Cover Story

FDA Relationship with Industry Complicated by New Science and Changing Expectations

Growing public demand for increased medical device and drug safety, as well as the need to develop medical products faster, is complicating the current regulatory approval process and relationship between the life sciences industry and its chief regulator, the U.S. Food and Drug Administration, according to Improving America’s Health V-- A survey of the working relationship between the life sciences industry and FDA.

The latest in a series of PwC reports over the past 15 years on the working relationship between the life sciences industry and FDA, Improving America’s Health V provides feedback from 50 life sciences companies, including the makers of biologics, drugs, medical devices and diagnostics. The study, which was conducted in partnership with BIOCOM, found that life sciences companies feel communication with FDA has improved steadily since passage of the FDA Modernization Act of 1997, but new expectations are fueling frustration with the regulatory review process.

· Thirty-eight percent of life sciences companies in the study said they feel that the overall working relationship with FDA has improved over the past two years, and 80 percent said that FDA is providing better guidance about its expectations. Sixty-eight percent of companies said they are incorporating this feedback into product development.

· Sixty-four percent of companies said that meeting with FDA before submitting review materials improved the quality of their applications, and 87 percent said it expedited their applications, but industry did not always take advantage of the meetings and only about half (53 percent) said FDA consistently encouraged these meetings.

· Six in ten companies expressed frustration that FDA had changed its position during a review, and four in ten feel that some products were denied because of FDA’s inadequate review resources.

· The industry feels that FDA is not keeping up with rapidly advancing technology. Only 8 percent of drug and device makers think FDA is doing enough to advance personalized medicine.

· More than half (56 percent) of respondents who are familiar with the FDA’s Critical Path Initiative to bring innovative, high priority therapies to market quickly think that FDA currently lacks the capability to implement the initiative.

Bringing a new drug to market can take up to 12 years in research and development and costs well in excess of $1 billion. However, the time, cost and complexity of the process are not well understood by most Americans, according to a separate PwC survey of 1,000 U.S. adults. PwC conducted the survey to gauge public perceptions of the FDA and how they compare to the industry's views and in recognition of the growing influence of consumers preferences and expectations in healthcare. The findings of this research, which is supplemental information and does not appear in the Improving America’s Health report, indicate that consumer expectations may be changing.

· Ninety-three percent of U.S. consumers are confident about the safety and effectiveness of drugs and medical devices approved for use in the United States, and two-thirds agree that the U.S. has the highest standards in the world for drug safety and effectiveness.

· Yet, more than half (56 percent) said they would be willing to use drugs and devices approved outside the U.S., before they are approved by FDA.

· Fifty-four percent of respondents think it takes only five years or less to develop a new drug or medical device.

“Consumers want safer, more effective drugs and devices and access to the latest medical innovation. Industry wants fast and efficient product approvals. And Congress wants better quality, lower cost healthcare that demonstrates enhanced economic and clinical value” said Michael Mentesana, PwC’s US Pharmaceutical and Life Sciences Research and Development Advisory Services Leader. “Hope lies in accelerating scientific and technological advancement as we learn more about genetic differences and individual responses to treatments. But the promise of faster product development has yet to be realized and the quality and productivity of the FDA-industry relationship would be better on both sides if there was more collaboration and clarity around expectations.”

User Fees in Question

According to the Improving America's Health V report, two post-2006 developments could account for the less positive industry feedback about FDA: The 2007 FDA reauthorization (FDAAA), which expanded the responsibilities of the already resource-constrained FDA, and the Prescription Drug User Fee Act (PDUFA), which authorizes FDA to collect fees from companies that make certain drugs and biologic products to help fund an accelerated review process of new, innovative medicines.

PDUFA requires companies that make the drugs pay user fees, which range up to $1.25 million per drug application. FDA maintains that this is a crucial funding source and has helped to expedite the drug approval process. Current authorization for collection of user fees will expire in September 2012, unless Congress renews it.

PwC’s surveys found mixed responses from both the life sciences industry and the American public regarding the topic of user fees.

· Nearly half (46 percent) of industry respondents do not see that user fees paid to FDA by industry have accelerated the review process.

· Forty-eight percent of companies in the study feel that FDA has not been clear about the intended purpose of user fees or transparent about the way they are applied.

· Thirty-percent of industry respondents feel that user fees are excessive compared with the time that FDA staff spends on reviews.

· Twenty-two percent of industry respondents feel that user fees create a potential conflict of interest, though half (50 percent) disagree that it creates a conflict of interest.

· While most consumers surveyed (68 percent) understand that FDA is largely taxpayer funded, only 36 percent know that industry also helps to fund its activities. This lack of visibility may explain why 70 percent of consumers do not agree that fees from industry should be used to accelerate the regulatory review process, an indication that, in principle, Americans may view user fees as a conflict of interest.

“Clearly there is a need for better communication between FDA and the industry over the intended use and effectiveness of user fees,” said Joseph D. Panetta, president and CEO of BIOCOM, the world’s largest regional life sciences association, which helped to develop and distribute the industry survey among its members. As PDUFA reauthorization is considered, and certainly before any fee increase, the FDA needs to meet the performance standards for timeliness and clarity that PDUFA is meant to ensure.”

PwC’s consumer survey of 1,000 American adults found:

· Seventy-two percent of respondents have confidence that the FDA monitors product safety after products are approved and being sold to the public, though 28 percent are not confident.

· Approximately one-half (51 percent) of respondents say they think FDA does a good job, but more than one-third (36 percent) of U.S. consumers say they have lost confidence in the FDA over the past two years as a result of high profile safety concerns and product recalls.

Court of Public Opinion Shows Some Signs of Doubt

· 88 percent of consumers say that the benefits of medicine and medical technology outweigh the risks.

· 97 percent of consumers said that the reputation of the company that makes the drug or device is important to them when deciding whether or not to use it, with half (49 percent) saying it is “very important.”

The complete findings of the study and a podcast on the report are available for download at: www.pwc.com/us/fdasurvey.

Media Coverage of Report

San Diego Union-Tribune

Xconomy

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