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Upcoming Event: FDA Webinar on Prescription Drug Shortages, September 30, at 11am ET.
Do you know that in 2010 there were a record number of shortages of prescription drugs, and that in 2011, FDA continues to see an increasing number of shortages, especially those involving older sterile injectable drugs?
As part of FDA Basics, FDA is hosting a webinar where you can learn how the agency helps reduce the impact of drug shortages for patients and our nation’s health care system. Captain Valerie Jensen, R.Ph., Associate Director for FDA’s Center for Drug Evaluation and Research’s (CDER’s) Drug Shortage Program, will discuss the extent of the current drug shortage issue and the importance of communication among FDA, drug manufacturers, health professionals, and the public, in helping to reduce its impact on public health.
The free 30 minute webinar will be held Friday, September 30m, at 11 am ET.
There are a limited number of spots available for the webinar. Materials from the webinar will also be made available on the FDA website following the presentation.
Learn more about the webinar, including instructions about how to join the webinar.
FDA Tells Farmers: We need to learn from you
Michael R. Taylor, FDA and Bob Nolan, Deer Run Farms
Photo taken by Erica Pomeroy
Last week, farmers from across the North and South forks of Suffolk county Long Island showed a group of us from the U.S. Departments of Agriculture and Health and Human Services, the Food and Drug Administration (FDA), and the New York State Department of Agriculture and Markets the incredible diversity of their farms and the challenges FDA faces in writing a “produce safety” rule.
Bob Nolan, who farms 30 acres with his son and uncle, invited us because he heard that we had walked the rows of other fresh fruit and vegetable farms across the country. In fact, this was the 14th state we visited in the last year or so. We have seen the orchards of Oregon, the vast vegetable fields of California, Amish farms in Ohio, irrigation-dependent produce operations in Texas, vegetable farms in Delaware, North Carolina family farms, and Florida tomato fields to name just a few.
And each time, we have come away with new insights from the farmers and their families about how they are already addressing produce safety concerns, what they expect from an FDA rule, and the challenges of maintaining their way of life.
Our Long Island tour was a microcosm of the diversity we have seen across the country. Organized by Cornell extension agent Sandy Menasha and Long Island Farm Bureau executive director Joe Gergela, the tour of seven farms ranged from small to large, conventional to organic, first-generation farmer to twelfth generation.
Let’s face it, the first question a federal official gets asked on a farm is as blunt as the summer day is long: Why are you here? Mike Taylor, the FDA deputy commissioner for foods, has a pretty good answer: If we’re going to get this produce safety rule right, we need to learn from you.
That’s it in a nutshell. While FDA and its colleagues at USDA bring to the table scientific and public health expertise, we all know that farms are very much the real world of soil, air and water open to the elements 24/7 and worked by humans and animals. Farmers can inform us from their experience and practices.
Just see the different perspectives shared with us last week: the first-generation organic farm of the Garden of Eve; the 225-acre Ed Zilnicki and Sons’ potato farm; Nolan’s 30-acre Deer Farms devoted to leafy greens; the “agritainment” and “u-pick” farms like Hank’s Pumpkin Town, Harbes’ Family Farm, and the Milk Pail; and the farm stand run by Jim and Jennifer Pike.
And we got to hear loud and clear what the farmers expect from the FDA. “I can’t hire a food safety guy. I am the food safety guy,” Bob Nolan said. Hank Kraszewski wants the produce safety rule to be “crystal clear.” Tell farmers straight out, “What do I have to do,” he said. Record-keeping can’t become burdensome for small farmers like themselves, Eve Kaplan-Walbrecht and Jim Pike told us.
Farmers are also thirsty to learn more. Horse manure is a time-honored soil amendment for the sandy fields of Long Island. How can they apply it safely, they want to know.
And, while we heard that while farmers get it about food safety, they also want us to get it about the economic realities they face. Several had struggled in the ‘90s when wholesale potato farming became less profitable and they moved to other commodities and on-farm retail sales.
