The Commissioner’s Fellowship Program: Fostering Scientific Talent at FDA - from FDA Voice

As the May 25th application deadline for the Commissioner’s Fellowship Program rapidly approaches, it’s time to acknowledge the tremendous contributions our Fellows and their FDA mentors have made in support of FDA’s Advancing Regulatory Science effort. I also want to highlight the opportunities the Fellowship Program offers health care professionals, scientists, and engineers who may not have considered FDA in planning their career path.

FDA launched the Fellowship Program in October 2008 to achieve three essential goals: to attract outstanding scientists who could tackle Center-selected and targeted research or regulatory issues, to train these scientists in regulatory science, and to help build our scientific staff. Since then, FDA has graduated 48 Fellows from the class of 2008 and 50 from the class of 2009. The class of 2010 will graduate this coming Sept. 25th.

This two-year program is open to scientists and medical professionals with doctoral level degrees, although we also welcome applicants with a bachelor’s in an engineering discipline. Fellows pursue a rigorous regulatory science curriculum and conduct research that addresses a scientific or regulatory gap, under the mentorship of an FDA senior scientist.

more at FDA Voice...
http://blogs.fda.gov/fdavoice/index.php/2012/05/the-commissioners-fellowship-program-fostering-scientific-talent-at-fda/

FDA’s Modern “Corps of Discovery” in China - from FDA Voice

Posted on May 10, 2012 by FDA_Voice

By: Christopher Hickey, Ph.D.

I love history. I especially love the story of Meriwether Lewis and William Clark who, in their famed venture to explore the newly-purchased Louisiana Territory at the direction of U.S. President Thomas Jefferson, fashioned a lean and mean team largely consisting of seasoned, highly qualified frontiersmen. While Lewis and Clark’s “Corps of Discovery” benefitted to some degree from maps that had been developed by previous explorers who had traversed similar terrain, there was a large swath of territory in the middle of their journey that was literally “off the map”—no non-native groups had ever set foot on those pieces of the North American continent. And while brawny, rough-and-tumble, frontiersmen may have dominated the rolls of the Lewis and Clark expeditionary force, they would have all frozen or starved to death had it not been for the keen and savvy brilliance of Sacagawea, surely one of the unlikeliest heroines in American history.

The Honorable Margaret Hamburg, Commissioner, FDA and Dr. Christopher Hickey, Country Director, FDA China

I also love my job. I run FDA’s China Office. Nearly four years in, I still pinch myself most mornings to make sure I’m actually getting paid to lead this fascinating, unpredictable 21^st century expedition to explore new public-health frontiers for my country.

Like Lewis and Clark, we in the FDA China Office have been fortunate enough to benefit from a surfeit of talented “frontiersmen” – and women! – who’ve volunteered for this pioneering venture. They include inspectors and policy analysts who, in some cases, have served FDA for nearly four decades! They’ve seen marked similarities between the challenges we face in China in 2012 and the challenges FDA faced in regulating domestic U.S.industry several decades ago. Our “pioneers” include FDA food scientists and biochemists with deep, rich expertise who are now applying that knowledge to work in collaboration with Chinese authorities as they develop a regulatory system that will keep pace with increasing Chinese economic growth, and ever-expanding exports to U.S.markets. And our “FDA Corps of Discovery” includes legal, policy and health diplomacy professionals. These professionals apply their knowledge of FDA standards and regulations, as well as their scientific and diplomatic expertise, to enhance the Agency’s knowledge base about China’s regulatory landscape. In addition, they track industry trends to inform U.S. regulatory decisions and actions, and strengthen collaboration on mutual regulatory challenges.


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Six Month Check-Up: FDA’s Work on Drug Shortages, uncut from FDA Voice

By Margaret Hamburg, M.D.
This week marks the six-month anniversary of President Obama signing an Executive Order to help FDA in our ongoing efforts to prevent and resolve prescription drug shortages. At FDA, we saw the Executive Order as an important step in bringing awareness to this critical public health issue and signaling the necessary tools and resources, such as early notification and additional staff, FDA must have to help address this problem. Following the Executive Order, we sent out letters to drug manufacturers asking them to voluntarily report to FDA if they saw the emerging potential for a drug shortage.
Six months later, I am both amazed and delighted to see the progress that’s been made. Early notification to FDA of potential disruptions in drug supply has made a huge difference in our efforts – and the numbers really tell the story. Since reaching out to industry, there has been a six-fold increase in early notifications from manufacturers. Also in that six month timeframe, we have been able to prevent 128 drug shortages, and we’re seeing fewer numbers of shortages occur – 42 new drugs in shortage reported in 2012, compared to 90 new shortages at this time last year. This data is a testament to how FDA exercises flexibility and discretion in much of our work on drug shortages and the importance of strong collaboration and constant communication with industry, health professionals, and patients.
But these are simply statistics. Consider instead the impact of our work on patients, who need particular drugs to treat life-threatening diseases. For instance, supplies of methotrexate, a cancer drug used to treat childhood leukemia and osteosarcoma, are currently meeting all demand, and we do not expect any further supply issues. Also, to address the shortage of Doxil (liposomal doxorubicin), a drug used for ovarian cancer and other cancer regimens, FDA exercised enforcement discretion for the importation of Lipodox, another brand of liposomal doxorubicin, from India, meeting patient needs until Doxil is available again.

