Category Archives: Medical Devices / Radiation-Emitting Products

FDA’s Collaboration with Chinese Partners Gets Stronger Each Year

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By: Mary Lou Valdez

“What’s in a name?” Shakespeare famously asked. “A rose,” his Juliet reasoned, “by any other name would smell as sweet.” And often, we know, that’s true.  But other times, a change in name can signify some larger, more substantive shift.

The latter was the case in mid-April when we sat down in Washington to meet with one of China’s key regulatory agencies, the China Food and Drug Administration (CFDA). Just weeks before arriving in Washington, during the 12th People’s Congress in Beijing, CFDA had gained new authorities from the Chinese government, and had been given a new name. CFDA became the new moniker for what was formerly known as the State Food and Drug Administration (SFDA). At the same time, it gained enhanced authorities. Most notably, CFDA was given overall authority over China’s domestic system for food safety, absorbing roles previously overseen three other Chinese government agencies. CFDA was also elevated to become a ministry, reporting directly to China’s State Council—the equivalent in U.S. terms of becoming a cabinet-level agency.

But even before this name change and “promotion” within the Chinese government, CFDA had evolved significantly in the years since we began high-level talks with them in 2007. Over the years, these bilateral meetings— which are required annually under the terms of the agreement the U.S. Department of Health and Human Services signed with then-SFDA in 2007—have served as a barometer of our evolving relationship with Chinese regulatory authorities.

Names and titles in the picture (from left to right): Xinyu WENG, Division Director, Dept. of Drug Safety & Inspection, CFDA; Enxue CUI, Council, Bureau of Investigation & Enforcement, CFDA; Zhenjia BIAN, Commissioner's Special Representative, CFDA; Margaret A. Hamburg, Commissioner, USFDA; Jianhua DING, Supervisor-General, Dept. of International Cooperation, CFDA; Lanming WANG, Director-General, Dept. of Medical Device Supervision, CFDA; Xiangyu WANG, Deputy Division Director, Dept. of International Cooperation, CFDA

In 2007 and 2008— years that by all accounts were difficult ones for China with respect to the safety of its exports— exchanges were often challenging, fraught with tension and growing pains. These early efforts represented the first-ever set of talks between senior officials at FDA and then-SFDA, and took place in the context of highly-publicized product-safety issues that dominated those years. Challenges have certainly not gone away in the intervening years, but our April 2013 talks made clear that our relationship with CFDA has matured significantly since those early efforts. Where 2007 represented, in many ways, an introduction, and 2008 marked the first-ever establishment of a bilateral work plan, today, most officials involved in these talks come to the table well-known by their colleagues on the other side of the table. And the slate of topics for our April meeting made clear the deep collaboration between FDA and CFDA across more than a dozen topic areas.

While much of the strengthening of our relationship with CFDA has come through day-to-day collaboration between FDA’s China Office and CFDA officials in Beijing, there are significant ties in multiple areas across our agencies:

  • A working group on economically-motivated adulteration (the fraudulent substitution of a substance in a product to increase value or reduce production costs for the purposes of economic gain) meets on a regular basis by video, linking Washington-based experts with CFDA’s key decision-makers.
  • Experts from FDA’s Center for Devices and Radiological Health now meet regularly with their counterparts from CFDA under the auspices of the International Medical Devices Regulatory Forum.
  • FDA and CFDA collaborate closely under the auspices of the World Health Organization’s Working Group for Member States on Substandard, Spurious, Falsely-Labeled, Falsified and Counterfeit Medicines. FDA and CFDA inspectors observe one another’s inspections, and in May 2013, FDA and CFDA will co-host workshops to enhance our collaboration in the fight against internet-based, illegal distribution of adulterated drugs.

The list goes on. Change— of organizational names, of personnel— will continue. Based on our recent talks with CFDA, however, it is clear that one constant will remain: the mature relationship our agencies have built enabling us to better address challenges to consumer and patient safety in years to come.

