Medical Device Daily Washington Editor

ARLINGTON, Virginia – The ramifications of a bill as complex as the FDA Amendments Act of 2007 (FDAAA) will always take time to play out, and that was the message underlying many of the discussions at Monday’s symposium on the FDAAA, sponsored by the Center for Business Intelligence (Woburn, Massachusetts).

Left unanswered, however, was the question of whether Congress changed the dynamic enough to allow the agency to stay abreast of its mission as ever-more-complex drugs and devices spring into regulatory daylight.

Gerald Masoudi, chief counsel at FDA, briefly discussed the implementation of FDAAA, opening with the observation that “[w]e expect there will be [legal] challenges.” He described the act as “a revolutionary piece of legislation” and said that “there is certainly more authority there” for FDA in a number of areas than was previously the case.

However, Masoudi acknowledged that the agency’s legal personnel are spending a substantial amount of time sorting through the language of the bill.

“There certainly will be many areas where the agency will want to issue guidances,” Masoudi said, adding that among the items on the agenda is the task of determining the nature of the interaction between FDA and the Reagan-Udall Foundation. Masoudi said the board of directors of the foundation boasts former FDA chief Mark McClellan, MD, as the chairman, but “now ... has to choose the rules that will govern the foundation.” The board has to decide on a policy on direct contributions to the foundation from industry and government as well as “what kind of rules will govern conflict of interest,” and “what kinds of fellowships will be granted by the foundation” to help FDA’s operations.

Natalie Zaidman, a senior attorney with Wyeth (Madison, New Jersey), gave an overview of the clinical trial data requirements embodied in the FDAAA. She reminded the audience that prior to FDAAA, drug and device firms posted data at clinicaltrials.gov largely on a voluntary basis, and that devices were exempt from mandatory listing.

Zaidman said “FDAAA has expanded that databank in two ways,” calling for more trials and more data from each trial, but sponsors will also have to provide certification that they are in compliance with these requirements in any future regulatory filings in connection with the drug or device in question.

“Its going to be searchable and user friendly,” and “will eventually pre-empt state and local laws” on clinical trial data registration, she said.

Zaidman said “there are [clinical trial] guidance documents released,” but “the challenging feature of these documents is that ... there are some elements that are [described as] ‘may be required’” elements, making compliance difficult.

“The bottom line is that much more information will be made public sooner” and “is going to be seen by everyone, including compliance lawyers, reporters and potential litigants,” Zaidman said.

Industry may want to track these guidances. According to Zaidman, “the registry issues include that the guidance documents are subject to change,” but “have been changed without advance notice.”

“Even when those changes take place, you have to look at the specific guidance to find out whether there are changes,” Zaidman said, adding that both agencies recognize that “it would be easier to notice an update if it were more prominently displayed.” How the two agencies will handle this is unknown.

Zaidman told Medical Device Daily it is not clear on what basis someone might challenge federal pre-emption of state clinical trial disclosure laws. “The language [of the law] does not speak to what the states can and cannot do,” she said, but since there is no stopgap measure prior to the pre-emptive state of affairs, a sponsor has to comply with all requirements until pre-emption takes effect.

Mark Leahy, executive director of the Medical Device Manufacturer’s Association (MDMA; Washington), discussed the impact of FDAAA on device makers, pointing out that “we’re in our second iteration” with device user fee legislation. He reminded the audience that industry’s contribution to FDA’s device review program jumped from $150 million to $293 million between the first and the second versions of the fee schedule, “so we’re seeing a doubling of industry’s contribution.” Industry saw this as inevitable given the budgetary environment, but “we saw a significant uptick in other fees as well,” Leahy said.

Those additional fees, including annual registration fees “provided a significant source” of FDA funding, which “goes to the ultimate objective of timely reviews.”

Leahy also discussed cycle and decision goals.

“What became apparent was that some of these cycle goals impeded meeting the decision goal.” He said MDUFMA II stripped the cycle goals, which should boost adherence to decision goals “because ultimately, that’s what industry is concerned about.”

One of the things that FDAAA offers industry is a more vigorous interactive review program for devices. Leahy said that the two guidances “lay out a roadmap that allows FDA and sponsors to interact” via a variety of means “so that issues can be addressed on a more real-time basis” rather than letting things pile up for the 100-day review. He said FDA is working with its reviewers to increase their interaction with industry toward this end. “That way, at the end of the cycle, there’s no surprise” in the review documentation.

Leahy said he had no sense of where any of the candidates for the presidency stand on the FDA budget, commenting that up on [Capitol] Hill, this doesn’t break down to a Republican vs. Democrat issue.

“I think there’s an acknowledgement that is similar to [that of the] NIH [budget] 10 or 15 years ago” in regard to FDA, but “they want some accountability.”

“The more tangible [a budget increase is] in terms of where it goes, the better chance it has,” Leahy said. “I don’t think we’re in a crisis state at CDRH” in terms of resources, but a crisis of resources could ensue absent further funding.