From MCMs to Egg Information Technology
ADVOCACY
$170 Million in New Money for Regulatory Science. As detailed in last week’s Friday Update, Secretary Sebelius announced results of HHS’ evaluation of efforts to increase the number of approved medical countermeasures (MCMs) -- drugs to protect our population in case of a bioterror attack and from naturally occurring emerging infectious diseases. As a result, FDA will receive significant funding ($170 million, available until expended) for regulatory science related to MCMs. The transfer of funds to FDA can be accomplished administratively, but the use of the funds for this broader purpose must be approved by Congress. Attached is a copy of the budget amendment sent by OMB to the Speaker of the House.
Resource Implications of the Egg Crisis. With significant media attention focused on the Salmonella outbreak in eggs, the Alliance issued a press release and talking points about the resource implications of the crisis.
Transparency and Measurements at FDA. FDA will announce next Tuesday its further steps in the process on its FDA-TRACK initiative, which is meant to provide transparency and measurements at FDA. A contingent from the Alliance will be at the meeting, and we will report back to the full Alliance on how this meeting goes.
ANALYSIS AND COMMENTARY
When the Alliance issues press releases in successive weeks, you would normally assume the President has announced his budget request or the appropriations committees are marking up FDA funding bills. August seems a most unlikely time. Yet last week’s announcement about new funding for regulatory science and medical countermeasures was followed by this week’s deepening of public debate about the egg recall. This is a time when the importance of FDA and its funding needs are receiving heightened attention and the Alliance is working hard to turn this into new resources for the agency.One of the most interesting articles this week tied the egg recall to one of our major themes: the need to invest in information technology at FDA. Some of FDA’s responsibilities cannot be accomplished without new data collection, sophisticated databases and analysts to translate the resulting information into useful knowledge. Other responsibilities are carried out in inefficient and often ineffective ways for the lack of good IT system.The article can be downloaded at: “Better use of IT could minimize the next salmonella egg-idemic.” The author, Daniel Castro, is a senior analyst at the Information Technology and Innovation Foundation and a former analyst at the General Accounting Office. He usually writes about cybersecurity, e-Government, health and privacy. He recognizes the possible impact of the new FDA rule on eggs and salmonella and notes the potential for upgraded enforcement in the future. He then analyzes all the ways that IT can help. It is worth reading.He concludes: "Is more IT the only solution to Salmonella outbreaks? Of course not. But policymakers should remember that IT has an important role to play in monitoring, detecting and responding to public health threats and protecting the safety of our food supply."The Alliance would add only that IT is also critical to safe and effective drugs, biologics, devices, veterinary drugs, over-the-counter medications and so on. No single thing would help FDA more than a large infusion of monies to build the IT system that supports a 21st Century FDA. We will keep working on it.
Note: This analysis and commentary is written by Steven Grossman, Deputy Executive Director of the Alliance.