Originally Published MDDI December 2002
NEWS & ANALYSIS
New Law Accelerates FDA's Combination Product Reforms |
| Transparency is one goal of Mark Kramer's program. |
For most of 2002, FDA has been quietly working to effect a complete overhaul of the way combination product applications are reviewed within the agency. Now, a section of the recently passed Medical Device User Fee and Modernization Act of 2002 makes the reforms permanent.
Describing the agency's reform efforts on October 8, a few weeks before the passage of the law, Mark Kramer, director of the Combination Products Program, said, "We don't want anything inherent in FDA to bog down the progress of reviewing products." Kramer spoke at the annual meeting of the Regulatory Affairs Professionals Society in Washington, DC.
Section 204 of the law requires the establishment of an office dedicated to combination products within the Office of the Commissioner. Evidently anticipating the idea, FDA set up a similar entity within the Office of the Ombudsman months earlier, in February.
Since being named the director of the new program, Kramer has undertaken a complete review of the agency's approach to combination products. To "separate anecdotes from facts about combination products," Kramer met last spring with 75 FDA employees from various centers who had experience reviewing such products. He found that "reviewers tend to view other centers as a black box," he said.
Citing a recent example of intercenter work on drug-eluting stents, Kramer noted that "in the beginning, CDER [the Center for Drug Evaluation and Research] was not in sync with the CDRH time frame." By the end of the process, however, things had changed. "I personally view the way these two centers are working on this as a model for the way all combination products should be handled," he said.
Much of the program's efforts have been devoted to improving the ability of reviewers in the centers to work with each other. In part, Kramer said, this is being accomplished by placing greater value and importance on the role of the consulting center reviewers. In the past, the center with lead responsibility for reviewing a product has tended to overshadow its consulting partner. The consulting center, in turn, tended to treat its role too lightly. Now, Kramer said, "it needs to be treated as a priority. In a nutshell, consult counts." The work consulting reviewers do, Kramer said, needs to be recognized by the consulting center. "They need to receive credit for their work, so that they are fully on the radar screen for management and personnel review purposes."
In addition, the Combination Products Program is helping to alleviate some pedestrian but persistent intercenter problems. As one example, Kramer cited the problems the centers had experienced in sharing documents. "From the employee point of view," he said, "there is no easy way to get documents from one center to another. In the past, people felt they couldn't sleep at night unless they drove the materials to the other center." Effective October 15, he said, FDA planned to begin a new courier system to solve this problem.
To ensure that the new office is working effectively, the law requires a report after one year detailing the "number and types" of products reviewed. This will apparently pose a challenge to the agency, given the state of its database. While stating that a key role of the program is "to make sure that things are staying on track," Kramer pointed out that "none of [FDA's] existing database systems have a flag to identify combination products." Ultimately, he added, "we would like to be able to post metrics—the number of products reviewed, review times, and so forth—but until the database problems are resolved, we can't."
Again anticipating the new law, which directs FDA to review all of its guidelines and agreements regarding combination products, Kramer emphasized the importance the program places on guidance documents. On July 31, the program released a new standard operating procedure on the consultative and collaborative review process. (Although an internal document, it is available for public review on the FDA Web site.)
More guidances are on the way, Kramer said. "It is time to begin providing a lot more clarity," he said. "Transparency is something that we are working to achieve."
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