As House and Senate lawmakers race to approve a bill to fund the US government for 2016, the US Food and Drug Administration (FDA) should see a slight bump in discretionary funding of $132 million over last year.
The proposed agreement, which is expected to face a vote on Friday, includes increases of $104.5 million for food safety related activities; $5 million for implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA); $8.7 million for the Combating Antibiotic Resistant Bacteria (CARB) initiative; $5 million for foreign high-risk inspections; $2.4 million for the precision medicine initiative; $2.5 million for the Orphan Product Development Grants Program, and $716,000 for sunscreen activities.
The legislators explain that the increases for orphan drug development grants come as the number of requests for orphan designation has more than tripled since 2000.
In addition, the extra funding for foreign high-risk inspections will allow FDA's Office of Global Regulatory Operations and Policy to continue efforts on its risk-based inspection model that incorporates commercially available information on high-risk establishments for onsite verifications.
Though Congress says it acknowledges FDA's effort to address biosimilar issues, particularly as it released draft guidance on biosimilar naming in August and has been receiving comments on it, the legislators say that FDA needs to provide the public “with a greater opportunity to review and comment on all regulatory standards for the approval and oversight of biosimilar drugs.”
The bill directs FDA to provide congressional committees with an estimated timeline by which the agency will finalize all pending draft biosimilars guidance documents and regulations “no later than 60 days after enactment” of the bill.
Essure, Other Concerns
Congressmen also are raising additional questions about the safety issues raised at the FDA’s Obstetrics and Gynecology Devices Panel from September, which focused on the Bayer birth control implant Essure and which Rep. Michael Fitzpatrick (R-PA) has already tried to direct FDA to pull from the market via a new bill.
The omnibus bill directs FDA to issue recommendations on how to address these concerns on Essure by 1 March, though FDA has already said it would make an announcement in February.
In addition to Essure, Congress says it “remains concerned about the FDA's reliance on the use of draft guidance to make substantive policy decisions. The agreement requests a report documenting the agency's review and solicitation of scientific data impacting bioequivalence standards and patients suffering from ophthalmologic conditions.”
Drug shortages are another concern of Congress, particularly with drugs to test for and treat tuberculosis (TB).
FDA’s Commissioner is directed to continue to prioritize the public reporting of manufacturing shortages, and to work with industry to prevent conditions that might lead to drug shortages.
The commissioner is also directed to report on the work of the FDA's intra-agency Drug Shortages Task Force, including how it works with other government agencies and outside stakeholders to address drug shortages.
“The report should specify what activities the Task Force has undertaken to prevent drug shortages affecting pediatric patients, including working with outside experts on this issue,” according to a statement.
Meanwhile, Congress is also taking note of new genome-editing tools and it seems to be taking a cautious approach. The omnibus bill includes a provision that prevents FDA from reviewing applications related to genome-editing tools to modify the DNA of human embryos “until serious and unquantifiable safety and ethical issues can be resolved.”
In addition to FDA provisions, the bill also would freeze the medical device tax from the Affordable Care Act for two years, extend the rare pediatric disease priority review voucher program by six months until 30 September, and provide a major bump in funding for the National Institutes of Health. A vote is expected on the bill Friday.
Explanatory Statement on FDA Portion of Spending Bill
FY2016 Agriculture, Rural Development, Food & Drug Administration Appropriations Bill Omnibus Agreement Summary
Full text of the omnibus bill