Mary Lou Valdez is FDA’s Associate Commissioner for International Programs

 

FDA Counterfeit Detector to Aid Battle Against Malaria

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By: Deborah M. Autor, Esq. and Melinda K. Plaisier

Deborah M. Autor

Somewhere right now, malaria patients facing a life-threatening illness are being treated with counterfeit or substandard anti-malarial drugs, including falsified products, that threaten their recovery and can contribute to drug resistance. We are proud to announce the Food and Drug Administration’s launch of a partnership that will use a clever, innovative tool invented by FDA scientists to quickly and cheaply test suspect counterfeit or substandard anti-malarial drugs, including falsified products. The partnership will test the effectiveness of this hand-held, battery-operated tool, called Counterfeit Detection Device, Version 3, or, simply, CD-3. It will be deployed first in Ghana and then, after data is collected, in a second testing region.

This effort, which we hope will expand worldwide, is aimed at catching products that both deprive people of critical, life-saving help and add to disease burden because substandard doses can lead to drug resistant strains of the malarial parasite.

Melinda K. Plaisier is FDA’s Acting Associate Commissioner for Regulatory Affairs

Melinda K. Plaisier

Malaria kills more than a 660,000 people each year, mostly children. It is most prevalent in Africa and Southeast Asia. In Southeast Asia and sub-Saharan Africa, more than a third of anti-malaria drugs are counterfeit or substandard, and a recent review indicates that number might be as high as two-thirds.

CD-3 is the brainchild of FDA scientists Nicola Ranieri and Mark Witkowski of FDA’s Forensic Chemistry Center (FCC), who recognized that since substances have unique responses to light, they might be able to develop a portable tool that could identify counterfeits on the spot, even in remote locations. As the initial tool has undergone a number of revisions, capabilities have been added, applications have been developed, and CD-3 has become a more powerful tool. From prototypes, scientists at FCC built a number of CD-3s, which are currently being used in the U.S. at ports and international mail centers, and during criminal investigations at the FCC.

To gear up for a global deployment strategy, FDA has separately signed a letter of intent with Corning, Inc., to optimize the tool, using information gathered from the studies in Ghana and the second testing region. FDA is hopeful that the improved tool will eventually be manufactured for use around the world.

The CD-3 tool contains a library of information about authentic drugs and the packaging they come in. It allows the user to compare authentic images of a product with the suspect product, instantaneously showing clear differences between suspect and authentic products that would not have been clear to the naked eye.

The Unites States Pharmacopeia, with funding through the U.S. Agency for International Development and the President’s Malaria Initiative, currently conducts drug surveillance programs at the test sites where CD-3 will be tested. FDA is providing ten CD-3s in the first test, and technical support will be provided by the Centers for Disease Control and Prevention and the National Institutes of Health. The non-profit Skoll Global Threats Fund is providing additional funding for the initial testing in Ghana.

We are thrilled about these developments and proud of this important, multi-sector collaboration and our highly dedicated staff who are making it possible. It is a credit to them, to our partners, and to all of FDA, that they are able to bring this innovative solution to such a significant global public health problem.

To learn more watch the CD-3 video below and read the Consumer Update: FDA Invention Fights Counterfeit Malaria Drugs

Deborah M. Autor, Esq., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

Melinda K. Plaisier is FDA’s Acting Associate Commissioner for Regulatory Affairs

High-Tech Methods to Monitor High-Tech Devices

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By: William Maisel, M.D., M.P.H.

Whether they are inserted into the human body to repair organs and joints or used outside the body to test and treat injuries and disease, medical devices in our high-tech world can seem miraculous.

William Maisel, M.D., M.P.H.But while they can help the lame to walk, make damaged hearts beat and even, in a recent innovation, help the blind with a rare disease to actually perceive some images and movement, they are not always perfect.

