The FDA has requested a 19% increase for the its budget or $295.2MM budget increase and $215.4 MM in industry user fees. What do you think will this mean for the medical device industry?
The FY 2010 request, which covers the period of Oct. 1, 2009, through Sept. 30, 2010, includes increases of $295.2 million in budget authority and $215.4 million in industry user fees. The FDA budget proposes two major initiatives for FY 2010: Protecting America’s Food Supply and Safer Medical Products.
The following are the FDA's key proposed budget increases:
Protecting America’s Food Supply ($259.3 million) – The goal of this effort is to protect American consumers by preventing intentional and unintentional contamination. This effort invests in priorities that strengthen the safety and security of the supply chain for foods. Within this initiative, the FDA proposes to collect a total of $94.4 million in new user fees to register food facilities and increase food inspections, issue food and feed export certifications, and reinspect food facilities that fail to meet the FDA’s safety standards.
Safer Medical Products ($166.4 million) – This effort provides targeted resources to improve the safety of human and animal drugs, medical devices, vaccines, blood, and other medical products. It will allow the FDA to strengthen safety and security of the supply chain for medical products. The initiative also includes $46.6 million in new user fees for generic drug review and new fees to reinspect medical product facilities that fail to meet safety standards.
Current Law User Fees ($74.4 million) – In addition to the new user fees proposed for FY 2010, the FDA request also includes inflationary and other authorized increases for fees that support FDA review of applications for new human drugs (+$67.5 million), animal drugs (+$2.3 million), and medical devices (+$4.5 million).
Follow-on Biologics & Drug Importation ($5 million) – Within the Safer Medical Products initiative, the budget proposes a new authority for the FDA to approve follow-on biologics through a regulatory pathway that protects patient safety and promotes innovation, and includes $5 million for the FDA to develop policies to allow Americans to buy drugs approved in other countries.
Does this mean more frequent audits, longer lasting audits or an improved compliance process or both? Will international audits increase? I do not know the answer to that what I do believe is that the compliance landscape will see significant changes. Medical Device quality professionals must be vigilant and continue thinking strategically as to how best to improveme our quality systems to ensure staying ahead of regulations and regulatory practices and improving product performance and compliance. This period resembles the changes occurred during 1992/1993. The industry emerged stronger from that period and I am confident we will also be strong when the economy gets better this time around.
For more information on the President's FY 2010 budget for the FDA, visit: http://www.fda.gov/oc/oms/ofm/budget/documentation.htm
