Lost cures and innovation, too high a price for Democrats’ drug pricing proposals

Democrats and Republicans alike can agree on one thing: prescription drug prices are unacceptably high. Predictably, however, we cannot seem to agree on a proper solution to this urgent issue.

The Trump administration has, thankfully, kickstarted efforts and approved record numbers of generic drugs while simultaneously lowering overall prescription drug prices by 13 percent. It is our responsibility in Congress to keep this momentum going and establish permanent fixes to the current pharmaceutical pricing standards. Despite the efforts of Republicans to make bipartisan progress to reform the prescription drug standards, our Democrat colleagues refuse to collaborate.

Unfortunately, the so-called “solutions” my Democrat colleagues have presented are inadequate and misguided. Their primary proposal, H.R. 3, The Elijah E. Cummings Lower Drug Costs Now Act, is not only an egregious government overreach, but would negatively affect seniors by expanding entitlements and disregarding the Medicare trust fund. This could risk the ultimate failure of the entire program and almost certainly increase out-of-pocket costs for our seniors.

Perhaps most concerningly, it would strangle innovation among the pharmaceutical industry and therefore prevent potential cures. The Congressional Budget Office (CBO) predicts that H.R. 3 would likely result in 38 fewer cures over the next 20 years. For an American waiting for a cure to save their life, this is unacceptable.

That is why the Republicans presented H.R.19, the Lower Cost, More Cures Act, a common-sense and inclusive drug pricing proposal. H.R. 19 sought to incentivize competition in the market to drive prices down and expand market access for more generic and biosimilar drugs. Despite the fact that each of the individual provisions included within H.R.19 were originally bipartisan bills, this legislation has not been spared the classic politicization of Speaker Nancy PelosiNancy PelosiBrown says Biden’s first moves as president should be COVID relief, voting rights Sunday shows – Spotlight shifts to positive tests among Pence aides Pelosi dismisses talk of White House compromise on stimulus: They ‘keep moving the goal post’ MORE (D-Calif.) and has failed to receive proper consideration on the House floor.

Specifically, this legislation contained more than 40 bipartisan provisions that would have been able to go to the president’s desk immediately to be signed into law and help our families. For drug pricing, it provided language for increased pricing transparency, public disclosure of drug discounts, a study of pharmaceutical supply chain intermediaries and merger activity and makes prescription drug marketing sample information reports available to individuals.

With over 3.5 million of my fellow Floridians enrolled in some form of Medicare prescription drug coverage, these issues have always been a top priority. For Medicare Part B, H.R. 19 would have provided increased pricing transparency by expanding a Medicare online tool to allow beneficiaries to compare costs. Additionally, the legislation would have also created maximum add-on payments for certain drugs and biologicals to help reduce out-of-pocket costs.

My constituents and countless Americans who depend on life-saving prescriptions everyday deserve better than the inadequate solutions that my Democrat colleagues have presented. While I was

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Trump administration proposals could stymie personalized medicine

“It is more important to know what kind of patient the disease has than to know what kind of disease the patient has.”

Although Hippocrates made this keen observation more than 2,400 years ago, physicians did not have the tools to decipher the biological and environmental factors influencing an individual’s health and well-being until recently.

Since the human genome was finally mapped in 2003, scientists have made tremendous progress in advancing personalized medicine. By tailoring health care to an individual’s biological characteristics, circumstances, and values, personalized medicine can bring unprecedented benefits to patients with rare genetic disorders, cancer, and other diseases.

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The widely variable effects of the novel coronavirus serve as a painful reminder of the importance of understanding how and why people respond differently to the same disease.

But two recent moves by the Trump administration threaten to turn back the clock on biomedical progress in personalized medicine, which most Americans want, by locking us into a one-size-fits-all world.

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In an executive order issued in mid-September, President Trump proclaimed his intention to cut drug prices by promising to tie what Medicare pays for prescription medications to their generally lower costs in other countries. These costs are most often based on crude one-size-fits-all health technology assessments.

The order would have a devastating effect on the future of personalized medicine and on patients’ access to lifesaving new drugs. By limiting the return on high-risk investment, it will make it more difficult for biopharmaceutical companies to bet on developing paradigm-changing products, including promising gene and cell-based therapies that may one day be able to cure, not just treat, sickle cell anemia, rare genetic disorders, some cancers, and other diseases.

The executive order was issued less than a month after the Department of Health and Human Services proposed eliminating the Food and Drug Administration’s authority to regulate laboratory-developed tests. That move may unfortunately decrease public confidence in groundbreaking diagnostic tests that have not undergone governmental review just when they are on the precipice of being able to predict cancer and Alzheimer’s disease in advance of the appearance of symptoms, when prevention and treatment plans may be more effective.

Drug pricing could and should encourage drug developers to focus on developing products that will deliver the most benefits to patients and society. Instead, in an effort to end what the president calls “global freeloading,” his executive order on pharmaceutical pricing would link the rates the Centers for Medicare and Medicaid Services pays for drugs covered under Medicare Parts B and D to the lower rates established by other developed countries. These rates are set using health technology assessments that typically do not acknowledge the heterogeneity of treatment effects, despite a rapidly expanding body of scientific evidence demonstrating that the effects of a drug often vary considerably among different subpopulations of patients.

Thus, at a moment when advanced data analytics, artificial intelligence, and real-world evidence are yielding unprecedented insights about which patients should receive which therapies, international reference pricing will rob the

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