Before most medical devices are allowed on the market, the U.S. Food and Drug Administration works intensively with manufacturers to analyze and review their scientific and technical data on the device. But not everything can be known about a device before it is marketed. That’s why it’s important to have a robust post-market system to collect data on how well medical devices work for patients once they have been marketed. While our current monitoring system is working well, we have proposed updates that rely in part on new technologies to collect better quality and more timely data.

These updates will combine new technologies with a reporting system that expands the engagement of both health professionals and patients in identifying problems, and is intended to more quickly and accurately identify problems as devices are used by a larger number of patients. At the same time, information from our updated system can help new devices get to patients who need them as quickly as possible.

These updates include:

  • A Unique Device Identification system: As proposed, a unique device identifier (UDI) is an alphanumeric and automatically identifiable code that would have to be assigned to every device model, unless exempt, and appear on their label and package. Once available, the UDI will allow rapid and precise responses to a reported problem while avoiding unnecessary responses. Data from the UDI might be able to pinpoint the source of a safety problem to a specific model, avoiding broader recalls of similar devices and even preventing unnecessary surgeries to remove a device that although similar, may not be the actual source of the problem.
  • The MedWatcher mobile application (app). This app allows medical device users to easily report suspected or known problems with a device from their smartphone or tablet. Manufacturers and health care facilities will continue to be required to report problems through the Medical Devices Reporting System and the Medical Product Safety Network.
  • A new planning board, which includes stakeholders outside the FDA, to facilitate the creation of a sustainable, integrated medical device post-market surveillance system; and
  • Medical device registries for selected medical devices.

All of these updates are tailored to protect the privacy of patients, and they can be accomplished under existing FDA authorities. They were developed in consultation with patient groups, academic experts, health care professionals and device makers.

Rapid technological advances are creating increasingly complex devices. We are determined to keep up, and believe this enhanced system will help us protect patients while making sure they can take advantage of life-saving and life-enhancing devices.

William H. Maisel, M.D., M.P.H., is Deputy Director for Science and Chief Scientist at FDA’s Center for Devices and Radiological Health

Keeping Up With Mobile App Innovations

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By: Christy Foreman

A smart phone that can perform an electrocardiogram (ECG)—measuring the electrical activity of a person’s heart to determine whether he or she is having a heart attack—is in my opinion an extremely smart phone. That is just one example of how mobile medical applications are transforming health care.

As we testified today before Congress, FDA has no intention of stifling innovation in this exciting and rapidly growing field. The fact is, only a fraction of mobile apps would require FDA review. However, when a mobile app is doing the job of a medical device that requires FDA clearance or approval, it’s only logical that both should be governed by the same rules. These are the small percentage of mobile apps that pose a risk of serious illness or death to patients. With these considerations in mind, FDA in coming weeks will be issuing a final guidance document that will help companies determine whether their product will require FDA clearance or approval.

They would be limited to mobile apps that meet the definition of device and are intended for use: 

  • to transform a mobile device into a medical device already regulated by FDA
  • as an accessory to a medical device already regulated by FDA

In addition to the smart phone that performs an ECG, other examples include a mobile medical app that controls the delivery of insulin; another that acts as a stethoscope; a mobile medical app that takes patient-specific information and provides a clinician with radiation dosage calculations, and mobile medical apps that allow doctors to view X-rays or other imaging on smart phones and tablets.

These examples show why FDA has a public health concern about the potential consequences of a malfunctioning mobile medical app. 

FDA’s Center for Devices and Radiological Health has been reviewing mobile medical apps for more than 10 years and in that period we have reviewed about 100 applications and each review has taken about 60 days to complete. We’re confident that the center has the expertise to continue the timely review of the small number of submissions we expect to receive from mobile app developers.

Our final guidance will be informed by some 130 public comments, most of which were overwhelmingly supportive of our risk-based, narrowly-focused approach proposed in the draft guidance. Once the guidance is released, we are confident that the public will see that it represents a careful balance between the need to encourage innovative technology with our mission of providing reasonable assurance that medical products are safe and effective.

