Joe Henderson: Gus Bilirakis keeps up fight to get medical drugs to market faster, easier - SaintPetersBlog

Joe Henderson: Gus Bilirakis keeps up fight to get medical drugs to market faster, easier

Anyone facing a dreaded disease themselves or watching a loved one go through it knows the frustration of seeking treatment. They want to know the system is on their side, but often it seems rigged against them.

I think it’s safe to conclude U.S. Rep. Gus Bilirakis, who represents Florida’s 12th District, is on their side. He has been a champion for increasing medical options.

In 2014, along with Democrat Kathy Castor, he was part of the congressional bipartisan 21st Century Cures initiative that sought to speed up the process for getting new life-saving drugs to market.

And while all the focus has been on the fate of the Affordable Care Act, Bilirakis took the opportunity of a hearing about the over-abundance of regulations at the Food and Drug Administration to push for a measure that would provide incentives for drug companies to develop treatments for rare diseases affecting a small portion of the population.

It’s called the Open Act.

“Today, it takes 10 to 12 to even 15 years and upwards of $2 billion to move a drug or biological product from a good idea to an approved product,” Kay Holcombe, Senior Vice President, Science Policy, Biotechnology Innovation Organization, said in a statement to the committee.

“During that lengthy period, unmet medical needs remain unmet and patients wait.”

And patients die.

Bilirakis asked, “There are about 500 approved rare disease drugs, but 7,000 rare diseases affecting some 30 million Americans.  They’re taking medication off-label, not knowing if their drugs are safe and effective for their conditions, or if it’s the proper dosage, and fighting with their insurance companies on coverage of their medications.

“Does it make sense to incentivize development for a targeted population when there are clearly defined needs?”

Holcombe answered simply: “Yes.”

Bilirakis has long argued that the lengthy development requirements hurt patient care and increase costs.

“This isn’t political at all,” Bilirakis told me during an interview about the 21st Century Cures initiative. “I want to take the politics out of it.”

Well, this is Washington, where politics is the milk on morning cereal. Diseases aren’t political, though, and there has to be a way to make it easier to develop these treatments and get them to market at prices people can afford. At least Bilirakis is trying.

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Joe Henderson has had a 45-year career in newspapers, including the last nearly 42 years at The Tampa Tribune. He covered a large variety of things, primarily in sports but also including hard news. The two intertwined in the decade-long search to bring Major League Baseball to the area. Henderson was also City Hall reporter for two years and covered all sides of the sales tax issue that ultimately led to the construction of Raymond James Stadium. He served as a full-time sports columnist for about 10 years before moving to the metro news columnist for the last 4 ½ years. Henderson has numerous local, state and national writing awards. He has been married to his wife, Elaine, for nearly 35 years and has two grown sons – Ben and Patrick.
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