Category Archives: Legislation

AZ Submits Recommendations to the Committee on Energy and Commerce to Better Serve Patients

With 3D printers that create human body parts to wearable technologies that transmit patients’ vitals in real-time to physicians, the paradigm of drug development is changing more rapidly than ever before. While the opportunities for innovation are boundless, recent figures from FasterCures, a center of the Milken Institute, suggest that there are still only 500 treatments available for an estimated 7,000 known diseases.

AZ1442_screenAt AstraZeneca, we’re committed to pushing the boundaries of drug development to get our medicines in the hands of those who need them most. This isn’t easy. For example, according to PhRMA, it takes drug companies 10-15 years to develop a new medicine, and costs $1 billion on average. For good reason, there are many laws and regulations that govern every step of the development process, but we need to ensure these laws do not unnecessarily hinder  innovation.

That’s why we’re excited to see the Committee on Energy and Commerce, part of the U.S. House of Representatives, taking a comprehensive look for the first time at how they can help pave the way for new cures and treatments for patients through the 21st Century Cures Initiative. The Committee on Energy and Commerce has  responsibility for a number of the nation’s key priorities, including food and drug safety, and oversight of multiple agencies like the Food and Drug Administration. Over the next several months, the Committee will continue to focus its efforts on finding ways to expedite the discovery, development and delivery of innovative treatments to patients. Representatives will examine how we conduct research, looking at newly available technologies and assessing the need to break down outdated administrative and procedural hurdles, to ensure the U.S. remains a leader in biomedical innovation. And they’re asking for input.

21st Century CuresMany key industry stakeholders have submitted recommendations to benefit the healthcare industry and patients around the world. On August 12, the President of AstraZeneca U.S., Paul Hudson, and Chief Medical Officer, Briggs Morrison, pledged our support for the initiative and submitted our recommendations, which:

  • ask the Committee to support translational research (research that turns basic discoveries into applicable outcomes);
  • encourage the modernization of the clinical trial ecosystem;
  • promote the regulatory acceptance of modern clinical trial designs, tools and methodologies; and
  • suggest that the Committee ensure that payers and formularly committees have relevant information about medicines from manufacturers to speed patient access to newly developed medicines.

It is our hope that these recommendations, taken together, can help to transform the healthcare industry, improve the lives of patients and dramatically enhance the current standard of care. We’ve already had several discussions with the Energy and Commerce Committee, and we applaud their efforts to look at how the Congress can play a role in accelerating progress in advancing medicine. We look forward to continuing this dialogue as part of our efforts to deliver on our ambition to achieve scientific leadership.

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.

New Law Protects Patients from Unsafe Medicines

While the U.S. pharmaceutical distribution supply chain is considered among the safest and strongest in the world, public health experts agree it is critical to remain vigilant in protecting it against infiltration and unsafe medicines.  In an effort to safeguard this complex and critical system and ensure Americans receive safe medications, President Obama has signed into law the Drug Quality and Security Act.

The new law enhances the security of the U.S. supply chain by establishing one uniform, federal standard for drug traceability.  Its enactment prevents the development of a patchwork of potentially conflicting state laws that would make manufacturer compliance difficult, and that would not adequately protect patients in all fifty states.

This law’s enactment is a significant and long awaited achievement.  It provides patient safety benefits through provisions based on the strongest state models.  The law also grants the Food and Drug Administration (FDA) new authorities and enhanced oversight to minimize the risk of illicit trade in the U.S. distribution network.  It requires that prescription drug packaging utilize serialization and advanced technologies to trace the source of prescription products and their distribution histories from the manufacturer to the pharmacy counter.  Further, it will institute an unprecedented accountability system that significantly improves the ability of the FDA and the industry to promptly recall products.

Working collaboratively and developing strategic alliances is an integral part of AstraZeneca’s global product strategy.  The company supported this legislation in Congress,  actively  working with legislators, industry groups and other stakeholders to ensure its passage.  AstraZeneca appreciates Congressional members’ commitment to this issue, and looks forward to continued efforts to implement this law which will help to make certain that the drugs patients receive are safe and effective as they travel through the U.S. supply chain.

House passes bill to protect America’s drug supply chain

Pharmacy imageOn June 3rd, the House of Representatives passed the Safeguarding America’s Pharmaceuticals Act of 2013.

The bipartisan legislation would enhance the security of the pharmaceutical distribution supply chain for America’s patients while preventing duplicative federal and state requirements from being imposed on drug manufacturers, wholesale distributors, and pharmacies.

Further, the legislation would establish a collaborative, transparent process between the FDA and stakeholders in order to better understand how and when to move to unit-level traceability.

A similar bill is pending before the U.S. Senate, currently scheduled to be considered in early July.  The bills would then proceed to a Conference Committee with the goal of being signed into law by the President in early August.

