House Committee Levels Sharp Criticism At FDA Over Meningitis Outbreak.

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Yesterday, Food and Drug Administration Commissioner Dr. Margaret Hamburg appeared at a hearing before the House Energy and Commerce Subcommittee on Oversight and Investigations in which both Democrats and Republicans leveled sharp criticism upon the FDA for its role in failing to prevent what became a deadly meningitis outbreak caused by tainted steroid products from the New England Compounding Center. Major print media and Washington insider sources carrying the story underscore the harsh nature of the criticisms leveled at the FDA, particularly from Republicans. After admitting that her agency could have acted in a more aggressive fashion and conceding the need for better policing of compounding pharmacies, Hamburg took the opportunity to ask for Federal legislation requiring all compounding pharmacies to register with the FDA.

        The Washington Post (4/17, Kindy) reports, "After reviewing 27,000 pages of documents from the Food and Drug Administration, Republicans and Democrats came to different conclusions about the agency's ability to prevent one of the worst public health crises in American history." Yesterday, "Republican members of the House Energy and Commerce Committee said...that its six-month investigation into the FDA's role in last fall's meningitis outbreak shows the agency knew for a decade about serious safety lapses at the specialized pharmacy that made the tainted drugs but failed to act." In addition, Dr. Hamburg, the "only person scheduled to testify at the hearing, was sharply criticized about the agency's efforts with the" New England Compounding Center (NECC).

        The New York Times (4/17, A15, Tavernise, Subscription Publication) reports that on Tuesday, Dr. Hamburg "told Congress...that her agency should have acted more aggressively against compounding pharmacies like the one that was responsible for a deadly meningitis outbreak last fall. In a hearing before a House Energy and Commerce subcommittee, she said the agency had become overly concerned about avoiding lawsuits, and as a result did not police the industry as effectively as it could have." Hamburg stated, "I think we allowed ourselves to be far too cautious because of fears of litigation that might further undermine our authority."

        The Los Angeles Times (4/17, Morin) "Science Now" blog reports that Commissioner Hamburg "endured heavy criticism Tuesday as House members accused the agency of failing to act on complaints against the New England Compounding Center, the Massachusetts firm linked to an outbreak of deadly meningitis. Under harsh questioning from Republican and Democratic lawmakers, FDA Commissioner Margaret Hamburg conceded that her agency could have handled the situation better." Hamburg told the committee, "I wish we had been more aggressive, and I can assure you that we are being more aggressive now."

        The AP (4/17) reports, "Republicans and Democrats took turns chastising the FDA for not being aggressive enough in going after compounding pharmacies like the New England Compounding Center, the specialty pharmacy which produced tainted pain injections that have sickened more than 700 people and killed 53 others. In the second hearing on the outbreak, FDA Commissioner Margaret Hamburg reiterated that her agency needs clearer authority to go after compounding pharmacies, which have challenged the FDA's authority in court since the 1990s." According to Hamburg, the FDA "is working to crack down on compounding pharmacies, despite legal challenges."

        Bloomberg News (4/17, Edney) points out, "Republicans have questioned whether the FDA could have shut down the pharmacy based on incidents dating as far back as 2002. They also want to know why the FDA didn't re-inspect NECC after stating it would in a 2006 warning letter and related correspondence two years later." However, "Democrats on the committee came to the FDA's defense, citing a law that left the agency with ambiguous authority over compounding pharmacies, as well as industry lobbying to undermine federal regulation and failures by states to oversee the businesses adequately."

        The Tennessean (4/16, Barton) reports that Hamburg "described the evolution of large-scale compounders like NECC, with production far exceeding that of neighborhood pharmacists who compound, or mix drugs, in response to prescriptions that apply to just one patient. 'It is clear that the industry and the health-care system have evolved and have outgrown the law, and FDA's ability to take action against (large-scale compounding) has been hampered by gaps and ambiguities in the law, which have led to legal challenges to FDA's authority to inspect pharmacies and take appropriate enforcement actions,' Hamburg testified."

        Modern Healthcare (4/17, Block, Subscription Publication) reports that at yesterday's hearing, Hamburg "warned lawmakers...that if Congress doesn't clarify and strengthen the FDA's authority over certain types of compounders, another NECC-type situation could happen." In particular, "Hamburg asked for legislation that requires all compounders to register with the agency. In addition, she called for uniform quality standards to abide by and mandatory reporting of adverse events to the FDA. Currently, section 503(a) of the Food, Drugs and Cosmetics Act exempts compounders from certain regulations that apply to other drug manufacturers."

