FDA Teams With National Forum to Reduce Deaths from Heart Disease: Program is first of its kind

By: Heidi C. Marchand, Pharm.D.

In the U.S., only about 1 in every 4 prescriptions is taken as directed by a health care provider – a problem that costs our nation more than 125,000 lives a year. Millions of Americans with heart disease – the nation’s No. 1 killer – are especially vulnerable.

Heidi MarchandTo stem that tide, FDA has teamed with the nonprofit National Forum for Heart Disease and Stroke Prevention to advance the cause of a heart-healthy and stroke-free society.

FDA’s Office of Health and Constituent Affairs has signed a Memorandum of Understanding with the National Forum to promote and increase the use of health knowledge, skills and practices by the public in their daily lives. The five-year agreement is a first-of-its-kind cooperative public education program to reduce the burdens of heart disease and stroke.

Heart disease, which kills 1 in 4 Americans, can be managed. To prevent heart attacks, transient ischemic attacks and other cardiac events, doctors prescribe medications and lifestyle therapies (e.g. heart-healthy diets). Because medication is not readily adhered to – and neither are lifestyle treatments – millions of people suffer from preventable cardiac episodes. As a nation, lack of medication adherence (which can be as simple as not getting a prescription filled or refilled) costs more than $100 billion annually in excess hospitalizations.

To confront this problem, FDA is taking the lead in support of Million Hearts®, a national initiative of the Department of Health and Human Services to prevent 1 million heart attacks and strokes by 2017. A key partner in that mission is the National Forum, whose members include more than 80 U.S. and international organizations representing public, private, health care, advocacy, academic, policy and community sectors.

Together we will:

  • Explore, demonstrate and evaluate innovative health promotion concepts.
  • Exchange information on nutrition, heart disease, and ways to increase the number of patients who take their medication and/or therapy.
  • Identify and systematize best practices in behavior modification education.
  • Develop concepts for community-based interventions.

Our goals are clear: create recommendations to improve compliance with prescribed medical therapies and implement the recommendations to improve the lives of patients living with heart disease.

FDA’s Dr. Helene Clayton-Jeter and Dr. Fortunato “Fred” Senatore are leading a diverse team in identifying strategies to help patients take their medicines as directed and follow the advice of their doctors.

Concurrently, the National Forum will recruit a Therapy Adherence Steering Committee, made up of experts and stakeholders from physician and nursing groups, pharmacy (retail/system), behavioral health, consumer/patient groups and others invested in complying with medical therapy.

We’ll then jointly develop action plans for high-probability, high-yield strategies to promote heart health by helping ensure that patients take their medicines and adopt healthier lifestyles. Our plan is to complete all steps in the next several years.

We cannot fix this problem overnight. But by addressing it strategically, we can move forward and improve the odds of preventing and surviving heart disease and stroke among Americans.

Heidi Marchand, PharmD, is Assistant Commissioner in FDA’s Office of Health and Constituent Affairs

FDA Reaches Out to Minorities During Hepatitis Awareness Month

By: Jovonni R. Spinner, M.P.H., C.H.E.S

Did you know that millions of Americans (mostly baby boomers) are living with chronic Hepatitis and up to 2/3 may not even know they are infected? Annually, in May, the public health community commemorates “Hepatitis Awareness Month” to bring attention to this disease, its symptoms, testing, and treatment options. This year, we are working with the Centers for Disease Control and Prevention (CDC) to conduct outreach for minority groups most affected by Hepatitis: Asian/Pacific Islanders (API) and African-Americans (AA).

Jovonni SpinnerWhat’s the issue?

Hepatitis, which means “inflammation of the liver”, can cause nausea, abdominal pain, jaundice, joint pain, and malaise. Chronic hepatitis can lead to serious complications like cirrhosis, end-stage liver disease, or cancer. Hepatitis A (HAV), hepatitis B (HBV), and hepatitis C (HCV) are the most common strains found in the United States. Knowing your status and getting treatment early can potentially prevent these life threatening complications.

