Drug makers are calling on FDA to initiate development of a Risk Evaluation and Mitigation Strategy earlier in the drug assessment process in order to avoid later delays in review decisions.

The REMS process and other provisions of the FDA Amendments Act have "led to a breakdown in FDA's review process," David Wheadon, senior vice president for scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers of America, suggested.

He spoke during an April 12 FDA public meeting to hear comments on how well the current prescription drug user fee program is operating and what changes should be made to it (Also see "PDUFA V Discussions To Begin With April 12 Meeting" - Pink Sheet, 15 March, 2010.). The current PDUFA program expires Sept. 12, 2012, and the meeting is part of FDA's effort to deliberate with stakeholders on elements to include in the program's renewal.

FDA's adjustments to new authorities imposed by the FDA Amendments Act, including REMS, contributed to the agency's missing the user fee dates for almost half of the new molecular entities approved in 2009, but Office of New Drugs Director John Jenkins says reviewers are getting back on schedule (Also see "Regulatory Updates, In Brief" - Pink Sheet, 25 January, 2010.).

To speed REMS approval, Wheadon said, "more transparent, science-based standards for benefit-risk assessments and drug approvals are needed" and should be incorporated into the next iteration of the Prescription Drug User Fee Act. "These standards need to be consistently applied across the FDA and communicated clearly."

Biopharma firms are not objecting to the REMS themselves, but rather to REMS becoming a source of review delays. Industry's perception of the REMS/delay link is underscored in a survey by the Biotechnology Industry Organization of its members.

Of respondents with a drug that has received a REMS, 77 percent said that the REMS discussion contributed to a review extension, and 81 percent said FDA did not initiate risk management discussions early enough in the review cycle, Andrew Emmett, director of science and regulatory affairs for BIO, reported. Sixty-seven firms responded to the survey.

To address the issue, he suggested that FDA update its Good Review Management Principles and Practices (GRMP) documents to specify that REMs, as well as post-market requirements and other FDAAA-related discussions, occur earlier in the review process.

"Best practices have demonstrated that it is critical that FDA and sponsors have a common understanding of when and how sponsors should communicate with FDA regarding a potential REMS and how that discussion should be integrated into the review process," Emmett pointed out.

He suggested that the multiple review cycles occurring with REMS could be a symptom of poor communication within the agency. The BIO survey found that 61 percent of respondents believe the Office of New Drugs and Office of Surveillance and Epidemiology do not adequately coordinate their efforts during product reviews.

There needs to be a "well-articulated and transparent method" for individuals to express differing opinions so "FDA managers can make a decision based on the available scientific data," he insisted. Industry would like a better understanding of how OND and OSE interact and "how differing safety interpretations are resolved both internally and with external stakeholders."

Pharmacists are concerned about REMS, as well, but in terms of application. There is "a pressing need for standardization and uniformity of REMS to help decrease the burden and interruption on patient care and pharmacy workflow," noted Kasey Thompson, vice president of policy, planning and communication at the American Society of Health System Pharmacists.

FDA should perform research on the impacts of REMS on patient safety, cost effectiveness and pharmacy workflow, he suggested. "Our members' experience indicates that significant burden is developing with an increase in the number of products that require a REMS. This will only continue to grow."

- Cathy Dombrowski (c.dombrowski@elsevier.com ) and Derrick Gingery (d.gingery@elsevier.com )

Earlier Attention To REMS Could Keep Drug Approvals On Schedule, Industry Says At FDA Meeting

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