        The Hill (4/17, Viebeck) "Healthwatch" blog quotes Hamburg as saying, "The tools we have for regulating these firms are simply not the right fit." She called "for new powers to regulate firms like the NECC, which fall between compounder and drug manufacturers. States traditionally oversee the former category, while federal authorities oversees the latter."

        CQ (4/17, Ethridge, Subscription Publication) reports that "Democrats on the subcommittee agreed that confusion prevented the agency from acting effectively to respond to complaints and concerns with the company. Several backed Hamburg's request for Congress to act to clarify the agency's authority, as well as give it new regulatory powers over compounding pharmacies." But, "Republicans said they were not sure that the agency was ready to implement any new authorities, and several accused the agency of using the conflicting court decisions as an excuse for not taking more aggressive action."

        Also covering the story are Politico (4/17, Norman), Reuters (4/17, Clarke), the NBC News (4/17, James) "Vitals" blog, and MedPage Today (4/17, Pittman).

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Cooperation Among Regulators: Impact on Stakeholders

Hear Firsthand from FDA Commissioner Hamburg, EMA Executive Director Rasi, and Health Canada Assistant Deputy Minister Glover             View Commissioner Hamburg at Last Year's Annual Meeting Cooperation Among Regulators: Impact on Stakeholders Monday, June 24 Hear views on important issues from the leaders of three of the most influential drug regulatory agencies: The Health Products and Food Branch of Health Canada, the European Medicines Agency, and the U.S. Food and Drug Administration. Join the regulators as they discuss current actions in public policy resulting from interagency actions and strategic communication. Speakers: Chairpersons: Paul Glover, MBA Assistant Deputy Minister of the Health Products and Food Branch Health Canada Marie Allison Dray, MA, MBA President International Regulatory Affairs Group LLC Margaret A. Hamburg, MD Commissioner, FDA  Murray M. Lumpkin, MD, MSc Commissioner's Senior Advisor and Representative for Global Issues, OC, FDA Guido Rasi, MD Executive Director European Medicines Agency European Union Late Breaker Sessions Collaborating to Streamline Drug Development: Are We Making Progress? Wednesday, June 26 In this forum, leaders of two of the best known initiatives – TransCelerate Biopharma Inc (TransCelerate) and the Clinical Trials Transformation Initiative (CTTI) – will provide a status report on current projects, with additional perspectives provided by representatives of the FDA, CROs, and research sites. TransCelerate’s Collaborative Approach to Risk-based Monitoring: The Methodology Wednesday, June 26 TransCelerate BioPharma Inc. (TransCelerate) developed a methodology for monitoring that shifts monitoring processes from an excessive concentration on source data verification to comprehensive risk-driven monitoring. This philosophical shift in monitoring processes employs centralized and offsite mechanisms to identify and monitor important study parameters holistically and uses adaptive onsite monitoring to further support subject safety and data quality. White Paper Showcase features the following two opportunities... Stay Tuned, More to Come! Next Generation Medical Information Call Center Tuesday, June 25 This session will discuss best practices for building a next generation medical information call center that expediently and efficiently delivers medical information on a global scale. We will discuss how advanced technology can enable and enhance critical patient and provider relationships.   Learning to Share-Sharing To Learn: How an Industry Learns to Honor it’s Volunteers Monday, June 24 This session will discuss the potential value of data sharing initiatives and what hurdles need to addressed to successfully create one. Learn what components are needed and how best to support or participate in this next step in the evolution of clinical research.   Coming Soon! Innovation Theater Schedule to be Announced - Stay Tuned!   Overview | Agenda | Register Online Keynote Speaker Preconference Tutorials Hotel & Travel Exhibiting Daniel Kraft, MD Executive Director, FutureMed Register for 2 half-day or 1 full-day tutorial, save $100 on your registration Book within the DIA Room Block, get special perks! 90% of the hall is SOLD. Reserve your booth today!

IOM Report Calls For Tracking System To Fight Counterfeit Drug Trade.