The statistics below show alarming disparities in the number of APIs and AAs being diagnosed with and dying from hepatitis.

Asian/Pacific Islanders

  • 50% or more of Americans living with chronic HBV are APIs
  • APIs experience mortality rates from HBV 7 times greater than Whites

African-Americans

  • 25% of all patients living with HCV are AAs
  • Among 45-65 year old AA’s, HCV-related chronic liver disease is the leading cause of death
  • HCV accounts for 8% of all AA deaths compared to 4% of White deaths
  • Patients with sickle cell disease (which primarily affects AAs) are at increased risk for contracting hepatitis if they received a blood transfusion prior to 1992, when blood banks began screening blood.

What is FDA’s Role?

FDA is committed to advancing the health, safety, and well-being of all Americans through the regulation of diagnostic tests, medicines, and vaccines, as well as monitoring post market safety of healthcare products and ensuring diversity in clinical trials. The most recent safety warning about possible side effects of hepatitis drugs can be found on FDA’s safety bulletin.

One area that my office specifically focuses on is increasing diversity in clinical trials. Data has shown that African Americans and other races respond differently to hepatitis treatments. For example, in the VIRAHEP-C clinical trial, 28% of African-Americans were cured by the tested treatment, compared to 52% of whites. These results highlight why it is important to increase diversity of participants in clinical trials so we can learn how all groups respond to FDA regulated products, thus helping to ensure the safety of medical products for all.

We are actively spearheading FDA’s efforts on the FDASIA 907: Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data. Under our leadership, we help the agency improve the quality and quantity of data collected; increase clinical trial participation; and increase the transparency of clinical trial data. In addition to the information on our website, we created a clinical trials brochure which discusses the importance of volunteering in clinical trials.

Call to Action

May 19th is National Hepatitis Testing Day!

Spread the word to increase testing and early treatment. These resources are available to help your community:

Patients and health professionals can receive updates about drug approvals, drug safety updates and other issues related to hepatitis by subscribing to the Hepatitis Email Updates.

More information about FDA’s OMH can be found here: www.fda.gov/minorityhealth

Follow us on Twitter @FDAOMH

Jovonni Spinner, M.P.H., C.H.E.S., is a Public Health Advisor in FDA’s Office of Minority Health

Biosimilars: New guidance from FDA to help manufacturers develop more treatment options

By: Leah Christl, Ph.D.

FDA has taken important new steps to continue to help manufacturers develop biologic products called biosimilars. Biosimilars are highly similar to, and have no clinically meaningful differences from, an already approved biological product. Biosimilars can provide more treatment options for patients, and possibly lower treatment costs.

Leah ChristlIn early March, FDA approved the first biosimilar, Zarxio (filgrastim-sndz), a biosimilar to Neupogen (filgrastim), used to help stimulate growth of white blood cells in patients with cancer and help them fight infection.

That’s a great start and we are pleased to see the progress. Manufacturers are working hard to develop more biosimilars for the U.S. market. By nature, biologic products are highly complex molecules, so developing biosimilar versions of these products is challenging. FDA is also working hard to help those manufacturers bring more biosimilars to the market.

Over the past few weeks, we have released four guidances for industry — useful tools to help manufacturers navigate the new terrain of biosimilar development.

  • One assists companies in demonstrating that a proposed product is indeed biosimilar to an existing biologic product, and is intended to provide clarity to manufacturers about the expectations for a biosimilar development program.
  • A second focuses on the analytical studies that demonstrate that the product is “highly similar” to an existing biological product, which supports the demonstration of biosimilarity.
  • A third guidance answers common questions about the biosimilar development and application process and contains information intended to provide a better understanding of the law that allows biosimilars development. 
  • A fourth, still in draft form — which means we are accepting public comment — answers a variety of additional questions that have arisen regarding the biosimilars development process.

Each of these guidances was developed to help industry more efficiently and effectively develop new biosimilars for patients in need.