Christy L. Foreman is Director, Office of Device Evaluation, at FDA’s Center for Devices and Radiological Health

Help Shape the Future of Health IT

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By: Bakul Patel, MS, MBA

Calling all movers and shakers in health care information technology!

We’re on a mission to help pave the way for innovative advances in safe and effective health information technology (HIT).

Who are “we”?

Under recent legislation, Congress charged FDA—in consultation with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission—to develop a report with a strategy and recommendations relating to a risk-based regulatory framework for HIT that would promote innovation, protect patient safety, and avoid regulatory duplication.

Congress also provided that the agency could assemble a working group that is geographically diverse and consists of experts and interested persons from all stakeholders in the HIT community to help develop the required strategy and recommendations. We put out a call for nominations with a deadline of March 8 on the ONC’s website, so the deadline is fast approaching.

Please take a look at the list of areas of expertise we’re seeking for the working group’s membership.  

The response so far has been gratifying, but our mission is large and if you haven’t already submitted a nomination—for yourself or someone you admire in your field—we urge you to do so now.  We’ll be looking in particular for people who represent a large segment of our stakeholder community.

I’m a technology guy, so I get fired up when it comes to thinking about the possibilities in this rapidly evolving field. But if your eyes glaze over when you hear the phrase “health information technology,” here’s why you should be interested, too:

We live in exciting times. Electronic health records, patient-to-doctor Skyping, smart phones, efficient workflow systems, and ingenious mobile apps provide us with vast reservoirs of health-related information—literally at our fingertips—in seconds.

For example, the National Institutes of Health’s LactMed app gives nursing mothers information about the effects of medicines on breast milk and nursing infants, and there are other apps aimed at helping health care providers improve and facilitate patient care.

But ready access also offers safety challenges. How can we best protect patient privacy? How do we make sure the information is accurate? How can we foster efficiency and curtail costs in the way this information is disseminated in, say, the interpretation and transmittal of radiological images from a medical imaging center to an electronic tablet in a pediatrician’s office to a hospital overseas?

Our working group will be tackling these issues and a host of others. And we want the group to be as varied, wide-reaching, and forward-thinking as possible.

Whether you’re a venture capitalist looking to fund innovative projects; a health care professional who works in a hospital or in private practice; an expert in another area of information technology; or a consumer who wants to ensure the privacy of your own data, we seek and value your participation.

Please, put your name in the hat. It’s a rare opportunity to help shape the future of how health care is provided for generations to come.

Bakul Patel, MS, MBA, is a Policy Advisor in the Office of the Center Director in FDA’s Center for Devices and Radiological Health

Celebrating African-American Contributions to Public Health

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By: Jonca Bull, M.D.

As a medical doctor and director of FDA’s Office of Minority Health, I am highly conscious of health disparities in the United States. Certain racial and ethnic populations respond differently to some medical products. FDA ensures that these differences are considered in its review of marketing applications for medical products.

But as an American, I am also highly aware how much all of us in this country have in common, a simple truth that emerges with particular clarity during this African American History Month, when we commemorate the 150th anniversary of President Lincoln’s Emancipation Proclamation and the 50th anniversary of the March on Washington.

Jonca Bull, M.D., is Director of FDA’s Office of Minority HealthBoth events have had a profound effect not only on African Americans, but on our entire nation. The Emancipation Proclamation was critical to President Lincoln’s efforts to end the Civil War and advance freedom. The March on Washington brought us Dr. Martin Luther King’s unforgettable call to America to live up to his “dream.” His vision of equality and racial harmony has been a steadfast guide for all Americans as we strive toward “e pluribus unum”— “Out of Many, One”, the ideal enshrined in the Seal of the United States.

This common bond unites us in many other ways.

As an ophthalmologist and a physician, I have a great admiration for the many distinguished African Americans who advanced medical science.

For example, Dr. Charles Drew discovered a method for the preservation of blood that was used extensively during World War II by the British military to save the lives of wounded soldiers. After the war, Drew was appointed the first director of the American Red Cross Blood Bank.

