Top biopharmaceutical company executives are frustrated with delays and inconsistencies in the Food and Drug Administration (FDA) regulatory review process and are concerned that passage of the healthcare reform law, which gave the already resource-constrained agency more responsibilities, will further complicate drug approvals, according to a new PricewaterhouseCoopers (PwC) survey.
The survey, called “Improving America’s Health V: A Study of the Working Relationship Between the Life Sciences Industry and FDA,” asked CEOs, COOs and vice presidents from 50 life sciences companies—including makers of biologics, drugs, medical devices and diagnostics—about their relationship with the FDA. It requested feedback about their experiences with the drug approval process based on applications filed during the past two years.
Overall, only one-third of survey respondents thought their overall working relationship with the FDA had improved during the past two years; this number was down from 70 percent in 2006, indicating deterioration in the relationship between the agency and industry.
Thirty percent of survey respondents also saw no improvement in the FDA approval process during the past two years and a high percentage of company executives said they encountered significant problems with regulatory submissions. For example, approximately 40 percent of respondents felt some of their products were denied primarily because of the FDA’s inadequate review resources. Nearly half of respondents said changes in FDA staff directly resulted in a continuity break in at least one of their reviews; only 12 percent said FDA turnaround time has improved.
The survey also reflected frustration over the unpredictability of FDA decisions. More than 60 percent of respondents said the FDA changed its position on at least one review, up 40 percent from 2006, and survey respondents said the FDA often came back to them during the review process to request additional information. “The number of times companies are blindsided late in the approval process with a number of requests that easily could have been dealt with had the company been aware of FDA concerns continues to increase,” said Randall Woods, president and CEO of California-based Sequel Pharmaceuticals, explaining the dissatisfaction felt by industry executives. “Staff turnover and training has to be addressed and consistency during the process has to be improved.”
Industry executives also expressed distrust about the FDA’s handling of user fees. As the FDA has begun to lobby for renewal of the Prescription Drug User Fee Act (PDUFA) before it expires in 2012, the survey results show a need for more transparency about the purpose and use of these fees. PDUFA requires industry to pay user fees, which range from $771,000 to $1.5 million per drug application, to allow an accelerated review of certain innovative products, particularly biologics. The FDA maintains this funding helps to expedite the drug approval process. Yet approximately half of survey participants said they were unclear about the purpose of these fees. Only 24 percent of respondents agreed the FDA is spending user fees as intended. And only one-third feel user fees accelerate the review process.
“The industry is expressing concern that the regulatory environment is growing increasingly unpredictable and risk-adverse to the point where industry has begun to seek product approval overseas,” said Joseph Panetta, president and CEO of life sciences trade association BIOCOM, which helped recruit survey participants. “There is frustration that the link between user fees and the time it takes to approve new products is broken.”
Adding to these concerns, the survey found that the new healthcare reform law will further complicate the regulatory approval process and could strain the relationship between the agency and industry. The law required the FDA to establish an approval pathway for biosimilars and authorized funding for comparative effectiveness research. “FDA is facing unprecedented challenges,” Panetta said. “With a renewed focus on product safety, approval of new drugs and therapies could face delays.”
Although the results identified many concerns about the industry-FDA relationship, Michael Mentesana, U.S. Pharmaceuticals & Life Sciences R&D Advisory Services Leader at PwC, said the survey also found opportunities for improving interactions. Nearly 48 percent of respondents agreed that greater collaboration with the FDA is needed. “Industry can and should make a greater effort to collaborate with FDA,” he said, “and work closely with legislators and regulators to draft guidelines, resolve issues and find solutions to problems.”