Global Market Access: Essential Knowledge for Clinical Trial Design

DIA 2012 Collaborate to Innovate

48th Annual Meeting
June 24-28, 2012
Philadelphia, PA

Pennsylvania Convention Center

Global Market Access: Essential Knowledge for
Clinical Trial Design
June 24, 8:30AM - 12:00PM

Instructor(s):John Brennick, MPA
Worldwide Market Access
Janssen Global Services, LLC, United States

Description:
Reimbursement approvals from payers (reimbursers) have become as important as regulatory approvals for pharmaceutical product success and providing access to patients. Even with reimbursement approval, payer restrictions such as step edits and individual patient approval significantly impact product usage. This tutorial will provide an overview of global reimbursement systems including health technology assessments (e.g., NICE), and discuss ways in which evidence of value from clinical trials can help or limit market access.

Event	Credit Type	Max Credits	CEU
#23: Global Market Access: Essential Knowledge for	IACET	3.25	0.300

Learning Objectives:
At the conclusion of this tutorial, attendees should be able to:
• Summarize the evidence demands of global payer customers
• Discuss the growing importance of the reimbursement hurdle to patient access to your medicine
• Recognize how aspects of clinical trial design, such as dosing and comparator choice, can impact reimbursement potential

Target Audience:
This tutorial is designed for pharmaceutical industry employees not familiar with market access (pricing, reimbursement, health economics) issues.

for more information...

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/

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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Read our Blog: FDA Voice⁷

Visit the FDA on Facebook⁸, Flickr⁹, YouTube¹⁰ and Twitter¹¹¹²

RSS Feed for FDA News Releases¹³

Links on this page:

1. /AboutFDA/ReportsManualsForms/Reports/ucm298576.htm
2. /AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htm
3. /AboutFDA/ReportsManualsForms/Reports/ucm298576.htm
4. http://www.fda.gov/global
5. http://terrance.who.int/mediacentre/messages/MSG_FDA_CHANm_13APR2012.wmv
6. http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/Disclaimers/default.htm
7. https://blogs.fda.gov/fdavoice/
8. http://www.facebook.com/FDA
9. http://www.flickr.com/photos/fdaphotos/
10. http://www.youtube.com/user/USFoodandDrugAdmin?blend=23&ob=5
11. http://twitter.com/us_fda
12. http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/Disclaimers/default.htm
13. http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/PressReleases/rss.xml

Page Last Updated: 04/23/2012

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

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/