VIDEO: Senator Moody Works to Increase Competition and Lower Prescription Drug Prices for Floridians

WASHINGTON D.C. - Senator Ashley Moody is working to unlock more competition in the drug market by cutting regulatory red tape. Right now, unnecessary regulation in the biosimilar drug approval process at the Food and Drug Administration (FDA) has led to delays and higher costs for Floridians. Senator Moody's new legislation would consolidate duplicative regulatory efforts, allow personnel to prioritize getting more biosimilars, which are affordable alternatives to brand name biological drugs, approved, and ultimately lower costs for Floridians. The broader usage of affordable alternatives to expensive brand name biological drugs has been shown to collectively save Americans billions of dollars on their health care.

"One of my top priorities in the Senate is getting control of runaway costs for Florida families, and that includes the cost of prescription drugs. My new legislation will help families save billions by cutting out unnecessary regulation from the approval process, ultimately reining in drug prices. This is an easy bipartisan fix, and that is why I fought hard to sponsor and pass this bill language out of the Senate Health, Education, Labor and Pension Committee this week," said Senator Ashley Moody.

"In Maryland, we are proud to have the FDA operating in our own backyard. This bill allows the FDA to streamline its review process, increasing efficiency and incentivizing innovation for our life sciences manufacturers in Maryland by getting drugs to market for patients faster. It will reduce confusion, slash the red tape that delays drug approvals, and ultimately, lower prices for patients. I look forward to working with Senator Moody to get this simple fix requested by the career experts at FDA across the finish line," said Senator Angela Alsobrooks.

"The Biosimilars Forum commends Senator Moody [and Senator Alsobrooks] for introducing an important bill to streamline and modernize development for safe, effective, and lower-cost biosimilars," said Juliana M. Reed, executive director of the Biosimilars Forum. "The Forum and its members take immense pride in developing and manufacturing lower-cost biosimilars, and supportive policies are essential to ensure these medicines can reach the patients who need them. Senator Moody's leadership will help bring more biosimilars to the market more quickly, ensure those biosimilars can reach patients, and improve affordability by lowering everyday health care costs for Americans."

BACKGROUND:

· Under the Biologics Price Competition and Innovation Act of 2009, FDA must require that all biosimilar applications be reviewed by the same review division that handled the reference product. This statute is preventing FDA from promoting the Office of Therapeutic Biologics and Biosimilars to handle biosimilars exclusively and save resources in the other review divisions.

· This bill simply strikes Section 351(k)(5)(B) of the Public Health Service Act.

· This effort is in line with President Trump's Great Healthcare Plan to increase health care affordability, making it easier for biosimilar drugs to come to market by reducing regulatory burden.

· The language in Senator Moody's bill passed out of the Senate Health, Education, Labor and Pension Committee this week.

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