In the heat of the healthcare reform debate, you might have missed the fact that President Obama signed an appropriations measure that provides the FDA (mostly CDER) with an additional $880.1 million in funding, of which at least $51.5 million will go to the generic drugs office -- a $10 million increase from fiscal 2009. CBER and related field activities will see a 12% budget increase to $305.2 million.
Importantly, the measure includes $18 million for the Critical Path initiative, with at least $6 million of this set aside for partnership activities. Huzzah! Of the $6 million, $2 million will support research partnerships for the treatment or rapid diagnosis of tropical diseases, particularly tuberculosis and drug-resistant TB. A bit of mission creep – but no complaints.
The fiscal 2010 appropriations bill also increases direct non-user fee funding to the agency by 15%, bringing the agency's total budget with user fees to $3.25 billion.
The FDA will receive about $2.35 billion in direct funding, plus $893 million in user fees. This includes $235 million in fees to fund the new tobacco products program.
Interestingly, and relative to the issue of generic drugs and bioequivalence, Congress also requires that FDA report on adverse events and seizures associated with branded and generic epilepsy medicines. According to the conference report, "Specifically, the agency should examine the pharmacokinetic properties of 'A' rated anti-epileptic drugs from different manufacturers of the same therapeutic agent," the states. The agency must submit a report by September 30th, 2010 detailing what changes, if any, should be made to the current bioequivalence testing.
Critical Path funding. Partnership activities. Bioeqivalence. That’s progress.
Importantly, the measure includes $18 million for the Critical Path initiative, with at least $6 million of this set aside for partnership activities. Huzzah! Of the $6 million, $2 million will support research partnerships for the treatment or rapid diagnosis of tropical diseases, particularly tuberculosis and drug-resistant TB. A bit of mission creep – but no complaints.
The fiscal 2010 appropriations bill also increases direct non-user fee funding to the agency by 15%, bringing the agency's total budget with user fees to $3.25 billion.
The FDA will receive about $2.35 billion in direct funding, plus $893 million in user fees. This includes $235 million in fees to fund the new tobacco products program.
Interestingly, and relative to the issue of generic drugs and bioequivalence, Congress also requires that FDA report on adverse events and seizures associated with branded and generic epilepsy medicines. According to the conference report, "Specifically, the agency should examine the pharmacokinetic properties of 'A' rated anti-epileptic drugs from different manufacturers of the same therapeutic agent," the states. The agency must submit a report by September 30th, 2010 detailing what changes, if any, should be made to the current bioequivalence testing.
Critical Path funding. Partnership activities. Bioeqivalence. That’s progress.
