20 Years of Improving Women’s Health: 1994 – 2014

By: Margaret A. Hamburg, M.D.

Margaret Hamburg, M.D.As we celebrate the 20th anniversary of the FDA’s Office of Women’s Health, I would like to highlight some of the work we’ve done to help improve women’s health, both looking across FDA and within the office. Whether it is approving new treatments for chronic conditions like heart disease, conducting research or helping to protect pregnant women from foodborne illnesses, the work we do at FDA makes a difference throughout a woman’s life.

Consider our product approvals. In 1996, for example, our agency approved a product for use in Pap smears that revolutionized the detection of cervical cancer; ten years later we approved the first vaccine for the prevention of this cancer. We have also approved advances in breast imaging, including 3D breast tomosynthesis and automated screening ultrasound.

We have encouraged innovation in lupus treatment and approved the first new lupus drug in 50 years. And we approved the latest generation of cardiac synchronization therapy devices which our own FDA scientists have shown particularly benefit women with heart failure.

FDA has also supported research to help us better understand how medical products affect women. Since 1994, the Office of Women’s Health research program has provided $30 million to support over 300 research projects, workshops, and trainings on a wide range of topics including cancer, HIV and osteoporosis. More than 25 percent of these research dollars have been directed at cardiovascular disease, the number one killer of women, with studies examining such issues as QT interval prolongation (a disorder of the heart’s electrical activity), how breast cancer drugs can affect the heart, and sex differences in various cardiac interventional therapies. FDA’s medical product centers have also sponsored women’s health research and initiatives such as the Health of Women Program that promote a better understanding of sex differences.

The results have been impressive: OWH’s research alone has been published in over 290 articles in peer-reviewed journals and has made impact on the regulatory decision-making process, including guidance documents, label changes, and standards development. Indeed, FDA’s guidance to industry is an important way that the agency has been helping to address important issues in women’s health.

Over the years, FDA guidance has encouraged greater inclusion of women in clinical trials and the evaluation of sex differences. Our own analysis last year found that women make up about half of the representation in these studies, but the numbers are lower for medical devices. So we have more to do and recently issued guidance to medical device developers to address this concern.

We have also made great strides in our communication and outreach to women during the past two decades. OWH’s Take Time to Care Program has built partnerships with other government agencies, retailers, and national organizations that provide millions of women with FDA safety information. Over the years, we have launched other educational initiatives like the Food Safety for Moms-to-Be and expanded the women’s health resources available via our “For Women” website and social media to make sure that women have tools to help them make informed decisions about the use of FDA-regulated products.

I am pleased at how much we have done to promote and protect women’s health since 1994. At the center of much of this change has been the consistent, driving force of the Office of Women’s Health and its determined leader, Marsha Henderson. I encourage you to check out OWH’s 20th Anniversary brochure to learn more about the progress that has been made. And I hope that you will collaborate with us on the work that still needs to be done.

Margaret A. Hamburg, M.D., is Commissioner of the U.S. Food and Drug Administration

FDA and Health Professionals, Safeguarding the Public’s Health

By: Anna M. Fine, Pharm.D.

At our recent third annual Health Professional Organizations Conference, some of FDA’s most senior leaders exchanged views and discussed issues of mutual interest with senior representatives from key health professional organizations.

Anna FineHeld on FDA’s White Oak campus in Silver Spring, Md., and organized by the FDA’s Office of Health & Constituent Affairs (OHCA), the event was attended by 30 professional organizations representing physicians, nurses, physician assistants, dentists, optometrists, nurse practitioners, pharmacists, and others.

An open and ongoing dialogue between these professionals and FDA is a vital part of addressing many important public health issues. In her opening remarks, FDA Commissioner Margaret Hamburg offered a few examples, such as health professionals’ contributions to the FDA’s MedWatch and Adverse Event Reporting programs and their work in interpreting and addressing medical products’ safety signals. A drug’s safety profile is continually evaluated after FDA approval, and health professionals are encouraged to report suspected adverse events to FDA which allows FDA to conduct comprehensive safety evaluations. Dr. Hamburg also emphasized the importance of health professionals’ engagement in regulatory science research, which provides essential support for the agency’s decisions and ability to bring innovative products to market.

