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Regulatory Focus™ > News Articles > With PDUFA VI Negotiation Process Fast Approaching, BIO Takes Critical Look at Regulations

With PDUFA VI Negotiation Process Fast Approaching, BIO Takes Critical Look at Regulations

Posted 06 August 2014 | By Alexander Gaffney, RAC

With PDUFA VI Negotiation Process Fast Approaching, BIO Takes Critical Look at Regulations

The Biotechnology Industry Organization (BIO), a trade group which represents biopharmaceutical companies, is launching a new tracking tool meant to assess how companies interact with the US Food and Drug Administration (FDA) in the hopes of improving the drug development process, it announced today.

The survey is specifically meant to inform negotiations over the next iteration of the Prescription Drug User Fee Act (PDUFA), which was last authorized in 2012 and it set to be reauthorized in 2017. In a statement, BIO indicated that it believes the PDUFA negotiation process—unique among most legislation in that the pharmaceutical industry directly negotiates with FDA to generate preferred statutory language, which is then passed on to legislators—is set to begin in 2015.

“Sponsor input is critically important for BIO and the entire industry to understand the real challenges associated with the regulatory process to help guide our discussions with FDA and ultimately work with Congress to establish new and effective measures to implement under PDUFA VI,” said John Maraganore, a BIO member and CEO of Alnylam Pharmaceuticals, in a statement.

BIO indicated that its survey will focus on a part of the drug development process that is critical for companies, but has traditionally not been given much attention in the PDUFA process: pre-clinical and clinical interactions between companies and FDA.

"Sponsor input will help identify areas where policies, regulations, and practices are working well and should not be changed; and identify areas where policies, regulations, and practices need improvement in order to make the process more efficient and effective," BIO said in a statement to Focus.

BIO is already engaged with another industry group, PhRMA, to assess interactions between companies and FDA during the drug application submission process as well as FDA's ability to adhere to promised deadlines. That tracking project is meant to allow BIO and PhRMA to assess how FDA is doing in real time, allowing for mid-cycle corrections to PDUFA (if necessary). "We can't just wait for five years until the next reauthorization cycle to make adjustments," PhRMA's VP of Regulatory Affairs Sascha Haverfield told Focus last year. "We want the latest information and technology to advance biomedical information and to strengthen FDA's review process."

As with BIO/PhRMA's PDUFA Tracking Tool, BIO's survey will collect responses which are "confidential, blinded and aggregated," presumably to ensure that anti-competition statutes aren't broken.

BIO's tool can be found online at

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