is taking notes from Peter Drucker’s famous adage, “you can’t manage what you can’t measure,” with their extension of State Price Transparency Reporting focusing on “you can’t regulate what you don’t measure.” Specifically, Florida introduced SB1750 which, if passed, will require each prescription drug manufacturer permit holder and nonresident prescription drug manufacturer permit holder to annually report international drug price data starting October 1, 2025. The data is to be reported to the Agency for Health Care Administration which supports prescription drug coverage in the Medicaid program and the state group insurance.
According to a 2021 study by the RAND Corporation, a non-profit global policy think tank, prices of prescription drugs in the U.S. are 2.4 times higher than the average prices of nine other nations (Austria, Australia, Belgium, Canada, Germany, Japan, Sweden, Switzerland and the United Kingdom). Armed with self-reported international pricing data, Florida will have a critical weapon as they potentially look to negotiate their drug pricing.
January 2024: FDA Authorizes Florida’s Drug Importation Program
Just last week, we published an article by our very own Director of Strategic Affairs, Deneen Fumich, RPH, on the FDA approval of Florida’s Drug Importation Program. The U.S. FDA’s approval of Florida’s request to import prescription drugs from Canada marks a significant milestone in American healthcare policy. This groundbreaking decision, under section 804 of the FD&C Act, allows Florida to initially import drugs for chronic conditions like HIV/AIDS, mental illness, and prostate cancer, with plans to extend to Medicaid patients. This initiative faces substantial challenges: opposition from the drug industry and the Canadian government, concerns over the potential influx of counterfeit or substandard drugs, and logistical hurdles in establishing a secure supply chain. However, despite these obstacles, this approval represents a major shift in drug importation policy, potentially paving the way for more affordable healthcare options in the United States.
July 2023: Florida Rolls out State Price Transparency Reporting
About 6 months ago, we published an article by our very own Director of Research, Kelly DiBattista, Esq, on Florida’s new State Price Transparency Reporting requirement. The “Prescription Drug Reform Act” (FL S1550) introduced in Florida on May 4, 2023, represents a significant legislative shift toward State Price Transparency Reporting. This new law mandates drug manufacturers to report detailed justifications for any significant price increases, offering a chance for greater insight into the pharmaceutical pricing process. Its implementation, requiring manufacturers to closely work with pharmacy benefit managers and adhere to strict reporting and attestation requirements, signifies a major step towards addressing the complexities and opacities of drug pricing, potentially leading to more informed stakeholders and consumer protections.
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