He was only one of many outstanding African-American scientists.

This honor roll includes Percy Julian, an Alabama native who earned a Ph.D. from the University of Vienna, and in 1935 synthesized physostigmine, a drug for the treatment of glaucoma, and cortisone for the treatment of rheumatoid arthritis.

It includes Daniel Hale Williams, the first surgeon to successfully perform open-heart surgery, Dewey Sanderson, the inventor of the urinalysis machine, Otis Boykin, who designed a control unit for the heart pacemaker, and Michael Croslin, who computerized blood pressure devices.

As a civil servant, I celebrate the history of African Americans by remembering their leadership in public health. The first to earn this distinction was Patricia Harris, a Howard University professor, who in 1979 became the Secretary of Health, Education and Welfare. Ten years later, the department was entrusted to the leadership of Dr. Louis Sullivan, the founder of the Morehouse School of Medicine. And in 1993, Dr. Joycelyn Elders, a pediatrician and public health administrator, became the first African-American to be named Surgeon General.

And as an FDA employee, I am proud to be working with many outstanding administrators and scientists of African-American ancestry who every day contribute to the public health and help advance FDA’s mission.

I have mentioned just a few of the distinguished narratives in our history that have been authored by remarkable African Americans—intellectuals, professionals, soldiers and artists of outstanding achievement.

I celebrate these women and men as fellow Americans whose extraordinary spirit, talent and efforts advance better health for all. I celebrate them as an inseparable part of my own proud heritage as an African American citizen.

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

No Longer In the Dark

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By: William Maisel, M.D., M.P.H.

We take so much for granted.

William Maisel, M.D., M.P.H.That was my thought when I first heard about the Argus II Retinal Prosthesis System, a new device approved by the FDA today.

This small electronic device, implanted in the eye, may improve the visual function of patients with advanced retinitis pigmentosa, or RP.

What is RP? It’s a rare genetic eye disease that affects approximately 100, 000 people in the U.S. RP gradually damages the light-sensitive cells that line the retina (a membrane within the eye). In time, a person’s limited ability to tell light from dark can erode. Far too often, the outcome is total blindness.

After carefully reviewing data from a clinical study of 30 patients with RP, FDA is giving the go-ahead to Second Sight Medical Products Inc. to sell the Argus II, the first device of its kind. It has three components: a small electronic device surgically implanted in the eye, a tiny video camera mounted on a pair of glasses and a control unit that is carried by the patient.

The camera captures images. The images become an electric signal. The brain perceives this signal as light.

I could say a lot about how this device works and what it can do for those with RP, but instead, I’ll let patients from the study speak for themselves. Here are excerpts from their comments at the public forum of FDA’s advisory meeting:

“The biggest thing to me was being able to see the crosswalk lines on the street so I can safely cross streets in Manhattan.”

“The most exciting day to me was October 27th, in 2009. It was the first time I was able to see letters on the monitor screen (during a test of visual perception). I had not seen letters since 1994, so that was huge.”

“I have a son who is 17 years old and … I don’t mind telling you how much — I mean, how happy that made me, not only to see the silhouette of my son, but to hear that voice coming and saying, ‘Yeah, it’s me, Dad. I’m here and I love you.’ ”

For many of the approximately 1,300 individuals who will develop the disease this year, this technology may change their lives. And FDA, on the cutting edge of regulatory science, played an important role in that.

It’s the difference between night and day.

William H. Maisel, M.D., M.P.H., is Deputy Director for Science and Chief Scientist at FDA’s Center for Devices and Radiological Health

 

FDA Commissioner’s Global Health Lectureship: Focusing the Lens on Product Safety

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By: Mary Lou Valdez

FDA is responsible for ensuring the safety and quality of tens of millions of foreign shipments of human food, animal feed, medical products and cosmetics that come into the United States every year. Many source countries are part of the developing world that is still forming its economic and industrial base. Thus, we have strong public health interests in making sure that the countries of origin have effective systems of regulatory oversight.