Many of our most important, but also expensive, drugs are biological products. These products are used to treat patients who have a variety of serious and life-threatening medical conditions including rheumatoid arthritis, psoriasis, diabetes, and cancer.

Having more approved biosimilars is good for public health. FDA looks forward to continuing to help manufacturers develop these important products.

Leah Christl, Ph.D., is FDA’s Associate Director for Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research

FDA Science Forum to Focus on Emerging Technologies

Dr. Luciana Borio, FDA’s Acting Chief Scientist, invites you to the FDA 2015 Science Forum at our White Oak headquarters in Silver Spring, Maryland on May 27-28. We’ll be showcasing exciting, cutting-edge regulatory science research. For more information and how to register for the forum before the deadline of May 15, 2015, go to The FDA Science Forum.

Congratulations to FDA’s Dr. Richard Pazdur, recipient of the AACR’s prestigious Distinguished Public Service Award

By: Stephen Ostroff, M.D.

In the past five years, FDA’s Center for Drug Evaluation and Research (CDER) has approved more than 40 novel cancer treatments, offering hope to many patients who previously had few or no treatment options. Among these products are new and cutting-edge targeted therapies—sometimes called “precision medicines”—tailored to treat patients based on their individual characteristics.

Acting FDA Commissioner, Stephen Ostroff, M.D.

Acting FDA Commissioner, Stephen Ostroff, M.D.

This achievement is a tribute to the dedicated CDER scientists and clinicians who support innovative development of cancer drugs, and evaluate the safety and effectiveness of new products for FDA approval. They are led by the dynamic and creative thinker, Dr. Richard Pazdur, a 16-year FDA veteran whose name has become synonymous with excellence in cancer drug research, development, evaluation and approval.

It is with great pride and admiration that I share with you today that the American Association for Cancer Research (AACR) has awarded its 2015 Distinguished Public Service Award to Dr. Pazdur. AACR selected Dr. Pazdur for this award based on his “extraordinary, steadfast leadership in scientific and regulatory affairs” and his “unwavering commitment to ensuring the development of safe and effective treatments for cancer patients.” The Association also noted that Dr. Pazdur’s “important work has been and continues to be nothing short of spectacular, and it is saving lives every day from this most feared disease that affects so many.”

Dr. Richard Pazdur (left) receives the 2015 Distinguished Public Service Award from AACR President Dr. Arteaga

Dr. Richard Pazdur (left) receives the 2015 Distinguished Public Service Award from AACR President Dr. Arteaga. Photo by © AACR/Todd Buchanan.

As director of the Office of Hematology and Oncology Products (OHOP) at FDA, Dr. Pazdur leads a staff of more than 150 oncologists, toxicologists, and other specialists dedicated to approving safe and effective drugs for cancer and blood-related conditions. Dr. Pazdur and his staff are committed to facilitating rapid development, review, and action on promising new treatments to combat these diseases and improve patient outcomes. Dr. Pazdur and the OHOP staff are also committed to outreach with the oncology community. In 2005, Dr. Pazdur established the Oncology Program, which coordinates oncology activities within FDA as well as with external stakeholders providing OHOP with a unique infrastructure within CDER to interact with professional societies and patient advocacy groups.

We are grateful for Dr. Pazdur’s sustained contributions and look forward to many more years of his leadership, and his adept and proficient manner in helping patients in need.

Stephen Ostroff, M.D., is Acting Commissioner of the U.S. Food and Drug Administration

FDA’s Keynote Address to the Annual Conference of the Food and Drug Law Institute

By Stephen Ostroff, M.D.

Today marks the start of my third week as Acting Commissioner of FDA and I “celebrated” by giving a keynote address to attendees at the annual conference of the Food and Drug Law Institute (FDLI). Few places offer a more appropriate stage for a newly designated leader of FDA. As our names suggest, our organizations have a lot in common.

Stephen OstroffFor decades, the FDA and FDLI have worked together to educate and inform the broad “food and drug” community about the latest developments in our field and FDA’s critical and complex role in promoting and protecting the public health.