AstraZeneca is pleased with the passage of this legislation and supports the protection of patients from counterfeit medications.

House approves counterfeit drug legislation

The House approved anti-counterfeiting legislation Monday.

AstraZeneca commends the U.S. House for passing bipartisan legislation to increase fines for individuals or companies caught selling fake medicines in the United States.

We’ll let bill co-sponsor Rep. Patrick Meehan of Pennsylvania explain the legislation, which cleared the House late Monday:

“With prescription drug costs rising, understandably people go online to find discounts on the drugs they need – seniors especially,” said Meehan. “All too often, the drugs they receive are counterfeit. Although it’s illegal to traffic in counterfeit goods, current law clearly is not an adequate deterrent. Stronger penalties are needed to deter the sale of these dangerous counterfeit drugs.”

The current penalties for introducing counterfeit drugs into interstate commerce are no different than those for trafficking other products, such as electronics or clothing. The Counterfeit Drug Penalty Enhancement Act will increase these penalties for criminals that knowingly manufacture, sell or traffic counterfeit medicines to the United States.

“We’re not just talking about mislabeled pills,” Meehan continued. “These drugs can have toxic additives, no active ingredient or a different active ingredient than what the patient believes they are taking. These drugs can be fatal.”

Meehan’s bill would increase the penalties to allow maximum fines and prison terms of $5 million or 20 years, or both, for an individual’s first offense and $15 million or 30 years, or both, for subsequent offenses. Businesses would be fined up to $15 million for a first offense and $30 million for subsequent offenses.

Similar legislation passed the Senate in March. Meehan said he is working to resolve any differences in the bills, which would allow the legislation to be sent to President Obama.

PDUFA: Seeking a more efficient drug review process

The US Congress must reauthorize PDUFA by September.

Sarah Kliff of the Washington Post has an instructive story up about the Prescription Drug User Fee Act – also known as PDUFA – and why it is important.

Kliff writes:

Right now, there’s a big health policy battle brewing on the Hill. It’s not about Obamacare. It has nothing to do with repeal — and everything to do with PDUFA, a very important law with a very funny name.

Try and get past the quirky acronym, which sounds more like a children’s cartoon character than a crucial piece of health policy. Because PDUFA is actually quite serious. It stands for the Prescription Drug User Fee Act. It generates the vast majority of the federal government’s budget for reviewing new medications. And so it plays a huge role in determining how safe our health-care system is, and how quickly we get access to new drugs.

PDUFA was first enacted in 1992 and authorizes the US Food and Drug Administration to collect fees from biopharmaceutical companies to help pay for the regulatory review process of medicines and biological products.

It was renewed in 1997, 2002 and 2007. The law paid for $573 million in drug review costs in fiscal year 2010. That accounts for 62 percent of the review costs for that year, according to the FDA’s most recent PDUFA financial report.

The law, however, is set to expire and must be reauthorized by September. More from Kliff:

Among all the players on PDUFA, there’s pretty widespread agreement that this is a fee that pharmaceuticals should be paying. It’s a law that nearly everyone, from Republicans to Democrats to industry, thinks is working. PhRMA’s David Wheadon describes it as a “great success for patients.”

The question, now, is whether Congress can keep the law working. PDUFA doesn’t make many headlines. But it’s the one piece of must-pass health policy legislation in 2012. Legislators have about five months, and a lot of details to sort out.

Because AstraZeneca stands for a strong, well-funded and well-managed FDA, we support a timely reauthorization of PDUFA that provides much needed resources to the agency.

We hope that the resulting legislation will lead to a more efficient, predictable, transparent and well coordinated drug review process within the FDA while strengthening the scientific base at the agency, supporting patient safety and promoting innovation.

AstraZeneca backs counterfeit drug legislation

AstraZeneca is supporting the Counterfeit Drug Penalty Enforcement Act. Photo via LostBob Photos at flickr.

AstraZeneca sent a letter to members of Congress today to express support for legislation that would increase penalties for those convicted of counterfeiting prescription medicines.

The letters sent to bill sponsors Rep. Patrick Meehan, Sen. Patrick Leahy, Sen. Chuck Grassley and Rep. Linda Sanchez note that the issue of counterfeit medicines is particularly serious via “Internet pharmacies”:

While the total incidence of counterfeit medicines sold in “brick and mortar “ pharmacies in the U.S. is estimated to be less than 1 percent of the total market value, the World Health Organization estimates that over 50 percent of medicines purchased from Internet sites without a physical address are counterfeit.

You can see the World Health Organization fact sheet on the issue here.