The AP (2/14, Neergaard) reports that the Institute of Medicine on Wednesday released a report that concludes, tackling the "problem of fake drugs will require creating a national drug-tracking system." The IOM's report calling "for putting medications through a chain of custody like US courts require for evidence in a trial comes a week after the Food and Drug Administration warned doctors, for the third time in about a year, that it discovered a counterfeit batch of the cancer drug Avastin [bevacizumab] that lacked the real tumor-killing ingredient."

        NPR (2/13, Knox) in its "Shots" blog reports that the "National Academies of Science, of which the IOM is part, was commissioned by the Food and Drug Administration to look at how to protect people against fake and substandard drugs." According to the report, the problem "extends to more than 120 countries...and has done incalculable damage to efforts to control tuberculosis, malaria, AIDS and other diseases."

        The Wall Street Journal (2/14) "Corporate Intelligence" notes that the IOM report also emphasized that oversight of prescription drug wholesalers needs to be strengthened.

        AFP (2/14, Santini) adds that FDA Commissioner Dr. Margaret Hamburg "commended the report" and the agency is already implementing many of its suggestions. "To meet the challenges of today's global marketplace, the FDA is transforming from a predominantly domestically focused agency to one that is fully prepared to help ensure product safety and quality within a globalized world," Dr. Hamburg said in a statement.

        However, according to The Hill (2/14, Wilson) "Regwatch" blog, "Members of Congress want to create legislation to increase the crackdown and oversight effort." Rep. Henry Waxman (R-CA), the "ranking member of the House Energy and Commerce Committee" said "I hope we can pass a law at the federal level that provides the same level of protection as California's model legislation," which requires "individual units of drugs to be accounted for at each step along the supply chain."

        Modern Healthcare (2/13, Zigmond, Subscription Publication), HealthDay (2/14, Gardner) and MedPage Today (2/14, Pittman) also cover the reports, which is titled, "Countering the Problem of Falsified and Substandard Drugs."

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Forbes Interviews FDA Commissioner.

On its website, Forbes (2/6) provides three videos of staff reporter Matthew Herper interviewing Food and Drug Administration Commissioner Dr. Margaret Hamburg. She discussed the vast array of consumer items the agency regulates - from drugs and medical devices, to cosmetics, food and tobacco products - essentially, overseeing a quarter of the US economy. Asked what her job is like, Dr. Hamburg said the best part of it is working with agency staff, whom she described as an "extraordinary group of dedicated professionals all working to do the things that will best benefit the public." The commissioner also emphasized the agency's commitment to evidence-based decision making in terms of drugs and medical device approvals; and she discussed the challenges involved in the different types of approval processes the FDA undertakes.

DIA Daily is a digest of the most important news selected from thousands of sources by the editors of BulletinHealthcare. The presence of content or advertising does not endorse, nor imply endorsement of, any products or services by the Drug Information Association. Neither BulletinHealthcare nor the Drug Information Association is liable for the use of or reliance on any information contained in this briefing.

If you would like more information about, or have a question pertaining to, DIA Membership and its benefits, please email membership@diahome.org.Click here to check your membership status.

Drug Information Association | 800 Enterprise Road, Suite 200 | Horsham, PA 19044

Copyright © 2012 by BulletinHealthcare| 11190 Sunrise Valley Drive, Suite 130 | Reston, VA 20191

Counterfeit Prescription Drugs - Partnership for Safe Medicines -> live on c-span

http://www.c-spanvideo.org/program/308446-1

Public Affairs Event
September 28, 2012

MAIN SPEAKERS:
Dr. Margaret Hamburg, Commissioner, U.S. Food & Drug Administration
John Castellani, President and Chief Executive Officer, Pharmaceutical Research and Manufacturers of America (PhRMA)
James Dinkins, Executive Associate Director, ICE s Homeland Security Investigations
Gerald Heddell, Director of Inspection, Enforcement and Standards, MHRA
Linda Marks, Senior Litigation Counsel, Department of Justice
Damon McCoy, Assistant Professor, George Mason University
Ralph G. Neas, President and Chief Executive Officer, Generic Pharmaceutical Association (GPhA)
John Roth, Director of the U.S. Food and Drug Administration Office of Criminal Investigations

NEHI Conference on Bridging the Innovation Gap FDA Innovates, from FDA.gov

FDA Innovates

Remarks given at the NEHI Conference on Bridging the Innovation Gap
By Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Boston, Massachusetts
April 26, 2012

Thank you, Beverly for the generous introduction.