It’s been an exciting, busy, and rewarding first three weeks since moving into my new office from the position of Chief Scientist. The FDLI annual meeting offered me the opportunity to highlight a number of FDA’s accomplishments over the last year. The credit for these achievements in no small measure goes to the immensely talented employees at FDA who are committed to assuring safe and nutritious foods, providing effective and high quality medical products, and reducing harm from tobacco products. Credit for these achievements also reflects the extraordinary leadership of my predecessor, Dr. Peggy Hamburg, over the last 6 years.

So today, I’m pleased and honored to present to this audience some of FDA’s accomplishments and challenges, and also to extend my sincere appreciation to FDA’s dedicated work force, who make my new job much easier. But much more importantly, our work force makes the lives of so many Americans safer and healthier. It is with great pride that I look forward to continuing to work with all of you in support of this noble goal.

Stephen Ostroff, M.D., is Acting Commissioner of the U.S. Food and Drug Administration

FDA and CMS Form Task Force on LDT Quality Requirements

By: Jeffrey Shuren, M.D., J.D. and Patrick H. Conway, MD, MSc

Health care providers and their patients expect that laboratory tests used in clinical management of patients should be consistent and of high quality.

Jeffrey Shuren

Jeff Shuren, M.D., J.D.

Under FDA’s proposed framework for the oversight of laboratory developed tests (LDTs), outlined in draft guidance documents issued in October 2014, FDA would oversee the quality of these laboratory tests, alongside the Centers for Medicare and Medicaid Services (CMS), which regulate the laboratories themselves through the Clinical Laboratory Improvement Amendments (CLIA). We have heard stakeholder confusion about the roles of the two agencies in ensuring quality and concerns about potentially duplicative efforts. To coordinate efforts across the Department, FDA and CMS are establishing an interagency task force that will continue and expand on our collaboration related to the oversight of LDTs, which are tests intended for clinical use and designed, manufactured, and used within a single lab. The task force, comprised of leaders and subject matter experts from each agency, will work to address a range of issues, including those involving quality requirements for LDTs.

Patrick H. Conway, MD, MSc

Patrick H. Conway, MD, MSc

Under the proposed LDT framework, FDA would phase in enforcement of premarket review requirements and the quality system regulation for some LDTs. FDA’s oversight of LDTs will assure that the tests are both analytically valid (able to accurately detect analytes) and clinically valid (able to measure or detect the clinical condition for which the test is intended). FDA is currently reviewing public comments on the draft guidances that it received through an open public docket and a two-day public meeting. In response to public comments, FDA may modify the proposed framework when we issue final guidance.

CMS, under CLIA, oversees the labs’ processes, rather than the tests they develop. CLIA and its implementing regulations include requirements for establishing and maintaining quality laboratory operations and ensuring the lab is staffed by qualified personnel. These laws do not require premarket review of tests or any evidence that a test is clinically valid.

When FDA’s proposed framework is implemented, both FDA and CMS will play a role in ensuring that LDTs are high quality—CMS through CLIA by continuing to focus on laboratory operations including the testing process and FDA by enforcing compliance with the agency’s quality systems regulation pertaining to the design and manufacture of the laboratory tests.

Although the roles of the agencies are different, FDA and CMS share an interest in ensuring effective and efficient oversight of LDTs so laboratories can offer tests to the American public with confidence that they are accurate and provide clinically meaningful information without unnecessary or duplicative agency oversight.

The goals of the FDA/CMS Task Force on LDT Quality Requirements include:

  • identifying areas of similarity between the FDA quality system regulation and requirements under CLIA;
  • working together to clarify responsibilities for laboratories that fall under the purview of both agencies; and
  • leveraging joint resources to avoid duplication and maximize efficiency.

The task force is currently exploring areas where collaboration may realize greater oversight efficiency and produce the greatest benefit to patients, providers, and laboratories. The task force understands stakeholders’ concerns about differences in terminology used by FDA and CMS. We intend to clarify the terms used so that labs may better understand what is expected of them.

