Posts Tagged ‘FDA’

This post is by Global Center Director Christine Lubinski.

The excitement in the room was palatable today as FDA Commissioner Margaret Hamburg joined representatives from the Global Alliance for TB Drug Development, the Bill & Melinda Gates Foundation, the Treatment Action Campaign, and representatives from the pharmaceutical industry to announce a new collaboration to accelerate the development of combination treatments for tuberculosis.

Known as the Critical Path to TB Drug Regimens (CPTR), the initiative will test promising combinations of individual TB drug candidates from different companies early in the development pipeline—and identify the best new treatment regimens.

“We are here today because every year almost two million people die from a disease we have known how to cure for decades,”   Dr. Hamburg said in opening remarks at the event. She went on to describe the scientific enterprise in TB as stagnant and characterized TB research as the “only field in medicine where you could go into hibernation for decades and emerge to find that nothing has changed.” 

She also spoke about her experience leading the effort to combat resurgence in TB, including MDR-TB in the early 1990s in New York city, and noted that $1 billion in costs associated with that effort might have been saved if appropriate resources had been marshaled to control TB in the first place.  She articulated her commitment–and that of the FDA–to advancing regulatory processes that bring urgently needed advances in the treatment of drug-susceptible and drug-resistant TB.

Mario Raviglione, MD,  the lead on TB for the World Health Organization, noted that 4,500 people who die of tuberculosis every day. And he pointed out that while there is a disproportionate burden of TB in some parts of the world—notably Asia and Africa—no country has even come close to eliminating tuberculosis.  He described the coalition of companies coming together to develop new, more effective combinations of drugs for TB treatment as “unprecedented” and pledged that the WHO would move forward rapidly to develop policies relevant to getting new treatments to the field.

Dr. Regina Rabinovich, head of infectious diseases for the Bill & Melinda Gates Foundation, said the CPTR the initiative was groundbreaking and forged “a new pathway.”  She also noted that the Gates Foundation could not do this alone and said it’s is essential that industry and governments step up to help finance this effort.

Paul Stoffels, MD, head of global research and development for Johnson & Johnson, talked about clinical trials under way for a new drug for MDR-TB in South Africa and said it’s been so long since there have been major TB clinical trials, that both capacity and know-how are a problem.

Professor Charles Mgore, executive director the the European and Developing Countries Clinical Trials Partnership (EDCTP) pledged the cooperation of his organization in the implementation of this initiative.  EDCTP aims to accelerate the development of new or improved drugs, vaccines and microbicides against HIV/AIDS, malaria and tuberculosis, with a focus on phase II and phase III clinical trials in sub-Saharan Africa. Dr. Mcgore noted the imperative of conducting trials in high burden countries but highlighted the challenges that exist from poor infrastructure to personnel in need of training.  

Mark Harrington, executive director of the Treatment Action Group, offered himself as a living example of what can be achieved when there is an effective collaboration among government, pharmaceutical companies and activists, as there was in the HIV context.   He also said he never thought he’d find himself in a room with five pharmaceutical companies interested and willing to invest in TB drug development, while highlighting the incredibly modest level of resources being invested today in TB research and development—only $178 million on drug development worldwide.

This collaboration, with its promise of game changing new tools to combat tuberculosis, challenges those of us who are advocates to press even harder for an allocation of resources from the U.S. and other wealthy countries for research and development and TB programming at a level commensurate with the impact of this ancient and deadly disease on the poorest people on earth.

More information on this exciting project can be found here: http://www.tballiance.org/newscenter/view-brief.php?id=904. And for a Q&A with Dr. Mel Spigelman, president and CEO of the Global Alliance for TB Drug Development, about this project, click here.

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Federal officials today celebrated the approval of the 100th antiretroviral drug authorized under an expedited regulatory framework created five years ago, as a way to fast-track the delivery of cheap HIV drugs to the developing world through the PEPFAR program. A panel discussion, held at the Pan American Health Organization Headquarters to mark the milestone, featured FDA Commissioner Margaret Hamburg, OGAC Director Ambassador Eric Goosby and ambassadors from Haiti and Tanzania.

The FDA process was launched in May 2004, in response to a call from activists, clinicians and members of Congress to use the WHO’s pre-certification drug list to make purchases of generic medications for PEPFAR-funded programs. Instead, a process was devised to allow the FDA to certify generic antiretrovirals (ARVs) for PEPFAR purchase, even if the branded drug was still protected by U.S. patent laws.

According to the first speaker, Dr. Mirta Roses Periago, director of the Pan American Health Organization, more than 4 million people now have access to lifesaving HIV medications, including 455,000 in Latin America and the Caribbean region. Periago noted that these numbers reflect only 42 percent of those who need ARVs and commented on the urgent need to bring down prices and increase availability of second-line treatments. (more…)

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The search for new TB drugs and diagnostics is a long and windy road, paved with regulatory bumps and expensive R & D hurdles.

But the path could get a little smoother under an amendment recently added to the Senate’s fiscal year 2010 funding bill for the Food and Drug Administration and other related programs. The provision, offered by Sen. Sam Brownback, R-Kansas, would require the FDA commissioner to create two review groups to recommend new solutions for “the prevention, diagnosis and treatment of rare diseases and neglected diseases in the developing world.”

Brownback’s provision aims to streamline the regulatory process for new drugs and other tools to combat rare and neglected diseases that can take a huge toll on poor people in the developing world, where the potential to make big bucks off a new drug are slim to none. Click here for the amendment text and status of the bill.

In his floor speech urging support for the provision, Brownback specifically mentioned tuberculosis as a neglected disease that is “rampant” in the developing world but that has not gotten adequate R & D attention.

“You can have millions, even more than that, who are affected by a disease, but there is not a large marketplace to support the research that is necessary to develop a cure,” Brownback said. “It is my hope that what this will lead to is us developing systems and ways where we can reduce the cost and the time for drug delivery and development.”

Brownback’s provision passed the Senate but is not included in the House version of the bill. So a House-Senate conference committee will decide its fate. The Center for Global Health Policy, along with a coalition of other groups, is strongly supporting final passage.

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A Food and Drug Administration advisory committee has decided that the threat posed by MDR-TB merits a fast-track approval process for potential new treatments.

The clock is ticking, as drug-resistant TB spreads across the globe and scientists search for new drugs to combat this virulent germ. Given that background, the FDA’s Anti-Infective Drugs Advisory Committee concluded on June 3 that sputum culture conversion could be the basis to support accelerated approval of drugs to treat MDR- TB.

Carol Dukes Hamilton, MD, co-chair of the Center for Global Health Policy’s Scientific Advisory Committee, was among the TB experts urging the FDA committee to approve the fast-track process. Sputum culture conversion is “the best we have” as a surrogate for measuring efficacy in MDR-TB drugs, Hamilton told the panel on Wednesday.

 The FDA panel’s action is a significant step forward for doctors and scientists who are on the front lines of battling the global TB epidemic. According to a story in the Pink Sheet Daily, the advisory committee “supported culture conversion, with improvement/resolution of signs and symptoms, as an acceptable surrogate endpoint for accelerated approval” by an 18-to-1 vote.

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