I am honored to be invited here today.

It is a privilege to address one of the largest, most diverse health care organizations in the United States. But I am especially pleased to be asked to address a topic that is very close to my heart—and occupies much of the thought, creativity and work of everyone at FDA.

I’ll get to innovation at FDA in a moment. But I want to start by commenting on the NEIH Innovation Barometer survey that Glen and Chrystine presented an hour ago. I thought it was very interesting. Working on the inside of a large complex agency, it is always valuable to gain the insights of health care leaders, and I don’t ever want to lose sight of how what we do affects health care and the public. Yes, we innovate. And, yes, we regulate. But we also need to make sure we’re listening and working together. That is why I was very pleased to learn from your survey that the great majority of the healthcare opinion leaders appreciate FDA’s work.

My colleagues and I take that appreciation to heart, and we will continue to work hard to earn the trust and support that Glen and Chrystine talked about.

I am particularly encouraged by the support indicated for increased funding for FDA.

This is a vital concern. Money alone does not guarantee a success, but FDA’s responsibilities have grown dramatically in recent years. It is hard to imagine, but FDA is actually responsible for the regulation of products that account for somewhere between 20 and 25 cents of every dollar of consumer product spending in this country. We regulate drugs, medical devices, biologics and vaccines, the safety of our nation’s blood supply and the vast majority of our food supply; cosmetics, dietary supplements, products that emit radiation…and most recently, tobacco products. The scope of our responsibilities is vast, and they concern things that really matter, to all of us, each and every day.

Increased funding would certainly help us address the many mandates given to us by Congress—and to fulfill our unique and essential mission to promote and protect the health of the public. I believe strongly that both consumers and industry groups have a tremendous stake in a strong FDA that takes science-based actions on behalf of public health.

And—without doubt—that includes promoting innovative products and advancing regulatory science.

So let me turn now to the topic of innovation. It is an issue that is important to us all, whether you come from industry, from academia, from clinical practice, or from government. Of course we each bring our own set of questions and concerns to the table. But we all recognize that we are at a critical juncture.

For the people here from the medical products side—those who develop new devices, diagnostics, and drugs—these have not been easy times. The trend lines for innovative products relative to investments in research and development are not what any of us would like. The costs of bringing new drugs to market have skyrocketed and the pipeline of promising new drug candidates is distressingly low.

Many companies are facing the so-called "patent cliff." Worsening the situation is the unstable economy, changing rules for reimbursement, and, I know, concerns with the FDA…fears that a lack of predictability, consistency, and transparency in our decision-making processes and actions will lead to less investment in innovative technologies and companies, as well as increased competition from foreign companies.

These are challenges that I understand, appreciate, and we are working hard to address.

And for the people here from the healthcare side—those responsible for delivering care to patients—many of you are frustrated that we, as a scientific and medical community, have not been able to adequately realize all of the seeming opportunities in science today. And that is true. Patients are urgently waiting for new therapies—and often not getting them. And we are not adequately addressing burgeoning public health needs. Disease conditions such as obesity and Alzheimer’s, are taking a growing toll, profoundly affecting American families, and measurably adding to our health care costs and our national debt.

How is it that we are in a veritable golden age for biomedical discovery…the sequencing of the human genome has revealed new potential drug targets; combinatorial chemistry, high throughput screening, and biosynthesis has led to thousands of candidate drugs; cutting-edge electronics, nanotechnology, and materials science has the power to transform medical devices...yet despite this, we are not effectively translating these scientific discoveries into therapies, prevention or cures.

There is nothing I would like better than to find a single solution to all of these challenges. But there isn’t one. Instead, we need a comprehensive, integrated strategy that engages the full "eco-system" to advance biomedical product innovation. This includes new and strategic investments in research, driven by American ingenuity and science with input from our global partners, and more thoughtful design and implementation of policies on everything from patents and intellectual property to economic incentives for innovative medicines, reimbursement issues, and, of course, sound regulation. Meaningful and enduring solutions will require true collaboration by stakeholders – and strong leadership from business, academia and government.

And that is why a meeting like this is so important.