Mitch Zeller, the Director of FDA’s Center for Tobacco Products, speaking at the third annual Health Professional Organizations Conference, on May 14, 2014

Mitch Zeller, Director of FDA’s Center for Tobacco Products, speaking at the agency’s third annual Health Professional Organizations Conference. See more photos of this event on Flickr.

Key FDA leaders who gave presentations throughout the day included Mitch Zeller, the Director of FDA’s Center for Tobacco Products; Dr. Stephen Ostroff, Acting Chief FDA Scientist; and Dr. Peter Lurie, Acting Associate Commissioner of FDA’s Office of Planning and Policy.

In addition, senior scientists from FDA’s centers for drugs, medical devices and food discussed FDA’s priorities and answered questions from the audience. The robust dialogue between the panel members and our stakeholders covered many public health issues including youth and tobacco and FDA’s proposed changes to the food label.

Feedback from the audience highlights the need for such a conference.

“It’s great to have this dialogue with FDA officials. It demonstrates that they respect our organizations and want our feedback,” said one stakeholder representative.

“I love coming to these annual meetings, not only to meet FDA personnel but to talk with colleagues in other professions. This is a one-of-a-kind forum,” said another.

As a pharmacist and team leader within OHCA, I can attest to the fact that my FDA colleagues and I benefited as well. We learned a lot about our stakeholders’ concerns and established new connections with health professional organizations—contacts that we plan to follow-up on to explore new opportunities for mutual cooperation and collaboration in the interest of the public health.

Anna M. Fine, Pharm.D., is Director of the Health Professional Liaison Program in FDA’s Office of Health and Constituent Affairs.

For National Women’s Health Week, FDA Resources Help Women Make Informed Health Choices

By: Marsha B. Henderson, M.C.R.P.

“Ask your mother.” In households throughout the country, women often make decisions about foods and medical products for themselves and their loved ones.

8547850411_6e188c4b11_o-1As we celebrate National Women’s Health Week (May 11-17), I want to highlight some of the many ways in which FDA is working to make sure that women have the resources they need to make informed health choices.

FDA’s Office of Women’s Health (OWH) offers educational resources to help women at every stage of their adult lives—covering topics that range from college health to healthy aging. We develop and disseminate easy-to-read health materials and educational videos for women. We also connect women to these resources and other safety information on the FDA’s For Women website.

Throughout this week, OWH will be conducting special health promotions to connect women to resources on how to stay healthy. Starting today, women can order a free kit of OWH health materials on topics including mammograms, sleep problems, pregnancy, and contact-lens care. OWH is also collaborating with FDA’s Office of Communications to share tips for new mothers and other resources.

Lastly, we’re using social media to challenge women to take better care of their health. Encourage the women in your networks to follow us on Pinterest for a special challenge and health tips each day of the week. Use #1wk4health to participate.  In addition, follow @fdawomen and join us on May 13 at 1 pm for a Twitter chat we are co-hosting with the National Institute of Health’s National Heart, Lung, and Blood Institute and Office of Research on Women’s Health; the Department of Health and Human Services’ Office of Minority Health; and Everyday Health.

Once the week is over, I hope you will continue to look to FDA for women’s health resources. Encourage the women in your community to read our health materials, watch a video or participate in one of our social media activities.

Marsha B. Henderson, M.C.R.P., is FDA’s Assistant Commissioner for Women’s Health

Building Expertise and Crossing Boundaries to Improve Oversight

By: Howard Sklamberg, J.D.

To keep the food supply safe, have safe, effective, and high quality medical products, and decrease the harms of tobacco product use, we have to work with the rest of the world.

Howard SklambergAs FDA’s Deputy Commissioner for Global Regulatory Operations and Policy (GO), I oversee FDA’s efforts to further advance its thinking and strategies from a primarily domestic to a globally focused regulator.

GO coordinates the efforts of FDA’s Office of Regulatory Affairs (ORA) and the Office of International Programs (OIP), and works with all of FDA’s product centers on scientific, manufacturing or other regulatory challenges. The highly skilled and dedicated workforce in ORA and OIP is responsible for conducting domestic and foreign inspections, deepening collaborations with local, state and foreign regulatory partners, helping these regulatory partners to strengthen their regulatory systems, and fostering the use of science-based standards and regulatory coherence around the globe to promote the public health of our citizens.