While many shortages of cancer drugs are resolving, we are still working hard to address others. Leucovorin injection, a cancer drug that is used along with methotrexate for children with a serious form of leukemia, has been in short supply for some time. We are working with the manufacturer, Teva Pharmaceuticals, to produce additional shipments in the coming weeks to help improve supplies. Mustargen (Mechlorethamine HCl) – another cancer drug used in multiple cancer regimens — has also been in shortage. FDA has worked with the manufacturer to resume production of Mustargen, and the company is planning to have product available again by August.
We are equally concerned about other types of drugs in shortage. Anesthesia drugs, such as benzodiazepines and fentanyl injections, have recently been in short supply. Here again, early notification is helping. One manufacturer, Hospira, notified FDA of anticipated delays in supply of the critical anesthesia drug propofol. This advanced notice allowed FDA to work with the other manufacturer of propofol who was able to increase supplies to keep the product available for patients undergoing surgery.

Drug shortages remain a serious, complex problem, and the agency remains extremely concerned about all current and potential drug shortages, not just those that I mentioned. Our efforts require a multifaceted approach involving industry, regulators, payers, and others. And we’re working with Congress on bipartisan legislation to expand early notification of drug supply problems that could cause shortages. All of us have a responsibility to help ensure that patients have reasonable access to the drugs they need. Drug manufacturers in particular have a responsibility to manufacture quality drugs and to have a process to ensure supply continuity of critical drugs.
In a blog I wrote earlier this year, I reminded readers that “the critical issue of drug shortages isn’t about industry; it isn’t about government, or even about the drugs themselves. It is about getting people the treatments they trust, they need, and they rely on.” While that remains as true as ever, I would like to add a different kind of reminder. Today’s six-month check-up demonstrates what government and industry can accomplish when we work together. While there’s no simple solution, we are making progress. And we’ll remain vigilant – doing all we can and using every resource available – to make sure patients have access to the critical medicines they need, when they need them.

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

http://blogs.fda.gov/fdavoice/index.php/2012/05/six-month-check-up-fdas-work-on-drug-shortages/

FDA Voice Interviews Jesse Goodman, M.D., M.P.H., on the DARPA and NIH Project Collaboration: Human on a Chip

FDA Voice: FDA has embarked on an exciting collaboration with the Defense Advanced Research Projects Agency (DARPA) and NIH—to develop a groundbreaking tool that could help bring new treatments to patients faster, more cheaply, and more safely. Can you talk about this new technology?
Dr. Goodman: Yes, it’s what we’re calling Human on a Chip. This is an ambitious project to create a tool that could revolutionize toxicology testing and it’s something I’m really excited to talk about. Scientists have relied largely on animal studies to determine if a drug is toxic before testing it in humans. And while animal testing is useful, it’s also expensive, time consuming, and has drawbacks. For example, it doesn’t always detect toxic effects specific to humans and doesn’t usually provide information about the role that genetic differences within human populations play in toxicity. It can also generate false alarms, showing an effect in animals that doesn’t predict an actual effect in people, which leads us to abandon promising new drugs. FDA is collaborating with DARPA, NIH, and the scientific community to spur innovation in this field by exploring how tools like Human on a Chip can be integrated into our development tool box to improve testing for toxicity and potentially reduce the need for animal testing.

FDA Voice: Can you describe Human on a Chip?

Dr. Goodman: Researchers are developing microsystems using human cells to test the effects of drugs or other substances. For example, scientists have developed a micro machine chip with human lung cells that grow on a surface to form a lung-like tissue that has both air spaces and blood circulation. FDA is supporting the coupling of this chip to a heart-like chip that beats and pumps blood. We can use this type of system to evaluate, with human cells, how specialized organs like the lung and heart react to a specific chemical.

more of the interview here... http://blogs.fda.gov/fdavoice/index.php/2012/04/fda-voice-interviews-jesse-goodman-m-d-m-p-h-on-the-darpa-and-nih-project-collaboration-human-on-a-chip/

Global Engagement, from FDA Voice

Posted on April 23, 2012 by FDA_Voice

By: Mary Lou Valdez

Last week I had the opportunity to discuss many of the challenges of globalization in my FDA Voice post entitled Collaboration for a Global Product Safety Net. Today I would like to tell you more about what FDA is doing to meet the challenges of globalization as described in our new report entitled Global Engagement. The report showcases FDA’s role as a strategic leader and partner in improving global product safety and quality.

