update

US biopharma regulators to get 2014 budget they wanted

By Gareth Macdonald contact

- Last updated on GMT

Related tags: Influenza, Fda

US biopharma regulatorst to get 2014 budget they wanted
US biopharma regulatorst to get 2014 budget they wanted
The US regulatory scientists who oversee biopharmaceuticals appear to be getting the funding they asked for after politicians pass a $1.2tr (€882bn) Government spending plan for fiscal 2014.

The US Senate voted 72 to 26 to approve the bill last night keeping in step with politicians in the House of Representatives who had backed the plan on Wednesday.

The decision came three months after Republicans opposed to laws designed to give more US citizens access to affordable healthcare – known as Obamacare – blocked the proposed 2014 budget. This prompted the Government to shutdown for 16 days and furlough thousands of employees​.

The now agreed fiscal 2014 budget​ gives the US Food and Drug Administration (FDA) $2.552bn in funding, which is an increase of $91m on the previous financial year and is in line with the amount the agency requested​.

In its original request the FDA said it would spend around 28% - $1.29bn – on programmes run by the Center for Drug Evaluation and Research (CDER) and some $333m on those overseen by the Center for Biologics Evaluation and Research (CBER).

Both FDA divisions are involved in the assessment and regulation of biopharmaceuticals. CBER is responsible for vaccines, blood products and gene and cell therapies, while CDER reviews monoclonal antibodies (mAbs) and therapeutic proteins.

Steven A. Grossman, deputy director of advocacy group the Alliance for a Stronger FDA told BioPharma-Reporter.com that: "FDA received almost exactly the amount and by-center distribution that the President requested last February. So, yes, FDA received what it asked for which itself a remarkable accomplishment in our tight budget environment​."  

Biosimilar user fees

The budget also permits the FDA to raise $1.795bn though user fees in fiscal 2014, which is an increase on the amount permitted in the previous financial year. 

According to the budget around $20m of this the FDA is allowed to charge the drugmakers whose products it reviews will come from biosimilars which, although still dwarfed by the $305m it can collect from small molecule generics firms, is an increase on the $17m it was allowed to gather in fiscal 2013​.

However, the actual firgue is more complex according to Grossman who told us that: "The way the biosimilars user fees are set up, FDA must allocate at least $20 million from its budget authority appropriations in order to receive the $20m in user fees. So the biosimilars budget is presumptively at least $40m."

He added that: "I suspect this number will grow over time or the additional costs will be subsumed under other drug review activities. I have heard no one complain that FDA is understaffing or underfunding the biosimilars effort." 

US President Barack Obama is expected to sign the budget Bill into US law in the next 24 hours.

Funds for influenza vaccine plants

The agreed budget also provides$115m to help the US respond to an influenza pandemic, with $83m being set aside to allow the Government to purchase vaccines, anti-viral therapies and other medical supplies.

Additionally, this funding may “be used for the construction or renovation of privately owned facilities for the production of pandemic influenza vaccines and other biologics, if the Secretary finds such construction or renovation necessary to secure sufficient supplies of such vaccines or biologics​.”

Related topics: Facilities, Markets & Regulations

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