Americans spend more on healthcare than any other nation. We also have one of the worst returns on healthcare investment in the world.
Why is that?
Rand Paul knows why: there’s too much bureaucracy and regulation stifling competition. Our flawed approach to healthcare leads to higher drug prices, extended illness, and shorter lives.
Paul Wants to Fast-track Biosimilars
Paul, an accomplished doctor, insists today’s science shows biosimilars are the equivalent of highly effective drugs.
The difference between biosimilars and brand name medications?
Biosimilars, sometimes referred to as “generics”, are more economical for patients. Moreover, biosimilars don’t require arguably pointless clinical studies.
The Kentucky Senator authored a bill designed to persuade the Food and Drug Administration to adhere to evidence proving the merit of biosimilars. The FDA took Paul’s advice, implementing reform to reduce costs without sacrificing medication quality.
Affordable Drugs Without the Red Tape
Thanks to Paul’s legislation, the path is paved to fast-track biosimilars.
What’s the plan?
Paul’s bill streamlines the bogged down process for biosimilar approval. The idea is to eliminate repetitive requirements for clinical studies that waste time, effort, and money.
The bill, dubbed Expedited Access to Biosimilars Act, hikes competition, boosts access to treatments that save lives, and decreases medication prices.
“For years, biopharmaceutical researchers have argued that new and advanced methods of determining biosimilar clinical equivalence in early development have eliminated the need for late-stage human studies. When a biosimilar proves it is safe, effective, and similar to the brand name product in the early stages of its analytical and safety assessment, there’s no scientific justification to delay access.” – Paul
The legislation removes the across-the-board immunogenicity requirement along with Clinical Efficacy standards and pharmacodynamics requirements unless there is sufficient scientific reason.
However, Paul’s legislation does not remove the requirement for pharmacokinetic studies.
Why is that?
Pharmacokinetic studies are imperative as they serve as a means of demonstrating medications’ clinical safety.
If the FDA pushes for even more study requirements, the agency will have to prove there is justification for those additional standards.
The purpose?
To guarantee all regulatory decisions pertaining to medication are made based on science as opposed to arbitrary government bureaucracy.
Affordability is the new Beltway Buzzword of the Beltway
In the end, Paul’s biosimilars bill centers on healthcare affordability. Removing government constraints in favor of a free market hastens competitor entrance.
It won’t be long until biosimilars are available at prices that are more affordable than brand name medications.
In other words, government will finally catalyze private sector innovation instead of impeding it.
The best part?
Paul’s push for modernization and medication affordability expedites the FDA biosimilar process for approval without jeopardizing consumer safety.
The right wing’s open mindedness toward biosimilars is the perfect example of how Republicans are the real progressives of America’s political scene.
The Democrats, who claim to be progressive, stifle free market innovation and competition, bogging down drug approval processes with unnecessary bureaucracy.
It’s quite ironic that Paul, a Republican, is the one who pounded the table for a more progressive approach.
Republicans like Paul are progressive where it matters: business, healthcare, and government efficiency.
Biosimilars Will Save Us Billions
Early estimates indicate biosimilar drugs will cut costly medication prices to surprisingly affordable levels. If those estimates are accurate, savings will amount to $38.4 billion every half-decade.
The money will be redirected toward paying the national debt, invested in America’s infrastructure, or possibly distributed to taxpayers.
“Americans pay too much for prescription treatments because of outdated FDA requirements. This bill would give pharmacists more options, subject to state law, to substitute unaffordable therapeutics with lower-cost alternatives. I offered similar reforms in the past because health care reform starts with giving patients more affordable choices. It’s time we stop letting red tape stand between patients and lower prices.”- Paul
Paul’s idea is an obvious solution that Democrats negligently overlooked in favor of Big Government. For that, they’ll likely pay at the polls.
Fast forward a couple years into the future and biosimilars will likely be ubiquitous.
More importantly, Americans will pay significantly less for medications that greatly improve wellbeing and also save lives.