And we are also launching a new Global Initiative web page where starting today you will see regular updates on our work to carry out our public health mission on the global stage.

FDA is undergoing a critical transformation. As I discussed last week, the food and medical products we use are increasingly coming from overseas. The globalization of commerce presents an incredible challenge to FDA. We are being asked to do more than ever before and consumers expect us to ensure the safety and quality of FDA-regulated products.

FDA has made great strides over the last few years to address the challenges of globalization. The Global Engagement report chronicles these activities, organized by seven key strategic areas, including:

1. Establishing foreign posts
2. Strengthening regulatory systems capacity
3. Harmonizing science based-standards
4. Leveraging knowledge and resources
5. Conducting risk-based monitoring and inspections
6. Preparing and responding to public health crises
7. Advancing regulatory science

for more... http://blogs.fda.gov/fdavoice/index.php/2012/04/global-engagement/

Collaboration for a Global Product Safety Net, from FDA Voice

By: Mary Lou Valdez
 
If it takes a village to raise a child, in today’s economy it takes the support and commitment of a global community to ensure the safety of the food we eat and the medications we rely on.
This point was made clear in an Institute of Medicine report released on April 4. The report was commissioned by the FDA as the agency addresses the challenges of global supply chains, international trade, and foreign sourcing of foods, feeds, and medical products. It complements the FDA Commissioner’s Report on Global Pathway to Product Safety and Quality released last summer.
Imports of food and drug products regulated by FDA have increased by more than 13 percent per year since 2002, resulting in a threefold increase of products produced outside of the United States. Almost 40 percent of the fruits and nuts and 85 percent of the seafood consumed in America comes from abroad. Similarly, more than 80 percent of the active pharmaceutical ingredients used to make medicines are imported. To ensure that the vast array of products Americans depend on are safe, FDA focus can no longer be solely domestic – it must be global.
Since many of the products imported are from emerging and developing countries, the FDA asked the IOM to take a look at the regulatory systems in those countries to identify major gaps and to design a strategy for how the FDA, along with other regulators and stakeholders, can help to strengthen their regulatory systems and build capacity.

http://blogs.fda.gov/fdavoice/index.php/2012/04/collaboration-for-a-global-product-safety-net/

Mary Lou Valdez is FDA’s Associate Commissioner for International Programs and Director, Office of International Programs

A Strategy to Keep Antimicrobials Effective

Mike Taylor is Deputy Commissioner for Foods at FDA
Over the past century, few innovations have been as important to public health as the development and use of antimicrobial drugs to treat bacterial infections. They have been successfully used for more than 50 years to treat, control, and prevent diseases in both humans and animals. But over the years, while physicians, veterinarians, and the livestock industry have been putting these important medications to their many uses, we’ve also learned a critical lesson: they have to be used judiciously to ensure they remain effective.
There are complex reasons for this development, including the overuse of antimicrobial drugs in human medicine – a problem FDA and the medical community are working to address. But we also know that an additional factor contributing to antimicrobial resistance is the use of medically important drugs for feed efficiency or growth promotion (so-called “production” uses) in food-producing animals. For the FDA, an agency that’s responsible for protecting the health of the public, this fact requires a response to help preserve the continued effectiveness of these drugs for both humans and animals.

So FDA has settled on a strategy to phase out production uses of medically important antimicrobials and provide that they be used only for targeted, FDA-approved animal health purposes under the supervision of a veterinarian. The important sea change that will enable us to implement this strategy efficiently and expeditiously has been the willingness of many drug companies, veterinarians and animal producers to work collaboratively with FDA to ensure that medically important antimicrobial drugs are used in food-producing animals only when necessary to ensure their health. Many animal producers already work in this way, and we look forward to working closely with the animal production community to make judicious use of antimicrobials standard practice throughout the industry.

In developing our strategy, FDA’s Center for Veterinary Medicine has consulted extensively with our colleagues at the U.S. Department of Agriculture, with the agricultural and veterinary communities, with the animal drug and feed industries, and with public health and consumer advocates. And, as a result of that work, we have released three documents that outline a collaborative approach to keeping antimicrobials effective by limiting their food animal use to specific medical needs.

First, we are publishing a final guidance for industry on The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals. This document establishes a framework for phasing out the use of these drugs for feed efficiency or growth promotion and phasing in veterinary consultation or oversight of their medical uses in food-producing animals.