History tells us that full engagement and leadership can work.

for complete article... http://www.fda.gov/NewsEvents/Speeches/ucm302037.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=hamburg&utm_content=1

FDA Stretches to Go Global, from The Burrill Report

The Burrill Report

With limited resources, agency targets trouble spots and seeks cooperation.

“The $10 million is a small drop in the bucket of what our overall needs are.”

Federal regulators struggling to catch up with global supply chains are working to strengthen ties to their foreign counterparts in China and beyond to better protect public health at home, the U.S. Food and Drug Administration says.

The agency is seeking $10 million from Congress to pay for additional staffing and drug manufacturer inspections in China and is developing new risk-based approaches to ensure product safety and quality to improve its results.

“The $10 million is a small drop in the bucket of what our overall needs are,” FDA Commissioner Margaret Hamburg testified recently before the Senate Appropriations subcommittee that oversees the FDA’s budget.

But coming to terms with globalization is “a huge priority,” she says. “FDA is at the cutting edge of much of this in terms of responding to the challenges of globalization. And at the present time we don’t have the tools and authorities that we fully need to achieve that nor do we have the resources.”

What the agency is doing with the limited resources it does have is covered in a new “Global Engagement Report” [http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm298576.htm] detailing its efforts and evolving responses to the growing complexities and dangers of imported food and drugs. More than 80 percent of the active pharmaceutical ingredients and 40 percent of finished drug dosages sold in the United States are manufactured abroad.
for complete article,
http://www.burrillreport.com/article-fda_stretches_to_go_global.html

FDA News Release: FDA strengthens international collaboration to ensure quality, safety of imported products

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FDA NEWS RELEASE

For Immediate Release: April 23, 2012

Media Inquiries: Gloria Sanchez, 301-796-7686, gloria.sanchez-contreras@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

FDA strengthens international collaboration to ensure quality, safety of imported products

New report presents FDA’s focus on global cooperation for product safety

The U.S. Food and Drug Administration Commissioner Margaret A. Hamburg, M.D. today released the agency’s “Global Engagement Report¹,” detailing the many activities and strategies FDA is using to transform from a domestic to a global public health agency.

The report describes the steps the agency is taking to ensure that imported food, drugs, medical devices, and other regulated products meet the same rigorous standards for safety and quality as those manufactured domestically.

“As our world transforms and becomes increasingly globalized, we must come together in new, unprecedented, even unexpected, ways to build a public health safety net for consumers around the world,” said FDA Commissioner Margaret A. Hamburg, M.D.

Global production of FDA-regulated goods and materials has exploded over the last decade and continues to grow. FDA-regulated products originate from more than 150 countries, 130,000 importers, and 300,000 foreign facilities. Each year from 2005-2011, food imports have grown by an average of 10 percent, while imports of pharmaceutical products have increased at nearly 13 percent and device imports have grown more than 10 percent. Approximately 50 percent of fresh fruits and 20 percent of fresh vegetables, as well as 80 percent of the seafood consumed in America come from abroad. Similarly, more than 80 percent of the active pharmaceutical ingredients used to make medicines are imported.

The report outlines a variety of engagement strategies the FDA is using in partnership with other agencies, organizations and coalitions around the world to strengthen global, regulatory capacity-building efforts; develop and harmonize science-based regulatory standards; increase awareness about the importance of regulatory systems; and share information and data globally to facilitate rapid identification of and response to public health emergencies.

Through its international offices in Africa, Asia, Europe, Latin America, and the Middle East, the FDA is increasing its knowledge base about local regulatory systems and landscapes. The agency is also increasing the understanding of foreign governments and industry of FDA regulations and standards for products destined for U.S. consumers, and collaborating to strengthen regulatory science and evidenced-based approaches to product safety and quality. All of this furthers the FDA’s implementation of its global strategy, set forth in the agency’s special report, Pathway to Global Product Safety and Quality², released last year.

To access the Global Engagement Report³, and learn more about the FDA global work please visit the agency’s web page dedicated to its work on globalization: www.fda.gov/global⁴. Also available are videotaped remarks from Dr. Margaret Chan, Director General of the World Health Organization: http://terrance.who.int/mediacentre/messages/MSG_FDA_CHANm_13APR2012.wmv^{5 6}.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Page Last Updated: 04/23/2012