Tag Archives: Legislation

“Innovation for Healthier Americans” U.S. Senate Initiative Aims to Advance R&D

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On March 10, the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee held its first hearing on its “Innovation for Healthier Americans” initiative. Dr. Francis Collins, Executive Director of the National Institutes of Health (NIH) and Dr. Margaret Hamburg, Commissioner of the Food and Drug Administration (FDA) were the witnesses at the hearing. This Senate effort to accelerate the development of new cures and treatments for patients is a similar, parallel effort to the U.S. House Energy & Commerce Committee’s 21st Century Cures Initiative.  Both of these Congressional endeavors share a common goal with President Obama’s Precision Medicine Initiative, which involves increasing funding for multiple federal agencies in order to improve health information technology interoperability, while expanding and optimizing treatments for cancer in a variety of ways.

AstraZeneca supports the Senate HELP Committee’s Innovation for Healthier Americans Initiative. We provided initial recommendations to the Committee, encouraging them to focus on exploring potential enhancements to the qualification pathway for certain drug development tools, such as biomarkers. We also encouraged the exploration of ways to get the FDA to more readily embrace modern clinical trial designs and methodologies. We are encouraged that the Senate HELP Committee and the House Energy & Commerce Committee are interested in tackling this important issue and we stand ready to work with both Committees in support of their efforts to advance medical innovation during this Congressional session.

As articulated by Sen. Lamar Alexander (R-TN,) the Chair of the Committee at the hearing, the goal of this bi-partisan effort is the identification of what the Congress, along with the President, can do to reduce the cost and the amount of time it takes to discover a medicine and deliver it to patients.

While much of the discussion at the hearing centered on the need for adequate and consistent funding for the NIH and the basic science it conducts, there was also discussion of the important role that biomarkers can play in advancing personalized therapies for patients. Both Dr. Collins and Dr. Hamburg indicated their appreciation for having the opportunity to discuss what more can be done to drive innovation in our nation, with Commissioner Hamburg stating that she “wants the FDA to be a gateway, not a barrier, to getting safe and effective medicines to patients.”

Learn more about the Innovation for Healthier Americans initiative here and follow the latest on 21st Century Cures with #Cures2015 on Twitter.

AZ Supports 21st Century Cures Initiative

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By Jacqueline Kirby, Vice President, US Government Affairs

Jacqui KirbyCongress recently moved biomedical innovation in the United States forward in a significant way, as the House Energy and Commerce Committee unveiled its draft 21st Century Cures Initiative legislation and the Senate HELP Committee released its “Innovation for Healthier Americans” report.

We at AstraZeneca support the 21st Century Cures Initiative as we noted last August. We believe it is an important step toward encouraging the discovery of cures and treatments for some of the most debilitating diseases and conditions while helping to ensure that the United States remains at the forefront of biomedical research.

The 21st Century Cures Initiative is designed to “take a comprehensive look at what steps we can take to accelerate the pace of cures in America.” The House E&C Committee examined “the full arc of this process – from the discovery of clues in basic science, to streamlining the drug and device development process, to unleashing the power of digital medicine and social media at the treatment delivery phase,” as noted in the mission statement.

Upon initial review, we are pleased to see that the draft of legislation addresses many of the topics we included in our written recommendations to the Committee, including biomarkers, antibiotic drug development and reimbursement, utilizing real world evidence for regulatory decision-making, modernizing clinical trials (through encouraging broader use of Bayesian statistics and adaptive trial designs), and FDA review and evaluation of combination products.

AstraZeneca likewise applauds the Senate HELP Committee’s release of the “Innovation for Healthier Americans” report. “’Innovation for Healthier Americans’ is an important call to action, soliciting input and participation from the full universe of stakeholders interested and/or involved in medical innovation in America,” former FDA Commissioner Dr. Andrew von Eschenbach wrote in introducing the report. The report aims to examine the current drug development process, identifying inefficiencies in this process that stand in the way of bringing new medicines to patients and soliciting stakeholder feedback.

AstraZeneca is committed to working closely with members of Congress on the 21st Century Cures Initiative and on the related Senate FDA reform effort in the months ahead to ensure the United States remains a leader in biomedical research.

21st Century Cures Twitter 2.2.15

Keeping Prescription Drugs Accessible

The Medicare Prescription Drug program, Medicare Part D, has been a successful public-private program that has literally changed lives by providing improved access to prescription drugs.  We believe it works for the seniors who rely on it and that its competitive, market-based structure has kept overall program costs low.  For these reasons, we have suggested:  Don’t mess with success.

We do not support policy proposals that suggest altering the benefit structure for those who receive Part D’s low-income subsidy (LIS).  These patients are among the most vulnerable in the program and stand to be harmed by proposals that would lower nominal co-pays on generics, while increasing brand drug co-pays.

Changing Part D prescription drug cost-sharing policies may have negative consequences for the people the program serves.  First, decreasing or eliminating some co-pays while increasing others can impact the prescribing decisions of physicians who are best suited to provide care and make clinical treatment decisions for their patents.  Second, a policy to encourage generic medication use by increasing co-pays for brand medicines assumes that patients’ financial considerations drive physicians’ prescription choices, as opposed to severity of illness or other health factors.

At AstraZeneca, we believe in the right medicine for the right patient.  Sometimes the right medicine will be a generic drug and sometimes a patient will require a branded product.  This decision is made by the  physician, and when a branded product is recommended, arbitrary cost-sharing proposals should not render the medication out of reach for the patient.  Generics are not always medically appropriate substitutes for brand medicines in a given class of drugs, and for the treatment of some diseases, a generic version of a branded drug may not even exist.

It should be noted that MedPAC, an independent Congressional agency that advises Congress on issues affecting Medicare, shows high generic use among Part D enrollees – approximately 74 percent of LIS beneficiary prescriptions in 2011.

LIS beneficiaries  – a group that MedPAC says are more likely to be disabled and tend to have a greater disease burden than non-LIS enrollees – would as a result be gravely impacted by any proposed changes to increase brand medicine co-payment amounts.  These proposals unfairly penalize patients who need brand medicines rather than generics, and patients who need multiple brand drugs, including those with chronic conditions who need medications on a regular, sometimes monthly basis.

If faced with higher out-of-pocket expenses, the most vulnerable Part D patient population may attempt to switch to less costly alternatives or worse – may delay or forego their use of prescribed medicines.  Such an outcome may actually lead to higher overall Medicare costs.  In 2012, the Congressional Budget Office (CBO) acknowledged that policies that increase the use of prescription medicines would decrease Medicare medical spending, and we believe the converse to be true as well. We want to encourage adherence, not discourage it.

In the end, it comes down to choices we like and those we don’t.  Medicare Part D beneficiaries have an increasing number of plan options in 2014 from which to choose – that’s a good thing.  Beneficiaries making choices that vary from their physicians’ recommendations, likely leading to higher overall healthcare costs – that’s a bad thing.  That’s why we return to the same refrain about Medicare Part D:  Don’t mess with success.

Making patent reform a priority

It’s heartening to see Senate Majority Leader Reid place patent reform legislation at the top of the agenda when Congress returns from recess.

The Senate will take up the House’s version of a bipartisan patent reform bill immediately after its summer recess in hopes of putting a bill on the president’s desk before the fall, The Hill reports.

The modernizing and strengthening of the U.S. patent system will encourage precisely what a strong patent system should – research and development of                                             innovative products and technologies throughout the economy.

More information on this legislation is available here.