Last week, Sens. Sherrod Brown (D-OH), Sam Brownback (R-KS), and Al Franken (D-MN) introduced legislation, the Creating Hope Act of 2010 (S 3697), to provide incentives for drug companies to develop treatments for rare and neglected pediatric diseases. The legislation hopes to build on a private–public model to encourage targeted development for rare diseases.
The bill was introduced following Congressional hearings in July 2010 by the Senate Health, Education, Labor and Pensions Committee on “Treating Rare and Neglected Pediatric Diseases: Promoting the Development of New Treatments and Cures.” The Creating Hope Act of 2010 would amend provisions of the Food and Drug Administration Amendments Act, which was signed into law in 2007, and which provided an incentive for pharmaceutical companies to develop innovative drugs for neglected tropical diseases. Under this law, companies that develop new drugs and biologics for neglected diseases are eligible for a priority review voucher that entitles them to expedited review of another drug developed by that manufacturer, according to a press release by Sen. Brown. The proposed legislation builds on that incentive by increasing the commercial value of the priority review voucher by making it transferable and expanding the priority review voucher to include rare pediatric diseases. In practice, the priority review voucher system seeks to create an incentive by allowing drug companies to use the voucher to expedite the marketing authorization review process for another drug, one that, for example, would be more commercially viable, thus providing a financial incentive to develop a drug for a rare disease.
Creating incentives for the private sector overall, and in this case, the pharmaceutical industry, specifically, to help select groups of people by encouraging the development of a specific product, technology, or service that would otherwise not be available to them is good public policy. No one would argue against the humanitarian interest in developing a treatment for a rare disease, particularly a rare pediatric disease, and ways to facilitate those efforts are valuable.
The proposed legislation also is helpful in engendering other ideas for models of public–private cooperation. In the pharmaceutical industry, for example, some incentives could include specific research and development (R&D) tax credits for companies developing drugs or treatments for rare and neglected diseases, a tax credit not only for the large pharmaceutical companies, but also for start-up companies. It could also include other tax incentives for R&D and financial investment to companies, including start-up companies, which are developing and making products and services that increase healthcare capacity and access, including in the developing world. Perhaps this legislation can serve as a way to stimulate further dialogue among many stakeholders—policy-makers, the pharmaceutical industry, private associations, and the public at large—on what some of those solutions may be.