House Committee Approves $33 Million FDA Funding Boost
The House Appropriations Committee has approved a 2017 funding bill that would provide FDA $2.7 billion in discretionary spending, a $33 million (1%) increase over fiscal year 2016 spending levels. Including revenue from user fees, total 2017 funding is $4.78 billion – $97.4 million (2%) more than 2016. Within this total, food safety activities are increased by $33.2 million, and medical product safety activities are increased by $9.4 million. The measure also provides $10 million in funding for the agency to combat Zika and Ebola outbreaks by helping to fund ongoing response activities, and to expedite the development and availability of medical products to fight the viruses.
The committee’s bill report notes concern with “FDA’s failure to resolve issues with and finalize its proposed rule entitled ‘Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.’ The proposed rule, as currently drafted, has the potential to threaten public health and create unprecedented patient and provider confusion by allowing multiple versions of safety labeling for the same bioequivalent product.” The committee urges the agency to establish in the final rule a system “where safety information in prescription drug labeling in a multisource environment (i.e., when there is both an innovator and a generic manufacturer or more than one generic manufacturer) is always FDA-approved, grounded in scientific evidence, and presents no opportunity for mismatched safety information between the innovator and generic versions of a drug. The FDA should be the final decision maker regarding whether a manufacturer should change its labeling in a multisource environment.”
Regarding laboratory developed tests (LDTs), the report criticizes FDA for not undergoing rulemaking to effect regulatory changes to overseeing the tests. It directs FDA to suspend further efforts to finalize its LDT guidance and “continue working with Congress to pass legislation that addresses a new pathway for regulation of LDTs in a transparent manner.
Additionally, the report expresses concern with medical device facility inspections and a lack of transparency and consistency with the inspection process. The committee report urges the agency to work with stakeholders and Congress to improve the facility inspection process. “Potential process improvements may include, but are not necessarily limited to, more timely and frequent communications related to inspection observations and remediation plans, as well as changes to the way medical device Export Certificates (e.g., Certificate to Foreign Government, etc.) are affected by FDA observational findings following a facility inspection. In addition, the agency shall produce a report to the committee by 9/30/2016, which provides information on the rates of inspection for facilities across districts and internationally and any FDA efforts to standardize rates of inspections across districts and internationally.”
The committee says it understands that five days is typically sufficient for the agency to complete an overseas inspection and determine the suitability of the facility, while inspections inside the U.S. can take several weeks or months to complete the same assessment. “These discrepancies lead to variations in inspection standards and potentially competitive advantages for those who choose to manufacture outside the U.S.,” the report says.