Regulatory Focus™ > News Articles > Pre-Competitive Partnerships Necessary to Solve Regulatory Problems, Says Eschenbach

Pre-Competitive Partnerships Necessary to Solve Regulatory Problems, Says Eschenbach

Posted 09 April 2013 | By Alexander Gaffney, RAC

Andrew von Eschenbach, the former commissioner of the US Food and Drug Administration (FDA), hasn't been quiet about his thoughts on his former agency since leaving the agency. But now he's turning his attention to the industry at large, saying biotechnology, medical device and diagnostic companies need to come together to address some of the most daunting regulatory challenges now facing them.

Background

Von Eschenbach was FDA commissioner from 2005 to 2009 under the presidential administration of George W. Bush. After stepping down in January 2009, he has remained active in regulatory circles, joining the Manhattan Institute's "Project FDA" to recommend reforms to FDA, and regularly taking to the pages of Bloomberg and The Wall Street Journal to argue for changes to the regulatory paradigm.

Those recommendations have rarely been for incremental changes. Twice in the last year, von Eschenbach has pushed for drug products to be approved based solely on safety, with an assessment based on efficacy to come at a later time.

"There is a growing recognition-at the agency, in the industry and among patients' groups-that it is at serious risk of falling behind its core responsibility of evaluating new medical products in a timely and predictable manner," von  Eschenbach wrote in a February 2012 editorial in the WSJ. "Without an FDA that is as innovative and sophisticated as the companies it regulates, patient health and US-based innovation will suffer."

A year later, in a February 2013 opinion piece in Bloomberg, von Eschenbach reiterated those claims, saying that under a system he proposed, a "drug could have come to market after promising early-stage research in targeted patients, with appropriate post-marketing studies required."

"Payers and patients would be the ultimate judge about the quality of the product, and companies could learn from the experience to develop superior products if needed," he added. "Companies would still be liable for unforeseen side effects, but patients and doctors would be warned -- through the drug's labeling -- that the product had been approved based on promising but provisional research."

Von Eschenbach has also at times turned his attention to medical devices, arguing that, like his plan for pharmaceuticals, devices should be subject to less onerous regulations.

"In the future, instead of implementing more clinical trials-with their long time frames, high cost and human risk-the FDA should enhance its "quality system" regulation process, and make more use of bench testing and computer modeling to identify potential clinical problems," von Eschenbach wrote in a July 2012 opinion piece in the WSJ.

Yet another WSJ editorial authored by von Eschenbach argued that a lack of funding was behind many of the agency's woes.

New Models of Cooperations

But more than just dialing back regulations, von Eschenbach also said that industry needs to cooperate more, and especially with FDA, to get products to patients more quickly.

"Both before and after approval, the FDA, industry and other stakeholders need to work together more," he wrote. "The reauthorization of the Medical Device User Fee and Modernization Act-which will provide better and more transparent metrics for evaluating the FDA's performance, and some limited reforms to premarket review-is only a start. We need a public-private partnership in which regulators, researchers and industry experts can learn from each other and develop patient-centered regulatory standards, focus on the most-serious safety challenges, and identify the greatest opportunities for medical-device innovation."

Now von Eschenbach is reiterating those concerns, going before a group of medical device industry professionals to argue that industry alone can play a critical role of mitigating the effects of regulation.

"You need to be collaborating and sharing intellectual property at the very outset," the Boston Business Journal reports von Eschenbach as saying. "Today, there are huge barriers to doing that."

The main problem, he said, is that companies are now facing complexities that span multiple products and even product areas. "No company… can ever get as big as it needs to be to do everything on this," he observed.

A Model from the Pharmaceutical Industry?

Similar pre-competitive initiatives have been discussed at length and even launched in recent years.

TransCelerate BioPharma, for example-a partnership between some of the largest pharmaceutical companies in the world-Abbott, AstraZeneca, Boehringer Ingelheim, BMS, Eli Lilly, GSK, J&J, Pfizer, Genentech and Sanofi-is  a pre-competitive entity specifically targeted at solving "common drug development challenges," including the improvement of the quality of clinical studies.

Under the terms of the agreement, each company will contribute financial, personnel and intellectual resources to TransCelerate, with the goal of solving common problems that currently drive up research and development costs.

The project will initially focus on the execution of clinical studies by funding five projects: development of a shared user interface for investigator site portals, mutual recognition of study site qualification and training, development of risk-based site monitoring approach and standards, development of clinical data standards and establishment of a comparator drug supply model.

At present, the medical device industry has no similar initiative-something that could stand to be changed in the future, von Eschenbach said.


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