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PwC Report Finds FDA Needs Resources, Communication

By Matt Jones

NEW YORK (GenomeWeb News) – Life sciences companies have mixed opinions on how the US Food and Drug Administration is faring in its efforts to keep up with innovations such as personalized medicine and about the extent communication with the agency is helping to bring new drugs and medical devices to market more swiftly, according to a new industry survey.

PriceWaterhouseCoopers conducted a survey of 50 life sciences firms with less than 5,000 employees and revenues under $500 million and found that although the survey respondents believe some improvements at FDA are helping the approval process, the agency does not have enough resources to deal with ever-advancing biomedical technologies, such as personalized medicine innovations.

According to PwC, 38 percent of the responding companies said that their working relationships with FDA have improved overall in the past two years, and 80 percent said that FDA is providing better guidance about its expectations. Sixty-eight percent of the firms said that they are incorporating FDA feedback into their product development, and 64 percent said that meeting with FDA before submitting their review materials improved the quality of their applications, while 87 percent said that these meetings helped expedite their applications.

However, the survey also found that six in 10 companies were frustrated by FDA because it had changed its position during the review process, and four in 10 felt that their products were denied because the agency does not have adequate resources.

FDA's Critical Path Initiative, personalized medicine, and biomarker-related efforts in particular were seen as needing more resources, according to the report.

Only 8 percent of drug and device makers reported that FDA is doing enough to advance personalized medicine in general, PwC found, while 30 percent of those surveyed said that FDA is not doing enough to advance personalized medicine, and 56 percent had a neutral opinion on the matter (medical devices and diagnostics companies made up less than 40 percent of the respondents).

There's a feeling that some of the resources are inadequate because scientific innovation is moving faster than FDA is; and that some of the review resources are inadequate and therefore they don't know enough about certain topics to even review [them]," Michael Mentesana, a principal in PwC's US Pharmaceuticals and Life Sciences R&D Advisory Services, told GenomeWeb Daily News on Friday.

In personalized medicine, Mentesana explained, innovation is quickly "surpassing FDA's ability to adapt – and 40 percent of respondents said that some products were denied primarily because of FDA's inadequate review resources and their knowledge of the science."

Mentesana said that FDA already knows, and has known for several years, that it has needed to make changes to keep up with new biomedical science, and that the agency has been taking actions in this actions in these areas.

"They're not just thinking about it, they're doing it. The question is: Are they doing it fast enough and are they equipped to actually implement the changes?" he asked.

The survey also found that 88 percent of responding firms agree that personalized medicine will lead to changes in the industry's business model, leading a shift away from blockbuster drugs for the masses and toward more targeted treatments. PwC suggested that industry will begin to take a more holistic approach to treatments, including finding ways to deliver diagnostics, counseling, and monitoring services that incorporate genetic information into treatment.

However, PwC said, the current regulatory scheme is "more suited to the old blockbuster model and does little to foster personalized medicine."

Forty-six percent of respondents said that FDA lacks the capability to implement the Critical Path Initiative, which calls for the agency to take steps to incorporate new science that harnesses biomarkers, bioinformatics, companion diagnostics, and other areas. Only 10 percent said that they think FDA does have the resources to implement the initiative.

Although FDA has specifically identified targeted investments in biomarkers as an important component of the Critical Path program, PwC found that the companies it surveyed would like to see more efforts in this area. "Despite the agency's efforts to encourage the development of biomarkers, the industry's perception is that the agency is not doing enough," PwC said.

The report states that 56 percent of respondents think that FDA needs to boost biomarker funding — specifically, funding "for the development of biomarkers that measure the progress of disease or the effects of treatment" — which shows that industry thinks that FDA's "current commitment falls short."

"What the industry is saying is that [FDA needs] to do more to identify and validate biomarkers," Mentesana added. He explained that industry appears to want FDA to make sure there are approved and agreed-upon biomarkers that are recognized and are given regulatory significance.

"It's really exciting to be in this industry now and to be a scientist – you're really moving very quickly," he said.

However, the question scientists find themselves asking when they strike scientific gold with a new biomedical innovation, Mentesana said, is, "Can I even get it through the regulatory pathway? The regulatory pathway does not necessarily support this new set of innovations."

PwC also found that communications between FDA and companies during review "are less than optimal," but that it is industry that is "not doing enough to take full advantage of FDA resources," according to PwC. "The industry could take a more active role in setting up and attending FDA preapproval and end-of-phase meetings," it said in the report.

Inquiring about meetings with FDA before and after submission, the survey found that 67 percent of respondents always have pre-submission and end-of-phase meetings with FDA. This compared to 53 percent in PwC's 2006 survey.

However, four years ago nearly 69 percent of respondents said that FDA encouraged such meetings, while in 2010 only 53 percent said the agency was providing enough encouragement.

"More clear and direct communication from FDA about major initiatives might alleviate the lack of awareness among some companies of programs that could benefit them," PwC said.

PwC also said that respondents suggested industry should "help FDA develop guidance documents by participating in agency-sponsored work groups and reviewing and commenting on drafts and proposals."

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