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The House of Representatives passed H.R. 3 in a nearly straight party-line vote last week. While prescription drug pricing reforms are needed, the legislation would unravel many of the market incentives that have made America the undisputed leader bringing new medicines – and new hope – to people facing devastating diagnoses.
Bipartisan legislation crafted by the Senate Finance Committee, and supported by the White House, is the last opportunity Congress has to strike a sensible bargain that lowers drug costs for patients while sustaining America’s leadership in this vital field.
More than 21 years ago, a neurologist told my wife and I that our two youngest children, Megan and Patrick, had a rare form of muscular dystrophy called Pompe disease and that they would not live to be two years old. The doctor said that he was sorry and that there was nothing that could be done to save their lives.
EYEING 2020, HOUSE EMPOWERS MEDICARE TO NEGOTIATE DRUG COSTS
Thankfully, a combination of cutting-edge science and sustained bipartisan Congressional support for public and private investment and research into innovative medicines for rare diseases helped reverse a certain death sentence.
Today, our children are thriving. Our daughter Megan, despite significant physical disabilities, is a Notre Dame graduate well on her way to an advanced degree in social work.
John Crowley, his wife and daughter Megan Crowley. (Courtesy of the author)
Her heroism in the face of life-long adversity was recognized by President Trump in his first address to a Joint Session of Congress in 2017. Hundreds of thousands of other children with rare diseases and cancers have seen their lives saved and extended thanks to Congress’ longstanding commitment to medical innovation.
As a rare disease parent advocate and biotechnology entrepreneur, I am a staunch believer in America’s robust free market-based system of basic research and venture capital-driven entrepreneurship.
Biotech companies must flourish to ensure that we can translate rapidly advancing science into FDA-approved treatments. And I am confident that new regenerative medicine technologies like cell and gene therapies will increasingly help treat or even cure once untreatable or incurable diseases.
As a rare disease parent advocate and biotechnology entrepreneur, I am a staunch believer in America’s robust free market-based system of basic research and venture capital-driven entrepreneurship.
But while we are at a pivot point in science and medicine, I am deeply saddened and concerned by the collapse of trust in the biopharmaceutical industry.
A September Gallup poll found that the pharmaceutical industry is the “most poorly regarded in Americans’ eyes,” with respondents more than twice as likely to rate the industry negatively as positively – lower than even the federal government.
Companies who’ve taken double-digit annual price increases on marketed medicines have created cynicism about the entire industry’s authentic dedication to patients.
Blatant attempts to derail market competition by refusing to sell branded drug samples to generic companies who require them to meet FDA regulations and gaming the patent system to overwhelm new entrants has also undermined faith in Congress’ carefully crafted balance between incentivizing innovation and lowering prices through generic and biosimilar competition.
To regain public trust, companies must demonstrate by their actions that meeting the needs of patients is their first obligation above all others. Medicines that are not fully accessible to all citizens undermine the sustainability of this ecosystem -- and ultimately will imperil the health of us all.
Still, there are clear limits to what individual companies – or even the pharmaceutical industry - can do to make health care more affordable and accessible for all Americans.
That’s why in addition to calling for industry to embrace meaningful self-regulation and patient-focused behaviors, I support bipartisan efforts in Congress to link drug pricing to broader health care reforms.
The Senate Finance Committee’s bipartisan Prescription Drug Pricing Reduction Act of 2019 is currently Congress’ best chance to strengthen public and private efforts to shift health- care payments from volume to value without derailing innovation.
The Senate legislation would cap medicines’ cost growth to Consumer Price Index while addressing other critical issues like out‐of-pocket limits on copays for seniors in Medicare Part D and providing state Medicaid programs the flexibility to engage in novel payment-over-time agreements with manufacturers of potentially curative gene therapies.
While limiting price increases for certain medicines to CPI may seem anti-free enterprise, it is necessary here to counter the failure of market forces to limit price increases.
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If competition were fierce and fair, this would be rightly viewed as unnecessary government intrusion into the marketplace. The reality is that the marketplace has failed because of the uneven power that many drug companies wield to enable these oftentimes unjustified price increases.
While addressing drug pricing, both the House and Senate should also require pharmaceutical benefit managers and insurers to pass more drug pricing rebates directly into the hands of patients with serious chronic diseases. It’s unconscionable that patients can pay hundreds or thousands of dollars out of pocket annually for their medicines based on drug list prices that no insurer pays.
Unfortunately, other policies debated in Washington, like international reference pricing, would extinguish hope for millions of American families facing a devastating diagnosis by sharply diminishing incentives to bring new medicines to market.
One-size-fits-all pricing policies have hamstrung innovation abroad. Adopting those polices would leave our patients far worse off by crippling venture funding for small and mid-size biotech companies, who conduct about 70 percent of all clinical trials.
The California Life Sciences Association found such a policy could result in an 88 percent reduction in the number of new medicines that are brought to market by small/emerging companies due to changed investor behavior. The decline would be felt most in higher-risk populations suffering from genetic and rare diseases, and pediatric cancers.
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Under the most extreme proposals, the financial, physical, and emotional burden of disease on families would rise as hopes of better treatments recede. Very quickly, innovative capital would shift from the U.S. to China – putting our nation’s long-term health and economic security at risk.
Pragmatic bipartisan reforms are the best path for restoring balance in drug pricing while maintaining American leadership of a vital global industry that has been the source of so many medical miracles – and that is poised to deliver so many more in the years to come.
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