BETHESDA, MD 23 Dec 2015—The budget package that President Obama signed in December includes a 5% boost in funding for FDA compared with the agency's 2015 funding allotment, for a total of about $4.7 billion.
"We're very happy to see that," said Joseph Hill, Director of Government Relations for ASHP.
The 887-page Consolidated Appropriations Act, 2016, which was signed into law on December 18, directs $1.4 billion in funding for FDA's Center for Drug Evaluation and Research and $3.5 million for the Center for Biologics Evaluation and Research.
Hill said he hopes the funding will provide support for a variety of FDA's activities not specifically named in the legislation, including the management of drug shortages and oversight of outsourcing facilities.
Hill said ASHP supports efforts to strengthen FDA's funding. ASHP is a member of the Alliance for a Stronger FDA, and Kasey K. Thompson, director of policy, planning, and communications for ASHP, is a past president and current board member of the alliance.
A congressional directive accompanying the legislation contains details not found in the final legislation and explains how FDA is expected to direct the funds that were appropriated.
For example, the directive states that $8,732,000 in new funding for FDA is intended to support participation in the National Strategy for Combating Antibiotic-Resistant Bacteria.
This Obama administration project coordinates efforts by stakeholders within and outside of the federal government to reduce the inappropriate use of antimicrobials and support efforts to develop new antiinfective drugs.
FDA is one of several agencies within the Department of Health and Human Services (HHS) to receive new funding for such activities. Hill said ASHP looks favorably on federal efforts to combat antimicrobial-resistant bacteria and has a history of supporting these efforts.
Other potentially notable activities described in the appropriations law or the accompanying congressional directives include:
- $1.4 billion in funding for public health preparedness activities, including $575 million for maintaining the Strategic National Stockpile
- $32 billion in funding for the National Institutes of Health, including $200,000,000 for Precision Medicine Initiative
- A directive to FDA to continue to prioritize the public reporting of drug shortages and seek ways to help manufacturers prevent shortages
- A directive to FDA to finalize the timeline for approving guidance documents and regulations for biosimilar drugs and to improve the opportunities for the public to comment on these documents
- An instruction for the Centers for Medicare and Medicaid Services to reassess the potential for adverse effects to arise from a proposed reduction in the Medicare reimbursement rate for critical access hospitals that are located within 10 miles of another hospital
- A requirement that HHS report to Congress on the preparedness of the department and healthcare stakeholders---a definition the includes pharmacists---to respond to cybersecurity threats
- A requirement that HHS provide Congress with specific, detailed information on trends in drug costs since 2003 in the Medicare and Medicaid programs and the Department of Veterans Affairs.