Physician Groups, Patient Advocates Applaud House Action Promoting Access to Cutting Edge Medicines

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Physician Groups, Patient Advocates Applaud House Action Promoting Access to Cutting Edge Medicines

Florida Medical Association, Florida Osteopathic Medical Association, NAMI Florida, Lupus Foundation of Florida applaud the committee approval of bill that updates pharmacy substitution rules for interchangeable biosimilars

Tallahassee, FL (March 7, 2013) – The Health & Human Services Committee of the Florida House of Representatives showed their support to strengthen patient access to needed medicines as they passed Florida House Bill 365 out of Committee earlier today. If passed and signed into law, this bill will enable biologic medicines to be substituted with interchangeable biosimilars at pharmacy counters across Florida, allowing patients to have access to these cutting-edge medicines.

“This sensible legislation will enable Floridians who suffer from serious medical conditions, such as cancer, arthritis, and Multiple Sclerosis, to access more affordable advanced medicines,” Florida State Representative Matt Hudson (FL-80) said. “When the federal Food and Drug Administration authorizes biosimilar interchangeability, I want Florida patients to have immediate access to these medicines – so I would urge colleagues to support this legislation.”

HB 365 provides conditions under which biosimilars may be substituted for a prescribed biologic drug while maintaining standards for patient safety. Specifically, pharmacists will be able to substitute only biosimilar products deemed “interchangeable” by the Food and Drug Administration (FDA). HB 365 also requires that doctors be notified within a reasonable period of time of the switch and that a record of substitution is kept by pharmacists.

The legislation is also supported by the Florida Medical Association, which represents more than 20,000 physicians, residents, and medical students.

“The Florida Medical Association recommends HB 365 to be implemented because it sets important standards for biosimilar substitution and is in the best interests of patients,” said Rebecca O’Hara, Vice President of Government Affairs, Florida Medical Association. “As biologics and biosimilars are similar – but not identical – products, it is essential that pharmacists inform physicians and doctors when their patients receive a different medication at the pharmacy than what is prescribed. This measure, together with the record-keeping requirement, will ensure that doctors have the most accurate information available to treat their patient in the case of a side effect or adverse reaction to a medicine.”
“Due to their therapeutic benefits, biosimilars that are licensed by the United States Food and Drug Administration should be available to Florida patients, provided that reasonable steps are taken to avoid potentially harmful substitutions,” said Gregory James, D.O., president of the Florida Osteopathic Medical Association. “The Florida Osteopathic Medical Association supports House Bill 365 by Representative Hudson because it contains such safeguards that are crucial to patient safety.”
The legislation is supported by the Lupus Foundation of Florida and the Florida Chapter of the National Alliance on Mental Illness (NAMI), the nation’s largest grassroots mental health organization dedicated to building better lives for the millions of Americans affected by mental illness.
“Biologic medicines are the most promising therapies for patient populations with autoimmune diseases, like Lupus, which has limited treatment options,” explained Rick McCollum, CEO and President of the Lupus Foundation of Florida. “As a patient advocacy group, we seek to lower the barriers to access new, affordable therapies, but are cognizant of the unique properties of biologics and biosimilars, which are much more complex than traditional chemical drugs. Physician notification and accurate record keeping, at a minimum, should be implemented before allowing for interchangeable biosimilar substitution.”

“We must nurture new advances in available therapies for millions of Americans with mental illness and ensure the safety and welfare of people living with disorders such as schizophrenia and bipolar disorder. It is important to recognize that there remains uncertainty about how biologic and biosimilar medicines can act, so NAMI recommends caution with respect to ‘interchangeability’ and substitution standards for biosimilars,” said Judith Evans, Executive Director NAMI-Florida. HB 365 is in keeping with the intentions of the Food and Drug Administration to uphold the safety of these advanced medicines.”

The next step for this legislation is to be approved by the Florida House of Representatives. A compendium bill, SB 732, will be considered by the Florida Senate later this month.


Media Contact: Tim Buckley (


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