U.S. Senators introduce legislation to encourage R&D aimed at neglected pediatric diseases

Aug 11 2010

"New bipartisan legislation was introduced in the U.S. Senate last week which seeks to encourage innovative [research and development] R&D by drugmakers aimed at treating rare and neglected pediatric diseases," PharmaTimes reports.

The Creating Hope Act of 2010 (S. 3697), sponsored by Sens. Sherrod Brown (D-Ohio), Sam Brownback (R-Kan.) and Al Franken (D-Minn.), builds upon the FDA Amendments Act, "to increase incentives for the development of treatments for disabling and deadly diseases, with a focus on rare conditions that may otherwise fail to attract sufficient R&D funding," the news service writes (Taylor, 8/9).

"The idea is that the financial incentive associated with bringing 'blockbuster' drugs to the market sooner will encourage companies to work harder researching the lesser needed treatments. The proposal expands on a 2007 law that offers 'priority review vouchers' to companies that develop new drugs for neglected tropical diseases," The Hill's "Healthwatch" blog reports (Lillis, 8/6).

Under the FDA Act, "companies that develop new drugs and biologics for neglected tropical diseases are eligible for a 'priority review voucher' entitling them to expedited review of another drug produced by that manufacturer," according to a press release by Brown's office. "The Creating Hope Act improves upon this important incentive not only by increasing the commercial value of the priority review voucher by making it transferable, but by expanding priority review voucher eligibility to include rare pediatric diseases," the release notes (8/6).

"The bill would also prohibit companies from getting vouchers under the 2007 law for drugs already on the market abroad. Closing that loophole would force the companies to create new treatments, rather than simply bringing old ones to market in the U.S.," the Hill continues (8/6).

"We are falling woefully and inadequately short in our efforts to cure and treat rare and neglected pediatric diseases and conditions," Brown said, according to the press release. "The National Institutes of Health (NIH) estimates that there are more than 6,000 rare diseases as defined by the Orphan Drug Act. Others, such as tuberculosis, malaria, and dengue fever are neglected because they affect impoverished populations in developing countries" (8/6).