Successful produce safety is possible if farmers and food safety officials work together, listening to each other and learning from each other.
Sharon Natanblut, Senior Advisor to the Deputy Commissioner for Foods, FDA
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Fostering Innovation Through Better Science
Science is the backbone of everything we do at FDA. Which is why today’s release of the agency’s Strategic Plan for Regulatory Science is a significant next step in the agency’s Regulatory Science Initiative, originally announced in October, 2010. We are releasing the plan along with a podcast and a consumer article to make it easier for everyone to join this conversation about regulatory science and understand what this plan really means.
“As new discoveries yield increasingly complex products,” says FDA Commissioner Margaret A. Hamburg, M.D. “this strategic plan ensures that our experts are equipped to make science-based decisions resulting in sound regulatory policy. It positions us to foster innovation through better science without compromising our high safety standard.”
This plan calls for a sweeping modernization of the science used in developing and evaluating products critical to the nation’s health, economy and security. It recognizes the important role the agency must play in fostering innovations in the marketplace today to address the public health challenges of tomorrow.
All around us we see evidence that new technologies are creating unprecedented opportunities to prevent and cure disease as well as to grow our high tech economy. As my colleague and FDA’s Chief Scientist Dr. Jesse Goodman says: “This plan will help turn advances in science into products that benefit people, and help FDA assure that happens more quickly and safely. It is win-win-win, because it will help the public, the agency and developers of new products.”
This plan signals clearly the agency’s intent to work collaboratively with our colleagues in academia and industry to enhance the process for developing and evaluating promising new products and novel materials emerging from fields such as cell therapies, tissue engineering, genomics and personalized medicine, and through use of advanced computing and information technology.
As we move forward, we welcome ideas and comments. We are inviting our partners, domestic and international, and the public to join the conversation as we take the steps necessary to advance and target the best regulatory science to help meet the nation’s highest public health priorities and medical needs.
Thank you.
Vicki Seyfert-Margolis
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FDA Continues to Issue Warning Letters for Illegal Tobacco Sales to Minors
Every day nearly 4,000 kids under 18 try their first cigarette and 1,000 kids under 18 become daily smokers. Virtually all new users of tobacco products are under the minimum legal age to purchase such products. Many of these kids will become addicted before they are old enough to understand the risks and will ultimately die too young of tobacco-related diseases.
FDA is working to protect the health of America’s children and ultimately reduce the burden of illness and death caused by tobacco use by enforcing the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) and Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents. This regulation, which took effect on June 22, 2010, limits the sale, distribution, and marketing of cigarettes and smokeless tobacco to protect the health of children and adolescents.
FDA works to inform retailers about these laws through the Break the Chain of Tobacco Addition campaign. FDA will also host a series of Compliance Training for Tobacco Retailers, to be held on March 29, April 26, May 18, June 28, July 26, and September 20, 2011, to provide retailers with training on federal tobacco regulations.
Last year, in order to help enforce these laws, FDA awarded contracts to 15 states to assist in inspecting retail establishments that sell cigarettes and/or smokeless tobacco products. In the upcoming years, FDA plans to award enforcement contracts to all states and U.S. territories to assist with enforcement of the Tobacco Control Act.
The goal of the State Enforcement Program is to improve public health and to protect young people by bringing enforcement action against retailers who violate the law. State inspectors under these FDA enforcement contracts conduct compliance check inspections to determine if retailers comply with the law, including whether the retailer:
- sells a tobacco product to a minor;
- requests proper identification;
- sells prohibited flavored cigarettes or individual cigarettes; and
- sells tobacco products in a self-service display, like a vending machine, which can be accessed by minors.
We appreciate the efforts and commitment of all states who have contracted with FDA to assist in enforcing the Tobacco Control Act and FDA regulation. More than 95 Warning Letters have been issued to retailers for illegal sales of cigarettes and/or smokeless tobacco to minors. FDA’s website posts Warning Letters that have been issued as well as a list of retailers that have been inspected and where no violations were observed.
