White House’s “Build Back Better” Plan Builds New Barriers for Patients and Scientists Discovering Groundbreaking Cures
Dr. Michelle McMurry-Heath, President and CEO of the Biotechnology Innovation Organization (BIO), made the following statement:
"Last week, Democratic leaders announced they had reached a drug pricing “deal.” We wanted to see the details before commenting.
"We have long fought for legislation to help patients with their out-of-pocket costs. Policymakers said that was their intention as well – and said that would be reflected in this “deal.” However, after reading through the nearly 3,000-page bill it seems as if they have continued to insist on using a price control scheme reminiscent of HR-3, which was rejected for being too extreme. CBO explicitly stated that legislation would reduce the number of new drugs for patients.
"The goal of the bill is to “build back better.” But for the scientists working in labs, this legislation makes building future drugs nearly impossible. This is one reason we ask that Congress take a deep breath and really understand what they are doing.
"This “deal” has been rushed and highly politicized. It will adversely impact clinical decision-making and deter investment in some of our society’s greatest unmet medical needs. Congress can do much better.
"When you dig into the legislative language, which was made available just yesterday, you quickly realize that in the race to solve a political problem, negotiators have adopted a risky and unintended approach that will hurt the very patients and seniors they are trying to help.
Unintended Consequences
"The centerpiece of the proposal -- “negotiation” -- is fundamentally government price fixing in disguise.
"The policy will create billions of dollars in market distortions and unintended consequences. It will disrupt our innovation ecosystem and crowd out the next generation of new therapies that could transform the standard of care for patients and help bring down our nation’s long-term health care costs. It will have enormous implications in what research investments are made and if important new classes of medicines can attract the funding they need to get from the bench to a patient’s bedside. To highlight one important consideration, the proposed legislation makes no accommodation for pediatric studies. We have significant concerns that these studies, often conducted later once a product has been in the realm of real-world evidence for some time, will suffer as products are targeted for price controls and the incentives for continued significant investment will dwindle.
"The COVID-19 pandemic has made clear the need for a robust biopharmaceutical sector. It has also highlighted exactly what our scientists, researchers, and entrepreneurs can achieve, with new vaccines and treatments developed in record time. We owe this historic success to the current ecosystem and policy environment that fosters and fuels innovation.
"Instead of building and strengthening this ecosystem, the drug pricing legislation released yesterday actively works to dismantle the foundation of one of America’s most productive and critical sectors. In effect, it will impair future efforts to combat health inequality, beat other deadly pandemics, and discover treatments for a myriad of other diseases from which millions of patients currently suffer. It will discourage investment in certain oncology drugs which are critical in the fight against various cancers and have long been a priority for the President. Moreover, the legislation directly impedes the successful operation of two long-standing bipartisan pieces of legislation: The Hatch-Waxman Act and the Biologics Price Competition and Innovation Act.
"BIO remains committed to smart, patient-focused policy solutions that will expand access to medicines -- all while preserving and protecting America’s status as the global leader in innovative drug development. This is why we strongly support legislation that reduces what patients pay out-of-pocket for their medicines and ensures more people, in more communities, can access groundbreaking medical breakthroughs. This “deal” falls far short of this commitment.
"We look forward to working alongside lawmakers and the current Administration to find solutions that achieve our vision for a healthier, more equitable America."