We have to be able to share information with our regulatory partners. We need their help to implement new regulations that have worldwide impact on the oversight of food under the Food Safety Modernization Act and medical products under the Food and Drug Administration Safety and Innovation Act. Working together with these partners, we can ensure an effective public health safety net for our citizens and communities.

An important new priority for FDA is to make fundamental changes in the way we operate in today’s world by aligning our efforts across the agency to keep pace with the acceleration of scientific innovation and the global expansion of the markets. So much of FDA’s work cuts across multiple product areas. How do we make that work as a large and complex agency?

Commissioner Hamburg and senior leaders across the Agency are committed to strengthening our ability to do just that and are collaborating to achieve greater operational and program alignment across the Centers and ORA.

A key part of this process is to enhance specialization across FDA. For ORA, enhanced specialization means that investigators, compliance officers, import reviewers, laboratory personnel, managers and others will have increased technical expertise in a specific commodity area and will work closely with subject matter experts in FDA’s centers. Over time, ORA’s geographic-based model will evolve to a commodity-specific, program-based model that will provide ORA staff the opportunity to gain increased expertise in specific product areas, such as pharmaceuticals, food, animal feed, medical devices, biologics, and tobacco. They will work as part of a team with the staff from other centers, collaborating, for example, with the Center for Drug Evaluation and Research on pharmaceutical oversight or with the Center for Food Safety and Applied Nutrition on food safety issues.

It is especially important that experts in the centers and ORA be engaged in helping to develop compliance policies and priorities. Working with the centers on these broader concerns puts ORA investigators and compliance officers in a better position to implement the preventive approaches contained in new statutes and work together more seamlessly with the centers.

These and other changes that are part of the agency’s focus on program alignment will deepen our knowledge and make us more effective and efficient, with more clarity and coherence in our communications and actions.

This process is still in its early stages. There is a lot of planning still to be done, and we will work to ensure a transparent and inclusive process. Nevertheless, change is coming and I am excited and proud to be part of a transformation that can only strengthen our efforts to safeguard the foods and medical products that are so important in the lives of people all over the world.

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

Compliance with the Tobacco Control Act: A Key Part of Reaching the Law’s Potential

By: Margaret A. Hamburg, M.D.

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) gave FDA the authority to regulate tobacco products, marking a groundbreaking advancement in protecting public health. One vital way in which FDA works to realize the potential of this important law is by making sure it’s followed. This is where a rigorous compliance and enforcement program comes into play.

Margaret Hamburg, M.D.FDA’s tobacco compliance and enforcement efforts run the gamut – from training and education, to monitoring compliance with the law, to initiating advisory and enforcement actions. And some key highlights and accomplishments are contained in FDA’s new comprehensive Compliance and Enforcement Report, which covers activities from June 22, 2009 through September 30, 2013.

While it’s clear that we’ve made progress in reducing the burden of tobacco use on the nation, it’s imperative that we end youth access to tobacco products. Each day in the U.S. more than 3,200 youth under age 18 smoke their first cigarette, and more than 700 become daily cigarette smokers. In order to combat this reality, FDA inspects tobacco retailers to ensure, among other things, that retailers are checking IDs and not selling regulated tobacco products to anyone under the age of 18.

Most tobacco retail establishments FDA inspects are in compliance with the law. In fact, as of May 1, 2014, more than 289,000 inspections show that retailers in 51 states and territories are keeping regulated tobacco products away from kids. However, when violations are found during an inspection, FDA is ready to take action. In a significant milestone this past summer, FDA issued its 10,000th Warning Letter for observed violations of federal laws found during tobacco retailer inspections. In addition, FDA has brought over 1430 civil money-penalty actions against tobacco retailers for violations found during follow-up inspections.

Notably, through its monitoring and surveillance efforts, as of May 1, 2014, FDA has issued over 150 Warning Letters for violations of Tobacco Control Act requirements related to tobacco product promotion, advertising and labeling found online or in print publications.

FDA also regularly inspects registered establishments involved in the manufacture or processing of a tobacco product to determine compliance with existing laws and regulations. Additionally, FDA performs investigations at sites that distribute free samples of smokeless tobacco to monitor for compliance with relevant restrictions, including age verification by photo ID.