Strengthening the ability of developing countries to regulate their industries could also produce tremendous benefits for the health and quality of life of individuals and communities in those countries. Additionally, the development of stronger regulatory systems in other countries can bolster other U.S. government investments in public health, trade and economic development.  

To enhance FDA’s knowledge of global public health trends, the Office of International Programs launched The Commissioner’s Global Health Lectureship in 2010. The lectureship invites highly respected and recognized leaders in global health to speak to FDA staff, and help the agency explore its role as a public health agency of the 21st century and consider the critical functions of regulatory science and systems that contribute to improved public health. 

Participating thought leaders have included:

  • Julio Frenk, M.D., M.P.H., Ph.D., Dean of the Harvard School of Public Health
  • Margaret Chan, M.D., Director-General of the World Health Organization
  • Sir George Alleyne, M.D., Director Emeritus of the Pan American Health Organization
  • Maria Freire, Ph.D., former President of the Albert and Mary Lasker Foundation and now President of the Foundation for the National Institutes of Health
  • Nils Daulaire, M.D., M.P.H., Director of the Office of Global Affairs, U.S. Department of Health and Human Services
  • Trevor Mundel, M.D., President of the Global Health Program, Bill & Melinda Gates Foundation

These lectures have inspired FDA staff to remain vigilant in protecting U.S. consumers and patients from harmful products, and to take action globally. For example, following Dr. Chan’s lecture, FDA is working with WHO and its member states on a long-term strategy for strengthening the review of applications for new pharmaceutical products and vaccines.  

Similarly, as a result of Dr. Mundel’s lecture, FDA and the Gates Foundation have committed to developing key messages on the strengthening of regulatory systems that the foundation and the agency can consistently and collaboratively deliver to governments and public or private institutions. Here, the Gates Foundation, through its investments in product development partners, supports research and development of medical products to treat diseases affecting poor and vulnerable populations in developing countries. Strong regulatory systems are also essential to ensuring that these products meet science-based quality and safety standards before they are approved for sale, and can be monitored afterwards. The Gates Foundation recognizes the need for regulators to make informed decisions about what products enter their markets. 

Our Global Health Lectureship has provided—and with future speakers will continue to provide—opportunities for FDA staff to engage in issues in new and unique ways, changing the agency’s global lens as we work to expand the product safety net all over the world. To learn more about FDA’s global strategies, read the “Pathway to Global Product Safety and Quality.”     

Mary Lou Valdez is FDA’s Associate Commissioner for International Programs

 

World AIDS Day

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By: CDR. Steve L. Morin, R.N., B.S.N.

World AIDS Day has been observed in the United States on December 1 since 1995. When I look back at early World AIDS Day observances, I remember them as a way of raising awareness of the men, women and children who had no advocates, no representation, no medicines, and practically no hope. They eventually died from the disease early in the epidemic.

In the beginning, World AIDS Day was an important platform for the HIV/AIDS community to help raise awareness among the many people who had never known or even met anyone living with HIV/AIDS. In those early years, the focus was on finding a treatment and keeping those diagnosed with the disease alive. 

Last year marked 30 years since AIDS was first reported in the Center for Disease Control and Prevention’s Mortality and Morbidity Weekly Report (MMWR), emerging as a permanent part of our lives. Today, when I think about World AIDS Day, I think of it as a day to acknowledge how far we have actually come in the fight against HIV/AIDS. We’ve come so far—not only in treatment, but also in preventing new infections, and reducing or eliminating the stigma associated with this disease. 

The Food and Drug Administration supports the fight against HIV/AIDS by promoting medical innovation, protecting the blood supply, and reviewing and regulating new and existing medical products, including devices used in prevention, such as condoms and medical gloves. Doctors, nurses, pharmacists, scientists and many others at FDA have worked hard in 2012 to make sure that there are safe and effective medical products and devices available to fight HIV/AIDS. I am happy to say that this year there were four major advances in the battle against HIV. 

