House Appropriators Target Areas for FDA Improvement

Regulatory NewsRegulatory News | 04 June 2019 |  By 

The House Appropriations Committee on Tuesday voted to send its FY 2020 spending bill for the US Food and Drug Administration (FDA) to the House floor, in addition to releasing a report explaining areas where FDA needs to focus its efforts.

The funding bill would provide FDA with $3.26 billion in non-user fee funding, an increase of $184 million (6%) above the FY 2019 enacted level. According to the Alliance for a Stronger FDA, the bill is expected to be taken up on the House floor later this month.

In addition, the committee spelled out several new initiatives that it’s expecting FDA to tackle with new funding.
For instance, as the proliferation of cancer immunotherapy trials continues (more than 1,500 immuno-oncology trials have been initiated), the committee urges FDA to work with researchers and the pharmaceutical industry to develop standardized templates for reporting toxicities in such trials.

And as there appears to be “a significant development gap for rare cancer therapies,” the committee notes that an additional $5 million for FDA’s Oncology Center of Excellence will “address gaps in the system, streamline resources, accelerate the development of rare cancer therapies and advance the field of cancer research overall.”

The committee also criticizes FDA for being “more than three years late” in meeting a statutory obligation to establish a federal licensing standard for third-party logistics providers and wholesale distributors under the Drug Supply Chain and Security Act.

“Congress mandated FDA complete this effort by 2015…The Committee directs the FDA to issue its proposed rule-making to fulfill this requirement without delay,” the report says.

On the topic of insulin and the migration of insulin products to biologics license applications by 23 March 2020, the committee calls on FDA to take special care with certain applications so that they do not have to be resubmitted to the agency after the deadline.

The committee also urges FDA to combat a shortage of epinephrine auto-injectors. Last August, the agency extended EpiPen expiration dates by four months.

The committee also asks for an FDA briefing on efforts to internationally harmonize technical and scientific standards for generic drugs, including which foreign regulators are being consulted and approximate timelines by which the agency expects to implement changes.

FDA is also urged to provide the committee with an update on its work around foreign high-risk manufacturing inspections.

On the medical device side, the committee raises concerns about the use of unapproved devices for the treatment of an eye condition known as keratoconus.

“The Committee is concerned that as many as 25% of all patients receiving corneal crosslinking procedures are put at risk by these non-approved devices. The Committee encourages FDA to investigate the manufacturers of these non-FDA approved devices, with specific regard to their marketing practices and medical claims, and to prohibit the utilization of non-FDA approved devices being used for corneal crosslinking procedures,” the report says.

Republicans on the House committee on Tuesday also re-inserted a provision into the bill that would effectively ban the editing of DNA in embryos intended for pregnancies. The rider, which has been quietly added to the appropriations bills each of the last four years without discussion, was initially not included in the bill this year.

House Appropriations Report


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