These achievements signify the impact of our compliance and enforcement program and its contribution towards assisting FDA in meeting its goal of protecting Americans, especially young people, from the dangers of tobacco use.

FDA understands that it is important to educate the regulated tobacco industry about their obligations under the law, and how they can best comply. As part of a broad compliance and training initiative, FDA recently developed the Sales to Minors: Age and ID Requirements for Sales of Regulated Tobacco video as a new tool to assist industry and retailers in protecting America’s youth. FDA also provides additional education and training opportunities, including guidance for industry publications and online webinars that aim to provide easily accessible educational opportunities.

The laws around tobacco control form the cornerstone of our efforts. And we are dedicated to providing compliance training and education to regulated industry; monitoring regulated industry’s compliance with the law through surveillance, inspections, and investigations; and initiating advisory and enforcement actions against non-compliant industry as appropriate. This way, FDA is better able to protect the health of tobacco users and non-users, and in turn, improve the lives of every American.

Margaret A. Hamburg, M.D., is Commissioner of the U.S. Food and Drug Administration

Proposed Rule Would Expand FDA’s Tobacco Control Authority

By: Margaret A. Hamburg, M.D.

Today we usher in a new chapter in FDA’s role in tobacco control, which began nearly five years ago when the Family Smoking Prevention and Tobacco Control Act enabled us to regulate certain tobacco products, including cigarettes and smokeless tobacco. Now, FDA has proposed a rule that would extend our authority to additional products meeting the legal definition of a tobacco product. This would include electronic cigarettes, some or all cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco and dissolvables not already under the FDA’s authority, as well as future tobacco products.

Margaret Hamburg, M.D.The tobacco product marketplace is evolving at a dizzying pace with many unanswered questions about the health effects of novel products. Especially in the shadow of alarming increases in the number of youths using unregulated products like electronic cigarettes and cigars, it’s more crucial than ever to help prevent early tobacco use that could lead to a lifetime of nicotine addiction. The proposed rule—which would “deem” other tobacco products to be subject to FDA authority—is poised to help make that happen.

FDA is committed to protecting public health. Expanding our authority over tobacco products gives FDA additional tools to help reduce the number of illnesses and premature deaths associated with the use of tobacco products. Under FDA’s proposal, these powerful regulatory tools would include age restrictions, rigorous review of new tobacco products and claims, and health warnings.

“Deeming” – and the new health warning requirements included in the proposed rule – would also help to correct a misperception by consumers that tobacco products not regulated by FDA are safe alternatives to currently regulated tobacco products. Equally important, “deeming” would allow FDA to issue future regulations regarding these products, including regulations to reduce their harmfulness, if we determine that would be appropriate to protect public health.

As we work to finalize the proposed rule, we welcome comments and will consider all that are submitted, as well as any data, research and other information submitted to the docket for this proposed rule.

For more information:

Margaret A. Hamburg, M.D., is Commissioner of the U.S. Food and Drug Administration

Crossing the Country to Connect with the Cancer Research Community

By: Mitch Zeller, J.D.

One of my goals as the director of FDA’s Center for Tobacco Products (CTP) is to get feedback from everyone interested in our groundbreaking work of regulating tobacco products. We’ve heard that some people outside the Beltway – meaning those beyond the nation’s capital – would appreciate the chance to interact with us. When we can, we make those opportunities happen. We especially want to hear more comments from the public on the scientific issues associated with our regulatory process.

Mitch Zeller

Mitch Zeller speaking to reporters at a media availability during the American Association of Cancer Research annual meeting in San Diego, Calif.

One of those opportunities occurred this week when about 10 FDA staff members and I participated in the annual meeting of the American Association for Cancer Research (AACR) in San Diego. The meeting provides a unique opportunity for members of the worldwide cancer research community to learn about cutting-edge advances, obtain feedback on their own research, and make connections that will foster future collaborations.

CTP kicked off its participation with an educational session to introduce cancer researchers to what tobacco regulatory science is – and what it is not. Science grounds all of our efforts to reduce the disease and death toll of tobacco use. This includes both funding and conducting research that helps determine the regulatory steps we must take to protect public health.