Our new task force is committed to its stakeholders and intends to provide education and outreach, including an upcoming webinar series, to address additional needs that are identified during this collaboration. We welcome any feedback and encourage you to contact us at LDTFramework@fda.hhs.gov.

Jeffrey Shuren, M.D., J.D., is Director of FDA’s Center for Devices and Radiological Health

Patrick H. Conway, MD, MSc, is Acting Principal Deputy Administrator CMS Chief Medical Officer

FDA Celebrates 30 Years of Advancing Health Equity

By: Jonca Bull, M.D.

April is Minority Health Month! I am proud to say that FDA’s Office of Minority Health (OMH), in collaboration with  the Department of Health and Human Service’s Office of Minority Health, is celebrating this year’s theme: “30 Years of Advancing Health Equity, The Heckler Report: A Force for Ending Health Disparities in America.” For us at FDA, this year also marks the 5th anniversary of OMH, which serves as the principal advisor to the Commissioner on minority health and health disparities.

Jonca BullThe Heckler Report was a major, ground breaking document that transformed HHS’s views and actions on minority health. For the first time in history, representatives from each agency convened to talk about minority health and, more importantly, put forth recommendations to achieve health equity. Findings illustrated huge disparities between African Americans and other minorities compared to the population at large for key health indicators, such as life expectancy and infant mortality. Key recommendations relevant to FDA’s mission centered around health information and education, cooperative efforts (inside and outside of the government), health professions development, data development, and developing a research agenda.

Let’s stroll down memory lane and recap FDA’s activities that resulted from the Heckler report.

Health Information and Education 

FDA has developed numerous outreach activities to improve consumer education and access to health information by utilizing the best cultural and linguistic practices to reach diverse minority populations. Hosting symposiums and webinars, participating in conferences, exhibiting in health fairs, and creating consumer educational materials are just some of the activities FDA has carried out to raise awareness and educate the public. Most recently, OMH has created a social media presence on Twitter and Pinterest, and maintains an active listserve with a quarterly newsletter. One of our most successful outreach campaigns has been the “Heart Health Toolkit” for American Heart Month, which reached over 6,000 people in February.

Our most recent consumer outreach occurred on March 25th via a webinar on how the public can respond to requests for comments on regulatory proposals and public health issues by using FDA dockets.

Cooperative Efforts/Health Professions Development

OMH embraces the notion that protecting the public’s health cannot be done in isolation. We have focused on four areas to improve stakeholder relations:

  • Work with Industry to increase diversity in clinical trials;
  • Work with minority serving institutions and organizations to implement strategies and programs to improve regulatory science (specific to minorities);
  • Provide platforms for stakeholders to become informed and involved about our work; and,
  • Host and promote mentoring programs to encourage minorities to stay in scientific and academic careers.

Data Development and Research Agenda

We have a robust research agenda that focuses on advancing regulatory science related to eliminating health disparities. The agenda consists of various intramural and extramural grant programs, giving preference to minority-serving institutions. FDA also promotes and funds research that aims to increase the quantity, and improve the quality, of data on minorities, and to make these efforts transparent to the public.

In short: FDA has been and will continue to be committed to narrowing the health disparities gap. OMH will continue our legacy of creating culturally and linguistically tailored tools, materials, and resources for minority communities to increase their awareness and understanding of FDA’s mission and of the products that FDA regulates, increase their participation in clinical trials, and increase diversity in the workforce. This ensures better representation in the workforce, and most importantly: better health for all minorities!

More information about specific programs can be found on our website.

The Heckler Report can be found at: http://collections.nlm.nih.gov/catalog/nlm:nlmuid-8602912-mvset.