The letter concludes:

Although the trafficking of counterfeit drugs is currently illegal in the United States, the penalties for such activity are the same for the trafficking of other products. The Counterfeit Drug Penalty Enforcement Act would significantly and meaningfully increase penalties for the trafficking of counterfeit drugs to reflect the severity of the crime and the harm to the public. The proposed sanctions and sentencing guidelines would serve as powerful deterrents to pharmaceutical counterfeiting, greatly benefitting patient safety and health.

Additional details on the bill can be found here.

Medicaid, budgets and patients: What must be done

As states transition or consider transitioning the Medicaid pharmacy benefit over to a managed care system, policymakers and regulators must ensure the program has protections in place for patients in need.

Editor’s note: Last week, we ran a four-part series on proposals in several states that would change the way they administer the pharmacy benefit in their Medicaid programs – transitioning from traditional fee-for-service Medicaid to a managed care model. Here is the full series in one story.

At a time when all levels of government – from cities and towns to states to the federal government – are taking a hard look at their finances, many states are seeking to find savings in their public health programs.

Some states – including New York, Kentucky, Texas and Ohio – are looking to reduce costs by considering moving their Medicaid pharmacy benefit from a fee-for-service model to a managed care system.

At its essence, this means these states would no longer pay for health care services separately for individual patients – and instead would impose a cap on total spending for patients that is below the fee-for-service model.

As John Iglehart of Health Affairs recently noted:

(The) most transformative change that states are embarking on is contracting with private managed care plans to provide care for more beneficiaries – especially the most expensive ones, the aged and disabled. And although the evidence suggests that states are in fact likely to achieve billions of dollars in savings through these arrangements, the impact on beneficiaries’ quality of care or their health outcomes is a major unknown.

What is AstraZeneca’s view of these potential changes?

In this extended blog post, we’ll be taking a look at different aspects of the proposals at the state level – most notably:

  • Under this model, who is making the decisions for patient care?
  • Do these changes put at-risk patients in greater jeopardy?
  • What kind of patient protections should be included in any Medicaid model?

Finally, here are some definitions of the programs we will be discussing in the posts:

Medicaid is a public health insurance program run by the states in partnership with the federal government. It is available to low-income residents who do not have private health insurance and meet certain eligibility requirements, which vary by state. More information is available at the Centers for Medicare and Medicaid Services website here.

Fee for service is the traditional Medicaid program in which health care providers are reimbursed for the individual services they provide. The state of Indiana provides useful information on the program here.

As noted above, Medicaid managed care plans provide set dollar benefit amounts for all services per patient – rather than reimbursing for individual services under the traditional fee-for-service Medicaid program. Read more here.

Doctors Know Best

Doctors know best what treatment options their patients need.

As we noted above, Health Affairs raised the question of what the Medicaid managed care model would mean for patient care.

One of the biggest reasons for this question is that changing to a managed care model could limit treatment options that doctors may consider when deciding how to treat Medicaid patients. This is because of caps imposed on the number or variety of services and/or treatments doctors may consider when treating these patients.

AstraZeneca believes that as any state considers a change to Medicaid, patients under managed care programs should have the same rights and protections they currently enjoy under traditional fee-for-service Medicaid.

Without these protections, the government becomes a barrier between patients and their doctors. Medicaid patients being shifted to managed care programs should receive at least the same coverage of and access to their medicines as they previously received under fee for service.

Why?

Doctors are best qualified to determine the best treatment for an individual, and a one-size-fits-all formula doesn’t work when determining the best care.

These decisions should be based on medical history, family history, drug interactions and other factors that doctors use in concert to prescribe the right treatment for patients.

Doctors carefully evaluate many factors when deciding on treatment for a patient and combine specific patient information with their medical training and judgment to prescribe the best medicine for individual patients.

Patients and doctors often work together for a long time to find the best medicine for the individual patient.

That progress cannot be lost and the patient should not be forced to endure a new medicine based on a government rule or guideline.

Patients at Risk

Medicaid is an essential program for millions of Americans who do not have private health insurance.

How essential? Consider a study of the Oregon Medicaid program that found:

  • One year after the enrollment, those receiving Medicaid benefits reported they had received 30 percent more hospital care than their uninsured counterparts, in addition to 35 percent more outpatient care and 15 percent more prescription drug care.
  • Medicaid patients were 70 percent more likely to find a regular doctor.
  • Insurance coverage decreased the probability of having a bill sent to a collection agency by 25 percent, out-of-pocket medical expenses by 35 percent and the need to borrow money or skip other bills by 40 percent.

Given the importance of Medicaid to these patients, they should have the same medical options available as elected officials and other public employees – and decisions about their care should be left to their doctors, as we noted above. Otherwise, those at risk will suffer most.

In many cases, doctors may not have full treatment options for vulnerable patients if states substitute government’s medical judgment for that of medical professionals.

Without patient protections, a patient’s choice will be to either use a medicine that the doctor and patient already know is ineffective – or submit confusing paperwork and wade through a bureaucratic government process to get the care that their physician recommends.