Next, CTP hosted a listening session so that our senior scientific staff could hear presentations on topics relevant to science-based regulation of tobacco products. This public session was held in conjunction with the AACR meeting for the convenience of the many researchers who attend and for members of the public living on the West Coast, but participants did not have to be registered for the AACR meeting to attend or present. We were particularly interested in hearing from the public in connection with FDA’s goals for regulating tobacco:

  • Prevent youth tobacco initiation.
  • Encourage adults who use tobacco to quit.
  • Reduce product harms and addictiveness.
  • Develop a science base and continue meaningful product regulation to reduce the toll of tobacco-related disease, disability and death.

Finally, I participated in a symposium panel and press conference marking AACR’s release of a special commemorative publication of the 2014 Surgeon General’s Report: The Health Consequences of Smoking: 50 Years of Progress. As I said in an interview for the special issue, it is amazing that, with everything we’ve learned about the dangers of tobacco use, our progress has slowed in terms of reducing smoking rates nationally. Nearly one in five adults still smokes, and too many kids become regular smokers. At the press conference, our panel of leaders in the field of tobacco research took questions from cancer and research media about current tobacco control efforts. We discussed smoking patterns and the evolution of tobacco control over the last 50 years, as well as highlighted this newest data from the Surgeon General’s Report on tobacco’s negative health effects. I emphasized the critical role that the regulation of tobacco products can play in these efforts.

Tobacco-related cancer researchers are key partners of FDA as we work toward our goal of ending the epidemic of tobacco use. Hearing from this audience – as well as others – was incredibly valuable to us because we use these insights and feedback as part of the regulatory process. We welcome the opportunity to further engage with the research community as we work to reduce the destructive health consequences of tobacco use.

Mitchell Zeller, J.D., is the Director of FDA’s Center for Tobacco Products  

For more information please visit these Web links:

Informing Tobacco Regulation through Research

2014 Surgeon General’s Report: The Health Consequences of Smoking: 50 Years of Progress

Q&A: Mitchell Zeller on the FDA and Tobacco, AACR Journals

FDA’s First-Ever NSE Orders for Marketed Tobacco Products

By: Ann Simoneau, J.D.

Ensuring compliance with the law is critical to FDA’s mission to protect public health. As part of that mission, FDA is committed to making sure that all tobacco products that are sold and distributed to the public meet the requirements of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).

Ann SimoneauIn support of this commitment, we recently announced that four tobacco products now on the market – Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone, and Sutra Bidis Menthol Cone – do not meet the criteria in the law to remain on the market. These products entered the market during a grace period set up in the Tobacco Control Act. However, after a thorough review of the submitted applications, FDA determined that Jash International, the manufacturer of the four new products, did not provide sufficient evidence to demonstrate that they are “substantially equivalent” to eligible products that were previously marketed (otherwise known as predicate products). Specifically, the company did not identify eligible predicate tobacco products and was unresponsive to multiple requests for information that was necessary for FDA to determine whether the new products raised different questions of public health. This marks the first time that we have used our authority under the Tobacco Control Act to stop the continued sale and distribution of currently marketed tobacco products because they were not found “substantially equivalent” – and it is not an action we take lightly.

New tobacco products that FDA determines to be “Not Substantially Equivalent” (NSE) to predicate products can no longer be legally imported, sold, or distributed in interstate commerce, and failure to comply may result in FDA initiating enforcement action—such as seizures or injunctions – without further notice.

We have released a draft guidance document that explains the enforcement policy the agency intends to follow with respect to tobacco products that entered the market during the grace period and later receive NSE orders. The draft guidance is available for public comment and details our current thinking on this topic, including:

  • Products determined to be NSE cannot be sold or distributed in interstate commerce and may be subject to seizure at any time;
  • Companies that continue to sell and distribute these products in the United States may be subject to enforcement actions by FDA;
  • FDA does not intend to take enforcement action at the retail level for 30 days after an NSE order is issued, understanding that retailers may have existing inventories of NSE products in specific retail locations as of today; and
  • Retailers are encouraged to contact their supplier or manufacturer to discuss possible options for the NSE products in their current inventory.