Jonca Bull, M.D., is Director of FDA’s Office of Minority Health

Reducing the number of unapproved drugs while working to prevent drug shortages: a job that calls for strong collaboration in FDA

By: CAPT Val Jensen and Cynthia Schnedar

Val Jensen

CAPT Valerie Jensen R.Ph., Associate Director of the Drug Shortage Staff, Center for Drug Evaluation and Research, FDA

Several of FDA’s recent drug approvals highlight how different parts of FDA work together to achieve the same goal: ensuring an adequate supply of FDA-approved drugs for U.S. consumers. Our drug shortages team partners with many groups within the agency to achieve this goal. One of these partnerships is with our unapproved prescription drugs staff.

Patients and doctors alike may be unaware that some prescription drugs are not FDA-approved, because versions of some of these products have been marketed for decades, often with little data to demonstrate whether these drugs are safe and effective. At FDA, one task of our unapproved prescription drugs team is to identify these products, and encourage companies to remove unapproved versions from the market, and begin the application process to obtain FDA approval.

A growing number of manufacturers have successfully obtained approval for formerly unapproved products. For example:

  • Bloxiverz (neostigmine methylsulfate injection), marketed by Éclat Pharmaceuticals and approved to reverse the effects of certain neuromuscular blocking agents after surgery, was approved in 2013, and,
  • Vasostrict (vasopressin), marketed by Par Sterile and approved to increase blood pressure in adults in vasodilatory shock whose blood pressure remains low despite administration of fluids and other efforts to raise it, was approved in 2014.
Cynthia Schnedar

Cynthia Schnedar, J.D., Director of the Office of Compliance at FDA’s Center for Drug Evaluation and Research

Such approvals highlight the strength of collaborations between FDA’s shortages staff, our unapproved drugs team, and the Office of New Drugs. These approvals are crucial for FDA: once a drug is approved, we know what ingredients are in the drug, how it is made, and that it has been shown to be safe and effective for its labeled use. Approval of formerly unapproved products also helps alleviate FDA’s concerns about a potential market disruption or shortage of these drugs, because the manufacturers of approved drugs have invested in a manufacturing process that helps to ensure the drug is produced the same way every single time, lowering the risk for shortage.

However, prescribers and their patients may sometimes think there is a shortage of product because once the manufacturer can produce an approved drug in sufficient quantities to meet market demand, the unapproved versions transition out of the market. To help allay such concerns, FDA’s unapproved drugs team works closely with the drug shortages staff to share information about the availability of the newly-approved product from the manufacturer, information that is then conveyed to patients and providers. This strong relationship between the different parts of the Agency facilitates adequate supply of safe and effective, FDA-approved drugs.

FDA is aware of another access-related issue as well when unapproved drugs are approved. If a single manufacturer is the sole maker of a newly-approved product, the price of the drug may be higher than what patients and prescribers paid for the unapproved drug. FDA welcomes manufacturers’ sensitivity to pricing of these newly approved versions. However, FDA is charged by Congress to ensure that drugs are safe, effective and properly labeled and does not factor costs into its drug approvals or safety related decisions. While approved drugs may cost more, patients are assured a safe and effective product.

FDA encourages companies to apply for approval of generic versions of newly-approved drugs since this would be anticipated to foster competition and promote price reductions. For example, neostigmine, a formerly unapproved drug, now has two approved manufacturers. FDA expects to receive more applications for approvals in the future.

Making safe and effective medicines available to patients is our number one goal. While working to bring FDA-approved drugs to market frequently involves exceptional challenges and complications, we believe that in the long run, our efforts enhance public health for all Americans.

CAPT Valerie Jensen R.Ph., is Associate Director of the Drug Shortage Staff, Center for Drug Evaluation and Research, FDA

Cynthia Schnedar, J.D., is Director of the Office of Compliance, Center for Drug Evaluation and Research, FDA

From New Jersey to New Delhi, a global focus on quality

By: Howard Sklamberg and Cynthia Schnedar

As we walked through the bustling, ancient city streets of Old Delhi last week, teeming with tourists and shop keepers selling spices and saris, we were struck by how resplendent this country is, and just how much it offers the world.

