Short-term government spending bill includes reauthorizations of orphan drug credits and other pharma perks
As bipartisan talks for a longer-term government spending bill continue, House Appropriations Chair Rosa DeLauro (D-CT) today filed a one-week continuing resolution to keep the government funded and avert a shutdown on Friday at midnight.
The short-term Band-Aid also includes several reauthorizations that are of interest to the pharma industry as they had been cut out of a recently passed FDA-industry user fee deal, which was tagged onto the last short-term funding extension.
The idea behind those exclusions from the user fee deal was to make time for adding in other reforms related to accelerated approvals, regulating lab-developed tests and cosmetics, and more.
This time around, however, those other riders may not be hitching a ride.
Instead, the DeLauro bill includes $6.9 million in orphan drug grants (up from $6.3 million last year) to defray the costs of developing drugs for rare diseases or conditions, including qualified testing expenses. The grants program, run by FDA, has funded clinical research since 1983, including trials that led to the approval of more than 80 products.
Another $5.7 million (about $500,000 more than last year) would be authorized, if the DeLauro bill passes, for the reauthorization of the Best Pharmaceuticals for Children program, which incentivizes sponsors with additional marketing exclusivity to complete pediatric clinical studies. As of early June, the FDA issued more than 500 written requests for such pediatric trials.
In addition to several medical device-related reauthorizations (e.g. humanitarian device exemption), it also includes a weeklong reauthorization of the part of FDA law that allows the agency to require certain drug and biologic application holders to make safety-related labeling changes based on new safety information that becomes available after an approval.
The bill also reauthorizes a section of the FDA Reauthorization Act of 2017 that requires the FDA to report on certain generic drug applications subject to priority review or with a competitive generic therapy designation.