We have also developed a new webpage, entitled Misbranded and Adulterated NSE Tobacco Products, to inform the public and companies in the distribution chain about products that have been on the market but are now considered misbranded and adulterated due to the failure of the manufacturer to satisfy the requirements for an SE marketing order. The webpage will be updated whenever any currently marketed products receive an NSE order.

Today’s announcement is an important step for the FDA as we continue to review new product applications, make science-based decisions, and take enforcement actions to ensure the protection of the nation’s public health.

Ann Simoneau is the Director of the Office of Compliance and Enforcement at FDA’s Center for Tobacco Products

FDA Public Education Campaign Aims to Prevent and Reduce Youth Tobacco Use

By: Margaret A. Hamburg, M.D.

Today, FDA launches something truly unique: its first public education campaign to prevent and reduce youth tobacco use. Never before has the Agency embarked on an education campaign of this nature and magnitude. It’s the ultimate synergy of public health and regulation. The first of five distinct youth-focused efforts we have in the works, “The Real Cost” campaign seeks to reduce the number of youth smokers in our country over the next few years. 

Margaret Hamburg, M.D.Those of us in the public health and medical communities know all too well the startling statistics surrounding teen tobacco use, especially smoking, and want to do all we can to prevent young people from becoming addicted. Unfortunately, there are more than 10 million youths ages 12 to 17 who are open to smoking or already experimenting with cigarettes. 

As a physician and especially as a parent, I also know getting the message right to reach teens is critical. We have to be smart about how we talk to children about  a behavior like experimenting with tobacco products. So instead of sounding like yet another authority figure citing statistics or telling teens not to do something because it is bad for them, we dedicated significant time and research into creating something that will catch their attention. Our multimedia campaign is designed around visually compelling and personally relevant messages that will appeal to, and resonate with, teens at-risk for smoking. 

Through television, radio, social media and outlets associated with their interests, including music, fashion, sports, gaming, and comedy, our campaign  seeks to surround at-risk teens with messages that reach them where they are in their daily lives. 

“The Real Cost” aims to make them acutely aware of the potential risk from every cigarette by highlighting consequences they are concerned about.  

One set of creative materials challenges the beliefs of independence-seeking youths who  think they will not get addicted or feel they can quit at any time by portraying addiction to cigarettes as a loss of control. 

Another approach dramatizes the health consequences of smoking by graphically depicting results like tooth loss and skin damage to demonstrate that every cigarette comes with a “cost” that is more than just financial. 

Some ads highlight the fact that menthol cigarettes cause the same health consequences as regular cigarettes, as youths are more likely to report smoking menthol cigarettes than regular cigarettes. 

The development of the “The Real Cost” campaign is grounded in research and supported by best marketing practices as well as multiple rounds of testing with our target audience. Our ads will run nationwide across multiple platforms beginning February 11.  And that’s only the beginning: subsequent youth tobacco prevention campaigns will target other audiences, including multicultural, rural, and lesbian, gay, bisexual, and transgender youths. 

So today, FDA is taking our mission of protecting kids from tobacco to the next level  – by reaching out to them with images and words that speak to them. We look forward to seeing the impact of this important public health effort and to making tobacco use a part of America’s past, not its future.

Margaret A. Hamburg, M.D., is Commissioner of Food and Drugs

We Moved Forward on Many Fronts This Year

By: Margaret A. Hamburg, M.D.

At the FDA, the agency that I’ve had the privilege to lead for the past five years, I am gratified to report that we have a lot to be proud of this year. In fact, this past year’s accomplishments on behalf of public health have been as substantial as any in FDA’s recent history.

Margaret Hamburg, M.D.We moved significantly forward, for example, in creating a system that will reduce foodborne illness, approving novel medical products in cutting-edge areas of science, and continuing to develop our new tobacco control program. We worked successfully with Congress and with regulated industry to reach agreement on a number of difficult issues, while continuing to use the law to the full extent possible to protect consumers and advance public health.

While there were many significant actions and events to recognize, below are some of the highlights of 2013.

In the foods area, there were many new actions this year that will have a long-standing impact on improving our food supply for consumers. Throughout the year we have been proposing new rules to reach the goals set forth by the FDA Food Safety Modernization Act (FSMA). These science-based standards will help ensure the safety of all foods produced for our market, whether they come from the U.S. or from other countries.