Doctors must be allowed to give the care that they judge to be most effective.  Including patient protections in managed care Medicaid plans is a simple step to protect patient health while saving money and time for all involved.

Patient Protections

As states transition or consider transitioning the Medicaid pharmacy benefit over to a managed care system, policymakers and regulators must ensure the new program has the same protections in place for patients in need.

Fee-for-service Medicaid patient protections provide a clear example of the types of pro-patient policies that should also be included in a managed care Medicaid system

What kind? Fee-for-service Medicaid patient protections provide a clear example of the types of pro-patient policies that should also be included in a managed care Medicaid system.

These established policies provide an accepted standard of patient protection in the Medicaid system and are a road map to preserving good patient care.

The following standards must be adopted from fee for service to managed care:

Continuity of Care  – If a patient is already being effectively treated with a specific medicine, they should not have to change medicines as a result of the state’s Medicaid policy.  Often patients and doctors work together for a long time to find the best medicine for the individual patient.  That progress cannot be lost and the patient should not be forced to endure a new medicine based on a government rule or guideline.

Prescriber Choice – A system must be included in managed care Medicaid plans that allows the expert opinion of a trained medical professional as to the best care for the patient to supersede the bureaucratic recommendation.  This is paramount to good healthcare and the safety of the patient.

Public Input – The formulary for managed care Medicaid should be arrived at in a transparent way, creating an opportunity for the interested, knowledgeable public to have their input included.  Patient advocates and healthcare providers have expertise, knowledge and experience that are indispensable when arriving at the best policies to provide healthcare to Medicaid patients.

Taken together, these protections will ensure patients will receive the care they need through the Medicaid program.

US Senate takes on the Superbugs

Congress should do everything it can to pass S.1734

Today the Senate introduced S.1734 – “A bill to provide incentives for the development of qualified infectious disease products,” which would provide balanced incentives for antibiotic research and development.

This is important because infection-causing bacteria, or Superbugs, are fighting back against the antibiotic therapies that are currently available to doctors and their patients.

At a time when nearly 2 million people get infections while in U.S. hospitals each year and almost 100,000 of them die as a result, the pipeline for new treatments is bleak.

As we explain here, the current regulatory environment is ridden with obstacles for biopharma companies to develop new antibiotics to beat these Superbugs.

The Senate bill mirrors legislation that was introduced in the House earlier this year and addresses regulatory challenges by proposing:

  • an extended term of exclusivity for infectious disease products, combined with priority review and fast track provisions
  • additional extended exclusivity provided for companion diagnostic tests
  • requirements of FDA to provide much-needed guidance on the conduct of clinical trials for antibiotic drugs generally as well as, upon request, specific advice on nonclinical and clinical investigations for individual qualifying pathogens

Congress should do everything it can to pass S.1734. It’s time for the fight against the Superbugs to move beyond our labs and into the hands of doctors who are on the front lines of patient care.

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Medicaid, budgets and patients part four: Patient protections

Fee-for-service Medicaid patient protections provide a clear example of the types of pro-patient policies that should also be included in a managed care Medicaid system

This week, we are taking a look at proposals in several states that would change the way they administer the pharmacy benefit in their Medicaid programs – transitioning from traditional fee-for-service Medicaid to a managed care model. Today we look at what patient protections must be included in Medicaid programs. Earlier posts can be found here, here and here.

As states transition or consider transitioning the Medicaid pharmacy benefit over to a managed care system, policymakers and regulators must ensure the new program has the same protections in place for patients in need.

What kind? Fee-for-service Medicaid patient protections provide a clear example of the types of pro-patient policies that should also be included in a managed care Medicaid system.

These established policies provide an accepted standard of patient protection in the Medicaid system and are a road map to preserving good patient care.

The following standards must be adopted from fee for service to managed care:

Continuity of Care  – If a patient is already being effectively treated with a specific medicine, they should not have to change medicines as a result of the state’s Medicaid policy.  Often patients and doctors work together for a long time to find the best medicine for the individual patient.  That progress cannot be lost and the patient should not be forced to endure a new medicine based on a government rule or guideline.

Prescriber Choice – A system must be included in managed care Medicaid plans that allows the expert opinion of a trained medical professional as to the best care for the patient to supersede the bureaucratic recommendation.  This is paramount to good healthcare and the safety of the patient.

Public Input – The formulary for managed care Medicaid should be arrived at in a transparent way, creating an opportunity for the interested, knowledgeable public to have their input included.  Patient advocates and healthcare providers have expertise, knowledge and experience that are indispensable when arriving at the best policies to provide healthcare to Medicaid patients.

Taken together, these protections will ensure patients will receive the care they need through the Medicaid program.

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