Howard Sklamberg

Howard Sklamberg, J.D., FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

This is certainly true about prescription drugs. India is a significant exporter of generic drugs to the United States. The American people benefit tremendously from generic drugs, as more and more generic medications reduce costs for patients, and the American healthcare system. The rise of India’s pharmaceutical star is one of the reasons why our trip to India is so important.

While here, we have had a chance to meet with our regulatory counterparts in the Indian government, as well as the drug manufacturers that are either based here, or who have facilities in the country. Needless to say, we are learning a great deal.

It’s no secret there have been challenges associated with the quality of generic drugs coming out of some facilities in India. Some people have asked us here if the FDA is “singling out” India for increased inspections. We simply reply that increased exports to the U.S. result in increased inspection, no matter where you are in the world. FDA inspections ensure that when a firm wants to export drugs to the United States, the drugs meet FDA standards and will be of the quality patients and consumers want and deserve.

Cynthia Schnedar

Cynthia Schnedar, J.D., Director of the Office of Compliance at FDA’s Center for Drug Evaluation and Research

And we’ve been happy to hear that this focus on quality is, in fact, a shared goal, held by both the Indian — and India-based — regulators and pharmaceutical manufacturers with whom we’ve met. They understand what we mean when we tell them the FDA is interested in helping to build a global network of quality; that it doesn’t matter whether a drug is made in Hoboken or Hyderabad, if it is intended for use in the United States, the drug, and the way and under what conditions it’s produced, will be reviewed using the same standards and levels of scrutiny.

That scrutiny, by the way, doesn’t always have to have negative results. The inspections associated with drug production have been a central discussion point on this trip, and we’ve brought news that has been well-received, especially by the drug industry. We shared our proposed plan to create a new approach to facility inspections, one that will not only note problems, but will also allow our inspectors to document where a firm’s quality management system exceeds what would be required to meet regulatory compliance. To put it simply: the inspections can yield also carrots, and not just sticks.

Meeting in India

Last week, FDA’s Howard Sklamberg and Cynthia Schnedar participated in a panel discussion on drug quality with drug associations in India

So what are the carrots? These findings could be used to influence the frequency of our inspection of a particular facility, and possibly even support regulatory flexibility around post-approval manufacturing changes. These kinds of decisions would be anchored by data that proves that the risks of manufacturing problems in a certain facility are minimal.

We have often said we cannot inspect our way to absolute drug quality. Many of our discussions on this trip have focused on the importance of firms enhancing their own “quality cultures.” And, to that end, we know there are initiatives we can take to help them succeed. For example, we will be piloting a new questionnaire that could be used to further standardize inspections, with the goal of uniformly harvesting the kind of data that supports accurate measures of quality. We believe that by improving the inspection process in this way, future “metrics” that define quality will be understood and aspired to by manufacturers — no matter where they are in the world.

CEO meeting in India

Last week, FDA’s Howard Sklamberg and Cynthia Schnedar met with pharmaceutical CEOs in India to discuss drug quality

Of course, enforcement has been, and will continue to be, an important part of our program to ensure drug quality. Enforcement is a particularly appropriate tool when a firm does not submit accurate data to us. FDA relies on information to do its job, and faulty information means that we cannot ensure the quality of the drugs that the firm produces.

It is already clear to us, after speaking with regulators and industry leaders here, that India intends to be part of that global community that is committed to producing the highest quality of drugs possible. Through workshops and joint inspections, we continue to work with the Indian government to raise awareness and understanding of our inspections processes. And to the industry leaders we have met with here, we have pledged to continue to collect their feedback on how we might be able to help them improve regarding quality issues, and to incentivize them to do so.

India has a significant spot in the constellation of drug-producing nations. As one Indian official so eloquently said to us, we have “a galaxy” in common. And, we are happy to add, that the brightest star in that galaxy may just be our shared commitment to a global system of drug quality.

Howard Sklamberg is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

Cynthia Schnedar, J.D., is Director of the Office of Compliance at FDA’s Center for Drug Evaluation and Research