We encourage anyone who is aware of retailers who may violate the Tobacco Control Act to report violations to FDA’s Center for Tobacco Products through our website, by email or by phone (1-877-CTP-1373).
Thank you,
Ann Simoneau
Director, Office of Compliance and Enforcement
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New Updates on FDA-TRACK, Agency’s Performance Management System
FDA’s performance management system, FDA-TRACK, allows the public to follow the agency’s progress on a range of measures (see April 7 blog post).
New performance data from December 2010 is now available on FDA-TRACK. Check out FDA-TRACK for updates, including complete FY 2010 data for projects related to human drugs and biological products, and animal drug products.
Afia Asamoah, Transparency Initiative Coordinator
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FDA Launches Web-based Resource to Make Regulatory Information More Accessible
Today, as part of the third phase of the Transparency Initiative, FDA launched a web-based resource called FDA Basics for Industry to provide basic information about the regulatory process, including information that is frequently requested by industry.
FDA Basics for Industry includes:
- Easier access to frequently requested content, including, guidance documents, information about the review process, and registration and listing information
- Links to training modules for industry, such as the Center for Devices and Radiological Health’s CDRH Learn educational tool
- Answers to questions frequently asked by industry
The launch of FDA Basics for Industry is one of the 19 steps outlined in a report issued today by the Transparency Task Force about ways FDA can improve its transparency to regulated industry.
Visit FDA Basics for Industry and let us know what you think. You can leave a comment on this blog or send an email to webmail@oc.fda.gov.
Afia Asamoah, Transparency Initiative Coordinator
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Additional Information About Post-Approval Studies Conducted with Medical Devices Now Available
FDA is taking steps to improve transparency about studies conducted with devices after approval. The Center for Devices and Radiological Health (CDRH) has a program that oversees studies that are required as a condition of approving certain applications. The CDRH Post-Approval Studies (PAS) program helps to ensure that well-designed post approval studies are conducted effectively and efficiently and in the least burdensome manner.
CDRH launched a webpage so that the public can keep informed of the progress of each post-approval study. The webpage displays general information about each post-approval study and now more information is available, including information about the study design, population studied, and data collection methods. For completed studies, you can find information about final study results, safety and effectiveness findings, strengths and weaknesses of the study, and recommended labeling changes, if any.
This post will be last one until January 2011. Happy holidays to all of our readers and best wishes for the New Year!
Afia Asamoah, Transparency Initiative Coordinator
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New Updates on FDA-TRACK, Agency’s Performance Management System
FDA’s performance management system, FDA-TRACK, allows the public to track the agency’s progress on a range of measures, including whether the agency is hitting its inspection targets and whether it is hitting its targets for completing reviews of product applications (see April 7 blog post).
New performance data is now available on FDA-TRACK. Check out FDA-TRACK for updates from November 2010, including updates on the number of Freedom of Information Act (FOIA) requests processed in FY 2010 and the agency’s progress filling vacancies on FDA advisory committees.
Afia Asamoah, Transparency Initiative Coordinator
FDA’s Center for Devices and Radiological Health (CDRH) Launches Inspections Database
Yesterday, as part of the FDA Transparency Initiative, CDRH launched the ‘CDRH Inspections Database’. The database provides information about medical device inspections that were the responsibility of CDRH from 2008 to the present (approximately 25% of the medical device inspections conducted since 2008). The database contains information about the firms, types of devices and inspections, and links to warning letters (when available).
You can search the inspection database by various parameters, including company name, inspection type, product code, inspection classifaction, inspection action, and date. You can find the database here.
We encourage your feedback on the database and welcome your suggestions for additional information you would like to see. You can provide feedback on the FDA Web site.
Afia Asamoah, Transparency Initiative Coordinator