  • Truvada is the first HIV drug approved for prophylactic (preventive) use. It has been shown to reduce the risk of sexual transmission of the HIV virus to uninfected adults.
  • OraQuick In-Home HIV Test is the first rapid home-use oral HIV test kit that does not require sending a sample to a laboratory for analysis. This test has the potential to identify previously undiagnosed HIV infections, especially if used by those unlikely to visit a doctor’s office or clinic.
  • Stribild is the first HIV medicine to combine four separate drugs and is the third HIV drug that can be taken once daily.
  • The number of antiretroviral drugs tentatively approved or approved for use under the President’s Emergency Program for AIDS Relief, or PEPFAR, has surpassed 150. PEPFAR is a program to treat those infected with HIV/AIDS in countries that lack the tools needed to fight the AIDS epidemic.

So today, as World AIDS Days approaches, I ask that you take a moment to remember the combined effort of patients, researchers, industry, FDA and other government agencies contributing to the successes in fighting HIV/AIDS. There are currently 36 approved therapies for treating HIV/AIDS in the United States. As new therapies are added to the list of treatments, patients’ quality of life has improved, with fewer side effects and simpler therapeutic regimens that make adhering to therapy easier. People living with HIV are now able to focus on life rather than death. Until there is a cure, we will continue to work together for an AIDS-free world.

CDR. Steve L. Morin, R.N., B.S.N., is a Health Programs Coordinator in FDA’s Office of Special Health Issues

A New Law Advances Public Health: New Web Page Tracks Progress

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By: Malcolm Bertoni and Leslie Kux

After Congress passes a law that affects how FDA carries out its public health mission, we must begin the task of implementing the law — that is, putting the law into effect and enforcing it.

For a major piece of legislation like the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law in July, this is a complex undertaking.  

Malcolm Bertoni

FDASIA is a 140-page law divided into 11 separate sections, officially known as “titles,” which address different aspects of drug and device law. FDASIA reauthorizes and makes some changes to user fee programs that provide FDA with the resources we need to maintain a predictable and efficient review process for human drugs, biological products (such as vaccines), and medical devices.  

FDASIA also creates two new user fee programs:  one for generic drugs and another for biosimilar biologics. These new programs will allow FDA to enhance its efforts to ensure that American consumers have more timely access to safe, high quality, affordable medicines. The law also gives the agency new authority to protect the safety of the drug supply chain, which is so important when these products arrive from all corners of the world; to combat drug shortages; and to improve products used to treat children. The law includes many other provisions, including those involving drug innovation and device regulation.

The requirements of the individual provisions vary; some direct FDA to write new regulations or guidance documents that will help industry meet the law’s requirements, while some call for the agency to issue reports or develop strategic plans. Some provisions set specific timetables for action, others don’t.

Leslie Kux

The successful implementation of FDASIA is one of our top priorities. To ensure its success, FDA set up a steering committee shortly after the law was passed to oversee the task of integrating the requirements of FDASIA into the agency’s ongoing workload. One of the committee’s projects has been to create a table that tracks what FDA must do to comply with the statute.

Today we are making available a website that will allow you to follow the agency’s progress in accomplishing the actions required by the new law. The website includes a table that lists information about FDASIA tasks such as the citation to the section of the law, a description of the task, the statutory due date, and the name of a primary contact person. The table will also include links to pertinent documents as they are completed and published.

Initially, the table will include only those requirements with a due date set by Congress. In 2013, other requirements that were not given a specific due date will be added, along with FDA’s target completion date.

FDASIA is an important law with significant provisions affecting industry, patients, consumers and health care providers. We will be updating the website on a regular basis as part of our commitment to transparency about our FDASIA implementation.

Malcolm J. Bertoni is FDA’s Assistant Commissioner for Planning

Leslie Kux is FDA’s Assistant Commissioner for Policy