The proposals, detailed in the Continuing Resolution (CR) Bill, provide the FDA with funding of $2.5bn (EUR1.9bn) which represents an increase of $24m in FY (fiscal year) 2013 over FY 2012, according to the Alliance for a Stronger FDA.
Gloria Sánchez, international public affairs specialist at the FDA, told in-pharmatechnologist.com that if the appropriations by Congress are approved, the extra $10m will allow the agency to add 16 inspectors in China and three US-based China analysts.
Sánchez said that in addition to inspecting Chinese manufacturing facilities, the FDA will also have resources to “inspect sites of clinical trials and conduct follow-up inspections to ensure that firms” continue to produce and manufacture drugs under “safe conditions, and that they apply sound production practices.”
In addition, the funding will expand “engagement with Chinese regulatory counterparts,” Sanchez said. “Direct observation of FDA inspections can bolster Chinese regulators’ understanding of FDA’s requirements and processes and strengthen China’s inspectional capacity.”
The FDA may also use some of the funding to support Chinese regulators’ knowledge of US safety standards through workshops and seminars. “These opportunities help facilitate dialogue and encourage scientific exchange on the critical role of inspections,” Sánchez added.
The Alliance for a Stronger FDA considers the Senate bill “strongly favorable to the FDA” because of the additional funding and all of the changes adopted from FDASIA (Food and Drug Administration Safety and Innovation Act) that were not in the initial House bill. That funding includes the new user fees for biosimilars and generic drugs, as well as higher cap levels for PDUFA (Prescription Drug User Fee Act) and MDUFA (Medical Device User Fee Act).
The $24m increase in funding will also provide $3.5m for advancing medical countermeasures, under which the FDA has the responsibility to work with sponsors on developing drugs to fight bioterror threats, Steven Grossman of the Alliance for a Stronger FDA told us.
“CROs are deeply involved in the development of medical countermeasures,” Grossman noted. “The $3.5m supplements money they were already given so they will have about $20m.”
In terms of when the bill is likely to become law, next Friday “is likely to be the last working day” before March 27, which is when Congress has to get the bill signed by President Obama, Grossman added. If they don’t get it signed or do a one month extension, the federal government would face a shutdown with furloughs.