Bollyky Tells Congress FDA Should Expand Leadership on Global Health Products

June 28, 2010
Tom Bollyky

CGD visiting fellow  Tom Bollyky said the U.S. Federal Drug Administration (FDA) should have a stronger mandate to support development of global health products during his testimony before the Senate Appropriations Subcommittee on Agriculture, Rural Development, the Food and Drug Administration, and Related Agencies. The hearing, initiated by Senator Sam Brownback (R-KS), brought together U.S. government witnesses and private experts to identify practical steps the United States can take to become, as Brownback said, a “good Samaritan” on neglected diseases that affect more than one billion people globally.

In their opening statements, subcommittee chairman Herb Kohl (D-WI) and ranking member Sam Brownback (R-KS) underscored the lack of existing treatments for neglected diseases. Sen. Brownback said doing a better job developing drugs and treating neglected diseases is “one of the best things we can possible do” because “people tend to really like the United States if we help save their lives.”

Bollyky, in his opening remarks, said one out of every six people worldwide suffers from neglected diseases such as malaria, tuberculosis, or hookworm. These diseases and the lack of treatment, he said, rob the world’s poorest of their hopes for a better future. Bollyky said Americans also experience the health and economic consequences of these diseases when they travel abroad and when diseases spread across borders. Sen. Brownback echoed these sentiments, describing how his son’s Peace Corps roommate had contracted dengue fever, a mosquito-borne illness that primarily affects tropical regions.

Despite the prevalence of neglected diseases, Bollyky said that of the 1400 products developed between 1975 and 1999, only 40 are for neglected diseases. “The essence of the problem is this,” said Bollyky. “While philanthropists and private companies have increasingly seen the value in devising products for heretofore neglected diseases, the regulatory infrastructure necessary to develop and introduce these therapies to the developing world is sadly inadequate. Regulatory inefficiencies and gaps add costs to product development, deter private investment, and delay patients’ access to potentially life-saving treatments. Building the needed regulatory infrastructure is a substantial challenge and unprecedented opportunity to improve the lives of millions around the globe and promote the well-being of Americans at home and abroad.”

Bollyky said the United States and the FDA in particular should expand its “leadership role in improving the clinical development and regulatory pathways for neglected disease products.” He urged the FDA to broaden its mandate to support WHO and developing-country regulatory bodies, and for all regulatory bodies—including the FDA, WHO, and developing-country regulatory authorities—to conduct simultaneous, coordinated product reviews. He also promoted more interactions between the FDA and nontraditional product developers, and Sen. Brownback praised the work of the Gates Foundation for their work attracting attention and focus to neglected diseases.

Bollyky’s testimony builds on ideas set forth in his recent CGD working paper, Bridging the Gap: Better, Faster and Cheaper Clinical Trials for Health Products for Neglected Diseases. He will lead a workshop this week on improving clinical trials for neglected diseases.

Jesse Goodman, FDA’s chief scientist and deputy commissioner for Science and Public Health, also testified at the hearing, saying that “diseases know no boundaries” and emphasizing that threats anywhere are threats here. He detailed some of the steps the FDA has taken to its review of global health products, including its greater role reviewing drugs as part of the President’s Emergency Plan for AIDS Relief (PEPFAR). Goodman said the FDA is “committed to doing all we can to help facilitate the availability of safe and effective therapies to patients in need.”

Other witnesses at the hearing included Christopher Austin, director of the Chemical Genomics Center at the National Institutes of Health; Gloria Steele, senior deputy assistant administrator for global health at USAID; Emil Kakkis, president and founder of Kakkis EveryLife Foundation; and Dianne Edquist Dorman, vice president for public policy at the National Organization for Rare Disorders.

By Sarah Jane Staats

Watch the hearing

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