We also took important steps towards reducing artery-clogging trans fat in processed foods, and understanding the health impact of arsenic in rice. With a final rule that defines when baked goods, pastas and other foods can be considered free of gluten, people with celiac disease can have confidence in foods labeled “gluten free.” And we are studying whether adding caffeine to foods may have an effect on the health of young people and others.

There have likewise been many accomplishments in advancing the safety and effectiveness of medical products. We worked closely with Congress on the recently enacted Drug Quality and Security Act, which contains important provisions relating to the oversight of human drug compounding. The law also has provisions to help secure the drug supply chain so that we can better help protect consumers from the dangers of counterfeit, stolen, contaminated, or otherwise harmful drugs.

Using tools provided by last year’s landmark Food and Drug Administration Safety and Innovation Act (FDASIA), we are continuing to improve the speed and efficiency of medical product reviews, including those involving low-cost, high quality generic drugs and innovative new medical devices. The average number of days it takes for pre-market review of a new medical device has been reduced by about one-third since 2010. The percentage of pre-market approval applications that we approve has increased since then, after steadily decreasing each year since 2004.

We launched a powerful new tool to accelerate the development and review of “breakthrough therapies,” allowing FDA to expedite development of a drug or biologic (such as a vaccine) if preliminary clinical evidence indicates that it may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases. This offers real opportunities to get promising drugs more quickly to patients who need them. In fact, using this new approach, FDA recently approved two advanced treatments for rare types of cancer and one for hepatitis C. We have also strengthened efforts to ensure product quality, increased protection of the drug supply chain, and reduced drug shortages.

We confronted the growing misuse of powerful opioid pain relievers by advising manufacturers on how to make these drugs harder to abuse with formulations that are more difficult to crush for inhalation or dissolve for injection. And we recommended that hydrocodone combination products be subject to stricter controls to help prevent abuse. 

We took an important step towards fighting the development of antibiotic-resistant bacteria by implementing a voluntary plan to phase out the use of antibiotics to enhance the growth of food-producing animals, and to move any remaining therapeutic uses of these drugs under the oversight of a licensed veterinarian. So-called “production” use is considered a contributing factor in the development of bacteria that are resistant to the antibiotics used in human medical treatment.

In many areas of our work we are supporting the emerging field of personalized medicine. Advances in sequencing the human genome and greater understanding of the underlying mechanisms of disease, combined with increasingly powerful computers and other technologies, are making it possible to tailor medical treatments to the specific characteristics, needs, and preferences of individual patients.

Many cancer drugs today are increasingly used with companion diagnostic tests that can help determine whether a patient will respond to the drug based on the genetic characteristics of the patient’s tumor. In May, FDA approved two drugs and companion diagnostic testing for the treatment of certain melanoma patients with particular genetic mutations.

Advances in science and technology are also seen in the creation of new medical devices. For example, 3-D printing - the making of a three-dimensional solid object from a digital model – was once considered the wave of the future. But in February, FDA cleared for marketing a device created by 3-D printing – a plate used in a surgical repair of the skull that is built specifically for the individual patient.

While we have worked hard to get therapies to patients, we are at the same time using the tools available to us to remove unsafe and dangerous products from the market. In November, we used new enforcement tools provided by the food-safety law to act quickly in the face of a potential danger to public health presented by certain OxyElite Pro products. These supplements had been linked to dozens of cases of acute liver failure and hepatitis. After FDA took action, the manufacturer agreed to recall and destroy the supplements.

Finally, we made significant progress in implementing the letter and spirit of the Family Smoking Prevention and Tobacco Control Act. We have signed contracts with numerous state and local authorities to enforce the ban on the sale of tobacco to children and teens; conducted close to 240,000 inspections; and written more than 12,100 warning letters to retailers. And, in the first quarter of 2014 we will launch a public education campaign aimed at reducing the number of young people who use tobacco products.

All of us take great pride in the skill and vigor with which we overcame the year’s challenges and new demands. And so, as the year draws to a close, I extend my gratitude to the employees at the FDA who work tirelessly on behalf of the American public year in and year out. To all of our stakeholders, my heartfelt wishes for a joyous holiday season and a safe and healthy 2014.

Margaret A. Hamburg, M.D., is the Commissioner of the Food and Drug Administration