The Year in Review
which adds 30 percent to the aggregate tax bill of American companies. This is an issue
we have been concerned about for several years, as we’ve seen manufacturers, especially
startups, increasingly turn to Europe for their initial product launches.
“FDA reform is a big issue, because if we do see significant improvements in the agen-
cy’s clinical trial and product approval processes, that would send a powerful signal to
investors and innovators alike that the U.S. is the place to do business,” Ubl continued.
“And to his credit, CDRH Director Shuren has publicly stated that it’s a goal of the agency
to create a regulatory environment in the United States where companies want to launch
their products here first. We are hopeful that progress can continue to be made.”
FDA certainly made strides this year to create a more appealing regulatory environ-
ment for medtech manufacturers: Besides revisiting its panel review process, the agency
provided customer service training to CDRH staff, began working on a new benefit risk
policy and reduced the number of pre-market approvals (PMA) issued with deficiency let-
ters. In addition, the PMA backlog has been halved, and the de novo classification process
has reduced review times from an average of more than 700 days earlier in the decade to
the current average of 166 days.
The agency also scored its first Parallel Review program success in August, jointly approving with CMS a non-invasive colorectal screening test from Madison, Wis.-based
Exact Sciences Corporation that can detect potentially cancerous growths through DNA
sampling. Created in 2011 and extended last year, the Parallel Review initiative allows
companies to concurrently pursue regulatory and reimbursement product approval, hypothetically reducing the gap between FDA approval and a reimbursement decision. The
program allows the final part of the FDA process to run conjointly with the CMS process,
cutting up to six months from the time of study initiation to coverage.
A handful of novel technologies were allowed access to undergo simultaneous FDA
and CMS review but Exact Sciences was the only company to reach the finish line. Medicare offered to cover the company’s testing once every three years for Medicare patients
aged 50-85 who display no symptoms but nonetheless are at“average” risk of developing
Skeptics claim the Parallel Review pathway is nothing more than a clone of existing
expedited review initiatives—namely, meeting early with CMS during the product development process to introduce a device and clinical trial design; seeking CMS input on data
requirements for future coverage determination; building reimbursement-driven data capture into clinical trials; and voluntarily authorizing data sharing between FDA and CMS—
but regulatory officials insist those efforts have failed to produce synchronous approvals.
“This is the first time in history that FDA has approved a technology and CMS has
proposed national coverage on the same day,” Patrick Conway, chief medical officer and
deputy administrator for innovation and quality at CMS, noted in a statement.
Obviously, many more same-day victories are needed before the FDA or CMS can declare their collaborative initiative a success. Authorities, however, are hoping to improve
their winning percentage by using the Exact Sciences review as a study guide. “...we will
apply what we have learned to improve the efficiency of the medical device approval pathway for devices that address an important public health need,” said Nancy Stade, deputy
director for policy at CDRH.
It’s a Small(er) World, After All
That pathway will likely be less congested, though. A wave of blockbuster acquisitions
swept through the industry this year, as medtech firms grappled with tougher purchasing decisions from tightfisted hospitals and physicians groups. Industry analysts claim the
megadeals are an outgrowth of hospital and payer consolidation, a trend driven mostly by
vendor/supplier streamlining, value-based reimbursement models, and overall operating
But the mergers also reflect a key long-term growth strategy among compa-
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