Second, we are asking for public comments on a draft guidance to drug companies on how to revise their FDA-approved product labels for medically important antimicrobial drugs to no longer include use for feed efficiency or growth promotion, and include veterinary oversight or consultation.
And third, we are publishing a draft proposed regulation, also for public comment, to streamline and modernize the current regulation that governs veterinary authorization for the use of certain drugs in animal feed.

I know there will be those who question why we have not taken mandatory action to ban production uses of antimicrobials. The answer is that, with the willingness of drug companies and others in the animal production industry to collaborate in implementing our strategy, we can make changes more quickly than if we had to rely solely on a cumbersome regulatory process that would require us to seek change drug by drug, and labeled use by labeled use. Working together is how we will get good results in a timely manner.

In implementing our strategy, we want to avoid adverse impacts on animal health and disruptions to the agricultural industry. We anticipate that the phase out of production uses of antimicrobials and establishment of veterinary oversight of remaining ones will take three years. For that reason, in the draft guidance to drug companies we are proposing this timeframe for implementation. We intend to monitor progress after the three-year timeframe has elapsed to evaluate the rate of adoption of these changes. If progress is not what we expected, we will consider further action as warranted in accordance with existing provisions of the FD&C for addressing matters related to the safety of approved new animal drugs.

We know, and so do our colleagues at USDA, that change will be more challenging for small-scale and geographically remote animal producers. It will take time to ensure they have the veterinary support these changes will require and other technical assistance to adjust to the phase out. And we won’t forget about these unique needs.

Concerns about the use of antimicrobial drugs in humans and food-producing animals have been on FDA’s agenda for many years. We see the collaborative strategy we are announcing as a major step forward. It is designed to protect and promote the health of the American public while minimizing disruption to animal health and the animal agriculture industry. We look forward to the public’s comments and to the work ahead to achieve these important goals.

http://blogs.fda.gov/fdavoice/index.php/2012/04/a-strategy-to-keep-antimicrobials-effective/

Making a Difference: Innovation Pathway and Entrepreneurs in Residence

Interview with Todd Park Chief Technology Officer of the United States

Prior to becoming Chief Technology Officer of the U.S. in March 2012, and prior to that, CTO at the U.S. Department of Health and Human Services in 2009, Park co-founded three companies that developed web-based and telehealth solutions for doctors and consumers.

Q – Since you joined HHS, what have you learned about making innovation happen in the government?
I’ve learned that a lot of the same rules that drive success in private sector innovation also apply in the public sector.  The philosophy I used extensively in the private sector boiled down to what Eric Ries calls “lean startup” — the whole idea behind lean startup being  that you want to engage customers early and rapidly prototype solutions in collaboration with them in order to achieve maximum success.

We have successfully applied lean startup principles at HHS across a range of key initiatives.  We’ve emphasized the need to rapidly prototype solutions, engage customers in f those solutions as soon as possible, and then quickly and repeatedly iterate those solutions based on working with customers, until we arrive at both an optimal understanding of what customers really want and a solution that delivers what they want.

more...
http://blogs.fda.gov/fdavoice/index.php/2012/04/making-a-difference-innovation-pathway-and-entrepreneurs-in-residence/

Improving the Integrity of the Drug Supply in a Global Marketplace

Last week FDA announced that a counterfeit version of a cancer drug had surfaced in the United States. It was labeled as Altuzan, a product approved in Turkey and not approved in the United States. The counterfeit did not contain the active ingredient of Altuzan. Unapproved foreign drugs, including the counterfeit, were purchased by medical practices in the U.S. from a foreign supplier.
This discovery comes only a few months after FDA informed 19 medical practices in three states that they had purchased unapproved foreign drugs, which may include the counterfeit version of Roche’s Avastin. Roche is the company that manufactures Avastin approved for marketing outside of the United States. This counterfeit also did not contain the active ingredient of Avastin. This counterfeit was also purchased from foreign suppliers and was also nothing but a sham.
For patients with cancer, combating the disease is difficult enough. But to learn that the cancer drug you were taking to save or prolong your life might be nothing but a counterfeit is unthinkable.
The only FDA-approved version of Avastin for use in the United States is marketed by Genentech (a member company of Roche). Genentech’s Avastin products are safe and effective for their intended uses, therefore cancer patients that have been receiving these products should not be concerned.
FDA does not know whether patients actually received counterfeit Altuzan or Avastin. Nevertheless, these cases illustrate that in today’s global economy much more needs to be done to ensure the integrity of the drug supply.

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

for more... http://blogs.fda.gov/fdavoice/index.php/2012/04/improving-the-integrity-of-the-drug-supply-in-a-global-marketplace/