The inclusion of HCAPS-supported report language emphasizes the critical importance of collaboration between the FTC and FDA to promote patient safety.

(WASHINGTON) – The Health Care Alliance for Patient Safety (HCAPS) commends the recent passage of an appropriations package by the House and Senate, which was subsequently signed by the President on March 9, that funded the Food and Drug Administration for FY2024. Specifically, the appropriations bill included HCAPS-supported report language emphasizing the critical importance of collaboration between the FTC and FDA to promote patient safety in the medical device marketplace.

This is a significant step forward in advocating for greater attention to patient safety, particularly concerning medical devices such as contact lenses. The report language underscores the necessity of enhanced cooperation between regulatory bodies to ensure the highest standards of safety and efficacy in medical device regulation. The FDA will now be required to brief Congress this year on the agency’s plan to improve communication and collaboration with the FTC on actions related to protecting public health, including the safety and effectiveness of medical devices like contact lenses.

By emphasizing the need for collaboration between the FTC and FDA, this report language recognizes the challenges in regulating medical devices and highlights the importance of a unified approach to safeguarding patient safety. It is a testament to the commitment of policymakers to prioritize the safety and welfare of individuals relying on medical devices for their health and well-being.

The inclusion of HCAPS-supported report language in the FY 2024 appropriations package marks a significant milestone in HCAPS' continued efforts to advocate for patient safety and the importance of the doctor patient relationship.

Dr. David Cockrell D.O., Chairman of the Health Care Alliance for Patient Safety, said, “Congress recognizing the need for greater collaboration between the FTC and FDA is a major step towards protecting consumers’ eye health. HCAPS remains committed to working with Congress to advance patient safety and protect the critical role of the doctor-patient relationship.”

The specific report language included in the FY24 appropriations package for Agriculture, Rural Development, Food and Drug Administration reads:

“Patient Awareness of Medical Device Safety.—The Committee is concerned that some FTC rulemaking on medical devices meant to protect competition in the market has had the unintended consequence of deprioritizing patient safety provisions in law as it relates to the sale of prescription medical devices, including contact lenses. Recent enforcement actions also overwhelmingly focus on physician regulatory compliance rather than medical device retailer compliance even as that industry has expanded rapidly. Therefore, the Committee urges the FDA to work more closely with and to better inform the FTC on the importance of protecting patient safety while promoting competition in the market for medical devices. The Committee requests a briefing within six months of enactment of this Act on the agency’s plan to improve communication and collaboration with the FTC on actions related to protecting public health and providing reasonable assurance of the safety and effectiveness of medical devices, including contact lenses.”

HCAPS is committed to continuing our work to promote patient safety and protect and defend the doctor-patient relationship in Washington and our communities across the country.

For more information on this legislation visit congress.gov. Stay up to date on all regulatory and policy news impacting patient safety by joining the Health Care Alliance for Patient Safety.

The Health Care Alliance for Patient Safety (HCAPS) was founded in 2018 to advocate for patient safety and to protect and defend the doctor-patient relationship – the essential foundation of personalized health care decision making. For more information, please visit www.PatientSafetyToday.com.

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