RESEARCHERS PROPOSE BLOCKBUSTER BENEFIT TO ENCOURAGE DRUG DEVELOPMENT
The FDA should provide new incentives for the drug industry to speed the development of pharmaceuticals to treat infectious diseases in developing countries, say Duke University researchers, who recommend tying priority reviews of potential U.S. blockbuster drugs to R&D for the infectious disease drugs that generate few profits.
Researchers are working to garner support from the FDA, industry, and Capitol Hill for their plan to develop a "priority-review voucher," David Ridley of Duke University's Fuqua School of Business announced at a recent meeting on global health policy.
The plan would allow companies to receive accelerated FDA review of blockbuster drugs in exchange for developing therapies for neglected diseases such as malaria or tuberculosis, which are found mostly in third-world countries, Ridley said.
While these diseases are responsible for a great loss of life in developing countries, they do not get the drug industry's attention because there is a negligible market in the U.S. and Europe, Ridley and other Duke researchers told attendees. There is "tremendous suffering from neglected diseases in the world," Ridley said. The opportunity to receive priority reviews for blockbusters -- which would cut as much as one year from the usual review time at a potential savings for industry of $300 million per drug -- would encourage R&D for new infectious disease treatments, he asserted.
In developing therapies for infectious diseases, companies would have to receive FDA or European Medicines Agency approval, forgo patent rights, and find at least one manufacturer for the product. The drug would also have to be deemed more effective than existing treatments. Furthermore, applicants would be expected to pay an additional user fee of $1 million or more to cover the FDA's costs in undertaking priority reviews for their blockbusters.
The researchers have approached the FDA and industry officials about their plan and will soon meet with congressional staff and lawmakers such as Sen. Richard Burr (R-N.C.) to get their support for a legislative vehicle to implement the voucher, Ridley told FDAnews. But proponents doubt their plan will get much attention from Congress anytime soon because of upcoming midterm elections. Getting traction for the bill will "be challenging, especially in the short run," Ridley said.
Thus far, the plan has received "a great deal of interest" from industry groups such as the Biotechnology Industry Organization (BIO), he added. However, BIO and other associations have yet to formally endorse the plan.
One potential vehicle for implementing the voucher plan will be the Prescription Drug Use Fee Act (PDUFA), in part because the plan would require an increase in user fees to cover additional priority reviews of blockbuster drugs, according to Ridley and Jeffery Moe, an executive-in-residence in Duke's Health Sector Management program. PDUFA "would be a logical fit," Ridley said. The current PDUFA program is due to expire in September 2007.