Bilirakis’ Provisions Included in 21st Century Cures Draft Legislation

Washington, D.C. – Congressman Gus Bilirakis (R-FL), released the following statement on the release of the 21st Century Cures draft legislation.

"Whether through medical devices or medicine, treatments for patients suffering from chronic and rare diseases are driven by the three D's: discovery on the ground level through basic science; development into a practical, usable, and marketable product; and delivery to the patients, so that the treatment may be utilized effectively," said Bilirakis.

"There are significant impediments at each stage of the cycle, in large part because of an outdated and bureaucratic regulatory structure. Ultimately, this renders a disservice to 130 million Americans who suffer from a chronic condition. The 21st Century Cures Initiative is about people – the people who need more efficient and effective treatments more quickly, but do not have access to them. I am proud that five of my legislative provisions have been included in the first 21st Century Cures draft legislation," Bilirakis continued. "This draft legislation is a fantastic first step toward producing concrete, bipartisan legislation to help tens of millions of Americans from all walks of life."

Congressman Bilirakis' legislation included in the 21st Century Cures draft legislation would:

• Add new delivery systems to drugs in order to increase patient benefits, like abuse deterrents, extended release, and reduced side effects;
• Incentivize drug makers and innovators to "repurpose" major market drugs for life-threatening rare diseases and pediatric cancers, which opens the door to the development of hundreds of safe, effective, and affordable treatments for rare disease patients.
• Provide seniors with transparency in Medicare Parts A and B, by allowing seniors to better identify the out of pocket costs they might face for a given treatment or service, and site of services that is right for them and their budget.
• Establish a Safe Pharmacy Access Program, which prevents high-risk beneficiaries from abusing controlled substances. Safe Pharmacy Access Programs monitor the point of sale to prevent prescription drug abuse and drug diversion. It is a cost-saving measure utilized by private industry, TRICARE, and state Medicaid programs.
• Require FDA to clarify guidance on the review process for products that include both drugs and devices.

A summary of the draft legislation can be found here. This draft legislation builds upon two roundtables Congressman Bilirakis held in Florida.